Telmisartan Teva

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 20 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 20 mg telmisartan 
 
Excipients with known effect:  
 
Each tablet contains 21.4 mg sorbitol (E420) 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
White to off white, oval shaped tablet; one side of the tablet is debossed with the number 
"93". The other side of the tablet is debossed with the number "7458". 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Hypertension 
Treatment of essential hypertension in adults. 
 
Cardiovascular prevention 
Reduction of cardiovascular morbidity in adults with: 
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral 

arterial disease) or 
• type 2 diabetes mellitus with documented target organ damage 
 
4.2 Posology and method of administration 
 
Posology 
 
Treatment of essential hypertension 
The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. 
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a 
maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type 
diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering 
effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum 
antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1). 
 
Cardiovascular prevention 
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan 
are effective in reducing cardiovascular morbidity. 
When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood 
pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be 
necessary. 
 



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Special populations 
 
Patients with renal impairment  
Limited experience is available in patients with severe renal impairment or haemodialysis. 
A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment 
is required for patients with mild to moderate renal impairment.  
 
Patients with hepatic impairment 
Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3). 
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see 
section 4.4). 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. 
 
Paediatric population 
 
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 have not been 
established.  
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be 
made. 
 
Method of administration 
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without 
food. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Second and third trimester of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders 
• Severe hepatic impairment 
 
The concomitant use of Telmisartan Teva with aliskiren-containing products is contraindicated in patients 
with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
 
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 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 sections 4.3 and 4.6). 
 
Hepatic impairment 
Telmisartan Teva is not to be given to patients with cholestasis, biliary obstructive disorders or severe 
hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile. These patients can 
be expected to have reduced hepatic clearance for telmisartan. Telmisartan Teva should be used only with 
caution in patients with mild to moderate hepatic impairment. 
 
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. 
 



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Renal impairment and kidney transplantation 
When Telmisartan Teva is used in patients with impaired renal function, periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Telmisartan Teva in patients with recent kidney transplantation. 
 
Intravascular hypovolaemia 
Symptomatic hypotension, especially after the first dose of Telmisartan Teva, may occur in patients who are 
volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. 
Such conditions should be corrected before the administration of Telmisartan Teva. Volume and/or sodium 
depletion should be corrected prior to administration of Telmisartan Teva. 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
 
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren 
increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). 
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or 
aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist 
supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with 
diabetic nephropathy. 
 
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 such as telmisartan 
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. 
 
Diabetic patients treated with insulin or antidiabetics 
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
approptiate 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. 
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, 
hyperkalaemia may be fatal. 
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone 
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-

aldosteronesystem and/or potassium supplements. Medicinal products or therapeutic classes of 
medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, 



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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 dehydratation, 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, extend trauma). 

 
Close monitoring of serum potassium in at risk patients is recommended (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Telmisartan Teva. 
 
Ethnic differences 
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor 
antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, 
possibly because of higher prevalence of low-renin states in the black hypertensive population. 
 
Other 
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic 
cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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. 

 

As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may 
provoke hyperkalaemia (see section 4.4). The risk may increase in case of treatment combination with other 
medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-
sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory 
medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives 
(cyclosporin or tacrolimus), and trimethoprim). 
 
The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the 
above-mentioned treatment combinations. The risk is particularly high in combination with potassium 
sparing-diuretics, and when combined with salt substitutes containing potassium. A combination with ACE 
inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly 
followed. 
 
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. spironolactone, 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 



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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 agents 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. 
 
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. 
 
Diuretics (thiazide or loop diuretics) 
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide 
diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with 
telmisartan. 
 
To be taken into account with concomitant use 
 
Other antihypertensive agents 
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through 
the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher 
frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including 
acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
 
Based on their pharmacological properties it can be expected that the following medicinal products may 
potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or 
antidepressants. 
 
Corticosteroïds (systemic route) 
Reduction of the antihypertensive effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
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 trimester of pregnancy (see sections 4.3 and 4.4). 
 
There are no adequate data from the use of Telmisartan Teva in pregnant women. Studies 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, 



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similar risks may exist for this class of drugs. 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). 
 
Breast-feeding 
Because no information is available regarding the use of Telmisartan Teva during breast-feeding, 
Telmisartan Teva is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
 
Fertility  
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
 
4.7 Effects on ability to drive and use machines 
 
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness 
may occasionally occur when taking antihypertensive therapy, such as Telmisartan Teva. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely 
(≥1/10,000 to <1/1,000), and acute renal failure. 
 
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo 
(41.4% vs 43.9 %) in controlled trials in patients treated for hypertension. The incidence of adverse reactions 
was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of 
telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained 
in hypertensive patients. 
 
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated 
for hypertension and from post-marketing reports. The listing also takes into account serious adverse 
reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies 
including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six 
years. 
 
Tabulated summary 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). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Infections and infestations 
Uncommon: Urinary tract infection including cystitis, upper 

respiratory tract infection including pharyngitis 



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and sinusitis 
Rare: Sepsis including fatal outcome1 
  
Blood and the lymphatic system disorders 
Uncommon Anaemia 
Rare: Eosinophilia thrombocytopenia 
  
Immune system disorders 
Rare: Anaphylactic reaction, hypersensitivity 
  
Metabolism and nutrition disorders 
Uncommon Hyperkalaemia 
Rare: Hypoglycaemia (in diabetic patients) 
  
Psychiatric disorders 
Uncommon: Insomnia, depression 
Rare: Anxiety 
  
Nervous system disorders 
Uncommon: Syncope 
Rare: Somnolence 
  
Eye disorders 
Rare: Visual disturbance 
  
Ear and labyrinth disorders 
Uncommon: Vertigo 
  
Cardiac disorders 
Uncommon: Bradycardia 
Rare: Tachycardia 
  
Vascular disorders 
Uncommon: Hypotension2, orthostatic hypotension 
  
Respiratory, thoracic and mediastinal disorders 
Uncommon: Dyspnoea, cough 
Very rare: Interstinal lung disease4 
  
Gastrointestinal disorders 
Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, 

vomiting 
Rare: Dry mouth, stomach discomfort, dysgeusia 
  
Hepato-biliary disorders 
Rare: Hepatic function abnormal/liver disorder3 
  
Skin and subcutaneous tissue disorders 
Uncommon: Pruritus, hyperhidrosis, rash 
Rare: Angioedema (also with fatal outcome), eczema, 

erythema, urticaria, drug eruption, toxic skin 
eruption  

  
Muscoloskeletal and connective tissue disorders 



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Uncommon: Back pain (e.g. sciatica), muscle spasms, myalgia 
Rare: Arthralgia, pain in extremetis, tendon pain 

(tendenitis like symptoms) 
  
Renal and urinary disorders 
Uncommon: Renal impairment including acute renal failure 
  
General disorders and administration site conditions 
Uncommon: Chest pain, asthenia (weakness) 
Rare: Influenza-like illness 
  
Investigations 
Uncommon: Blood creatinine increased 
Rare: Haemoglobin decreased, blood uric acid 

increased, hepatic enzyme increased, blood 
creatine phosphokinase increased 

 
1, 2, 3, 4: for further descriptions, please see sub-section  “Description of selected adverse reactions”. 
 
Description of selected adverse reactions 
 
Sepsis 
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with 
placebo. The event may be a chance finding or related to a mechanism currently not known (see also section 
5.1). 
 
Hypotension 
This adverse reaction was reported as common in patients with controlled blood pressure who were treated 
with telmisartan for the reduction of cardiovascular morbidity on top of standard care. 
 
Hepatic function abnormal / liver disorder 
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in 
Japanese patients. Japanese patients are more likely to experience these adverse reactions. 
 
Interstitial lung disease 
Cases of interstitial lung disease have been reported from post-marketing experience in temporal association 
with the intake of telmisartan. However, a causal relationship has not been established. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
There is limited information available with regard to overdose in humans. 
 
