Onduarp

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/5 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
Excipient(s) with known effect:  
Each tablet contains 168.64 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Blue and white oval shaped two layer tablets engraved with the product code A1 and the company 
logo on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension in adults: 
 
Add on therapy 
Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. 
 
Replacement therapy 
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses. 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose of Onduarp is one tablet per day. 
 
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp is indicated 
for long term treatment. 
 
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability 
may be increased in some patients resulting in increased blood pressure lowering effects (see section 
4.5). 
 
Add on therapy 
Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately 
controlled with amlodipine 5 mg alone. 
 
Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 

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Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as 
oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine 
without reducing the overall expected antihypertensive response. 
 
Replacement therapy 
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience 
or compliance 
 
Special population 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. Little information is available in the very elderly 
patients. 
 
Patients with renal impairment  
No posology adjustment is required for patients with mild to moderate renal impairment. Limited 
experience is available in patients with severe renal impairment or haemodialysis. Caution is advised 
when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section 
4.4). 
 
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment 
(GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
Patients with hepatic impairment 
In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 
For telmisartan the posology should not exceed 40 mg once daily (see section 4.4). Onduarp is 
contraindicated in patients with severe hepatic impairment (see section 4.3). 
 
Paediatric population 
 
The safety and efficacy of Onduarp in children aged below 18 years have not been established. No 
data are available. 
 
Method of administration 
Onduarp can be taken with or without food. It is recommended to take Onduarp with some liquid. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the 

excipients listed in section 6.1 
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders and severe hepatic impairment 
• Shock (including cardiogenic shock) 
• Severe hypotension  
• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)  
• Haemodynamically unstable heart failure after acute myocardial infarction 
 
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus 
or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 

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be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 
4.6). 
 
Hepatic impairment 
Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic 
insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, 
amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations 
have not been established. Onduarp should therefore be used with caution in these patients. 
 
Renovascular hypertension 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system.  
 
Renal impairment and kidney transplantation 
When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Onduarp in patients with a recent kidney transplant. Telmisartan and amlodipine are not dialysable. 
 
Intravascular hypovolaemia  
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of telmisartan. If hypotension occurs with 
Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous 
infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. 
 
Dual blockade of the renin-angiotensin-aldosterone system 
The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes 
mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, 
hyperkalaemia and changes in renal function (including acute renal failure) have been reported in 
susceptible individuals, especially if combining medicinal products that affect this system. Dual 
blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other 
blockers of the renin-angiotensin-aldosterone system) is therefore not recommended. Close monitoring 
of renal function is advisable if co-administration is considered necessary. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
In patients whose vascular tone and renal function depend predominantly on the activity of the 
renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying 
renal disease, including renal artery stenosis), treatment with medicinal products that affect this system 
has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 

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Unstable angina pectoris, acute myocardial infarction 
There are no data to support the use of Onduarp in unstable angina pectoris and during or within one 
month of a myocardial infarction. 
 
Heart failure 
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV 
heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of 
pulmonary oedema despite no significant difference in the incidence of worsening heart failure as 
compared to placebo (see section 5.1). 
 
Diabetic patients treated with insulin or antidiabetics 
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or 
antidiabetics may be required when indicated. 
 
Hyperkalaemia 
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause 
hyperkalaemia. Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in 
diabetic patients, in patients concomitantly treated with other medicinal products that may increase 
potassium levels, and/or in patients with intercurrent events.  
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-
aldosterone system, the benefit risk ratio should be evaluated. 
The main risk factors for hyperkalaemia to be considered are: 
-  Diabetes mellitus, renal impairment, age (>70 years) 
-  Combination with one or more other medicinal products that affect the renin-angiotensin-

aldosterone system and/or potassium supplements. Medicinal products or therapeutic classes of 
medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, 
potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal 
anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, 
immunosuppressives (cyclosporin or tacrolimus), and trimethoprim. 

-  Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, 
worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), 
cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma). 

 
Serum potassium should be monitored closely in these patients (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Onduarp. 
 
Other 
As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with 
ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction 
or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
  
No interactions between the two components of this fixed dose combinations have been observed in 
clinical studies.  
 
Interactions common to the combination 
No drug interaction studies have been performed. 
 

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To be taken into account with concomitant use  
 
Other antihypertensive medicinal products  
The blood pressure lowering effect of Onduarp can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Medicinal products with blood pressure lowering potential 
Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, 
amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated 
by alcohol. 
 
Corticosteroids (systemic route) 
Reduction of the antihypertensive effect. 
 
Interactions linked to telmisartan  
 
Contraindicated (see section 4.3) 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or 
renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 
4.3, 4.4). 
 
Concomitant use not recommended 
 
Potassium sparing diuretics or potassium supplements 
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. 
Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium 
supplements, or potassium-containing salt substitutes may lead to a significant increase in serum 
potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used 
with caution and with frequent monitoring of serum potassium. 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with 
angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, 
careful monitoring of serum lithium levels is recommended.  
 
Concomitant use requiring caution 
 
Non-steroidal anti-inflammatory medicinal products 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-
selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function), the co-administration of angiotensin II receptor antagonists and 
medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, 
including possible acute renal failure, which is usually reversible. Therefore, the combination should 
be administered with caution, especially in the elderly. Patients should be adequately hydrated and 
consideration should be given to monitoring of renal function after initiation of concomitant therapy 
and periodically thereafter. 
 
Ramipril 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 

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Concomitant use to be taken into account 
 
Digoxin 
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 
Interactions linked to amlodipine 
 
Concomitant use requiring caution 
 
CYP3A4 inhibitors 
With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in 
elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % 
respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that 
strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma 
concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with 
caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction 
have been reported. 
 
CYP3A4 inducers 
There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant 
use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma 
concentration of amlodipine. 
 
Grapefruit and grapefruit juice 
Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine 
in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of 
amlodipine. The concomitant use of amlodipine and grapefruit or grapefruit juice is still not 
recommended in patients as the bioavailability of amlodipine may increase in some and may result in 
increased hypotensive effects. 
 
Concomitant use to be taken into account 
 
Simvastatin 
Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in 
exposure to simvastatin up to 77 % compared to simvastatin alone. Therefore, the dose of simvastatin 
in patients on amlodipine should be limited to 20 mg daily. 
 
Others 
Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid 
medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, 
ciclosporin, antibiotics and oral hypoglycaemic medicinal products. When amlodipine and sildenafil 
were used in combination, each agent independently exerted its own blood pressure lowering effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of Onduarp in pregnant women. Animal reproductive toxicity 
studies with Onduarp have not been performed. 
 

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Telmisartan 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).  
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). 
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of 
pregnancy, ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 
Amlodipine 
 
Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium 
receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of 
prolonged delivery. 
 
Breast-feeding 
Because no information is available regarding the use of telmisartan and/or amlodipine during breast-
feeding, Onduarp is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant. 
 
Fertility 
No data from controlled clinical studies with the Fixed Dose Combination or with the individual 
components are available. 
 
Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not 
been conducted. 
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3). 
 
Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been 
observed for calcium channel blockers in preclinical and in vitro studies. No clinical relevance has 
been established. 
 
4.7 Effects on ability to drive and use machines 
 
Onduarp has moderate influence on the ability to drive and use machines. Patients should be advised 
that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during 
treatment (see section 4.8). Therefore, caution should be recommended when driving a car or using 
machines. If patients experience these adverse reactions, they should avoid potentially hazardous tasks 
such as driving or using machines. 

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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may 
occur rarely (less than 1 case per 1,000 patients). 
 
The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 
3500 patients, over 2500 of whom received telmisartan in combination with amlodipine. 
 
Tabulated list of adverse reactions 
Adverse reactions have been ranked under headings of frequency using the following convention: 
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available 
data).  
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

System Organ 
Class 

Common 
 

Uncommon 
 

Rare 
 

Infections and 
infestations 

  cystitis 

Psychiatric disorders   depression,  
anxiety, 
insomnia 

Nervous system 
disorders 

dizziness somnolence, 
migraine,  
headache,  
paraesthesia 

syncope,  
peripheral neuropathy, 
hypoaesthesia, 
dysgeusia, 
tremor 
 

Ear and labyrinth 
disorders 

 vertigo   

Cardiac disorders  bradycardia, 
palpitations 

 

Vascular disorders  hypotension, 
orthostatic 
hypotension, flushing 

 

Respiratory, thoracic 
and mediastinal 
disorders 

 cough 
 

 

Gastro-intestinal 
disorders 

 abdominal pain, 
diarrhoea, 
nausea 

vomiting, 
gingival hypertrophy, 
dyspepsia, 
dry mouth 

Skin and subcutaneous 
tissue disorders 

 pruritus eczema, erythema,  
rash  

Musculoskeletal and 
connective tissue 
disorders 

 arthralgia, 
muscle spasms 
(cramps in legs), 
myalgia 

back pain, 
pain in extremity (leg 
pain) 

Renal and urinary 
disorders 

  nocturia  
 

Reproductive system, 
and breast disorders 

 erectile dysfunction  

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General disorders and 
administration site 
conditions 

peripheral oedema 
 

asthenia, 
chest pain, fatigue, 
oedema 

 

malaise 
 
 

 
Investigations  hepatic enzymes 

increased 
blood uric acid 
increased 

 
Additional information on individual components   
 
Adverse reactions previously reported with one of the individual components (telmisartan or 
amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical 
trials or during the post-marketing period. 
 
Telmisartan 
 
Infections and infestations  
 Uncommon: 
 
 Rare: 

Upper respiratory tract infection including pharyngitis and 
sinusitis, urinary tract infection including cystitis  
Sepsis including fatal outcome1 
 

Blood and lymphatic system disorders 
 Uncommon: 
 Rare: 

Anaemia  
Thrombocytopenia, eosinophilia 
 

Immune system disorders 
 Rare: 
 

Hypersensitivity, anaphylactic reaction 
 

Metabolism and nutrition disorders 
 Uncommon: 
 Rare: 
 

Hyperkalaemia 
Hypoglycaemia (in diabetic patients) 

Eye disorders  
 Rare: Visual disturbance 

 
Cardiac disorders  
 Rare: Tachycardia  

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea 

 
Gastrointestinal disorders  
 Uncommon: 
 Rare: 

Flatulence 
Stomach discomfort 
 

Hepato-biliary disorders  
 Rare: 
 

Hepatic function abnormal, liver disorder2 

Skin and subcutaneous tissue disorders 
 Uncommon: 
 Rare: 

Hyperhidrosis 
Angioedema (with fatal outcome), drug eruption, toxic skin 
eruption, urticaria 
 

Musculoskeletal and connective tissue disorders 
 Rare: 
 

Tendon pain (tendinitis like symptoms) 

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Renal and urinary disorders  
 Uncommon: Renal impairment including acute renal failure 

 
General disorders and administration site conditions 
 Rare: Influenza-like illness 

 
Investigations  
 Uncommon: 
 Rare: 

Blood creatinine increased 
Blood creatine phosphokinase increased, haemoglobin decreased 

1: the event may be a chance finding or related to a mechanism currently not known 
2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Amlodipine 
 
Blood and lymphatic system disorders 
 Very rare: Leukocytopenia, thrombocytopenia 

 
Immune system disorders 
 Very rare: Hypersensitivity 

 
Metabolism and nutrition disorders 
 Very rare: Hyperglycaemia 

 
Psychiatric disorders 

Uncommon: 
Rare 

Mood change 
Confusion 
 

Nervous system disorders  
Very rare: Extrapyramidal syndrome 

 
Eye disorders  
 Uncommon: Visual impairment 

 
Ear and labyrinth disorders  

Uncommon: Tinnitus 
 

Cardiac disorders  
 Very rare: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial 

fibrillation 
 

Vascular disorders 
 Very rare: Vasculitis 

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea, rhinitis 

 
Gastrointestinal disorders  
 Uncommon: 
 Very rare: 

Change of bowel habit 
Pancreatitis, gastritis 
 

Hepatobiliary disorders  
 Very rare: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent 

with cholestasis 
 

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Skin and subcutaneous tissue disorders 
 Uncommon: 
 Very rare: 

Alopecia, purpura, skin discolouration, hyperhidrosis 
Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, 
Stevens-Johnson syndrome, photosensitivity 
 

Renal and urinary disorders  
 Uncommon: Micturition disorder, pollakiuria 

 
Reproductive system and breast disorders 

Uncommon: Gynaecomastia 
 

General disorders and administration site conditions 
 Uncommon: Pain 

 
Investigations  
 Uncommon: Weight increased, weight decreased 
 
4.9 Overdose 
 
Symptoms 
Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects. 
The most prominent manifestations of telmisartan overdose are expected to be hypotension and 
tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also 
been reported. 
Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex 
tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with 
fatal outcome have been reported. 
 
Treatment 
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Management depends on the time since ingestion and the severity of the symptoms. Suggested 
measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the 
treatment of overdose of both telmisartan and amlodipine.  
Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient 
should be placed in a supine position with elevation of extremities, with salt and volume replacement 
given quickly. Supportive treatment should be instituted. Intravenous calcium gluconate may be 
beneficial in reversing the effects of calcium channel blockade. Telmisartan and Amlodipine are not 
removed by haemodialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists 
and calcium channel blockers; ATC Code: C09DB04. 
 
Onduarp combines two antihypertensive compounds with complementary mechanisms to control 
blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, 
telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. 
The combination of these substances has an additive antihypertensive effect, reducing blood pressure 
to a greater degree than either component alone. 
Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour 
therapeutic dose range.   
 

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Telmisartan 
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan 
displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, 
which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial 
agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is 
long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less 
characterised AT receptors. The functional role of these receptors is not known, nor is the effect of 
their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma 
aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or 
block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the 
enzyme which also degrades bradykinin. Therefore it is not expected to potentiate bradykinin-
mediated adverse reactions. 
 
In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood 
pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 
48 hours. 
 
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of 
treatment and is sustained during long-term therapy. 
 
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours 
before the next dose as shown by ambulatory blood pressure measurements. This is confirmed by 
trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in 
placebo controlled clinical studies. There is an apparent trend to a dose relationship to a time to 
recovery of baseline systolic blood pressure (SBP). In this respect data concerning diastolic blood 
pressure (DBP) are inconsistent.  
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The contribution of the medicinal product's diuretic and natriuretic effect to its 
hypotensive activity has still to be defined. The antihypertensive efficacy of telmisartan is comparable 
to that of substances representative of other classes of antihypertensive medicinal products 
(demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, 
hydrochlorothiazide, and lisinopril). 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension.  
 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Amlodipine 
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or 
calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and 
vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a 
direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular 
resistance and in blood pressure. Experimental data indicate that amlodipine binds to both 
dihydropyridine and non-dihydropyridine binding sites. Amlodipine is relatively vessel-selective, with 
a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 
 
In patients with hypertension, once daily dosing provides clinically significant reductions of blood 
pressure in both the supine and standing positions throughout the 24 hour interval. Due to the slow 
onset of action, acute hypotension is not a feature of amlodipine administration. 
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a 
decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal 
plasma flow, without change in filtration fraction or proteinuria. 

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Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids 
and is suitable for use in patients with asthma, diabetes, and gout. 
 
Use in patients with heart failure 
Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure 
patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise 
tolerance, left ventricular ejection fraction and clinical symptomatology. 
 
A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart 
failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an 
increase in risk of mortality or combined mortality and morbidity with heart failure. 
 
In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with 
NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of 
underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine 
had no effect on total cardiovascular mortality. In this same population amlodipine was associated 
with increased reports of pulmonary oedema despite no significant difference in the incidence of 
worsening heart failure as compared to placebo. 
 
Telmisartan/Amlodipine 
In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study 
in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and 
≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater 
diastolic and systolic blood pressure reductions and higher control rates compared to the respective 
monotherapy components. 
 
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic 
dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg), 
−24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg). The reduction in diastolic 
blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively. 
Values are adjusted for baseline and country. 
 
The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy. 
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % 
responded sufficiently to monotherapy of either telmisartan or amlodipine. The observed mean 
changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg 
(−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or 
greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant 
lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 
10 mg). 
 
Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients 
confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently 
over the entire 24-hours dosing period. 
 
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg). After 8 
weeks of treatment, each of the combinations was statistically significantly superior to both 
amlodipine monotherapy doses in reducing systolic and diastolic blood pressures (−13.6/−9.4 mmHg, 
−15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with 
amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the 
respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 
42 %, 56.7 % with amlodipine 5 mg and 10 mg). Oedema rates were significantly lower with 
40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4 % versus 24.9 %, respectively). 

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In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg). After 8 weeks 
of treatment, each of the combination treatments was statistically significantly superior to amlodipine 
monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg 
with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic 
blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 
40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
 
In two corresponding open-label long-term follow up studies performed over a further 6 months the 
effect of Onduarp was maintained over the trial period. Furthermore it was shown that some patients 
not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by up-
titration to Onduarp 80 mg/10 mg. 
 
The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with 
only 12.7 % of patients on treatment experiencing adverse reactions. The most common adverse 
reactions were peripheral oedema and dizziness, see also section 4.8. The adverse reactions reported 
were in agreement with those anticipated from the safety profiles of the components telmisartan and 
amlodipine. No new or more severe adverse reactions were observed. The oedema related events 
(peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who 
received Onduarp as compared to patients who received amlodipine 10 mg. In the factorial design trial 
the oedema rates were 1.3 % with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 
40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg. In patients not controlled on 
amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for 
amlodipine 10 mg. 
 
The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in 
patients with and without diabetes. 
 
Onduarp has not been studied in any patient population other than hypertension. Telmisartan has been 
studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET). 
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and 
angiographically documented coronary artery disease. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic of the fixed dose combination (FDC) 
The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and 
amlodipine when administered as individual tablets. 
 
Absorption 
Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute 
bioavailability for telmisartan is about 50 %. When telmisartan is taken with food, the reduction in the 
area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 
6 % (40 mg dose) to approximately 19 % (160 mg dose). By 3 hours after administration, plasma 
concentrations are similar whether telmisartan is taken fasting or with food.  
 
After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels 
between 6-12 hours post dose. Absolute bioavailability has been estimated to be between 64 and 80%. 
Amlodipine bioavailability is not affected by food ingestion. 
 

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Distribution 
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid 
glycoprotein. The mean steady state apparent volume of distribution (Vdss) is approximately 500 l. 
 
The volume of distribution of amlodipine is approximately 21 l/kg. In vitro studies have shown that 
approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No 
pharmacological activity has been shown for the conjugate.  
 
Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites. 
 
Elimination 
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination 
half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a smaller extent, the area 
under the plasma concentration-time curve (AUC), increase disproportionately with dose. There is no 
evidence of clinically relevant accumulation of telmisartan taken at the recommended dose. Plasma 
concentrations were higher in females than in males, without relevant influence on efficacy. 
 
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, 
mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose. Total plasma 
clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 
1,500 ml/min). 
 
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of 
approximately 30 to 50 hours consistent with once daily dosing. Steady-state plasma levels are 
reached after continuous administration for 7-8 days. Ten per cent of original amlodipine and 60 % of 
amlodipine metabolites are excreted in urine.  
 
Linearity/non-linearity  
The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic 
efficacy. There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent 
AUC increase disproportionately at doses above 40 mg. 
 
Amlodipine exhibits linear pharmacokinetics.  
 
Special populations 
 
Paediatric population (age below 18 years) 
No pharmacokinetic data are available in the paediatric population. 
 
Gender 
Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being 
approximately 3- and 2-fold higher, respectively, in females compared to males. 
 
Elderly 
The pharmacokinetics of telmisartan do not differ in young and elderly patients. 
The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects. 
In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and 
elimination half-life. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of 
telmisartan was observed. However, lower plasma concentrations were observed in patients with renal 
insufficiency undergoing dialysis. Telmisartan is highly bound to plasma protein in renal-insufficient 
subjects and cannot be removed by dialysis. The elimination half-life is not changed in patients with 

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renal impairment. The pharmacokinetics of amlodipine are not significantly influenced by renal 
impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability of telmisartan up to nearly 100 %. The elimination half-life of telmisartan is not 
changed in patients with hepatic impairment. Patients with hepatic insufficiency have decreased 
clearance of amlodipine with resulting increase of approximately 40-60 % in AUC. 
 
5.3 Preclinical safety data 
 
Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no 
exacerbation of toxicity was expected for the combination. This has been confirmed in a subchronic 
(13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of 
telmisartan and amlodipine were tested. 
 
Preclinical data available for the components of this fixed dose combination are reported below. 
 
Telmisartan 
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic 
range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal 
haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium 
in normotensive animals. In dogs, renal tubular dilation and atrophy were observed. Gastric mucosal 
injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These pharmacologically-
mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation. In 
both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular 
cells were observed. These changes, also a class effect of angiotensin converting enzyme inhibitors 
and other angiotensin II receptor antagonists, do not appear to have clinical significance. 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offspring such as lower body weight and delayed eye 
opening was observed. 
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no 
evidence of carcinogenicity in rats and mice. 
 
Amlodipine 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup 
survival were seen at high doses. There was no effect on the fertility of rats treated orally with 
amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 
10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on 
an mg/m2 basis).  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Colloidal anhydrous silica 
Brilliant blue FCF (E 133) 
Ferric oxide black (E172) 
Ferric oxide yellow (E172) 
Magnesium stearate 
Maize starch 
Meglumine 
Microcrystalline cellulose 

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Povidone K25 
Pregelatinised starch 
Sodium hydroxide 
Sorbitol (E420) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
Store in the original package in order to protect from light and moisture. 
Remove the tablets from the blister only directly prior to intake. 
 
6.5 Nature and contents of container 
 
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/11/729/001 (28 tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 November 2011 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/10 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
Excipient(s) with known effect:  
Each tablet contains 168.64 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Blue and white oval shaped two layer tablets engraved with the product code A2 and the company 
logo on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension in adults: 
 
Add on therapy 
Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. 
 
Replacement therapy 
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses. 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose of Onduarp is one tablet per day. 
 
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp is indicated 
for long term treatment. 
 
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability 
may be increased in some patients resulting in increased blood pressure lowering effects (see section 
4.5). 
 
Add on therapy 
Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately 
controlled with amlodipine 10 mg. 
 
Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 

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Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as 
oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine 
without reducing the overall expected antihypertensive response. 
 
Replacement therapy 
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience 
or compliance 
 
Special population 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. Little information is available in the very elderly 
patients. 
 
Patients with renal impairment  
No posology adjustment is required for patients with mild to moderate renal impairment. Limited 
experience is available in patients with severe renal impairment or haemodialysis. Caution is advised 
when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section 
4.4). 
 
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment 
(GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
Patients with hepatic impairment 
In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 
For telmisartan the posology should not exceed 40 mg once daily (see section 4.4). Onduarp is 
contraindicated in patients with severe hepatic impairment (see section 4.3). 
 
Paediatric population 
 
The safety and efficacy of Onduarp in children aged below 18 years have not been established. No 
data are available. 
 
Method of administration 
Onduarp can be taken with or without food. It is recommended to take Onduarp with some liquid. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the 

excipients listed in section 6.1 
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders and severe hepatic impairment 
• Shock (including cardiogenic shock) 
• Severe hypotension  
• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)  
• Haemodynamically unstable heart failure after acute myocardial infarction 
 
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus 
or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 

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be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 
4.6). 
 
Hepatic impairment 
Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic 
insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, 
amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations 
have not been established. Onduarp should therefore be used with caution in these patients. 
 
Renovascular hypertension 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system.  
 
Renal impairment and kidney transplantation 
When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Onduarp in patients with a recent kidney transplant. Telmisartan and amlodipine are not dialysable. 
 
Intravascular hypovolaemia  
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of telmisartan. If hypotension occurs with 
Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous 
infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. 
 
Dual blockade of the renin-angiotensin-aldosterone system 
The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes 
mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, 
hyperkalaemia and changes in renal function (including acute renal failure) have been reported in 
susceptible individuals, especially if combining medicinal products that affect this system. Dual 
blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other 
blockers of the renin-angiotensin-aldosterone system) is therefore not recommended. Close monitoring 
of renal function is advisable if co-administration is considered necessary. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
In patients whose vascular tone and renal function depend predominantly on the activity of the 
renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying 
renal disease, including renal artery stenosis), treatment with medicinal products that affect this system 
has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 

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Unstable angina pectoris, acute myocardial infarction 
There are no data to support the use of Onduarp in unstable angina pectoris and during or within one 
month of a myocardial infarction. 
 
Heart failure 
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV 
heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of 
pulmonary oedema despite no significant difference in the incidence of worsening heart failure as 
compared to placebo (see section 5.1). 
 
Diabetic patients treated with insulin or antidiabetics 
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or 
antidiabetics may be required when indicated. 
 
Hyperkalaemia 
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause 
hyperkalaemia. Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in 
diabetic patients, in patients concomitantly treated with other medicinal products that may increase 
potassium levels, and/or in patients with intercurrent events.  
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-
aldosterone system, the benefit risk ratio should be evaluated. 
The main risk factors for hyperkalaemia to be considered are: 
-  Diabetes mellitus, renal impairment, age (>70 years) 
-  Combination with one or more other medicinal products that affect the renin-angiotensin-

aldosterone system and/or potassium supplements. Medicinal products or therapeutic classes of 
medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, 
potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal 
anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, 
immunosuppressives (cyclosporin or tacrolimus), and trimethoprim. 

-  Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, 
worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), 
cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma). 

 
Serum potassium should be monitored closely in these patients (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Onduarp. 
 
Other 
As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with 
ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction 
or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
  
No interactions between the two components of this fixed dose combinations have been observed in 
clinical studies.  
 
Interactions common to the combination 
No drug interaction studies have been performed. 
 

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To be taken into account with concomitant use  
 
Other antihypertensive medicinal products  
The blood pressure lowering effect of Onduarp can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Medicinal products with blood pressure lowering potential 
Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, 
amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated 
by alcohol. 
 
Corticosteroids (systemic route) 
Reduction of the antihypertensive effect. 
 
Interactions linked to telmisartan  
 
Contraindicated (see section 4.3) 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or 
renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 
4.3, 4.4). 
 
Concomitant use not recommended 
 
Potassium sparing diuretics or potassium supplements 
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. 
Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium 
supplements, or potassium-containing salt substitutes may lead to a significant increase in serum 
potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used 
with caution and with frequent monitoring of serum potassium. 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with 
angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, 
careful monitoring of serum lithium levels is recommended.  
 
Concomitant use requiring caution 
 
Non-steroidal anti-inflammatory medicinal products 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-
selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function), the co-administration of angiotensin II receptor antagonists and 
medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, 
including possible acute renal failure, which is usually reversible. Therefore, the combination should 
be administered with caution, especially in the elderly. Patients should be adequately hydrated and 
consideration should be given to monitoring of renal function after initiation of concomitant therapy 
and periodically thereafter. 
 
Ramipril 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 

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Concomitant use to be taken into account 
 
Digoxin 
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 
Interactions linked to amlodipine 
 
Concomitant use requiring caution 
 
CYP3A4 inhibitors 
With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in 
elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % 
respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that 
strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma 
concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with 
caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction 
have been reported. 
 
CYP3A4 inducers 
There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant 
use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma 
concentration of amlodipine. 
 
Grapefruit and grapefruit juice 
Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine 
in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of 
amlodipine. The concomitant use of amlodipine and grapefruit or grapefruit juice is still not 
recommended in patients as the bioavailability of amlodipine may increase in some and may result in 
increased hypotensive effects. 
 
Concomitant use to be taken into account 
 
Simvastatin 
Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in 
exposure to simvastatin up to 77 % compared to simvastatin alone. Therefore, the dose of simvastatin 
in patients on amlodipine should be limited to 20 mg daily. 
 
Others 
Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid 
medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, 
ciclosporin, antibiotics and oral hypoglycaemic medicinal products. When amlodipine and sildenafil 
were used in combination, each agent independently exerted its own blood pressure lowering effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of Onduarp in pregnant women. Animal reproductive toxicity 
studies with Onduarp have not been performed. 
 

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Telmisartan 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).  
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). 
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of 
pregnancy, ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 
Amlodipine 
 
Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium 
receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of 
prolonged delivery. 
 
Breast-feeding 
Because no information is available regarding the use of telmisartan and/or amlodipine during breast-
feeding, Onduarp is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant. 
 
Fertility 
No data from controlled clinical studies with the Fixed Dose Combination or with the individual 
components are available. 
 
Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not 
been conducted. 
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3). 
 
Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been 
observed for calcium channel blockers in preclinical and in vitro studies. No clinical relevance has 
been established. 
 
4.7 Effects on ability to drive and use machines 
 
Onduarp has moderate influence on the ability to drive and use machines. Patients should be advised 
that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during 
treatment (see section 4.8). Therefore, caution should be recommended when driving a car or using 
machines. If patients experience these adverse reactions, they should avoid potentially hazardous tasks 
such as driving or using machines. 

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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may 
occur rarely (less than 1 case per 1,000 patients). 
 
The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 
3500 patients, over 2500 of whom received telmisartan in combination with amlodipine. 
 
Tabulated list of adverse reactions 
Adverse reactions have been ranked under headings of frequency using the following convention: 
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available 
data).  
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

System Organ 
Class 

Common 
 

Uncommon 
 

Rare 
 

Infections and 
infestations 

  cystitis 

Psychiatric disorders   depression,  
anxiety, 
insomnia 

Nervous system 
disorders 

dizziness somnolence, 
migraine,  
headache,  
paraesthesia 

syncope,  
peripheral neuropathy, 
hypoaesthesia, 
dysgeusia, 
tremor 
 

Ear and labyrinth 
disorders 

 vertigo   

Cardiac disorders  bradycardia, 
palpitations 

 

Vascular disorders  hypotension, 
orthostatic 
hypotension, flushing 

 

Respiratory, thoracic 
and mediastinal 
disorders 

 cough 
 

 

Gastro-intestinal 
disorders 

 abdominal pain, 
diarrhoea, 
nausea 

vomiting, 
gingival hypertrophy, 
dyspepsia, 
dry mouth 

Skin and subcutaneous 
tissue disorders 

 pruritus eczema, erythema,  
rash  

Musculoskeletal and 
connective tissue 
disorders 

 arthralgia, 
muscle spasms 
(cramps in legs), 
myalgia 

back pain, 
pain in extremity (leg 
pain) 

Renal and urinary 
disorders 

  nocturia  
 

Reproductive system, 
and breast disorders 

 erectile dysfunction  

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General disorders and 
administration site 
conditions 

peripheral oedema 
 

asthenia, 
chest pain, fatigue, 
oedema 

 

malaise 
 
 

 
Investigations  hepatic enzymes 

increased 
blood uric acid 
increased 

 
Additional information on individual components   
 
Adverse reactions previously reported with one of the individual components (telmisartan or 
amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical 
trials or during the post-marketing period. 
 