Symptoms 
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia 
dizziness, increase in serum creatinine, and acute renal failure have also been reported. 
 
Treatment 
Telmisartan is not removed by haemodialysis. 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 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored 
frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume 
replacement given quickly. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07. 
 
Mechanism of action 
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 effects. 
 
In human, 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. 
 
Clinical efficacy and safety 
 
Treatment of essential hypertension 
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 agents 
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. 
 
Cardiovascular prevention 
 
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) 
compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on 



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cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, 
stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ 
damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at 
risk for cardiovascular events. 
 
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), 
ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and 
followed for a mean observation time of 4.5 years.  
 
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular 
death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure. The 
incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups. The 
hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a 
margin of 1.13). The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated 
patients, respectively. 
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with 
Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) 
have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker. 
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, 
or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in 
patients with type 2 diabetes mellitus and diabetic nephropathy. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to 
monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant 
for other ACE-inhibitors and angiotensin II receptor blockers. 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients 
with diabetic nephropathy. 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a 
study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an 
angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, 
cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse 
outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than 
in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension 
and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group. 
 
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of 
cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p 
(non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes 
Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.  
 
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as 
ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. The 
mean duration of follow up was 4 years and 8 months. No statistically significant difference in the incidence 
of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or 
hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo 
groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)]. There was evidence for a benefit of 
telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, 
non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)]. There was no 
evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24). 
 
Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients 
treated with ramipril, whereas hypotension was more frequently reported with telmisartan.  
 
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV 
mortality and all cause mortality were numerically higher with the combination. In addition, there was a 



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significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination 
arm. Therefore the use of a combination of telmisartan and ramipril is not recommended in this population. 
 
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years 
and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan 
compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence 
of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 
%) [RR 2.07 (95 % confidence interval 1.14 - 3.76)]. The observed increased occurrence rate of sepsis 
associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently 
known. 
 
Paediatric population  
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been 
established. 
 
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely 
overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking 
telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By 
inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients 
the doses used were higher than those recommended in the treatment of hypertension in the adult population, 
reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group 
effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 
2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group. The 
adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg 
respectively. The change was dose dependent. The safety data from this study in patients aged 6 to < 18 
years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan 
in children and adolescents was not evaluated. 
An increase in eosinophils reported in this patient population has not been recorded in adults. Its clinical 
significance and relevance is unknown. 
These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in 
hypertensive paediatric population. 
 
5.2 Pharmacokinetic properties 
 
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. 
 
Linearity/non-linearity 
The small reduction in AUC 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. 
 
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. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological 
activity has been shown for the conjugate. 
 
Elimination 



13 

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). 
 
Special Populations 
 
Paediatric population 
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive 
patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment 
period. Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children 
and adolescents, and investigation of age-related differences. Although the study was too small for a 
meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally 
consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax. 
 
Gender 
Differences in plasma concentrations 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 between the elderly and those younger than 65 years. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations 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 patients and cannot 
be removed by dialysis. The elimination half-life is not changed in patients with renal impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability 
up to nearly 100 %. The elimination half-life is not changed in patients with hepatic impairment. 
 
5.3 Preclinical safety data 
 
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. 
 



14 

There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence 
of carcinogenicity in rats and mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Microcrystalline cellulose (Avicel PH 102) 
Sodium starch glycolate (Type A) 
Poloxamers 
Meglumine 
Povidone (PVP K-30) 
Sorbitol (E420) 
Magnesium stearate 
 
 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Aluminium-Aluminium peelable perforated unit-dose blisters and aluminium-aluminium perforated unit-
dose blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated 
blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters. 
 
Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/001 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium 



15 

blisters 
EU/1/09/610/002 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/003 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/004 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/005 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/006 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/007 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/008 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/009 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 
EU/1/09/610/010 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium-

aluminium blisters 
EU/1/09/610/031 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/032 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/033 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/034 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/035 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/036 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/037 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/038 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/039 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/040 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 January 2010 
 
Date of the latest renewal: 19 December 2014 
 
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/. 
 

http://www.emea.europa.eu/


16 

1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 40 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 40 mg telmisartan 
 
Excipients with known effect:  
 
Each tablet contains 42.8 mg sorbitol (E420) 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
White to off white, oval shaped tablet; one side of the tablet is debossed with the number 
"93". The other side of the tablet is debossed with the number "7459". 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Hypertension 
Treatment of essential hypertension in adults. 
 
Cardiovascular prevention 
Reduction of cardiovascular morbidity in adults with: 
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral 

arterial disease) or 
• type 2 diabetes mellitus with documented target organ damage 
 
4.2 Posology and method of administration 
 
Posology 
 
Treatment of essential hypertension 
The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. 
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a 
maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type 
diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering 
effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum 
antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1). 
 
Cardiovascular prevention 
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan 
are effective in reducing cardiovascular morbidity. 
When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood 
pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be 
necessary. 
 



17 

Special populations 
 
Patients with renal impairment  
Limited experience is available in patients with severe renal impairment or haemodialysis. 
A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment 
is required for patients with mild to moderate renal impairment.  
 
Patients with hepatic impairment 
Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3). 
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see 
section 4.4). 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. 
 
Paediatric population 
 
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 have not been 
established.  
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be 
made. 
 
Method of administration 
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without 
food. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Second and third trimester of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders 
• Severe hepatic impairment 
 
The concomitant use of Telmisartan Teva with aliskiren-containing products is contraindicated in patients 
with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
 
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 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 sections 4.3 and 4.6). 
 
Hepatic impairment 
Telmisartan Teva is not to be given to patients with cholestasis, biliary obstructive disorders or severe 
hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile. These patients can 
be expected to have reduced hepatic clearance for telmisartan. Telmisartan Teva should be used only with 
caution in patients with mild to moderate hepatic impairment. 
 
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. 
 



18 

Renal impairment and kidney transplantation 
When Telmisartan Teva is used in patients with impaired renal function, periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Telmisartan Teva in patients with recent kidney transplantation. 
 
Intravascular hypovolaemia 
Symptomatic hypotension, especially after the first dose of Telmisartan Teva, may occur in patients who are 
volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. 
Such conditions should be corrected before the administration of Telmisartan Teva. Volume and/or sodium 
depletion should be corrected prior to administration of Telmisartan Teva. 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren 
increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). 
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or 
aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist 
supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with 
diabetic nephropathy. 
 
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 such as telmisartan 
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. 
 
Diabetic patients treated with insulin or antidiabetics  
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
approptiate 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. 
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, 
hyperkalaemia may be fatal. 
 
Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone 
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 



19 

medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives 
(cyclosporin or tacrolimus), and trimethoprim. 

- Intercurrent events, in particular dehydratation, 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, extend trauma). 

 
Close monitoring of serum potassium in at risk patients is recommended (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Telmisartan Teva. 
 
Ethnic differences 
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor 
antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, 
possibly because of higher prevalence of low-renin states in the black hypertensive population. 
 
Other 
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic 
cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 

 

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. 
 
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may 
provoke hyperkalaemia (see section 4.4). The risk may increase in case of treatment combination with other 
medicinal products that may also provoke hyperkalaemia (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). 
 
The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the 
above-mentioned treatment combinations. The risk is particularly high in combination with potassium 
sparing-diuretics, and when combined with salt substitutes containing potassium. A combination with ACE 
inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly 
followed. 
 
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. spironolactone, 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 hypokalemia, 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 



20 

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 agents 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. 
 
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. 
 
Diuretics (thiazide or loop diuretics) 
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide 
diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with 
telmisartan. 
 
To be taken into account with concomitant use 
 
Other antihypertensive agents 
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through 
the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher 
frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including 
acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
 
Based on their pharmacological properties it can be expected that the following medicinal products may 
potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or 
antidepressants. 
 