Telmisartan 
 
Infections and infestations   
 Uncommon: 
 
 Rare: 

Upper respiratory tract infection including pharyngitis and 
sinusitis, urinary tract infection including cystitis  
Sepsis including fatal outcome1 
 

Blood and lymphatic system disorders 
 Uncommon: 
 Rare: 

Anaemia  
Thrombocytopenia, eosinophilia 
 

Immune system disorders 
 Rare: 
 

Hypersensitivity, anaphylactic reaction 

Metabolism and nutrition disorders 
 Uncommon: 
 Rare: 
 

Hyperkalaemia  
Hypoglycaemia (in diabetic patients) 
 

Eye disorders  
 Rare: Visual disturbance 

 
Cardiac disorders  
 Rare: Tachycardia  

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea 

 
Gastrointestinal disorders  
 Uncommon: 
 Rare: 

Flatulence 
Stomach discomfort 
 

Hepato-biliary disorders  
 Rare: 
 

Hepatic function abnormal, liver disorder2 

Skin and subcutaneous tissue disorders 
 Uncommon: 
 Rare: 

Hyperhidrosis 
Angioedema (with fatal outcome), drug eruption, toxic skin 
eruption, urticaria 
 

Musculoskeletal and connective tissue disorders 
 Rare: 
 

Tendon pain (tendinitis like symptoms) 

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Renal and urinary disorders  
 Uncommon: Renal impairment including acute renal failure 

 
General disorders and administration site conditions 
 Rare: Influenza-like illness 

 
Investigations  
 Uncommon: 
 Rare: 

Blood creatinine increased  
Blood creatine phosphokinase increased, haemoglobin decreased 

1: the event may be a chance finding or related to a mechanism currently not known 
2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Amlodipine 
 
Blood and lymphatic system disorders 
 Very rare: Leukocytopenia, thrombocytopenia 

 
Immune system disorders 
 Very rare: Hypersensitivity 

 
Metabolism and nutrition disorders 
 Very rare: Hyperglycaemia 

 
Psychiatric disorders 

Uncommon:  
Rare: 

Mood change 
Confusion 
 

Nervous system disorders  
Very rare: Extrapyramidal syndrome 

 
Eye disorders  
 Uncommon: 
 

Visual impairment 

Ear and labyrinth disorders  
Uncommon: 
 

Tinnitus 

Cardiac disorders  
 Very rare: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial 

fibrillation 
 

Vascular disorders 
 Very rare: Vasculitis 

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea, rhinitis 

 
Gastrointestinal disorders  
 Uncommon: 
 Very rare: 

Change of bowel habit 
Pancreatitis, gastritis 
 

Hepatobiliary disorders  
 Very rare: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent 

with cholestasis 

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Skin and subcutaneous tissue disorders 
 Uncommon: 
 Very rare: 

Alopecia, purpura, skin discolouration, hyperhidrosis 
Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, 
Stevens-Johnson syndrome, photosensitivity 
 

Renal and urinary disorders  
 Uncommon: 
 

Micturition disorder, pollakiuria 

Reproductive system and breast disorders 
Uncommon: 
 

Gynaecomastia 

General disorders and administration site conditions 
 Uncommon: 
 

Pain 

Investigations  
 Uncommon: Weight increased, weight decreased 
 
4.9 Overdose 
 
Symptoms 
Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects. 
The most prominent manifestations of telmisartan overdose are expected to be hypotension and 
tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also 
been reported. 
Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex 
tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with 
fatal outcome have been reported. 
 
Treatment 
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Management depends on the time since ingestion and the severity of the symptoms. Suggested 
measures include induction of emesis and / or gastric lavage. Activated charcoal may be useful in the 
treatment of overdose of both telmisartan and amlodipine.  
Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient 
should be placed in a supine position with elevation of extremities, with salt and volume replacement 
given quickly. Supportive treatment should be instituted. Intravenous calcium gluconate may be 
beneficial in reversing the effects of calcium channel blockade. Telmisartan and Amlodipine are not 
removed by haemodialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists 
and calcium channel blockers; ATC Code: C09DB04. 
 
Onduarp combines two antihypertensive compounds with complementary mechanisms to control 
blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, 
telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. 
The combination of these substances has an additive antihypertensive effect, reducing blood pressure 
to a greater degree than either component alone. 
Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour 
therapeutic dose range.   
 

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Telmisartan 
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan 
displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, 
which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial 
agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is 
long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less 
characterised AT receptors. The functional role of these receptors is not known, nor is the effect of 
their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma 
aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or 
block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the 
enzyme which also degrades bradykinin. Therefore it is not expected to potentiate bradykinin-
mediated adverse reactions. 
 
In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood 
pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 
48 hours. 
 
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of 
treatment and is sustained during long-term therapy. 
 
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours 
before the next dose as shown by ambulatory blood pressure measurements. This is confirmed by 
trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in 
placebo controlled clinical studies. There is an apparent trend to a dose relationship to a time to 
recovery of baseline systolic blood pressure (SBP). In this respect data concerning diastolic blood 
pressure (DBP) are inconsistent.  
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The contribution of the medicinal product's diuretic and natriuretic effect to its 
hypotensive activity has still to be defined. The antihypertensive efficacy of telmisartan is comparable 
to that of substances representative of other classes of antihypertensive medicinal products 
(demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, 
hydrochlorothiazide, and lisinopril). 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension.  
 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Amlodipine 
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or 
calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and 
vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a 
direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular 
resistance and in blood pressure. Experimental data indicate that amlodipine binds to both 
dihydropyridine and non-dihydropyridine binding sites. Amlodipine is relatively vessel-selective, with 
a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 
 
In patients with hypertension, once daily dosing provides clinically significant reductions of blood 
pressure in both the supine and standing positions throughout the 24 hour interval. Due to the slow 
onset of action, acute hypotension is not a feature of amlodipine administration. 
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a 
decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal 
plasma flow, without change in filtration fraction or proteinuria. 

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Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids 
and is suitable for use in patients with asthma, diabetes, and gout. 
 
Use in patients with heart failure 
Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure 
patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise 
tolerance, left ventricular ejection fraction and clinical symptomatology. 
 
A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart 
failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an 
increase in risk of mortality or combined mortality and morbidity with heart failure. 
 
In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with 
NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of 
underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine 
had no effect on total cardiovascular mortality. In this same population amlodipine was associated 
with increased reports of pulmonary oedema despite no significant difference in the incidence of 
worsening heart failure as compared to placebo. 
 
Telmisartan/Amlodipine 
In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study 
in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and 
≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater 
diastolic and systolic blood pressure reductions and higher control rates compared to the respective 
monotherapy components. 
 
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic 
dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg), 
−24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg). The reduction in diastolic 
blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively. 
Values are adjusted for baseline and country. 
 
The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy. 
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % 
responded sufficiently to monotherapy of either telmisartan or amlodipine. The observed mean 
changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg 
(−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or 
greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant 
lower oedema rates (1.4 % with 40 mg/5 mg; 0.5% with 80 mg/5 mg; 17.6 % with amlodipine 10 mg). 
 
Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients 
confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently 
over the entire 24-hours dosing period. 
 
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg). After 
8 weeks of treatment, each of the combinations was statistically significantly superior to both 
amlodipine monotherapy doses in reducing systolic and diastolic blood pressures (−13.6/−9.4 mmHg, 
−15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with 
amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the 
respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 
42 %, 56.7 % with amlodipine 5 mg and 10 mg). Oedema rates were significantly lower with 
40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4 % versus 24.9 %, respectively). 
 

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In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg). After 8 weeks 
of treatment, each of the combination treatments was statistically significantly superior to amlodipine 
monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg 
with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic 
blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 
40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
 
In two corresponding open-label long-term follow up studies performed over a further 6 months the 
effect of Onduarp was maintained over the trial period. Furthermore it was shown that some patients 
not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by up-
titration to Onduarp 80 mg/10 mg. 
 
The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with 
only 12.7 % of patients on treatment experiencing adverse reactions. The most common adverse 
reactions were peripheral oedema and dizziness, see also section 4.8. The adverse reactions reported 
were in agreement with those anticipated from the safety profiles of the components telmisartan and 
amlodipine. No new or more severe adverse reactions were observed. The oedema related events 
(peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who 
received Onduarp as compared to patients who received amlodipine 10 mg. In the factorial design trial 
the oedema rates were 1.3 % with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 
40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg. In patients not controlled on 
amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for 
amlodipine 10 mg. 
 
The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in 
patients with and without diabetes. 
 
Onduarp has not been studied in any patient population other than hypertension. Telmisartan has been 
studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET). 
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and 
angiographically documented coronary artery disease. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic of the fixed dose combination (FDC) 
The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and 
amlodipine when administered as individual tablets. 
 
Absorption 
Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute 
bioavailability for telmisartan is about 50 %. When telmisartan is taken with food, the reduction in the 
area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 
6 % (40 mg dose) to approximately 19 % (160 mg dose). By 3 hours after administration, plasma 
concentrations are similar whether telmisartan is taken fasting or with food.  
 
After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels 
between 6-12 hours post dose. Absolute bioavailability has been estimated to be between 64 and 80 %. 
Amlodipine bioavailability is not affected by food ingestion. 
 

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Distribution 
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid 
glycoprotein. The mean steady state apparent volume of distribution (Vdss) is approximately 500 l. 
 
The volume of distribution of amlodipine is approximately 21 l/kg. In vitro studies have shown that 
approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No 
pharmacological activity has been shown for the conjugate.  
 
Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites. 
 
Elimination 
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination 
half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a smaller extent, the area 
under the plasma concentration-time curve (AUC), increase disproportionately with dose. There is no 
evidence of clinically relevant accumulation of telmisartan taken at the recommended dose. Plasma 
concentrations were higher in females than in males, without relevant influence on efficacy. 
 
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, 
mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose. Total plasma 
clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 
1,500 ml/min). 
 
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of 
approximately 30 to 50 hours consistent with once daily dosing. Steady-state plasma levels are 
reached after continuous administration for 7-8 days. Ten per cent of original amlodipine and 60 % of 
amlodipine metabolites are excreted in urine.  
 
Linearity/non-linearity  
The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic 
efficacy. There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent 
AUC increase disproportionately at doses above 40 mg. 
 
Amlodipine exhibits linear pharmacokinetics.  
 
Special populations 
 
Paediatric population (age below 18 years) 
No pharmacokinetic data are available in the paediatric population. 
 
Gender 
Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being 
approximately 3- and 2-fold higher, respectively, in females compared to males. 
 
Elderly 
The pharmacokinetics of telmisartan do not differ in young and elderly patients. 
The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects. 
In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and 
elimination half-life. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of 
telmisartan was observed. However, lower plasma concentrations were observed in patients with renal 
insufficiency undergoing dialysis. Telmisartan is highly bound to plasma protein in renal-insufficient 
subjects and cannot be removed by dialysis. The elimination half-life is not changed in patients with 

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renal impairment. The pharmacokinetics of amlodipine are not significantly influenced by renal 
impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability of telmisartan up to nearly 100 %. The elimination half-life of telmisartan is not 
changed in patients with hepatic impairment. Patients with hepatic insufficiency have decreased 
clearance of amlodipine with resulting increase of approximately 40–60 % in AUC. 
 
5.3 Preclinical safety data 
 
Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no 
exacerbation of toxicity was expected for the combination. This has been confirmed in a subchronic 
(13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of 
telmisartan and amlodipine were tested. 
 
Preclinical data available for the components of this fixed dose combination are reported below. 
 
Telmisartan 
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic 
range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal 
haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium 
in normotensive animals. In dogs, renal tubular dilation and atrophy were observed. Gastric mucosal 
injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These pharmacologically-
mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation. In 
both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular 
cells were observed. These changes, also a class effect of angiotensin converting enzyme inhibitors 
and other angiotensin II receptor antagonists, do not appear to have clinical significance. 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offspring such as lower body weight and delayed eye 
opening was observed. 
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no 
evidence of carcinogenicity in rats and mice. 
 
Amlodipine 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup 
survival were seen at high doses. There was no effect on the fertility of rats treated orally with 
amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 
10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on 
an mg/m2 basis).  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Colloidal anhydrous silica 
Brilliant blue FCF (E 133) 
Ferric oxide black (E172) 
Ferric oxide yellow (E172) 
Magnesium stearate 
Maize starch 
Meglumine 
Microcrystalline cellulose 

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Povidone K25 
Pregelatinised starch 
Sodium hydroxide 
Sorbitol (E420) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
Store in the original package in order to protect from light and moisture. 
Remove the tablets from the blister only directly prior to intake. 
 
6.5 Nature and contents of container 
 
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/11/729/002 (28 tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 November 2011 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
Excipient(s) with known effect:  
Each tablet contains 337.28 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Blue and white oval shaped two layer tablets engraved with the product code A3 and the company 
logo on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension in adults: 
 
Add on therapy 
Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. 
 
Replacement therapy 
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses. 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose of Onduarp is one tablet per day. 
 
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp is indicated 
for long term treatment. 
 
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability 
may be increased in some patients resulting in increased blood pressure lowering effects (see section 
4.5). 
 
Add on therapy 
Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately 
controlled with Onduarp 40 mg/5 mg. 
 
Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 

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Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as 
oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine 
without reducing the overall expected antihypertensive response. 
 
Replacement therapy 
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience 
or compliance 
 
Special population 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. Little information is available in the very elderly 
patients. 
 
Patients with renal impairment  
No posology adjustment is required for patients with mild to moderate renal impairment. Limited 
experience is available in patients with severe renal impairment or haemodialysis. Caution is advised 
when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section 
4.4). 
 
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment 
(GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
Patients with hepatic impairment 
In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 
For telmisartan the posology should not exceed 40 mg once daily (see section 4.4). Onduarp is 
contraindicated in patients with severe hepatic impairment (see section 4.3). 
 
Paediatric population 
 
The safety and efficacy of Onduarp in children aged below 18 years have not been established. No 
data are available. 
 
Method of administration 
Onduarp can be taken with or without food. It is recommended to take Onduarp with some liquid. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the 

excipients listed in section 6.1 
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders and severe hepatic impairment 
• Shock (including cardiogenic shock) 
• Severe hypotension  
• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)  
• Haemodynamically unstable heart failure after acute myocardial infarction 
 
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus 
or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 

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be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 
4.6). 
 
Hepatic impairment 
Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic 
insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, 
amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations 
have not been established. Onduarp should therefore be used with caution in these patients. 
 
Renovascular hypertension 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system.  
 
Renal impairment and kidney transplantation 
When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Onduarp in patients with a recent kidney transplant. Telmisartan and amlodipine are not dialysable. 
 
Intravascular hypovolaemia  
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of telmisartan. If hypotension occurs with 
Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous 
infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. 
 
Dual blockade of the renin-angiotensin-aldosterone system 
The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes 
mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, 
hyperkalaemia and changes in renal function (including acute renal failure) have been reported in 
susceptible individuals, especially if combining medicinal products that affect this system. Dual 
blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other 
blockers of the renin-angiotensin-aldosterone system) is therefore not recommended. Close monitoring 
of renal function is advisable if co-administration is considered necessary. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
In patients whose vascular tone and renal function depend predominantly on the activity of the 
renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying 
renal disease, including renal artery stenosis), treatment with medicinal products that affect this system 
has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 

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Unstable angina pectoris, acute myocardial infarction 
There are no data to support the use of Onduarp in unstable angina pectoris and during or within one 
month of a myocardial infarction. 
 
Heart failure 
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV 
heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of 
pulmonary oedema despite no significant difference in the incidence of worsening heart failure as 
compared to placebo (see section 5.1). 
 
Diabetic patients treated with insulin or antidiabetics 
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or 
antidiabetics may be required when indicated. 
 
Hyperkalaemia 
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause 
hyperkalaemia. Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in 
diabetic patients, in patients concomitantly treated with other medicinal products that may increase 
potassium levels, and/or in patients with intercurrent events.  
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-
aldosterone system, the benefit risk ratio should be evaluated. 
The main risk factors for hyperkalaemia to be considered are: 
-  Diabetes mellitus, renal impairment, age (>70 years) 
-  Combination with one or more other medicinal products that affect the 

renin-angiotensin-aldosterone system and/or potassium supplements. Medicinal products or 
therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes 
containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor 
antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective 
COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim. 

-  Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, 
worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), 
cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma). 

 
Serum potassium should be monitored closely in these patients (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Onduarp. 
 
Other 
As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with 
ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction 
or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
  
No interactions between the two components of this fixed dose combinations have been observed in 
clinical studies.  
 
Interactions common to the combination 
No drug interaction studies have been performed. 
 
To be taken into account with concomitant use  
 
Other antihypertensive medicinal products  

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The blood pressure lowering effect of Onduarp can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Medicinal products with blood pressure lowering potential 
Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, 
amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated 
by alcohol. 
 
Corticosteroids (systemic route) 
Reduction of the antihypertensive effect. 
 
Interactions linked to telmisartan  
 
Contraindicated (see section 4.3) 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or 
renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 
4.3, 4.4). 
 
Concomitant use not recommended 
 
Potassium sparing diuretics or potassium supplements 
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. 
Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium 
supplements, or potassium-containing salt substitutes may lead to a significant increase in serum 
potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used 
with caution and with frequent monitoring of serum potassium. 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with 
angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, 
careful monitoring of serum lithium levels is recommended.  
 
Concomitant use requiring caution 
 
Non-steroidal anti-inflammatory medicinal products 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-
selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function), the co-administration of angiotensin II receptor antagonists and 
medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, 
including possible acute renal failure, which is usually reversible. Therefore, the combination should 
be administered with caution, especially in the elderly. Patients should be adequately hydrated and 
consideration should be given to monitoring of renal function after initiation of concomitant therapy 
and periodically thereafter. 
 
Ramipril 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 
Concomitant use to be taken into account 
 
Digoxin 

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When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 
Interactions linked to amlodipine 
 
Concomitant use requiring caution 
 
CYP3A4 inhibitors 
With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in 
elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % 
respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that 
strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma 
concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with 
caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction 
have been reported. 
 
CYP3A4 inducers 
There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant 
use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma 
concentration of amlodipine. 
 
Grapefruit and grapefruit juice 
Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine 
in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of 
amlodipine. The concomitant use of amlodipine and grapefruit or grapefruit juice is still not 
recommended in patients as the bioavailability of amlodipine may increase in some and may result in 
increased hypotensive effects. 
 
Concomitant use to be taken into account 
 
Simvastatin 
Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in 
exposure to simvastatin up to 77 % compared to simvastatin alone. Therefore, the dose of simvastatin 
in patients on amlodipine should be limited to 20 mg daily. 
 
Others 
Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid 
medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, 
ciclosporin, antibiotics and oral hypoglycaemic medicinal products. When amlodipine and sildenafil 
were used in combination, each agent independently exerted its own blood pressure lowering effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of Onduarp in pregnant women. Animal reproductive toxicity 
studies with Onduarp have not been performed. 
 
Telmisartan 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).  

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Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). 
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of 
pregnancy, ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 
Amlodipine 
 
Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium 
receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of 
prolonged delivery. 
 
Breast-feeding 
Because no information is available regarding the use of telmisartan and/or amlodipine during breast-
feeding, Onduarp is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant. 
 
Fertility 
No data from controlled clinical studies with the Fixed Dose Combination or with the individual 
components are available. 
 
Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not 
been conducted. 
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3). 
 
Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been 
observed for calcium channel blockers in preclinical and in vitro studies. No clinical relevance has 
been established. 
 
4.7 Effects on ability to drive and use machines 
 
Onduarp has moderate influence on the ability to drive and use machines. Patients should be advised 
that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during 
treatment (see section 4.8). Therefore, caution should be recommended when driving a car or using 
machines. If patients experience these adverse reactions, they should avoid potentially hazardous tasks 
such as driving or using machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may 
occur rarely (less than 1 case per 1,000 patients). 

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The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 
3500 patients, over 2500 of whom received telmisartan in combination with amlodipine. 
 
Tabulated list of adverse reactions 
Adverse reactions have been ranked under headings of frequency using the following convention: 
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available 
data).  
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

System Organ 
Class 

Common 
 

Uncommon 
 

Rare 
 

Infections and 
infestations 

  cystitis 

Psychiatric disorders   depression,  
anxiety, 
insomnia 

Nervous system 
disorders 

dizziness somnolence, 
migraine,  
headache,  
paraesthesia 

syncope,  
peripheral neuropathy, 
hypoaesthesia, 
dysgeusia, 
tremor 
 

Ear and labyrinth 
disorders 

 vertigo   

Cardiac disorders  bradycardia, 
palpitations 

 

Vascular disorders  hypotension, 
orthostatic 
hypotension, flushing 

 

Respiratory, thoracic 
and mediastinal 
disorders 

 cough 
 

 

Gastro-intestinal 
disorders 

 abdominal pain, 
diarrhoea, 
nausea 

vomiting, 
gingival hypertrophy, 
dyspepsia, 
dry mouth 

Skin and subcutaneous 
tissue disorders 

 pruritus eczema, erythema,  
rash  

Musculoskeletal and 
connective tissue 
disorders 

 arthralgia, 
muscle spasms 
(cramps in legs), 
myalgia 

back pain, 
pain in extremity (leg 
pain) 

Renal and urinary 
disorders 

  nocturia  
 

Reproductive system, 
and breast disorders 

 erectile dysfunction  

General disorders and 
administration site 
conditions 

peripheral oedema 
 

asthenia, 
chest pain, fatigue, 
oedema 

 

malaise 
 
 

 
Investigations  hepatic enzymes 

increased 
blood uric acid 
increased 

 

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Additional information on individual components   
 
Adverse reactions previously reported with one of the individual components (telmisartan or 
amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical 
trials or during the post-marketing period. 
 
Telmisartan 
 
Infections and infestations  
 Uncommon: 
 
 Rare: 

Upper respiratory tract infection including pharyngitis and 
sinusitis, urinary tract infection including cystitis  
Sepsis including fatal outcome1 
 

Blood and lymphatic system disorders 
 Uncommon: 
 Rare: 
 

Anaemia  
Thrombocytopenia, eosinophilia 

Immune system disorders 
 Rare: 
 

Hypersensitivity, anaphylactic reaction 

Metabolism and nutrition disorders 
 Uncommon: 
 Rare: 
 

Hyperkalaemia 
Hypoglycaemia (in diabetic patients) 

Eye disorders  
 Rare: Visual disturbance 

 
Cardiac disorders  
 Rare: Tachycardia  

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea 

 
Gastrointestinal disorders  
 Uncommon: 
 Rare: 

Flatulence 
Stomach discomfort 
 

Hepato-biliary disorders  
 Rare: 
 

Hepatic function abnormal, liver disorder2 

Skin and subcutaneous tissue disorders 
 Uncommon: 
 Rare: 

Hyperhidrosis 
Angioedema (with fatal outcome), drug eruption, toxic skin 
eruption, urticaria 
 

Musculoskeletal and connective tissue disorders 
 Rare: 
 

Tendon pain (tendinitis like symptoms) 

Renal and urinary disorders  
 Uncommon: Renal impairment including acute renal failure 

 
General disorders and administration site conditions 
 Rare: Influenza-like illness 

 
Investigations  
 Uncommon: Blood creatinine increased 

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 Rare: Blood creatine phosphokinase increased, haemoglobin decreased 
1: the event may be a chance finding or related to a mechanism currently not known 
2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Amlodipine 
 
Blood and lymphatic system disorders 
 Very rare: Leukocytopenia, thrombocytopenia 

 
Immune system disorders 
 Very rare: Hypersensitivity 

 
Metabolism and nutrition disorders 
 Very rare: Hyperglycaemia 

 
Psychiatric disorders 

Uncommon: 
Rare 

Mood change 
Confusion 
 

Nervous system disorders  
Very rare: Extrapyramidal syndrome 

 
Eye disorders  
 Uncommon: 
 

Visual impairment 

Ear and labyrinth disorders  
Uncommon: 
 

Tinnitus 

Cardiac disorders  
 Very rare: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial 

fibrillation 
 

Vascular disorders 
 Very rare: 
 

Vasculitis 

Respiratory, thoracic and mediastinal disorders 
 Uncommon: 
 

Dyspnoea, rhinitis 

Gastrointestinal disorders  
 Uncommon: 
 Very rare: 
 

Change of bowel habit 
Pancreatitis, gastritis 
 

Hepatobiliary disorders  
 Very rare: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent 

with cholestasis 
 

Skin and subcutaneous tissue disorders 
 Uncommon: 
 Very rare: 

Alopecia, purpura, skin discolouration, hyperhidrosis 
Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, 
Stevens-Johnson syndrome, photosensitivity 
 

Renal and urinary disorders  
 Uncommon: 
 

Micturition disorder, pollakiuria 

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Reproductive system and breast disorders 
Uncommon: 
 

Gynaecomastia 

General disorders and administration site conditions 
 Uncommon: 
 

Pain 

Investigations  
 Uncommon: Weight increased, weight decreased 
 
4.9 Overdose 
 
Symptoms 
Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects. 
The most prominent manifestations of telmisartan overdose are expected to be hypotension and 
tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also 
been reported. 
Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex 
tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with 
fatal outcome have been reported. 
 
Treatment 
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Management depends on the time since ingestion and the severity of the symptoms. Suggested 
measures include induction of emesis and / or gastric lavage. Activated charcoal may be useful in the 
treatment of overdose of both telmisartan and amlodipine.  
Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient 
should be placed in a supine position with elevation of extremities, with salt and volume replacement 
given quickly. Supportive treatment should be instituted. Intravenous calcium gluconate may be 
beneficial in reversing the effects of calcium channel blockade. Telmisartan and Amlodipine are not 
removed by haemodialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists 
and calcium channel blockers; ATC Code: C09DB04. 
 
Onduarp combines two antihypertensive compounds with complementary mechanisms to control 
blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, 
telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. 
The combination of these substances has an additive antihypertensive effect, reducing blood pressure 
to a greater degree than either component alone. 
Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour 
therapeutic dose range.   
 
Telmisartan 
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan 
displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, 
which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial 
agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is 
long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less 
characterised AT receptors. The functional role of these receptors is not known, nor is the effect of 
their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma 
aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or 

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block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the 
enzyme which also degrades bradykinin. Therefore it is not expected to potentiate 
bradykinin-mediated adverse reactions. 
 
In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood 
pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 
48 hours. 
 
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of 
treatment and is sustained during long-term therapy. 
 
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours 
before the next dose as shown by ambulatory blood pressure measurements. This is confirmed by 
trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in 
placebo controlled clinical studies. There is an apparent trend to a dose relationship to a time to 
recovery of baseline systolic blood pressure (SBP). In this respect data concerning diastolic blood 
pressure (DBP) are inconsistent.  
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The contribution of the medicinal product's diuretic and natriuretic effect to its 
hypotensive activity has still to be defined. The antihypertensive efficacy of telmisartan is comparable 
to that of substances representative of other classes of antihypertensive medicinal products 
(demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, 
hydrochlorothiazide, and lisinopril). 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension.  
 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Amlodipine 
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or 
calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and 
vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a 
direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular 
resistance and in blood pressure. Experimental data indicate that amlodipine binds to both 
dihydropyridine and non-dihydropyridine binding sites. Amlodipine is relatively vessel-selective, with 
a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 
 
In patients with hypertension, once daily dosing provides clinically significant reductions of blood 
pressure in both the supine and standing positions throughout the 24 hour interval. Due to the slow 
onset of action, acute hypotension is not a feature of amlodipine administration. 
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a 
decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal 
plasma flow, without change in filtration fraction or proteinuria. 
 
Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids 
and is suitable for use in patients with asthma, diabetes, and gout. 
 
Use in patients with heart failure 
Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure 
patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise 
tolerance, left ventricular ejection fraction and clinical symptomatology. 
 

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A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart 
failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an 
increase in risk of mortality or combined mortality and morbidity with heart failure. 
 
In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA 
III and IV heart failure without clinical symptoms or objective findings suggestive of underlying 
ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine had no effect 
on total cardiovascular mortality. In this same population amlodipine was associated with increased 
reports of pulmonary oedema despite no significant difference in the incidence of worsening heart 
failure as compared to placebo. 
 
Telmisartan/Amlodipine 
In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study 
in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and 
≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater 
diastolic and systolic blood pressure reductions and higher control rates compared to the respective 
monotherapy components. 
 
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic 
dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg), 
−24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg). The reduction in diastolic 
blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3% of patients respectively. 
Values are adjusted for baseline and country. 
 
The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy. 
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % 
responded sufficiently to monotherapy of either telmisartan or amlodipine. The observed mean 
changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg 
(−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or 
greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant 
lower oedema rates (1.4% with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg). 
 
Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients 
confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently 
over the entire 24-hours dosing period. 
 
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg). After 
8 weeks of treatment, each of the combinations was statistically significantly superior to both 
amlodipine monotherapy doses in reducing systolic and diastolic blood pressures (−13.6/−9.4 mmHg, 
−15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with 
amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the 
respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 
42 %, 56.7 % with amlodipine 5 mg and 10 mg). Oedema rates were significantly lower with 
40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4% versus 24.9 %, respectively). 
 
In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg). After 8 weeks 
of treatment, each of the combination treatments was statistically significantly superior to amlodipine 
monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/−9.3 mmHg 
with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic 
blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 
40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
 

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In two corresponding open-label long-term follow up studies performed over a further 6 months the 
effect of Onduarp was maintained over the trial period. Furthermore it was shown that some patients 
not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by up-
titration to Onduarp 80 mg/10 mg. 
 
The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with 
only 12.7 % of patients on treatment experiencing adverse reactions. The most common adverse 
reactions were peripheral oedema and dizziness, see also section 4.8. The adverse reactions reported 
were in agreement with those anticipated from the safety profiles of the components telmisartan and 
amlodipine. No new or more severe adverse reactions were observed. The oedema related events 
(peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who 
received Onduarp as compared to patients who received amlodipine 10 mg. In the factorial design trial 
the oedema rates were 1.3 % with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 
40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg. In patients not controlled on 
amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for 
amlodipine 10 mg. 
 
The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in 
patients with and without diabetes. 
 
Onduarp has not been studied in any patient population other than hypertension. Telmisartan has been 
studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET). 
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and 
angiographically documented coronary artery disease. 
 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic of the fixed dose combination (FDC) 
The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and 
amlodipine when administered as individual tablets. 
 
Absorption 
Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute 
bioavailability for telmisartan is about 50 %. When telmisartan is taken with food, the reduction in the 
area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 
6 % (40 mg dose) to approximately 19 % (160 mg dose). By 3 hours after administration, plasma 
concentrations are similar whether telmisartan is taken fasting or with food.  
 
After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels 
between 6-12 hours post dose. Absolute bioavailability has been estimated to be between 64 and 80 %. 
Amlodipine bioavailability is not affected by food ingestion. 
 
Distribution 
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid 
glycoprotein. The mean steady state apparent volume of distribution (Vdss) is approximately 500 l. 
 
The volume of distribution of amlodipine is approximately 21 l/kg. In vitro studies have shown that 
approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients. 
 

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Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No 
pharmacological activity has been shown for the conjugate.  
 
Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites. 
 
Elimination 
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination 
half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a smaller extent, the area 
under the plasma concentration-time curve (AUC), increase disproportionately with dose. There is no 
evidence of clinically relevant accumulation of telmisartan taken at the recommended dose. Plasma 
concentrations were higher in females than in males, without relevant influence on efficacy. 
 
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, 
mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose. Total plasma 
clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 
1,500 ml/min). 
 