Corticosteroïds (systemic route) 
Reduction of the antihypertensive effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
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 trimester of pregnancy (see sections 4.3 and 4.4). 
 
There are no adequate data from the use of Telmisartan Teva in pregnant women. Studies 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, 



21 

similar risks may exist for this class of drugs. 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). 
 
Breast-feeding 
Because no information is available regarding the use of Telmisartan Teva during breast-feeding, 
Telmisartan Teva is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
 
Fertility  
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
 
4.7 Effects on ability to drive and use machines 
 
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness 
may occasionally occur when taking antihypertensive therapy such as Telmisartan Teva. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely 
(≥1/10,000 to <1/1,000), and acute renal failure. 
 
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo 
(41.4% vs 43.9 %) in controlled trials in patients treated for hypertension. The incidence of adverse reactions 
was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of 
telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained 
in hypertensive patients. 
 
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated 
for hypertension and from post-marketing reports. The listing also takes into account serious adverse 
reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies 
including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six 
years.  
 
Tabulated summary 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). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Infections and infestations 
Uncommon: Urinary tract infection including cystitis, upper 

respiratory tract infection including pharyngitis 



22 

and sinusitis, 
Rare: Sepsis including fatal outcome1 
  
Blood and the lymphatic system disorders 
Uncommon Anaemia 
Rare: Eosinophilia, thrombocytopenia 
  
Immune system disorders 
Rare: Anaphylactic reaction, hypersensitivity  
  
Metabolism and nutrition disorders 
Uncommon Hyperkalaemia 
Rare: Hypoglycaemia (in diabetic patients) 
  
Psychiatric disorders 
Uncommon: Insomnia, depression 
Rare: Anxiety 
  
Nervous system disorders 
Uncommon: Syncope 
Rare: Somnolence 
  
Eye disorders 
Rare: Visual disturbance 
  
Ear and labyrinth disorders 
Uncommon: Vertigo 
  
Cardiac disorders 
Uncommon: Bradycardia 
Rare: Tachycardia 
  
Vascular disorders 
Uncommon: Hypotension2, orthostatic hypotension 
  
Respiratory, thoracic and mediastinal disorders 
Uncommon: Dyspnoea, cough 
Very rare: Interstinal lung disease4 
  
Gastrointestinal disorders 
Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, 

vomiting 
Rare: Dry mouth, stomach discomfort, dysgeusia 
  
Hepato-biliary disorders 
Rare: Hepatic function abnormal/liver disorder 3 
  
Skin and subcutaneous tissue disorders 
Uncommon: Pruritus, hyperhidrosis, rash 
Rare: Angioedema (also with fatal outcome), eczema, 

erythema, urticaria, drug eruption, toxic skin 
eruption 

  
Muscoloskeletal and connective tissue disorders 



23 

Uncommon: Back pain (e.g. sciatica), muscle spasms, myalgia 
Rare: Arthralgia, pain in extremetis, tendon pain 

(tendenitis like symptoms) 
  
Renal and urinary disorders 
Uncommon: Renal impairment including acute renal failure 
  
General disorders and administration site conditions 
Uncommon: Chest pain, asthenia (weakness) 
Rare: Influenza-like illness 
  
Investigations 
Uncommon: Blood creatinine increased 
Rare: Haemoglobin decreased, blood uric acid 

increased, hepatic enzyme increased, blood 
creatine phosphokinase increased 

 
1, 2, 3, 4: for further descriptions, please see sub-section “Description of selected adverse reactions”. 
 
Description of selected adverse reactions 
 
Sepsis 
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with 
placebo. The event may be a chance finding or related to a mechanism currently not known (see also section 
5.1). 
 
Hypotension 
This adverse reaction was reported as common in patients with controlled blood pressure who were treated 
with telmisartan for the reduction of cardiovascular morbidity on top of standard care. 
 
Hepatic function abnormal / liver disorder 
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in 
Japanese patients. Japanese patients are more likely to experience these adverse reactions. 
 
Interstitial lung disease 
Cases of interstitial lung disease have been reported from post-marketing experience in temporal association 
with the intake of telmisartan. However, a causal relationship has not been established. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
There is limited information available with regard to overdose in humans. 
 
Symptoms 
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia 
dizziness, increase in serum creatinine, and acute renal failure have also been reported. 
 
Treatment 
Telmisartan is not removed by haemodialysis. 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 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


24 

may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored 
frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume 
replacement given quickly. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07. 
 
Mechanism of action 
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 bradykininmediated adverse effects. 
 
In human, 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. 
 
Clinical efficacy and safety 
 
Treatment of essential hypertension 
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 agents 
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. 
 
Cardiovascular prevention 
 
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) 
compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on 



25 

cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, 
stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ 
damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at 
risk for cardiovascular events. 
 
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), 
ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and 
followed for a mean observation time of 4.5 years.  
 
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular 
death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure. The 
incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups. The 
hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a 
margin of 1.13). The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated 
patients, respectively. 
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with 
Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) 
have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker. 
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, 
or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in 
patients with type 2 diabetes mellitus and diabetic nephropathy. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to 
monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant 
for other ACE-inhibitors and angiotensin II receptor blockers. 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients 
with diabetic nephropathy. 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a 
study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an 
angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, 
cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse 
outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than 
in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension 
and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group. 
 
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of 
cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p 
(non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes 
Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.  
 
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as 
ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. The 
mean duration of follow up was 4 years and 8 months. No statistically significant difference in the incidence 
of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or 
hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo 
groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)]. There was evidence for a benefit of 
telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, 
non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)]. There was no 
evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24). 
 
Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients 
treated with ramipril, whereas hypotension was more frequently reported with telmisartan.  
 
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV 
mortality and all cause mortality were numerically higher with the combination. In addition, there was a 



26 

significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination 
arm. Therefore the use of a combination of telmisartan and ramipril is not recommended in this population. 
 
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years 
and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan 
compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence 
of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 
%) [RR 2.07 (95 % confidence interval 1.14 - 3.76)]. The observed increased occurrence rate of sepsis 
associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently 
known. 
 
Paediatric population  
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been 
established. 
 
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely 
overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking 
telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By 
inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients 
the doses used were higher than those recommended in the treatment of hypertension in the adult population, 
reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group 
effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 
2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group. The 
adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg 
respectively. The change was dose dependent. The safety data from this study in patients aged 6 to < 18 
years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan 
in children and adolescents was not evaluated. 
An increase in eosinophils reported in this patient population has not been recorded in adults. Its clinical 
significance and relevance is unknown. 
These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in 
hypertensive paediatric population. 
 
5.2 Pharmacokinetic properties 
 
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. 
 
Linearity/non-linearity 
The small reduction in AUC 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. 
 
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. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological 
activity has been shown for the conjugate. 
 
Elimination 



27 

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). 
 
Special Populations 
 
Paediatric population 
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive 
patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment 
period. Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children 
and adolescents, and investigation of age-related differences. Although the study was too small for a 
meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally 
consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax. 
 
Gender 
Differences in plasma concentrations 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 between the elderly and those younger than 65 years. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations 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 patients and cannot 
be removed by dialysis. The elimination half-life is not changed in patients with renal impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability 
up to nearly 100 %. The elimination half-life is not changed in patients with hepatic impairment. 
 
5.3 Preclinical safety data 
 
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. 
  



28 

There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence 
of carcinogenicity in rats and mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Microcrystalline cellulose (Avicel PH 102) 
Sodium starch glycolate (Type A) 
Poloxamers 
Meglumine 
Povidone (PVP K-30) 
Sorbitol (E420) 
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Aluminium-Aluminium peelable perforated unit-dose blisters and aluminium-aluminium perforated unit-
dose blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated 
blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters. 
Aluminium-Aluminium blisters : pack size of 30 tablets 
 
Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/011 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 



29 

EU/1/09/610/012 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/013 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/014 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/015 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/016 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/017 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/018 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/019 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/020 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium-
aluminium blisters 

EU/1/09/610/041 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/042 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/043 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/044 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/045 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/046 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/047 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/048 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/049 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/050 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/061 Carton of 30 tablets in aluminium-aluminium blister 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 January 2010 
 
Date of latest renewal: 19 December 2014 
 
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/. 
 

http://www.emea.europa.eu/


30 

1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 80 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 80 mg telmisartan 
 
Excipients with known effect:  
 
Each tablet contains 85.6 mg sorbitol (E420) 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
 
White to off white, oval shaped tablet; one side of the tablet is debossed with the number 
"93". The other side of the tablet is debossed with the number "7460". 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Hypertension 
Treatment of essential hypertension in adults. 
 
Cardiovascular prevention 
Reduction of cardiovascular morbidity in adults with: 
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral 

arterial disease) or 
• type 2 diabetes mellitus with documented target organ damage 
 
4.2 Posology and method of administration 
 
Posology 
 
Treatment of essential hypertension 
The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. 
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a 
maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type 
diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering 
effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum 
antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1). 
 
Cardiovascular prevention 
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan 
are effective in reducing cardiovascular morbidity. 
When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood 
pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be 
necessary. 
 
 



31 

Special populations 
 
Patients with renal impairment  
Limited experience is available in patients with severe renal impairment or haemodialysis. 
A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment 
is required for patients with mild to moderate renal impairment.  
 
Patients with hepatic impairment 
Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3). 
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see 
section 4.4). 
 
Elderly patients 
No dose adjustment is necessary for elderly patients. 
 
Paediatric population 
 
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been 
established.  
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be 
made. 
 
Method of administration 
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without 
food. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Second and third trimester of pregnancy (see sections 4.4 and 4.6) 
• Biliary obstructive disorders 
• Severe hepatic impairment 
 
The concomitant use of Telmisartan Teva with aliskiren-containing products is contraindicated in patients 
with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 
 
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 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 sections 4.3 and 4.6). 
 
Hepatic impairment 
Telmisartan Teva is not to be given to patients with cholestasis, biliary obstructive disorders or severe 
hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile. These patients can 
be expected to have reduced hepatic clearance for telmisartan. Telmisartan Teva should be used only with 
caution in patients with mild to moderate hepatic impairment. 
 
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. 
 



32 

Renal impairment and kidney transplantation 
When Telmisartan Teva is used in patients with impaired renal function, periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
Telmisartan Teva in patients with recent kidney transplantation. 
 
Intravascular hypovolaemia 
Symptomatic hypotension, especially after the first dose of Telmisartan Teva, may occur in patients who are 
volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. 
Such conditions should be corrected before the administration of Telmisartan Teva. Volume and/or sodium 
depletion should be corrected prior to administration of Telmisartan Teva. 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren 
increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal 
failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor 
blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist 
supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with 
diabetic nephropathy. 

 
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 such as telmisartan 
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. 
 
Diabetic patients treated with insulin or antidiabetics  
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an 
approptiate 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. 
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, 
hyperkalaemia may be fatal. 
 
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 



33 

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 dehydratation, 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, extend trauma). 

 
Close monitoring of serum potassium in at risk patients is recommended (see section 4.5). 
 
Sorbitol 
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take Telmisartan Teva. 
 
Ethnic differences 
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor 
antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, 
possibly because of higher prevalence of low-renin states in the black hypertensive population. 
 
Other 
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic 
cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. 
 
4.5 Interaction with other medicinal products and other forms of interaction 

 

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. 
 
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may 
provoke hyperkalaemia (see section 4.4). The risk may increase in case of treatment combination with other 
medicinal products that may also provoke hyperkalaemia (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). 
 
The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the 
above-mentioned treatment combinations. The risk is particularly high in combination with potassium 
sparing-diuretics, and when combined with salt substitutes containing potassium. A combination with ACE 
inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly 
followed. 
 
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. spironolactone, 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 hypokalemia, 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 



34 

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 agents 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. 
 
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. 
 
Diuretics (thiazide or loop diuretics) 
 
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide 
diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with 
telmisartan. 
 
To be taken into account with concomitant use 
 
Other antihypertensive agents 
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other 
antihypertensive medicinal products. 
 
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through 
the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher 
frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including 
acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
 
Based on their pharmacological properties it can be expected that the following medicinal products may 
potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or 
antidepressants. 
 
Corticosteroïds (systemic route) 
Reduction of the antihypertensive effect. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
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). 
 
There are no adequate data from the use of Telmisartan Teva in pregnant women. Studies 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. 



35 

Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, 
similar risks may exist for this class of drugs. 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). 
 
Breast-feeding 
Because no information is available regarding the use of Telmisartan Teva during breast-feeding, 
Telmisartan Teva is not recommended and alternative treatments with better established safety profiles 
during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
 
Fertility  
In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
 
4.7 Effects on ability to drive and use machines 
 
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness 
may occasionally occur when taking antihypertensive therapy such as Telmisartan Teva. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely 
(≥1/10,000 to < 1/1000), and acute renal failure. 
 
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo 
(41.4% vs 43.9 %) in controlled trials in patients treated for hypertension. The incidence of adverse reactions 
was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of 
telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained 
in hypertensive patients. 
 
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated 
for hypertension and from post-marketing reports. The listing also takes into account serious adverse 
reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies 
including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six 
years.  
 
Tabulated summary 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). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Infections and infestations 
Uncommon: Urinary tract infection including cystitis, upper 



36 

respiratory tract infection including pharyngitis 
and sinusitis, 

Rare: Sepsis including fatal outcome1 
  
Blood and the lymphatic system disorders 
Uncommon Anaemia 
Rare: Eosinophilia, thrombocytopenia 
  
Immune system disorders 
Rare: Anaphylactic reaction, hypersensitivity 
  
Metabolism and nutrition disorders 
Uncommon Hyperkalaemia 
Rare: Hypoglycaemia (in diabetic patients) 
  
Psychiatric disorders 
Uncommon: Insomnia, depression 
Rare: Anxiety 
  
Nervous system disorders 
Uncommon: Syncope 
Rare: Somnolence 
  
Eye disorders 
Rare: Visual disturbance 
  
Ear and labyrinth disorders 
Uncommon: Vertigo 
  
Cardiac disorders 
Uncommon: Bradycardia 
Rare: Tachycardia 
  
Vascular disorders 
Uncommon: Hypotension2, orthostatic hypotension 
  
Respiratory, thoracic and mediastinal disorders 
Uncommon: Dyspnoea, cough 
Very rare: Interstinal lung disease4 
  
Gastrointestinal disorders 
Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, 

vomiting 
Rare: Dry mouth, stomach discomfort, dysgeusia 
  
Hepato-biliary disorders 
Rare: Hepatic function abnormal/liver disorder 3 
  
Skin and subcutaneous tissue disorders 
Uncommon: Pruritus, hyperhidrosis, rash 
Rare: Angioedema (also with fatal outcome), eczema, 

erythema, urticaria, drug eruption, toxic skin 
eruption 

  



37 

Muscoloskeletal and connective tissue disorders 
Uncommon: Back pain (e.g. sciatica), muscle spasms, myalgia 
Rare: Arthralgia, pain in extremetis, tendon pain 

(tendenitis like symptoms) 
  
Renal and urinary disorders 
Uncommon: Renal impairment including acute renal failure 
  
General disorders and administration site conditions 
Uncommon: Chest pain, asthenia (weakness) 
Rare: Influenza-like illness 
  
Investigations 
Uncommon: Blood creatinine increased 
Rare: Haemoglobin decreased, blood uric acid 

increased, hepatic enzyme increased, blood 
creatine phosphokinase increased 

 
1, 2, 3, 4: for further descriptions, please see sub-section ”Description of selected adverse reactions”. 
 