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of 
approximately 30 to 50 hours consistent with once daily dosing. Steady-state plasma levels are 
reached after continuous administration for 7–8 days. Ten per cent of original amlodipine and 60 % of 
amlodipine metabolites are excreted in urine.  
 
Linearity/non-linearity  
The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic 
efficacy. There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent 
AUC increase disproportionately at doses above 40 mg. 
 
Amlodipine exhibits linear pharmacokinetics.  
 
Special populations 
 
Paediatric population (age below 18 years) 
No pharmacokinetic data are available in the paediatric population. 
 
Gender 
Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being 
approximately 3- and 2-fold higher, respectively, in females compared to males. 
 
Elderly 
The pharmacokinetics of telmisartan do not differ in young and elderly patients. 
The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects. 
In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and 
elimination half-life. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of 
telmisartan was observed. However, lower plasma concentrations were observed in patients with renal 
insufficiency undergoing dialysis. Telmisartan is highly bound to plasma protein in renal-insufficient 
subjects and cannot be removed by dialysis. The elimination half-life is not changed in patients with 
renal impairment. The pharmacokinetics of amlodipine are not significantly influenced by renal 
impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability of telmisartan up to nearly 100 %. The elimination half-life of telmisartan is not 

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changed in patients with hepatic impairment. Patients with hepatic insufficiency have decreased 
clearance of amlodipine with resulting increase of approximately 40–60 % in AUC. 
 
5.3 Preclinical safety data 
 
Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no 
exacerbation of toxicity was expected for the combination. This has been confirmed in a subchronic 
(13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of 
telmisartan and amlodipine were tested. 
 
Preclinical data available for the components of this fixed dose combination are reported below. 
 
Telmisartan 
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic 
range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal 
haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium 
in normotensive animals. In dogs, renal tubular dilation and atrophy were observed. Gastric mucosal 
injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These pharmacologically-
mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation. In 
both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular 
cells were observed. These changes, also a class effect of angiotensin converting enzyme inhibitors 
and other angiotensin II receptor antagonists, do not appear to have clinical significance. 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offspring such as lower body weight and delayed eye 
opening was observed. 
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no 
evidence of carcinogenicity in rats and mice. 
 
Amlodipine 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup 
survival were seen at high doses. There was no effect on the fertility of rats treated orally with 
amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 
10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on 
an mg/m2 basis).  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Colloidal anhydrous silica 
Brilliant blue FCF (E 133) 
Ferric oxide black (E172) 
Ferric oxide yellow (E172) 
Magnesium stearate 
Maize starch 
Meglumine 
Microcrystalline cellulose 
Povidone K25 
Pregelatinised starch 
Sodium hydroxide 
Sorbitol (E420) 
 

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6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
Store in the original package in order to protect from light and moisture. 
Remove the tablets from the blister only directly prior to intake. 
 
6.5 Nature and contents of container 
 
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or 
aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 
packs of 90 x 1) tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/11/729/003 (28 tablets) 
EU/1/11/729/004 (360 (4 x 90 x 1) tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 November 2011 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
Excipient(s) with known effect:  
Each tablet contains 337.28 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Blue and white oval shaped two layer tablets engraved with the product code A4 and the company 
logo on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of essential hypertension in adults: 
 
Add on therapy 
Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. 
 
Replacement therapy 
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses. 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose of Onduarp is one tablet per day. 
 
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp is indicated 
for long term treatment. 
 
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability 
may be increased in some patients resulting in increased blood pressure lowering effects (see section 
4.5). 
 
Add on therapy 
Onduarp 80 mg/10 mg may be administered in patients whose blood pressure is not adequately 
controlled on Onduarp 40 mg/10 mg or Onduarp 80 mg/5 mg. 
 
Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before 
changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy 
to the fixed combination may be considered. 
 

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Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as 
oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine 
without reducing the overall expected antihypertensive response. 
 
Replacement therapy 
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of 
Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience 
or compliance 
 
Special population 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. Little information is available in the very elderly 
patients. 
 
Patients with renal impairment  
No posology adjustment is required for patients with mild to moderate renal impairment. Limited 
experience is available in patients with severe renal impairment or haemodialysis. Caution is advised 
when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section 
4.4). 
 
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment 
(GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
Patients with hepatic impairment 
In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 
For telmisartan the posology should not exceed 40 mg once daily (see section 4.4). Onduarp is 
contraindicated in patients with severe hepatic impairment (see section 4.3). 
 
Paediatric population 
 
The safety and efficacy of Onduarp in children aged below 18 years have not been established. No 
data are available. 
 
Method of administration 
Onduarp can be taken with or without food. It is recommended to take Onduarp with some liquid. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the 

excipients listed in section 6.1 
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders and severe hepatic impairment 
• Shock (including cardiogenic shock) 
• Severe hypotension  
• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)  
• Haemodynamically unstable heart failure after acute myocardial infarction 
 
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus 
or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). 
 
4.4 Special warnings and precautions for use 
 
Pregnancy 
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 

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be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 
4.6). 
 
Hepatic impairment 
Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic 
insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, 
amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations 
have not been established. Onduarp should therefore be used with caution in these patients. 
 
Renovascular hypertension 
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral 
renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal 
products that affect the renin-angiotensin-aldosterone system.  
 
Renal impairment and kidney transplantation 
When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Onduarp in patients with a recent kidney transplant. Telmisartan and amlodipine are not dialysable. 
 
Intravascular hypovolaemia  
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or 
sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such 
conditions should be corrected before the administration of telmisartan. If hypotension occurs with 
Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous 
infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. 
 
Dual blockade of the renin-angiotensin-aldosterone system 
The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes 
mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
 
As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, 
hyperkalaemia and changes in renal function (including acute renal failure) have been reported in 
susceptible individuals, especially if combining medicinal products that affect this system. Dual 
blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other 
blockers of the renin-angiotensin-aldosterone system) is therefore not recommended. Close monitoring 
of renal function is advisable if co-administration is considered necessary. 
 
Other conditions with stimulation of the renin-angiotensin-aldosterone system 
In patients whose vascular tone and renal function depend predominantly on the activity of the 
renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying 
renal disease, including renal artery stenosis), treatment with medicinal products that affect this system 
has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see 
section 4.8). 
 
Primary aldosteronism 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 
acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not 
recommended. 
 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy 
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 
stenosis, or obstructive hypertrophic cardiomyopathy. 
 

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Unstable angina pectoris, acute myocardial infarction 
There are no data to support the use of Onduarp in unstable angina pectoris and during or within one 
month of a myocardial infarction. 
 
Heart failure 
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV 
heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of 
pulmonary oedema despite no significant difference in the incidence of worsening heart failure as 
compared to placebo (see section 5.1). 
 
Diabetic patients treated with insulin or antidiabetics 
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or 
antidiabetics may be required when indicated. 
 
Hyperkalaemia 
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause 
hyperkalaemia. Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in 
diabetic patients, in patients concomitantly treated with other medicinal products that may increase 
potassium levels, and/or in patients with intercurrent events,.  
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-
aldosterone system, the benefit risk ratio should be evaluated. 
The main risk factors for hyperkalaemia to be considered are: 
-  Diabetes mellitus, renal impairment, age (>70 years) 
-  Combination with one or more other medicinal products that affect the renin-angiotensin-

aldosterone system and/or potassium supplements. Medicinal products or therapeutic classes of 
medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, 
potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal 
anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, 
immunosuppressives (cyclosporin or tacrolimus), and trimethoprim. 

-  Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, 
worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), 
cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma). 

 
Serum potassium should be monitored closely in these patients (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Onduarp. 
 
Other 
As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with 
ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction 
or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
  
No interactions between the two components of this fixed dose combinations have been observed in 
clinical studies.  
 
Interactions common to the combination 
No drug interaction studies have been performed. 
 

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To be taken into account with concomitant use  
 
Other antihypertensive medicinal products  
The blood pressure lowering effect of Onduarp can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Medicinal products with blood pressure lowering potential 
Based on their pharmacological properties it can be expected that the following medicinal products 
may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, 
amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated 
by alcohol. 
 
Corticosteroids (systemic route) 
Reduction of the antihypertensive effect. 
 
Interactions linked to telmisartan  
 
Contraindicated (see section 4.3) 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or 
renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 
4.3, 4.4). 
 
Concomitant use not recommended 
 
Potassium sparing diuretics or potassium supplements 
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. 
Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium 
supplements, or potassium-containing salt substitutes may lead to a significant increase in serum 
potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used 
with caution and with frequent monitoring of serum potassium. 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with 
angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, 
careful monitoring of serum lithium levels is recommended.  
 
Concomitant use requiring caution 
 
Non-steroidal anti-inflammatory medicinal products 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-
selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. 
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with 
compromised renal function), the co-administration of angiotensin II receptor antagonists and 
medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, 
including possible acute renal failure, which is usually reversible. Therefore, the combination should 
be administered with caution, especially in the elderly. Patients should be adequately hydrated and 
consideration should be given to monitoring of renal function after initiation of concomitant therapy 
and periodically thereafter. 
 
Ramipril 
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the 
AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known. 
 

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Concomitant use to be taken into account 
 
Digoxin 
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma 
concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and 
discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic 
range. 
 
Interactions linked to amlodipine 
 
Concomitant use requiring caution 
 
CYP3A4 inhibitors 
With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in 
elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % 
respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that 
strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma 
concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with 
caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction 
have been reported. 
 
CYP3A4 inducers 
There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant 
use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma 
concentration of amlodipine. 
 
Grapefruit and grapefruit juice 
Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine 
in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of 
amlodipine. The concomitant use of amlodipine and grapefruit or grapefruit juice is still not 
recommended in patients as the bioavailability of amlodipine may increase in some and may result in 
increased hypotensive effects. 
 
Concomitant use to be taken into account 
 
Simvastatin 
Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in 
exposure to simvastatin up to 77 % compared to simvastatin alone. Therefore, the dose of simvastatin 
in patients on amlodipine should be limited to 20 mg daily. 
 
Others 
Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid 
medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, 
ciclosporin, antibiotics and oral hypoglycaemic medicinal products. When amlodipine and sildenafil 
were used in combination, each agent independently exerted its own blood pressure lowering effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of Onduarp in pregnant women. Animal reproductive toxicity 
studies with Onduarp have not been performed. 
 

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Telmisartan 
 
The use of angiotensin II receptor antagonists is not recommended during the first trimester of 
pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during 
the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
 
Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).  
 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors 
during the first trimester of pregnancy has not been conclusive; however a small increase in risk 
cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II 
receptor antagonists, similar risks may exist for this class of medicinal products. Unless continued 
angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should 
be changed to alternative antihypertensive treatments which have an established safety profile for use 
in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should 
be stopped immediately, and, if appropriate, alternative therapy should be started. 
 
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known 
to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification 
retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). 
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of 
pregnancy, ultrasound check of renal function and skull is recommended. 
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for 
hypotension (see sections 4.3 and 4.4). 
 
Amlodipine 
 
Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium 
receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of 
prolonged delivery. 
 
Breast-feeding 
Because no information is available regarding the use of telmisartan and/or amlodipine during breast-
feeding, Onduarp is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant. 
 
Fertility 
No data from controlled clinical studies with the Fixed Dose Combination or with the individual 
components are available. 
 
Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not 
been conducted. 
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3). 
 
Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been 
observed for calcium channel blockers in preclinical and in vitro studies. No clinical relevance has 
been established. 
 
4.7 Effects on ability to drive and use machines 
 
Onduarp has moderate influence on the ability to drive and use machines. Patients should be advised 
that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during 
treatment (see section 4.8). Therefore, caution should be recommended when driving a car or using 
machines. If patients experience these adverse reactions, they should avoid potentially hazardous tasks 
such as driving or using machines. 

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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may 
occur rarely (less than 1 case per 1,000 patients). 
 
The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 
3500 patients, over 2500 of whom received telmisartan in combination with amlodipine. 
 
Tabulated list of adverse reactions 
Adverse reactions have been ranked under headings of frequency using the following convention: 
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available 
data).  
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

System Organ 
Class 

Common 
 

Uncommon 
 

Rare 
 

Infections and 
infestations 

  cystitis 

Psychiatric disorders   depression,  
anxiety, 
insomnia 

Nervous system 
disorders 

dizziness somnolence, 
migraine,  
headache,  
paraesthesia 

syncope,  
peripheral neuropathy, 
hypoaesthesia, 
dysgeusia, 
tremor 
 

Ear and labyrinth 
disorders 

 vertigo   

Cardiac disorders  bradycardia, 
palpitations 

 

Vascular disorders  hypotension, 
orthostatic 
hypotension, flushing 

 

Respiratory, thoracic 
and mediastinal 
disorders 

 cough 
 

 

Gastro-intestinal 
disorders 

 abdominal pain, 
diarrhoea, 
nausea 

vomiting, 
gingival hypertrophy, 
dyspepsia, 
dry mouth 

Skin and subcutaneous 
tissue disorders 

 pruritus eczema, erythema,  
rash  

Musculoskeletal and 
connective tissue 
disorders 

 arthralgia, 
muscle spasms 
(cramps in legs), 
myalgia 

back pain, 
pain in extremity (leg 
pain) 

Renal and urinary 
disorders 

  nocturia  
 

Reproductive system, 
and breast disorders 

 erectile dysfunction  

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General disorders and 
administration site 
conditions 

peripheral oedema 
 

asthenia, 
chest pain, fatigue, 
oedema 

 

malaise 
 
 

 
Investigations  hepatic enzymes 

increased 
blood uric acid 
increased 

 
Additional information on individual components   
 
Adverse reactions previously reported with one of the individual components (telmisartan or 
amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical 
trials or during the post-marketing period. 
 
Telmisartan 
 
Infections and infestations  
 Uncommon: 
 
 Rare: 

Upper respiratory tract infection including pharyngitis and 
sinusitis, urinary tract infection including cystitis  
Sepsis including fatal outcome1 
 

Blood and lymphatic system disorders 
 Uncommon: 
 Rare: 

Anaemia  
Thrombocytopenia, eosinophilia 
 

Immune system disorders 
 Rare: 
 

Hypersensitivity, anaphylactic reaction 
 

Metabolism and nutrition disorders 
 Uncommon: 
 Rare: 
 

Hyperkalaemia 
Hypoglycaemia (in diabetic patients) 

Eye disorders  
 Rare: Visual disturbance 

 
Cardiac disorders  
 Rare: Tachycardia  

 
Respiratory, thoracic and mediastinal disorders 
 Uncommon: Dyspnoea 

 
Gastrointestinal disorders  
 Uncommon: 
 Rare: 

Flatulence 
Stomach discomfort 
 

Hepato-biliary disorders  
 Rare: 
 

Hepatic function abnormal, liver disorder2
 

Skin and subcutaneous tissue disorders 
 Uncommon: 
 Rare: 

Hyperhidrosis 
Angioedema (with fatal outcome), drug eruption, toxic skin 
eruption, urticaria 
 

Musculoskeletal and connective tissue disorders 
 Rare: 
 

Tendon pain (tendinitis like symptoms) 
 

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Renal and urinary disorders  
 Uncommon: Renal impairment including acute renal failure 

 
General disorders and administration site conditions 
 Rare: Influenza-like illness 

 
Investigations  
 Uncommon: 
 Rare: 

Blood creatinine increased 
Blood creatine phosphokinase increased, haemoglobin decreased 

1: the event may be a chance finding or related to a mechanism currently not known 
2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these 
adverse reactions. 
 
Amlodipine 
 
Blood and lymphatic system disorders 
 Very rare: Leukocytopenia, thrombocytopenia 

 
Immune system disorders 
 Very rare: Hypersensitivity 

 
Metabolism and nutrition disorders 
 Very rare: Hyperglycaemia 

 
Psychiatric disorders 

Uncommon: 
Rare: 
 

Mood change 
Confusion 

Nervous system disorders  
Very rare: 
 

Extrapyramidal syndrome 

Eye disorders  
 Uncommon: 
 

Visual impairment 

Ear and labyrinth disorders  
Uncommon: 
 

Tinnitus 

Cardiac disorders  
 Very rare: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial 

fibrillation 
 

Vascular disorders 
 Very rare: 
 

Vasculitis 

Respiratory, thoracic and mediastinal disorders 
 Uncommon: 
 

Dyspnoea, rhinitis 

Gastrointestinal disorders  
 Uncommon: 
 Very rare: 
 

Change of bowel habit 
Pancreatitis, gastritis 

Hepatobiliary disorders  
 Very rare: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent 

with cholestasis 
 

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Skin and subcutaneous tissue disorders 
 Uncommon: 
 Very rare: 

Alopecia, purpura, skin discolouration, hyperhidrosis 
Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, 
Stevens-Johnson syndrome, photosensitivity 
 

Renal and urinary disorders  
 Uncommon: 
 

Micturition disorder, pollakiuria 

Reproductive system and breast disorders 
Uncommon: 
 

Gynaecomastia 

General disorders and administration site conditions 
 Uncommon: 
 

Pain 

Investigations  
 Uncommon: Weight increased, weight decreased 
 
4.9 Overdose 
 
Symptoms 
Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects. 
The most prominent manifestations of telmisartan overdose are expected to be hypotension and 
tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also 
been reported. 
Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex 
tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with 
fatal outcome have been reported. 
 
Treatment 
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Management depends on the time since ingestion and the severity of the symptoms. Suggested 
measures include induction of emesis and / or gastric lavage. Activated charcoal may be useful in the 
treatment of overdose of both telmisartan and amlodipine.  
Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient 
should be placed in a supine position with elevation of extremities, with salt and volume replacement 
given quickly. Supportive treatment should be instituted. Intravenous calcium gluconate may be 
beneficial in reversing the effects of calcium channel blockade. Telmisartan and Amlodipine are not 
removed by haemodialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists 
and calcium channel blockers; ATC Code: C09DB04. 
 
Onduarp combines two antihypertensive compounds with complementary mechanisms to control 
blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, 
telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. 
The combination of these substances has an additive antihypertensive effect, reducing blood pressure 
to a greater degree than either component alone. 
Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour 
therapeutic dose range.   
 

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Telmisartan 
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan 
displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, 
which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial 
agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is 
long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less 
characterised AT receptors. The functional role of these receptors is not known, nor is the effect of 
their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma 
aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or 
block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the 
enzyme which also degrades bradykinin. Therefore it is not expected to potentiate bradykinin-
mediated adverse reactions. 
 
In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood 
pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 
48 hours. 
 
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 
3 hours. The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of 
treatment and is sustained during long-term therapy. 
 
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours 
before the next dose as shown by ambulatory blood pressure measurements. This is confirmed by 
trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in 
placebo controlled clinical studies. There is an apparent trend to a dose relationship to a time to 
recovery of baseline systolic blood pressure (SBP). In this respect data concerning diastolic blood 
pressure (DBP) are inconsistent.  
 
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without 
affecting pulse rate. The contribution of the medicinal product’s diuretic and natriuretic effect to its 
hypotensive activity has still to be defined. The antihypertensive efficacy of telmisartan is comparable 
to that of substances representative of other classes of antihypertensive medicinal products 
(demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, 
hydrochlorothiazide, and lisinopril). 
 
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment 
values over a period of several days without evidence of rebound hypertension.  
 
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those 
given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two 
antihypertensive treatments. 
 
Amlodipine 
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or 
calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and 
vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a 
direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular 
resistance and in blood pressure. Experimental data indicate that amlodipine binds to both 
dihydropyridine and non-dihydropyridine binding sites. Amlodipine is relatively vessel-selective, with 
a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 
 
In patients with hypertension, once daily dosing provides clinically significant reductions of blood 
pressure in both the supine and standing positions throughout the 24 hour interval. Due to the slow 
onset of action, acute hypotension is not a feature of amlodipine administration. 
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a 
decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal 
plasma flow, without change in filtration fraction or proteinuria. 

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Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids 
and is suitable for use in patients with asthma, diabetes, and gout. 
 
Use in patients with heart failure 
Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure 
patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise 
tolerance, left ventricular ejection fraction and clinical symptomatology. 
 
A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart 
failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an 
increase in risk of mortality or combined mortality and morbidity with heart failure. 
 
In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with 
NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of 
underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine 
had no effect on total cardiovascular mortality. In this same population amlodipine was associated 
with increased reports of pulmonary oedema despite no significant difference in the incidence of 
worsening heart failure as compared to placebo. 
 
Telmisartan/Amlodipine 
In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study 
in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and 
≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater 
diastolic and systolic blood pressure reductions and higher control rates compared to the respective 
monotherapy components. 
 
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic 
dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg), 
−24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg). The reduction in diastolic 
blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively. 
Values are adjusted for baseline and country. 
 
The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy. 
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % 
responded sufficiently to monotherapy of either telmisartan or amlodipine. The observed mean 
changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg 
(−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or 
greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant 
lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 
10 mg). 
 
Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients 
confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently 
over the entire 24-hours dosing period. 
 
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg). After 
8 weeks of treatment, each of the combinations was statistically significantly superior to both 
amlodipine monotherapy doses in reducing systolic and diastolic blood pressures (−13.6/−9.4 mmHg, 
−15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with 
amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the 
respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 
42 %, 56.7 % with amlodipine 5 mg and 10 mg). Oedema rates were significantly lower with 
40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4% versus 24.9 %, respectively). 

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In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 
947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 
10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg). After 8 weeks 
of treatment, each of the combination treatments was statistically significantly superior to amlodipine 
monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg 
with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic 
blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 
40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
 
In two corresponding open-label long-term follow up studies performed over a further 6 months the 
effect of Onduarp was maintained over the trial period. Furthermore it was shown that some patients 
not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by up-
titration to Onduarp 80 mg/10 mg. 
 
The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with 
only 12.7 % of patients on treatment experiencing adverse reactions. The most common adverse 
reactions were peripheral oedema and dizziness, see also section 4.8. The adverse reactions reported 
were in agreement with those anticipated from the safety profiles of the components telmisartan and 
amlodipine. No new or more severe adverse reactions were observed. The oedema related events 
(peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who 
received Onduarp as compared to patients who received amlodipine 10 mg. In the factorial design trial 
the oedema rates were 1.3% with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 
40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg. In patients not controlled on 
amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for 
amlodipine 10 mg. 
 
The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in 
patients with and without diabetes. 
 
Onduarp has not been studied in any patient population other than hypertension. Telmisartan has been 
studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET). 
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and 
angiographically documented coronary artery disease. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic of the fixed dose combination (FDC) 
The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and 
amlodipine when administered as individual tablets. 
 
Absorption 
Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute 
bioavailability for telmisartan is about 50 %. When telmisartan is taken with food, the reduction in the 
area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 
6 % (40 mg dose) to approximately 19 % (160 mg dose). By 3 hours after administration, plasma 
concentrations are similar whether telmisartan is taken fasting or with food.  
 
After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels 
between 6-12 hours post dose. Absolute bioavailability has been estimated to be between 64 and 80 %. 
Amlodipine bioavailability is not affected by food ingestion. 
 

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Distribution 
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid 
glycoprotein. The mean steady state apparent volume of distribution (Vdss) is approximately 500 l. 
 
The volume of distribution of amlodipine is approximately 21 l/kg. In vitro studies have shown that 
approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No 
pharmacological activity has been shown for the conjugate.  
 
Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites. 
 
Elimination 
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination 
half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a smaller extent, the area 
under the plasma concentration-time curve (AUC), increase disproportionately with dose. There is no 
evidence of clinically relevant accumulation of telmisartan taken at the recommended dose. Plasma 
concentrations were higher in females than in males, without relevant influence on efficacy. 
 
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, 
mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose. Total plasma 
clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 
1,500 ml/min). 
 
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of 
approximately 30 to 50 hours consistent with once daily dosing. Steady-state plasma levels are 
reached after continuous administration for 7-8 days. Ten per cent of original amlodipine and 60 % of 
amlodipine metabolites are excreted in urine.  
 
Linearity/non-linearity  
The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic 
efficacy. There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent 
AUC increase disproportionately at doses above 40 mg. 
 
Amlodipine exhibits linear pharmacokinetics.  
 
Special populations 
 
Paediatric population (age below 18 years) 
No pharmacokinetic data are available in the paediatric population. 
 
Gender 
Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being 
approximately 3-  and 2-fold higher, respectively, in females compared to males. 
 
Elderly 
The pharmacokinetics of telmisartan do not differ in young and elderly patients. 
The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects. 
In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and 
elimination half-life. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of 
telmisartan was observed. However, lower plasma concentrations were observed in patients with renal 
insufficiency undergoing dialysis. Telmisartan is highly bound to plasma protein in renal-insufficient 
subjects and cannot be removed by dialysis. The elimination half-life is not changed in patients with 

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68 

renal impairment. The pharmacokinetics of amlodipine are not significantly influenced by renal 
impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute 
bioavailability of telmisartan up to nearly 100 %. The elimination half-life of telmisartan is not 
changed in patients with hepatic impairment. Patients with hepatic insufficiency have decreased 
clearance of amlodipine with resulting increase of approximately 40-60 % in AUC. 
 
5.3 Preclinical safety data 
 
Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no 
exacerbation of toxicity was expected for the combination. This has been confirmed in a subchronic 
(13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of 
telmisartan and amlodipine were tested. 
 
Preclinical data available for the components of this fixed dose combination are reported below. 
 
Telmisartan 
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic 
range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal 
haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium 
in normotensive animals. In dogs, renal tubular dilation and atrophy were observed. Gastric mucosal 
injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These pharmacologically-
mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme 
inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation. In 
both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular 
cells were observed. These changes, also a class effect of angiotensin converting enzyme inhibitors 
and other angiotensin II receptor antagonists, do not appear to have clinical significance. 
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an 
effect on the postnatal development of the offsprings such as lower body weight and delayed eye 
opening was observed. 
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no 
evidence of carcinogenicity in rats and mice. 
 
Amlodipine 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup 
survival were seen at high doses. There was no effect on the fertility of rats treated orally with 
amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 
10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on 
an mg/m2 basis).  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Colloidal anhydrous silica 
Brilliant blue FCF (E 133) 
Ferric oxide black (E172) 
Ferric oxide yellow (E172) 
Magnesium stearate 
Maize starch 
Meglumine 
Microcrystalline cellulose 

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69 

Povidone K25 
Pregelatinised starch 
Sodium hydroxide 
Sorbitol (E420) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
Store in the original package in order to protect from light and moisture. 
Remove the tablets from the blister only directly prior to intake. 
 
6.5 Nature and contents of container 
 
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or 
aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 
packs of 90 x 1) tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/11/729/005 (28 tablets) 
EU/1/11/729/006 (36 (4 x 90 x 1) tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 November 2011 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

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70 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE  
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORIZATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Binger Strasse 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription  
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORIZATION  
 
• Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 

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72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 40 mg/5 mg 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/001 (28 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 40 mg/5 mg  

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister of 7 tablets – 40 mg/5 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  
 

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77 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 40 mg/10 mg  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/002 (28 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 40 mg/10 mg  

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79 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister of 7 tablets – 40 mg/10 mg  
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 40 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 

 

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80 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 80 mg/5 mg 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/003 (28 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/5 mg  
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) 
– WITHOUT BLUE BOX – 80 mg/5 mg  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Component of a multipack comprising 4 packs, each containing 90 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/004 (360 (4 x 90 x 1) tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/5 mg  

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLED – 
INCLUDING THE BLUE BOX – 80 mg/5 mg  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack comprising 4 packs, each containing 90 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/004 (360 (4 x 90 x 1) tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/5 mg  

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister of 7 tablets – 80 mg/5 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Unit dose blister of 10 tablets – 80 mg/5 mg 
  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/5 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 80 mg/10 mg  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/005 (28 tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/10 mg  
 

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90 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) 
– WITHOUT BLUE BOX – 80 mg/10 mg  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Component of a multipack comprising 4 packs, each containing 90 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/006 (360 (4 x 90 x 1) tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/10 mg  

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92 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLED – 
INCLUDING THE BLUE BOX – 80 mg/10 mg  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack comprising 4 packs, each containing 90 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light and moisture. 
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/729/006 (360 (4 x 90 x 1) tablets) 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Onduarp 80 mg/10 mg  

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister of 7 tablets – 80 mg/10 mg 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Unit dose blister of 10 tablets – 80 mg/10 mg 
 
  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Onduarp 80 mg/10 mg tablets 
telmisartan/amlodipine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Boehringer Ingelheim (Logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
 
 

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B. PACKAGE LEAFLET 

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Package leaflet: Information for the user 
Onduarp 40 mg/5 mg tablets 

Telmisartan/Amlodipine 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. 
 
What is in this leaflet:  
1. What Onduarp is and what it is used for 
2. What you need to know before you take Onduarp 
3. How to take Onduarp 
4. Possible side effects 
5. How to store Onduarp 
6. Contents of the pack and other information 
 
 
1. What Onduarp is and what it is used for 
 
Onduarp tablets contain two active substances called telmisartan and amlodipine. Both of these 
substances help to control your high blood pressure: 
- Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. 
Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus 
increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. 
- Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops 
calcium from moving into the blood vessel wall which stops the blood vessels from tightening. 
This means that both of these active substances work together to help stop your blood vessels 
tightening. As a result, the blood vessels relax and blood pressure is lowered. 
 
Onduarp is used to treat high blood pressure 
- in adult patients whose blood pressure is not controlled enough with amlodipine. 
- in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish 
to take instead the same doses in one tablet for convenience. 
 
High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at 
risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are 
usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly 
measure blood pressure to verify if it is within the normal range. 
 
 
2. What you need to know before you take Onduarp 

 
Do not take Onduarp 
 
• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine 

(listed in section 6). 
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel 

blocker). 
• if you are more than 3 months pregnant. (It is also better to avoid Onduarp in early pregnancy – 

see Warnings and precautions and Pregnancy section.) 

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• if you have severe liver problems or biliary obstruction (problems with drainage of the bile from 
the liver and gall bladder). 

• if you suffer from severe low blood pressure (including shock). 
• if you suffer from low heart output because of a serious heart problem. 
• if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp. 
 
Warnings and precautions 
 
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or 
illnesses: 
 
• Kidney disease or kidney transplant. 
• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis). 
• Liver disease. 
• Heart trouble. 
• Raised aldosterone levels (which lead to water and salt retention in the body along with 

imbalance of various blood minerals). 
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, 
or vomiting. 

• Elevated potassium levels in your blood. 
• Diabetes. 
• Narrowing of the aorta (aortic stenosis). 
• Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). 
• A heart attack within the last four weeks. 
 
Talk to your doctor before taking Onduarp:  
• if you are taking Rasilez, a medicine used to treat high blood pressure. 
• if you are taking digoxin. 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp. 
 
Children and adolescents 
The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.  
 
Other medicines and Onduarp 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Onduarp: 
 
• Lithium-containing medicines to treat some types of depression. 
• Medicines that may increase blood potassium levels such as salt substitutes containing 

potassium, potassium-sparing diuretics (certain ‘water tablets’). 
• ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors. 
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), 

heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
• Rifampicin, St. John’s wort. 
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. 

ketoconazole). 
• Erythromycin (antibiotic). 
• Diltiazem (cardiac medicine). 

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• Simvastatin to treat elevated levels of cholesterol. 
• Rasilez, a medicine used to treat high blood pressure. 
• Digoxin. 
 
As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you 
take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or 
corticosteroids. 
 
Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, 
neuroleptics or antidepressants). Furthermore low blood pressure may be aggravated by alcohol. You 
may notice this as dizziness when standing up. 
 
Onduarp with food and drink 
 
See section 3. 
 
Grapefruit juice and grapefruit should not be consumed when you take Onduarp. This is because 
grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine 
in some patients and may increase the blood pressure lowering effect of Onduarp. 
 
Pregnancy and breast-feeding 
 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Onduarp before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Onduarp. Onduarp is not 
recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Onduarp is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
 
Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of 
spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, 
do not drive or use machines. 
 
Onduarp contains sorbitol.  
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor 
before taking this medicine. 
 
 
3. How to take Onduarp 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. 
Remove your Onduarp tablet from the blister only directly prior to intake. 
 

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You can take Onduarp with or without food. The tablets should be swallowed with some water or 
other non-alcoholic drink. 
 
If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 
40 mg/10 mg tablet per day. 
 
If you take more Onduarp than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. You might experience low blood pressure and rapid heart beat. 
Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged 
low blood pressure including shock and death have also been reported. 
 
If you forget to take Onduarp 
If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not 
take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make 
up for forgotten individual doses. 
 
If you stop taking Onduarp 
It is important that you take Onduarp every day until your doctor tells you otherwise. If you have the 
impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Some side effects can be serious and need immediate medical attention: 
 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), 
rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 
1,000 people) but are extremely serious and patients should stop taking the medicine and see their 
doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis 
has been observed with telmisartan only, however can not be ruled out for Onduarp. 
 
Common side effects (may affect up to 1 in 10 people): 
Dizziness, ankle swelling (oedema). 
 
Uncommon side effects (may affect up to 1 to 100 people): 
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning 
(vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure 
(hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache 
(abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, 
inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of 
hepatic enzymes. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve 
damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged 
gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back 
pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid 
in the blood. 
 

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The following side effects have been observed with the components telmisartan or amlodipine and 
may occur also with Onduarp: 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people):  
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common 
cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, 
bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, 
increased levels of creatinine. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood 
pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, 
abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness 
(for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), 
increased levels of creatinine phosphokinase in the blood. 
 
* Most cases of abnormal liver function and liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side 
effect. 
 
Amlodipine 
In patients taking amlodipine alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, 
change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin 
discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at 
night, enlarging of male breasts, pain, weight increased, weight decreased. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Confusion. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), 
excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart 
beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining 
(gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic 
enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives 
(urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes 
(exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun. 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet.  
 
 
5. How to store Onduarp 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
The expiry date refers to the last day of that month. 

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This medicine does not require any special temperature storage conditions. Store in the original 
package in order to protect from light and moisture. Remove your Onduarp tablet from the blister only 
directly prior to intake. 
 
Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Onduarp contains 
 
- The active substances are telmisartan and amlodipine.  

Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate). 
 

- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide 
black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, 
microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol 
(E420). 

 
What Onduarp looks like and contents of the pack 
 
Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the 
product code A1 and the company logo on the other side. 
 
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters. 
 
  
Marketing Authorisation Holder Manufacturer 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

Boehringer Ingelheim Pharma GmbH & Co. KG 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 

 

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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 

Lietuva 
Boehringer Ingelheim RCV GmbH & Co KG 
Lietuvos filialas 
Tel.: +370 37 473922 
 

България 
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ - 
клон България 
Тел: +359 2 958 79 98 
 

Luxembourg/Luxemburg 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 
 

Česká republika 
Boehringer Ingelheim spol. s r.o. 
Tel: +420 234 655 111 

Magyarország 
Boehringer Ingelheim RCV GmbH & Co KG 
Magyarországi Fióktelepe 
Tel.: +36 1 299 89 00 
 

Danmark 
Boehringer Ingelheim Danmark A/S 
Tlf: +45 39 15 88 88 

Malta 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

Deutschland 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 

Nederland 
Boehringer Ingelheim b.v. 
Tel: +31 (0) 800 22 55 889 
 

Eesti 
Boehringer Ingelheim RCV GmbH & Co KG 
Eesti Filiaal 
Tel: +372 612 8000 
 

Norge 
Boehringer Ingelheim Norway KS 
Tlf: +47 66 76 13 00 
 

Ελλάδα 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Österreich 
Boehringer Ingelheim RCV GmbH & Co KG 
Tel: +43 1 80 105-0 
 

España 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Boehringer Ingelheim Sp.zo.o. 
Tel.: +48 22 699 0 699 
 

France 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 
 

Portugal 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 

Hrvatska 
Boehringer Ingelheim Zagreb d.o.o. 
Tel: +385 1 2444 600 
 

România 
Boehringer Ingelheim RCV GmbH & Co KG 
Viena - Sucursala Bucuresti 
Tel: +40 21 302 2800 
 

Ireland 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 

Slovenija 
Boehringer Ingelheim RCV GmbH & Co KG 
Podružnica Ljubljana 
Tel: +386 1 586 40 00 
 

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Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Boehringer Ingelheim RCV GmbH & Co KG 
organizačná zložka 
Tel: +421 2 5810 1211 
 

Italia 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 

Suomi/Finland 
Boehringer Ingelheim Finland Ky 
Puh/Tel: +358 10 3102 800 
 

Κύπρος 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Sverige 
Boehringer Ingelheim AB 
Tel: +46 8 721 21 00 
 

Latvija 
Boehringer Ingelheim RCV GmbH & Co KG 
Latvijas filiāle 
Tel: +371 67 240 011 
 

United Kingdom 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 

This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 

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Package leaflet: Information for the user 
Onduarp 40 mg/10 mg tablets 

Telmisartan/Amlodipine 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. 
 
What is in this leaflet:  
1. What Onduarp is and what it is used for 
2. What you need to know before you take Onduarp 
3. How to take Onduarp 
4. Possible side effects 
5. How to store Onduarp 
6. Contents of the pack and other information 
 
 
1. What Onduarp is and what it is used for 
 
Onduarp tablets contain two active substances called telmisartan and amlodipine. Both of these 
substances help to control your high blood pressure: 
- Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. 
Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus 
increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. 
- Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops 
calcium from moving into the blood vessel wall which stops the blood vessels from tightening. 
This means that both of these active substances work together to help stop your blood vessels 
tightening. As a result, the blood vessels relax and blood pressure is lowered. 
 
Onduarp is used to treat high blood pressure 
- in adult patients whose blood pressure is not controlled enough with amlodipine. 
- in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish 
to take instead the same doses in one tablet for convenience. 
 
High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at 
risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are 
usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly 
measure blood pressure to verify if it is within the normal range. 
 
 
2. What you need to know before you take Onduarp 

 
Do not take Onduarp 
 
• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine 

(listed in section 6). 
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel 

blocker). 
• if you are more than 3 months pregnant. (It is also better to avoid Onduarp in early pregnancy – 

see Warnings and precautions and Pregnancy section.) 

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• if you have severe liver problems or biliary obstruction (problems with drainage of the bile from 
the liver and gall bladder). 

• if you suffer from severe low blood pressure (including shock). 
• if you suffer from low heart output because of a serious heart problem. 
• if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp. 
 
Warnings and precautions 
 
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or 
illnesses: 
 
• Kidney disease or kidney transplant. 
• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis). 
• Liver disease. 
• Heart trouble. 
• Raised aldosterone levels (which lead to water and salt retention in the body along with 

imbalance of various blood minerals). 
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, 
or vomiting. 

• Elevated potassium levels in your blood. 
• Diabetes. 
• Narrowing of the aorta (aortic stenosis). 
• Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). 
• A heart attack within the last four weeks. 
 
Talk to your doctor before taking Onduarp: 
• if you are taking Rasilez, a medicine used to treat high blood pressure. 
• if you are taking digoxin. 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.  
 
Children and adolescents 
The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.  
 
Other medicines and Onduarp 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Onduarp: 
 
• Lithium-containing medicines to treat some types of depression. 
• Medicines that may increase blood potassium levels such as salt substitutes containing 

potassium, potassium-sparing diuretics (certain ‘water tablets’). 
• ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors. 
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), 

heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
• Rifampicin, St. John’s wort. 
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. 

ketoconazole). 
• Erythromycin (antibiotic). 
• Diltiazem (cardiac medicine). 

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• Simvastatin to treat elevated levels of cholesterol. 
• Rasilez, a medicine used to treat high blood pressure. 
• Digoxin. 
 
As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you 
take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or 
corticosteroids. 
 
Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, 
neuroleptics or antidepressants). Furthermore low blood pressure may be aggravated by alcohol. You 
may notice this as dizziness when standing up. 
 
Onduarp with food and drink 
 
See section 3. 
 
Grapefruit juice and grapefruit should not be consumed when you take Onduarp. This is because 
grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine 
in some patients and may increase the blood pressure lowering effect of Onduarp. 
 
Pregnancy and breast-feeding 
 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Onduarp before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Onduarp. Onduarp is not 
recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Onduarp is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
 
Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of 
spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, 
do not drive or use machines. 
 
Onduarp contains sorbitol.  
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor 
before taking this medicine. 
 
 
3. How to take Onduarp 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. 
Remove your Onduarp tablet from the blister only directly prior to intake. 
 

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You can take Onduarp with or without food. The tablets should be swallowed with some water or 
other non-alcoholic drink. 
 
If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 
40 mg/10 mg tablet per day. 
 
If you take more Onduarp than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. You might experience low blood pressure and rapid heart beat. 
Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged 
low blood pressure including shock and death have also been reported. 
 
If you forget to take Onduarp 
If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not 
take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make 
up for forgotten individual doses. 
 
If you stop taking Onduarp 
It is important that you take Onduarp every day until your doctor tells you otherwise. If you have the 
impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Some side effects can be serious and need immediate medical attention: 
 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), 
rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 
1,000 people) but are extremely serious and patients should stop taking the medicine and see their 
doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis 
has been observed with telmisartan only, however can not be ruled out for Onduarp. 
 
Common side effects (may affect up to 1 in 10 people):  
Dizziness, ankle swelling (oedema). 
 
Uncommon side effects (may affect up to 1 in 100 people):  
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning 
(vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure 
(hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache 
(abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, 
inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of 
hepatic enzymes. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve 
damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged 
gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back 
pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid 
in the blood. 
 

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The following side effects have been observed with the components telmisartan or amlodipine and 
may occur also with Onduarp: 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people):  
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common 
cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, 
bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, 
increased levels of creatinine. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood 
pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, 
abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness 
(for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), 
increased levels of creatinine phosphokinase in the blood. 
 
* Most cases of abnormal liver function and liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side 
effect. 
 
Amlodipine 
In patients taking amlodipine alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, 
change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin 
discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at 
night, enlarging of male breasts, pain, weight increased, weight decreased. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Confusion. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), 
excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart 
beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining 
(gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic 
enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives 
(urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes 
(exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun. 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet.  
 
 
5. How to store Onduarp 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
The expiry date refers to the last day of that month. 

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This medicine does not require any special temperature storage conditions.Store in the original 
package in order to protect from light and moisture. Remove your Onduarp tablet from the blister only 
directly prior to intake. 
 
Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Onduarp contains 
 
- The active substances are telmisartan and amlodipine.  

Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate). 
 

- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide 
black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, 
microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol 
(E420). 

 
What Onduarp looks like and contents of the pack 
 
Onduarp 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the 
product code A2 and the company logo on the other side. 
 
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters. 
 
 
Marketing Authorisation Holder Manufacturer 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

Boehringer Ingelheim Pharma GmbH & Co. KG 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 

 

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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 

Lietuva 
Boehringer Ingelheim RCV GmbH & Co KG 
Lietuvos filialas 
Tel.: +370 37 473922 
 

България 
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ – 
клон България 
Тел: +359 2 958 79 98 
 

Luxembourg/Luxemburg 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 
 
 

Česká republika 
Boehringer Ingelheim spol. S r.o. 
Tel: +420 234 655 111 

Magyarország 
Boehringer Ingelheim RCV GmbH & Co KG 
Magyarországi Fióktelepe 
Tel.: +36 1 299 89 00 
 

Danmark 
Boehringer Ingelheim Danmark A/S 
Tlf: +45 39 15 88 88 

Malta 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

Deutschland 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 

Nederland 
Boehringer Ingelheim b.v. 
Tel: +31 (0) 800 22 55 889 
 

Eesti 
Boehringer Ingelheim RCV GmbH & Co KG 
Eesti Filiaal 
Tel: +372 612 8000 
 

Norge 
Boehringer Ingelheim Norway KS 
Tlf: +47 66 76 13 00 
 

Ελλάδα 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Österreich 
Boehringer Ingelheim RCV GmbH & Co KG 
Tel: +43 1 80 105-0 
 

España 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Boehringer Ingelheim Sp.zo.o. 
Tel.: +48 22 699 0 699 
 

France 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 
 

Portugal 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 

Hrvatska 
Boehringer Ingelheim Zagreb d.o.o. 
Tel: +385 1 2444 600 
 

România 
Boehringer Ingelheim RCV GmbH & Co KG 
Viena – Sucursala Bucuresti 
Tel: +40 21 302 2800 
 

Ireland 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 

Slovenija 
Boehringer Ingelheim RCV GmbH & Co KG 
Podružnica Ljubljana 
Tel: +386 1 586 40 00 
 

Ísland 
Vistor hf. 

Slovenská republika 
Boehringer Ingelheim RCV GmbH & Co KG 

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Sími: +354 535 7000 
 

organizačná zložka 
Tel: +421 2 5810 1211 
 

Italia 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 

Suomi/Finland 
Boehringer Ingelheim Finland Ky 
Puh/Tel: +358 10 3102 800 
 

Κύπρος 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Sverige 
Boehringer Ingelheim AB 
Tel: +46 8 721 21 00 
 

Latvija 
Boehringer Ingelheim RCV GmbH & Co KG 
Latvijas filiāle 
Tel: +371 67 240 011 
 

United Kingdom 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 

This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

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Package leaflet: Information for the user 
Onduarp 80 mg/5 mg tablets 

Telmisartan/Amlodipine 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. 
 
What is in this leaflet:  
1. What Onduarp is and what it is used for 
2. What you need to know before you take Onduarp 
3. How to take Onduarp 
4. Possible side effects 
5. How to store Onduarp 
6. Contents of the pack and other information 
 
 
1. What Onduarp is and what it is used for 
 
Onduarp tablets contain two active substances called telmisartan and amlodipine. Both of these 
substances help to control your high blood pressure: 
- Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. 
Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus 
increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. 
- Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops 
calcium from moving into the blood vessel wall which stops the blood vessels from tightening. 
This means that both of these active substances work together to help stop your blood vessels 
tightening. As a result, the blood vessels relax and blood pressure is lowered. 
 
Onduarp is used to treat high blood pressure 
- in adult patients whose blood pressure is not controlled enough with amlodipine. 
- in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish 
to take instead the same doses in one tablet for convenience. 
 
High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at 
risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are 
usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly 
measure blood pressure to verify if it is within the normal range. 
 
 
2. What you need to know before you take Onduarp 

 
Do not take Onduarp 
• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine 

(listed in section 6). 
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel 

blocker). 
• if you are more than 3 months pregnant. (It is also better to avoid Onduarp in early pregnancy – 

see Warnings and precautions and Pregnancy section.) 
• if you have severe liver problems or biliary obstruction (problems with drainage of the bile from 

the liver and gall bladder). 

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• if you suffer from severe low blood pressure (including shock). 
• if you suffer from low heart output because of a serious heart problem. 
• if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp. 
 
Warnings and precautions 
 
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or 
illnesses: 
 
• Kidney disease or kidney transplant. 
• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis). 
• Liver disease. 
• Heart trouble. 
• Raised aldosterone levels (which lead to water and salt retention in the body along with 

imbalance of various blood minerals). 
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, 
or vomiting. 