Description of selected adverse reactions 
 
Sepsis 
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with 
placebo. The event may be a chance finding or related to a mechanism currently not known (see also section 
5.1). 
 
Hypotension 
This adverse reaction was reported as common in patients with controlled blood pressure who were treated 
with telmisartan for the reduction of cardiovascular morbidity on top of standard care. 
 
Hepatic function abnormal / liver disorder 
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in 
Japanese patients. Japanese patients are more likely to experience these adverse reactions. 
 
Interstitial lung disease 
Cases of interstitial lung disease have been reported from post-marketing experience in temporal association 
with the intake of telmisartan. However, a causal relationship has not been established. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V.  
 
4.9 Overdose 
 
There is limited information available with regard to overdose in humans. 
 
Symptoms 
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia 
dizziness, increase in serum creatinine, and acute renal failure have also been reported. 
 
Treatment 
Telmisartan is not removed by haemodialysis. 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 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

the symptoms. Suggested measures include induction of emesis and / or gastric lavage. Activated charcoal 
may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored 
frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume 
replacement given quickly. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07. 
 
Mechanism of action 
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 bradykininmediated adverse effects. 
 
In human, 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. 
 
Clinical efficacy and safety 
 
Treatment of essential hypertension 
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 agents 
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. 
 
Cardiovascular prevention 
 



39 

ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) 
compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on 
cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, 
stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ 
damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at 
risk for cardiovascular events. 
 
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), 
ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and 
followed for a mean observation time of 4.5 years.  
 
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular 
death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure. The 
incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups. The 
hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a 
margin of 1.13). The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated 
patients, respectively. 
 
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of 
cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p 
(non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes 
Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.  
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with 
Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) 
have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker. 
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, 
or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in 
patients with type 2 diabetes mellitus and diabetic nephropathy. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to 
monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant 
for other ACE-inhibitors and angiotensin II receptor blockers. 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients 
with diabetic nephropathy. 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a 
study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an 
angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, 
cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse 
outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than 
in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension 
and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group. 
 
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as 
ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. The 
mean duration of follow up was 4 years and 8 months. No statistically significant difference in the incidence 
of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or 
hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo 
groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)]. There was evidence for a benefit of 
telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, 
non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)]. There was no 
evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24). 
 
Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients 
treated with ramipril, whereas hypotension was more frequently reported with telmisartan.  
 



40 

Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV 
mortality and all cause mortality were numerically higher with the combination. In addition, there was a 
significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination 
arm. Therefore the use of a combination of telmisartan and ramipril is not recommended in this population. 
 
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years 
and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan 
compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence 
of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 
%) [RR 2.07 (95 % confidence interval 1.14 - 3.76)]. The observed increased occurrence rate of sepsis 
associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently 
known. 
 
Paediatric population  
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been 
established. 
 
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely 
overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking 
telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By 
inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients 
the doses used were higher than those recommended in the treatment of hypertension in the adult population, 
reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group 
effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 
2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group. The 
adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg 
respectively. The change was dose dependent. The safety data from this study in patients aged 6 to < 18 
years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan 
in children and adolescents was not evaluated. 
An increase in eosinophils reported in this patient population has not been recorded in adults. Its clinical 
significance and relevance is unknown. 
These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in 
hypertensive paediatric population. 
 
5.2 Pharmacokinetic properties 
 
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. 
 
Linearity/non-linearity 
The small reduction in AUC 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. 
 
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. 
 
Biotransformation 
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological 
activity has been shown for the conjugate. 
 



41 

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). 
 
Special Populations 
 
Paediatric population 
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive 
patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment 
period. Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children 
and adolescents, and investigation of age-related differences. Although the study was too small for a 
meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally 
consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax. 
 
Gender 
Differences in plasma concentrations 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 between the elderly and those younger than 65 years. 
 
Renal impairment 
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations 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 patients and cannot 
be removed by dialysis. The elimination half-life is not changed in patients with renal impairment. 
 
Hepatic impairment 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability 
up to nearly 100 %. The elimination half-life is not changed in patients with hepatic impairment. 
 
5.3 Preclinical safety data 
 
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. 
  



42 

There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence 
of carcinogenicity in rats and mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Microcrystalline cellulose (Avicel PH 102) 
Sodium starch glycolate (Type A) 
Poloxamers 
Meglumine 
Povidone (PVP K-30) 
Sorbitol (E420) 
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Aluminium-Aluminium peelable perforated unit dose blisters and aluminium-aluminium perforated unit-dose 
blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated 
blisters. 
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.  
Aluminium-Aluminium blisters : pack size of 30 tablets 
 
Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/021 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium 

blisters 



43 

EU/1/09/610/022 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/023 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/024 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/025 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/026 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/027 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/028 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/029 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium 
blisters 

EU/1/09/610/030 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium-
aluminium blisters 

EU/1/09/610/051 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/052 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/053 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/054 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/055 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/056 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/057 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/058 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/059 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/060 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters 
EU/1/09/610/062 Carton of 30 tablets in aluminium-aluminium blister 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 January 2010 
 
Date of the latest renewal: 19 December 2014 
 
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/. 
 

http://www.emea.europa.eu/


44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 AUTHORISATION 
 

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



45 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
TEVA Pharmaceutical Works Private Limited Company 
HU-4042 Debrecen 
Pallagi út 13 
Hungary 
 
TEVA Pharmaceutical Works Private Limited Company  
H-2100 Gödöllő 
Táncsics Mihály út 82  
Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)  
 
TEVA UK Ltd  
Brampton Road 
Hampden Park 
Eastbourne 
East Sussex, BN22 9AG  
United Kingdom  
 
Pharmachemie B.V.  
Swensweg 5,  
2031 GA Haarlem,  
The Netherlands  
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• 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. 
 
• Pharmacovigilance system 
 
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing 
Authorisation, is in place and functioning before and whilst the product is on the market. 
 
 
 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 



46 

• Risk Management Plan (RMP) 

Not applicable  



47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



49 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of peelable blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 20 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use. 
 

 
 
1. Separate one individual blister cell from the rest of the strip by gently tearing along the perforations 

around it 
2. Carefully peel off the top paper layer 
3. Push the tablet through the exposed foil 
4. Put the tablet in your mouth and swallow with water or a suitable liquid 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 



50 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/001 14x1 tablets 
EU/1/09/610/002 28x1 tablets 
EU/1/09/610/003 30x1 tablets 
EU/1/09/610/004 40x1 tablets 
EU/1/09/610/005 56x1 tablets 
EU/1/09/610/006 60x1 tablets 
EU/1/09/610/007 84x1 tablets 
EU/1/09/610/008 90x1 tablets 
EU/1/09/610/009 98x1 tablets 
EU/1/09/610/010 100x1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 



51 

 
16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



52 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 20 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before 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  
 



53 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/031 14x1 tablets 
EU/1/09/610/032 28x1 tablets 
EU/1/09/610/033 30x1 tablets 
EU/1/09/610/034 40x1 tablets 
EU/1/09/610/035 56x1 tablets 
EU/1/09/610/036 60x1 tablets 
EU/1/09/610/037 84x1 tablets 
EU/1/09/610/038 90x1 tablets 
EU/1/09/610/039 98x1 tablets 
EU/1/09/610/040 100x1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



54 

PC: 
SN: 
NN: 
 



55 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of peelable blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 40 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use. 
 

 
 

1. Separate one individual blister cell from the rest of the strip by gently tearing along the perforations 
around it 

2. Carefully peel off the top paper layer 
3. Push the tablet through the exposed foil 
4. Put the tablet in your mouth and swallow with water or a suitable liquid 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 



56 

Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/011 14x1 tablets 
EU/1/09/610/012 28x1 tablets 
EU/1/09/610/013 30x1 tablets 
EU/1/09/610/014 40x1 tablets 
EU/1/09/610/015 56x1 tablets 
EU/1/09/610/016 60x1 tablets 
EU/1/09/610/017 84x1 tablets 
EU/1/09/610/018 90x1 tablets 
EU/1/09/610/019 98x1 tablets 
EU/1/09/610/020 100x1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



57 

16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 40 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



58 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 40 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before 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  



59 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/041 14x1 tablets 
EU/1/09/610/042 28x1 tablets 
EU/1/09/610/043 30x1 tablets 
EU/1/09/610/044 40x1 tablets 
EU/1/09/610/045 56x1 tablets 
EU/1/09/610/046 60x1 tablets 
EU/1/09/610/047 84x1 tablets 
EU/1/09/610/048 90x1 tablets 
EU/1/09/610/049 98x1 tablets 
EU/1/09/610/050 
EU/1/09/610/061 

100x1 tablets 
30 tablets 

 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 40 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



60 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



61 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of peelable blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 80 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use. 
 

 
 

1. Separate one individual blister cell from the rest of the strip by gently tearing along the perforations 
around it 

2. Carefully peel off the top paper layer 
3. Push the tablet through the exposed foil 
4. Put the tablet in your mouth and swallow with water or a suitable liquid 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 



62 

Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/021 14x1 tablets 
EU/1/09/610/022 28x1 tablets 
EU/1/09/610/023 30x1 tablets 
EU/1/09/610/024 40x1 tablets 
EU/1/09/610/025 56x1 tablets 
EU/1/09/610/026 60x1 tablets 
EU/1/09/610/027 84x1 tablets 
EU/1/09/610/028 90x1 tablets 
EU/1/09/610/029 98x1 tablets 
EU/1/09/610/030 100x1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



63 

16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 80 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



64 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton of blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 80 mg tablets 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420). Read the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14x1 tablets 
28x1 tablets 
30x1 tablets 
40x1 tablets 
56x1 tablets 
60x1 tablets 
84x1 tablets 
90x1 tablets 
98x1 tablets 
100x1 tablets 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before 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  



65 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/610/051 14x1 tablets 
EU/1/09/610/052 28x1 tablets 
EU/1/09/610/053 30x1 tablets 
EU/1/09/610/054 40x1 tablets 
EU/1/09/610/055 56x1 tablets 
EU/1/09/610/056 60x1 tablets 
EU/1/09/610/057 84x1 tablets 
EU/1/09/610/058 90x1 tablets 
EU/1/09/610/059 98x1 tablets 
EU/1/09/610/060 
EU/1/09/610/062 

100x1 tablets 
30 tablets 

 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Teva 80 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



66 

 
PC: 
SN: 
NN: 
 



67 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 20 mg tablets 
telmisartan 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
  
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



68 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 40 mg tablets 
telmisartan 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
  
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



69 

  
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Teva 80 mg tablets 
telmisartan 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
  
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



70 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



71 

 
Package leaflet: Information for the user 

 
Telmisartan Teva 20 mg Tablets 

Telmisartan 
 
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 side effects talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
 
What is in this leaflet:  
1. What Telmisartan Teva is and what it is used for 
2. What you need to know before you take Telmisartan Teva 
3. How to take Telmisartan Teva 
4. Possible side effects 
5. How to store Telmisartan Teva 
6. Contents of the pack and other information 
 
 
1. What Telmisartan Teva is and what it is used for 
 
Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists. 
Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels 
relax, and your blood pressure is lowered. 
 
Telmisartan Teva is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means 
that the high blood pressure is not caused by any other condition. 
 
High blood pressure, if not treated, can damage blood vessels in several organs,  which could lead sometimes 
to heart attacks, heart or kidney failure, strokes 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. 
 
Telmisartan Teva is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at 
risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have 
high risk diabetes. Your doctor can tell you if you are at high risk for such events. 
 
 
2. What you need to know before you take Telmisartan Teva 
 
Do not take Telmisartan Teva 
- if you are allergic  to telmisartan or any other ingredients of this medicine (listed in section 6). 
- if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva in early pregnancy 

– see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the 

drainage of the bile from the liver and gall bladder) or any other severe liver disease. 
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering 

medicine containing aliskiren.   
 
If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva. 



72 

 
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 
-  Renal artery stenosis (narrowing of the blood vessels to one or both kidneys) 
- Liver disease 
- Heart trouble 
- Raised aldosterone levels (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 
 
Talk to your doctor before taking Telmisartan Teva: 
• if you are taking digoxin. 
• if you are taking any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-
related kidney problems. 
- aliskiren 

 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) 
in your blood at regular intervals. 
 
See also information under the heading “Do not take Telmisartan Teva”. 
 
You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may 
cause serious harm to your baby if used at that stage (see pregnancy section). 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva. 
 
Telmisartan Teva may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Telmisartan Teva 
 
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 Telmisartan Teva. 
 

• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Telmisartan Teva” and “Warnings and precautions”). 

• 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, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, 
immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 

• Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva, may lead 
to excessive loss of body water and low blood pressure (hypotension). 

• Digoxin. 



73 

 
The effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Teva may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure. 
 
If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from 
a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take 
Telmisartan Teva in combination with: 

• Other medicines used to treat high blood pressure 
• Baclofen (a muscle relaxant) 
• Amifostine (a protective medicine during radiotherapy for cancer treatment) 
• Alcohol 
• Barbiturates (strong sleeping tablets) 
• Narcotics (strong pain killers) 
• Antidepressants 

 
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 Telmisartan Teva before you become pregnant or as soon as you know you are pregnant 
and will advise you to take another medicine instead of Telmisartan Teva.  Telmisartan Teva 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.  Telmisartan Teva 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. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Telmisartan Teva. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
Telmisartan Teva contains sorbitol.  
If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva. 
 
 
3. How to take Telmisartan Teva 
 
Always take Telmisartan Teva exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose of Telmisartan Teva is one tablet a day. Try to take the tablet at the same time each 
day. You can take Telmisartan Teva with or without food. The tablets should be swallowed with some water 
or other non-alcoholic drink.  It is important that you take Telmisartan Teva every day until your doctor tells 
you otherwise.  If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk 
to your doctor or pharmacist. 
 
For treament of high blood pressure, the usual dose of Telmisartan Teva for most patients is 40 mg once a 
day to control your blood pressure over the 24-hour period. Your doctor has recommended a lower dose of 
one 20 mg tablet daily.  Alternatively, Telmisartan Teva may be used in combination with diuretics (“water” 
tablets) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering 
effect with Telmisartan Teva. 
 



74 

For reduction of cardiovascular events, the usual dose of Telmisartan Teva is one 80 mg tablet once a day. At 
the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently 
monitored. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg once a day. 
 
If you take more Telmisartan Teva than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. 
 
If you forget to take Telmisartan Teva 
If you forget to take a dose, do not worry.  Take it as soon as you remember 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 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 usually 
accompanied by high fevers, hot, flushed skin, elevated heart rate, rapid breathing, altered mental status, 
swelling, and low blood pressure), 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. 
 
Other possible side effects of telmisartan: 
 
Common side effects (may affect up to 1 in10 people):  
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events. 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), 
deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad 
(depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood 
pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic 
hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, 
vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney 
impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of 
creatinine in the blood. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic 
reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling 
of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, 
impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), 
abnormal liver function (Japanese patients are more likely to experience these side effects), eczema (a skin 
disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon 
pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased 
hepatic enzymes or creatine phosphokinase in the blood. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 



75 

Progressive scarring of lung tissue (interstitial lung disease). 
 
Reporting of side effects 
If you get any side effects,talk to your doctor or pharmacist. This includes any possible side effects not listed 
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
 
5. How to store Telmisartan Teva 
 
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. 
 
This medicinal product does not require any special storage conditions. 
 
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 Telmisartan Teva contains 
 
- The active substance is telmisartan.  Each Telmisartan Teva tablet contains 20 mg telmisartan. 
- The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type 

A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate 
 
What Telmisartan Teva looks like and contents of the pack 
 
Telmisartan Teva 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed 
with the number "93". The other side of the tablet is debossed with the number "7458". 
 
Telmisartan Teva is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated 
unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 
100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. 
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton 
of the peelable blisters. 
 
Marketing Authorisation Holder and Manufacturer 
 
The Marketing Authorisation Holder is: 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
The manufacturer is: 
 
TEVA Pharmaceutical Works Private Limited Company  
H-4042 Debrecen, 
Pallagi út 13,  
Hungary 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


76 

Or: 
 
TEVA Pharmaceutical Works Private Limited Company 
H-2100 Gödöllő,  
Táncsics Mihály út 82 
Hungary  
 
Or: 
 
TEVA UK Ltd  
Brampton Road,  
Hampden Park,  
Eastbourne,  
East Sussex,  
BN22 9AG  
United Kingdom 
 
Or: 
 
Pharmachemie B.V.  
Swensweg 5,  
2031 GA, Haarlem, 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the Marketing 
Authorisation Holder 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A.  
Tel/Tél: +32 3 820 73 73  

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 02 03 

 
България  
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 

 
Luxembourg/Luxemburg  
Teva Pharma Belgium S.A. 
Belgien/Belgique  
Tél/Tel: +32 3 820 73 73 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251 007 111 

 
Magyarország  
Teva Gyógyszergyár Zrt. (TPW) 
Tel.: +36 1 288 64 00  

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44 98 55 11 

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321740  

 
Deutschland 
Teva GmbH 
Tel: (49) 731 40208 

 
Nederland  
Teva Nederland B.V. 
Tel: +31 (0) 800 0228400  

 
Eesti 
Teva Eesti esindus UAB Sicor Biotech 
Eesti filiaal 
Tel: +372 661 0801 

 
Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 

 
Österreich 
 ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 00 7 



77 

 
España 
Teva Pharma, S.L.U 
Tél: +(34) 91 387 32 80   

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +(48) 22 345 93 00 

 
France 
Teva Santé 
Tél: +(33) 1 55 91 7800 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos Lda 
Tel: (351) 214 235 910 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 

 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 (0)51 321 740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 

 
Ísland 
ratiopharm Oy 
Finnland 
Sími: +358 9 180 452 5900 

 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +(421) 2 5726 7911 

 
Italia 
Teva Italia S.r.l. 
Tel: +(39) 028917981 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Ελλάδα 
Τηλ: +30 210 72 79 099 

 
Sverige 
Teva Sweden AB 
Tel: +(46) 42 12 11 00 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67 784 980 

 
United Kingdom 
Teva UK Limited 
Tel: +(44) 1977 628 500 

 
 
This leaflet was last revised in {12/2014}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


78 

Package leaflet: Information for the user 
 

Telmisartan Teva 40 mg Tablets 
Telmisartan 

 
Read all of this leaflet carefully before you start taking this medicine because it contains inportant 
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 side effects talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
 
What is in this leaflet:  
1. What Telmisartan Teva is and what it is used for 
2. What you need t know before you take Telmisartan Teva 
3. How to take Telmisartan Teva 
4. Possible side effects 
5. How to store Telmisartan Teva 
6. Contents of the pack and other information 
 
 
1. What Telmisartan Teva is and what it is used for 
 
Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists. 
Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels 
relax, and your blood pressure is lowered. 
 
Telmisartan Teva is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means 
that the high blood pressure is not caused by any other condition. 
 
High blood pressure, if not treated, can damage blood vessels in several organs,  which could lead sometimes 
to heart attacks, heart or kidney failure, strokes 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. 
 
Telmisartan Teva is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at 
risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have 
high risk diabetes. Your doctor can tell you if you are at high risk for such events. 
 
 
2. What you need to know before you take Telmisartan Teva 
 
Do not take Telmisartan Teva 
- if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6). 
- if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva in early pregnancy 

– see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the 

drainage of the bile from the liver and gall bladder) or any other severe liver disease.   
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering 

medicine containing aliskiren. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva. 
 



79 

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 
-  Renal artery stenosis (narrowing of the blood vessels to one or both kidneys) 
- Liver disease 
- Heart trouble 
- Raised aldosterone levels (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 
 
Talk to your doctor before taking Telmisartan Teva: 
• if you are taking digoxin. 
• if you are taking any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-
related kidney problems. 
- aliskiren. 

 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) 
in your blood at regular intervals. 
 
See also information under the heading “Do not Telmisartan Teva”. 

 
You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may 
cause serious harm to your baby if used at that stage (see pregnancy section). 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva. 
 
Telmisartan Teva may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Telmisartan Teva 
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 Telmisartan Teva. 
 

• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Telmisartan Teva” and “Warnings and precautions”). 

• 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, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, 
immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 

• Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva, may lead 
to excessive loss of body water and low blood pressure (hypotension). 

• Digoxin. 
 



80 

The effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Teva may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure. 
 
If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from 
a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take 
Telmisartan Teva in combination with: 

• Other medicines used to treat high blood pressure 
• Baclofen (a muscle relaxant) 
• Amifostine (a protective medicine during radiotherapy for cancer treatment) 
• Alcohol 
• Barbiturates (strong sleeping tablets) 
• Narcotics (strong pain killers) 
• Antidepressants 

 
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 Telmisartan Teva before you become pregnant or as soon as you know you are pregnant 
and will advise you to take another medicine instead of Telmisartan Teva.  Telmisartan Teva 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.  Telmisartan Teva 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. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Telmisartan Teva. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
Telmisartan Teva contains sorbitol.  
If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva. 
 
 
3. How to take Telmisartan Teva 
 
Always take Telmisartan Teva exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose of Telmisartan Teva is one tablet. Try to take the tablet at the same time each day. 
You can take Telmisartan Teva with or without food. The tablets should be swallowed with some water or 
other non-alcoholic drink.  It is important that you take Telmisartan Teva every day until your doctor tells 
you otherwise.  If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk 
to your doctor or pharmacist. 
 
For treatment of high blood pressure, the usual dose of Telmisartan Teva for most patients is 40 mg once a 
day to control your blood pressure over the 24-hour period. However, your doctor may recommend a lower 
dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartan Teva may be used in combination with 
diuretics (“water” tablets) such as hydrochlorothiazide which has been shown to have an additive blood 
pressure lowering effect with Telmisartan Teva. 
 



81 

For reduction of cardiovascular events, the usual dose of Telmisartan Teva is one 80 mg tablet once a day. At 
the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently 
monitored. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg once a day. 
 
If you take more Telmisartan Teva than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. 
 
If you forget to take Telmisartan Teva 
If you forget to take a dose, do not worry.  Take it as soon as you remember 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 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 usually 
accompanied by high fevers, hot, flushed skin, elevated heart rate, rapid breathing, altered mental status, 
swelling, and low blood pressure), 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. 
 
Other possible side effects of telmisartan: 
 
Common side effects (may affect up to 1 in 10 people):  
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events. 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), 
deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad 
(depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood 
pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic 
hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, 
vomiting, itching, increased sweating, drug rash, back pain, muscle cramps,  muscle pain (myalgia), kidney 
impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of 
creatinine in the blood. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic 
reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling 
of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, 
impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), 
abnormal liver function (Japanese patients are more likely to experience these side effects), eczema (a skin 
disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon 
pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased 
hepatic enzymes or creatine phosphokinase in the blood. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 



82 

Progressive scarring of lung tissue (interstitial lung disease). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 
V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
 
5. How to store Telmisartan Teva 
 
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. 
 
This medicinal product does not require any special storage conditions. 
 
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 Telmisartan Teva contains 
 
- The active substance is telmisartan.  Each Telmisartan Teva tablet contains 40 mg telmisartan. 
- The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type 

A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate 
 
What Telmisartan Teva looks like and contents of the pack 
 
Telmisartan Teva 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed 
with the number "93". The other side of the tablet is debossed with the number "7459". 
 
Telmisartan Teva is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated 
unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 
100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. 
Telmisartan Teva is also provided in aluminium-aluminium blister packs of 30 tablets. 
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton 
of the peelable blisters. 
 
Marketing Authorisation Holder and Manufacturer 
 
The Marketing Authorisation Holder is: 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
The manufacturer is: 
 
TEVA Pharmaceutical Works Private Limited Company  
H-4042 Debrecen, 
Pallagi út 13,  
Hungary 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


83 

 
Or: 
 
TEVA Pharmaceutical Works Private Limited Company 
H-2100 Gödöllő,  
Táncsics Mihály út 82 
Hungary  
 
Or: 
 
TEVA UK Ltd  
Brampton Road,  
Hampden Park,  
Eastbourne,  
East Sussex,  
BN22 9AG  
United Kingdom 
 
Or: 
 
Pharmachemie B.V.  
Swensweg 5,  
2031 GA, Haarlem, 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the Marketing 
Authorisation Holder 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A.  
Tel/Tél: +32 3 820 73 73  

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 02 03 

 
България  
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 

 
Luxembourg/Luxemburg  
Teva Pharma Belgium S.A.  
Belgien/Belgique 
Tél/Tel: +32 3 820 73 73 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251 007 111 

 
Magyarország  
Teva Gyógyszergyár Zrt. (TPW) 
Tel.: +36 1 288 64 00  

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44 98 55 11 

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321740 

 
Deutschland 
Teva GmbH 
Tel: (49) 731 40208 

 
Nederland  
Teva Nederland B.V. 
Tel: +31 (0) 800 0228400  

 
Eesti 
Teva Eesti esindus UAB Sicor Biotech 
Eesti filiaal 
Tel: +372 661 0801 

 
Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 

 
Österreich 
 ratiopharm Arzneimittel Vertriebs-GmbH 



84 

Τηλ: +30 210 72 79 099 Tel: +43 1 97 00 7 

 
España 
Teva Pharma, S.L.U 
Tél: +(34) 91 387 32 80   

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +(48) 22 345 93 00 

 
France 
Teva Santé 
Tél: +(33) 1 55 91 7800 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos Lda 
Tel: (351) 214 235 910 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 

 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 (0)51 321 740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 

 
Ísland 
ratiopharm Oy 
Finnland 
Sími: + 358 9 180 452 5900 

 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +(421) 2 5726 7911 

 
Italia 
Teva Italia S.r.l. 
Tel: +(39) 028917981 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Ελλάδα 
Τηλ: +30 210 72 79 099 

 
Sverige 
Teva Sweden AB 
Tel: +(46) 42 12 11 00 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67 784 980 

 
United Kingdom 
Teva UK Limited 
Tel: +(44) 1977 628 500 

 
 
This leaflet was last revised in {12/2014}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


85 

Package leaflet: Information for the user 
 

Telmisartan Teva 80 mg Tablets 
Telmisartan 

 
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 side effects talk to your doctor or pharmacist. This includes any side effects not listed 

in this leaflet. See section 4. 
 
 
What is in this leaflet:  
1. What Telmisartan Teva is and what it is used for 
2. What you need to know before you take Telmisartan Teva 
3. How to take Telmisartan Teva 
4. Possible side effects 
5. How to store Telmisartan Teva 
6. Contents of the pack and other information 
 
 
1. What Telmisartan Teva is and what it is used for 
 
Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists. 
Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels 
relax, and your blood pressure is lowered. 
 
Telmisartan Teva is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means 
that the high blood pressure is not caused by any other condition. 
 
High blood pressure, if not treated, can damage blood vessels in several organs,  which could lead sometimes 
to heart attacks, heart or kidney failure, strokes 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. 
 
Telmisartan Teva is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at 
risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have 
high risk diabetes. Your doctor can tell you if you are at high risk for such events. 
 
 
2. What you need to know before you take Telmisartan Teva 
 
Do not take Telmisartan Teva 
- if you are allergic  to telmisartan or any other ingredients of medicine (listed in section 6). 
- if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva in early pregnancy 

– see pregnancy section). 
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the 

drainage of the bile from the liver and gall bladder) or any other severe liver disease.   
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering 

medicine containing aliskiren. 
 
If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva. 
 



86 

 
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 
-  Renal artery stenosis (narrowing of the blood vessels to one or both kidneys) 
- Liver disease 
- Heart trouble 
- Raised aldosterone levels (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 
 
Talk to your doctor before taking Telmisartan Teva: 
• if you are taking digoxin. 
• if you are taking any of the following medicines used to treat high blood pressure: 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-
related kidney problems. 
- aliskiren. 

 
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) 
in your blood at regular intervals. 
 
See also information under the heading “Do not take Telmisartan Teva”. 
 
You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may 
cause serious harm to your baby if used at that stage (see pregnancy section). 
 
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva. 
 
Telmisartan Teva may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended. 
 
Other medicines and Telmisartan Teva 
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 Telmisartan Teva. 
 

• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Telmisartan Teva” and “Warnings and precautions”). 

• 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, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, 
immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 

• Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva, may lead 
to excessive loss of body water and low blood pressure (hypotension). 

• Digoxin. 
 



87 

The effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory 
medicines, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Teva may increase the blood pressure lowering effect of other medicines used to treat high blood 
pressure. 
 
If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from 
a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take 
Telmisartan Teva in combination with: 

• Other medicines used to treat high blood pressure 
• Baclofen (a muscle relaxant) 
• Amifostine (a protective medicine during radiotherapy for cancer treatment) 
• Alcohol 
• Barbiturates (strong sleeping tablets) 
• Narcotics (strong pain killers) 
• Antidepressants 

 
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 Telmisartan Teva before you become pregnant or as soon as you know you are pregnant 
and will advise you to take another medicine instead of Telmisartan Teva.  Telmisartan Teva 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.  Telmisartan Teva 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. 
 
Driving and using machines 
Some people feel dizzy or tired when taking Telmisartan Teva. If you feel dizzy or tired, do not drive or 
operate machinery. 
 
Telmisartan Teva contains sorbitol.  
If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva. 
 
 
3. How to take Telmisartan Teva 
 
Always take Telmisartan Teva exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose of Telmisartan Teva is one tablet a day. Try to take the tablet at the same time each 
day. You can take Telmisartan Teva with or without food. The tablets should be swallowed with some water 
or other non-alcoholic drink.  It is important that you take Telmisartan Teva every day until your doctor tells 
you otherwise.  If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk 
to your doctor or pharmacist. 
 
For treatment of high blood pressure, the usual dose of Telmisartan Teva for most patients is 40 mg once a 
day to control your blood pressure over the 24-hour period. Your doctor has recommended a higher dose of 
one 80 mg tablet daily. Alternatively, Telmisartan Teva may be used in combination with diuretics (“water” 
tablets) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering 
effect with Telmisartan Teva. 
 



88 

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the 
beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored. 
 
If your liver is not working properly, the usual dose should not exceed 40 mg once a day. 
 
If you take more Telmisartan Teva than you should 
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital 
emergency department immediately. 
 
If you forget to take Telmisartan Teva 
If you forget to take a dose, do not worry.  Take it as soon as you remember 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 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 usually 
accompanied by high fevers, hot, flushed skin, elevated heart rate, rapid breathing, altered mental status, 
swelling, and low blood pressure), 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. 
 
Other possible side effects of telmisartan: 
 
Common side effects (may affect up to 1 in10 people): 
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events. 
 