• Elevated potassium levels in your blood. 
• Diabetes. 
• Narrowing of the aorta (aortic stenosis). 
• Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). 
• A heart attack within the last four weeks. 
 
Talk to your doctor before taking Onduarp: 
• if you are taking Rasilez, a medicine used to treat high blood pressure. 
• if you are taking digoxin. 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.  
 
Children and adolescents 
The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.  
 
Other medicines and Onduarp 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Onduarp: 
 
• Lithium-containing medicines to treat some types of depression. 
• Medicines that may increase blood potassium levels such as salt substitutes containing 

potassium, potassium-sparing diuretics (certain ‘water tablets’). 
• ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors. 
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), 

heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
• Rifampicin, St. John’s wort. 
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. 

ketoconazole). 
• Erythromycin (antibiotic). 
• Diltiazem (cardiac medicine). 
• Simvastatin to treat elevated levels of cholesterol. 
• Rasilez, a medicine used to treat high blood pressure. 

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• Digoxin. 
 
As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you 
take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or 
corticosteroids. 
 
Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, 
neuroleptics or antidepressants). Furthermore low blood pressure may be aggravated by alcohol. You 
may notice this as dizziness when standing up. 
 
Onduarp with food and drink 
 
See section 3. 
 
Grapefruit juice and grapefruit should not be consumed when you take Onduarp. This is because 
grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine 
in some patients and may increase the blood pressure lowering effect of Onduarp. 
 
Pregnancy and breast-feeding 
 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Onduarp before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Onduarp. Onduarp is not 
recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Onduarp is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
 
Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of 
spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, 
do not drive or use machines. 
 
Onduarp contains sorbitol.  
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor 
before taking this medicine. 
 
 
3. How to take Onduarp 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. 
Remove your Onduarp tablet from the blister only directly prior to intake. 
 
You can take Onduarp with or without food. The tablets should be swallowed with some water or 
other non-alcoholic drink. 

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If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 
40 mg/10 mg tablet per day. 
 
If you take more Onduarp than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. You might experience low blood pressure and rapid heart beat. 
Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged 
low blood pressure including shock and death have also been reported. 
 
If you forget to take Onduarp 
If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not 
take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make 
up for forgotten individual doses. 
 
If you stop taking Onduarp 
It is important that you take Onduarp every day until your doctor tells you otherwise. If you have the 
impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Some side effects can be serious and need immediate medical attention: 
 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), 
rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 
1,000 people) but are extremely serious and patients should stop taking the medicine and see their 
doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis 
has been observed with telmisartan only, however can not be ruled out for Onduarp. 
 
Common side effects (may affect up to 1 in 10 people):  
Dizziness, ankle swelling (oedema). 
 
Uncommon side effects (may affect up to 1 in 100 people):  
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning 
(vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure 
(hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache 
(abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, 
inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of 
hepatic enzymes. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve 
damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged 
gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back 
pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid 
in the blood. 
 
The following side effects have been observed with the components telmisartan or amlodipine and 
may occur also with Onduarp: 

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Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people):  
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common 
cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, 
bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, 
increased levels of creatinine. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood 
pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, 
abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness 
(for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), 
increased levels of creatinine phosphokinase in the blood. 
 
* Most cases of abnormal liver function and liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side 
effect. 
 
Amlodipine 
In patients taking amlodipine alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, 
change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin 
discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at 
night, enlarging of male breasts, pain, weight increased, weight decreased. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Confusion. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), 
excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart 
beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining 
(gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic 
enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives 
(urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes 
(exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun. 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet.  
 
 
5. How to store Onduarp 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
The expiry date refers to the last day of that month. 
 

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This medicine does not require any special temperature storage conditions. Store in the original 
package in order to protect from light and moisture. Remove your Onduarp tablet from the blister only 
directly prior to intake. 
 
Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Onduarp contains 
 
- The active substances are telmisartan and amlodipine.  

Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate). 
 

- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide 
black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, 
microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol 
(E420). 

 
What Onduarp looks like and contents of the pack 
 
Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the 
product code A3 and the company logo on the other side. 
 
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a 
folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
  
Marketing Authorisation Holder Manufacturer 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

Boehringer Ingelheim Pharma GmbH & Co. KG 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 

 

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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 

Lietuva 
Boehringer Ingelheim RCV GmbH & Co KG 
Lietuvos filialas 
Tel.: +370 37 473922 
 

България 
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ - 
клон България 
Тел: +359 2 958 79 98 
 

Luxembourg/Luxemburg 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 
 

Česká republika 
Boehringer Ingelheim spol. s r.o. 
Tel: +420 234 655 111 

Magyarország 
Boehringer Ingelheim RCV GmbH & Co KG 
Magyarországi Fióktelepe 
Tel.: +36 1 299 89 00 
 

Danmark 
Boehringer Ingelheim Danmark A/S 
Tlf: +45 39 15 88 88 

Malta 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

Deutschland 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 

Nederland 
Boehringer Ingelheim b.v. 
Tel: +31 (0) 800 22 55 889 
 

Eesti 
Boehringer Ingelheim RCV GmbH & Co KG 
Eesti Filiaal 
Tel: +372 612 8000 
 

Norge 
Boehringer Ingelheim Norway KS 
Tlf: +47 66 76 13 00 
 

Ελλάδα 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Österreich 
Boehringer Ingelheim RCV GmbH & Co KG 
Tel: +43 1 80 105-0 
 

España 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Boehringer Ingelheim Sp.zo.o. 
Tel.: +48 22 699 0 699 
 

France 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 

Portugal 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 
 

Hrvatska 
Boehringer Ingelheim Zagreb d.o.o. 
Tel: +385 1 2444 600 
 

România 
Boehringer Ingelheim RCV GmbH & Co KG 
Viena - Sucursala Bucuresti 
Tel: +40 21 302 2800 
 

Ireland 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 

Slovenija 
Boehringer Ingelheim RCV GmbH & Co KG 
Podružnica Ljubljana 
Tel: +386 1 586 40 00 
 

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Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Boehringer Ingelheim RCV GmbH & Co KG 
organizačná zložka 
Tel: +421 2 5810 1211 
 

Italia 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 

Suomi/Finland 
Boehringer Ingelheim Finland Ky 
Puh/Tel: +358 10 3102 800 
 

Κύπρος 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Sverige 
Boehringer Ingelheim AB 
Tel: +46 8 721 21 00 
 

Latvija 
Boehringer Ingelheim RCV GmbH & Co KG 
Latvijas filiāle 
Tel: +371 67 240 011 
 

United Kingdom 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 

This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 

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Package leaflet: Information for the user 
Onduarp 80 mg/10 mg tablets 

Telmisartan/Amlodipine 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. 
 
What is in this leaflet:  
1. What Onduarp is and what it is used for 
2. What you need to know before you take Onduarp 
3. How to take Onduarp 
4. Possible side effects 
5. How to store Onduarp 
6. Contents of the pack and other information 
 
 
1. What Onduarp is and what it is used for 
 
Onduarp tablets contain two active substances called telmisartan and amlodipine. Both of these 
substances help to control your high blood pressure: 
- Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. 
Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus 
increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. 
- Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops 
calcium from moving into the blood vessel wall which stops the blood vessels from tightening. 
This means that both of these active substances work together to help stop your blood vessels 
tightening. As a result, the blood vessels relax and blood pressure is lowered. 
 
Onduarp is used to treat high blood pressure 
- in adult patients whose blood pressure is not controlled enough with amlodipine. 
- in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish 
to take instead the same doses in one tablet for convenience. 
 
High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at 
risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are 
usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly 
measure blood pressure to verify if it is within the normal range. 
 
 
2. What you need to know before you take Onduarp 

 
Do not take Onduarp 
 
• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine 

(listed in section 6). 
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel 

blocker). 
• if you are more than 3 months pregnant. (It is also better to avoid Onduarp in early pregnancy – 

see Warnings and precautions and Pregnancy section.) 

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• if you have severe liver problems or biliary obstruction (problems with drainage of the bile from 
the liver and gall bladder). 

• if you suffer from severe low blood pressure (including shock). 
• if you suffer from low heart output because of a serious heart problem. 
• if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp. 
 
Warnings and precautions 
 
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or 
illnesses: 
 
• Kidney disease or kidney transplant. 
• Narrowing of the blood vessels to one or both kidneys (renal artery stenosis). 
• Liver disease. 
• Heart trouble. 
• Raised aldosterone levels (which lead to water and salt retention in the body along with 

imbalance of various blood minerals). 
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body 

water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, 
or vomiting. 

• Elevated potassium levels in your blood. 
• Diabetes. 
• Narrowing of the aorta (aortic stenosis). 
• Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). 
• A heart attack within the last four weeks. 
 
Talk to your doctor before taking Onduarp: 
• if you are taking Rasilez, a medicine used to treat high blood pressure. 
• if you are taking digoxin. 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.  
 
Children and adolescents 
The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.  
 
Other medicines and Onduarp 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Your doctor may need to change the dose of these other medicines or take other 
precautions. In some cases you may have to stop taking one of the medicines. This applies especially 
to the medicines listed below taken at the same time with Onduarp: 
 
• Lithium-containing medicines to treat some types of depression. 
• Medicines that may increase blood potassium levels such as salt substitutes containing 

potassium, potassium-sparing diuretics (certain ‘water tablets’). 
• ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors. 
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), 

heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
• Rifampicin, St. John’s wort. 
• Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. 

ketoconazole). 
• Erythromycin (antibiotic). 
• Diltiazem (cardiac medicine). 

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• Simvastatin to treat elevated levels of cholesterol. 
• Rasilez, a medicine used to treat high blood pressure. 
• Digoxin. 
 
As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you 
take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or 
corticosteroids. 
 
Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, 
neuroleptics or antidepressants). Furthermore low blood pressure may be aggravated by alcohol. You 
may notice this as dizziness when standing up. 
 
Onduarp with food and drink 
 
See section 3. 
 
Grapefruit juice and grapefruit should not be consumed when you take Onduarp. This is because 
grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine 
in some patients and may increase the blood pressure lowering effect of Onduarp. 
 
Pregnancy and breast-feeding 
 
Pregnancy 
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Onduarp before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Onduarp. Onduarp is not 
recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may 
cause serious harm to your baby if used after the third month of pregnancy. 
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding. Onduarp is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
 
Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of 
spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, 
do not drive or use machines. 
 
Onduarp contains sorbitol.  
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor 
before taking this medicine. 
 
 
3. How to take Onduarp 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. 
Remove your Onduarp tablet from the blister only directly prior to intake. 
 

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You can take Onduarp with or without food. The tablets should be swallowed with some water or 
other non-alcoholic drink. 
 
If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 
40 mg/10 mg tablet per day. 
 
If you take more Onduarp than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. You might experience low blood pressure and rapid heart beat. 
Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged 
low blood pressure including shock and death have also been reported. 
 
If you forget to take Onduarp 
If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not 
take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make 
up for forgotten individual doses. 
 
If you stop taking Onduarp 
It is important that you take Onduarp every day until your doctor tells you otherwise. If you have the 
impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Some side effects can be serious and need immediate medical attention: 
 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), 
rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 
1,000 people) but are extremely serious and patients should stop taking the medicine and see their 
doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis 
has been observed with telmisartan only, however can not be ruled out for Onduarp. 
 
Common side effects (may affect up to 1 in 10 people): 
Dizziness, ankle swelling (oedema). 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning 
(vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure 
(hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache 
(abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, 
inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of 
hepatic enzymes. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve 
damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged 
gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back 
pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid 
in the blood. 
 

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The following side effects have been observed with the components telmisartan or amlodipine and 
may occur also with Onduarp: 
 
Telmisartan 
In patients taking telmisartan alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common 
cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, 
bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, 
increased levels of creatinine. 
 
Rare side effects (may affect up to 1 in 1,000 people):  
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood 
pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, 
abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness 
(for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), 
increased levels of creatinine phosphokinase in the blood. 
 
* Most cases of abnormal liver function and liver disorder from post-marketing experience with 
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side 
effect. 
 
Amlodipine 
In patients taking amlodipine alone the following additional side effects have been reported: 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, 
change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin 
discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at 
night, enlarging of male breasts, pain, weight increased, weight decreased. 
 
Rare side effects are (may affect up to 1 in 1,000 people):  
Confusion. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic 
reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), 
excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart 
beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining 
(gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic 
enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives 
(urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes 
(exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun. 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet.  
 
 
5. How to store Onduarp 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 
The expiry date refers to the last day of that month. 

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This medicine does not require any special temperature storage conditions. Store in the original 
package in order to protect from light and moisture. Remove your Onduarp tablet from the blister only 
directly prior to intake. 
 
Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Onduarp contains 
 
- The active substances are telmisartan and amlodipine.  

Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate). 
 

- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide 
black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, 
microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol 
(E420). 

 
What Onduarp looks like and contents of the pack 
 
Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the 
product code A4 and the company logo on the other side. 
 
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a 
folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
  
Marketing Authorisation Holder Manufacturer 
Boehringer Ingelheim International GmbH 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 

Boehringer Ingelheim Pharma GmbH & Co. KG 
Binger Str. 173 
D-55216 Ingelheim am Rhein 
Germany 
 

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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 

Lietuva 
Boehringer Ingelheim RCV GmbH & Co KG 
Lietuvos filialas 
Tel.: +370 37 473922 
 

България 
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ - 
клон България 
Тел: +359 2 958 79 98 
 

Luxembourg/Luxemburg 
SCS Boehringer Ingelheim Comm.V 
Tél/Tel: +32 2 773 33 11 
 

Česká republika 
Boehringer Ingelheim spol. s r.o. 
Tel: +420 234 655 111 

Magyarország 
Boehringer Ingelheim RCV GmbH & Co KG 
Magyarországi Fióktelepe 
Tel.: +36 1 299 89 00 
 

Danmark 
Boehringer Ingelheim Danmark A/S 
Tlf: +45 39 15 88 88 

Malta 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

Deutschland 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 

Nederland 
Boehringer Ingelheim b.v. 
Tel: +31 (0) 800 22 55 889 
 

Eesti 
Boehringer Ingelheim RCV GmbH & Co KG 
Eesti Filiaal 
Tel: +372 612 8000 
 

Norge 
Boehringer Ingelheim Norway KS 
Tlf: +47 66 76 13 00 
 

Ελλάδα 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Österreich 
Boehringer Ingelheim RCV GmbH & Co KG 
Tel: +43 1 80 105-0 
 

España 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Boehringer Ingelheim Sp.zo.o. 
Tel.: +48 22 699 0 699 
 

France 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 

Portugal 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 
 

Hrvatska 
Boehringer Ingelheim Zagreb d.o.o. 
Tel: +385 1 2444 600 
 

România 
Boehringer Ingelheim RCV GmbH & Co KG 
Viena - Sucursala Bucuresti 
Tel: +40 21 302 2800 
 

Ireland 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 

Slovenija 
Boehringer Ingelheim RCV GmbH & Co KG 
Podružnica Ljubljana 
Tel: +386 1 586 40 00 
 

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Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Boehringer Ingelheim RCV GmbH & Co KG 
organizačná zložka 
Tel: +421 2 5810 1211 
 

Italia 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 

Suomi/Finland 
Boehringer Ingelheim Finland Ky 
Puh/Tel: +358 10 3102 800 
 

Κύπρος 
Boehringer Ingelheim Ellas A.E. 
Tηλ: +30 2 10 89 06 300 

Sverige 
Boehringer Ingelheim AB 
Tel: +46 8 721 21 00 
 

Latvija 
Boehringer Ingelheim RCV GmbH & Co KG 
Latvijas filiāle 
Tel: +371 67 240 011 
 

United Kingdom 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 

This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET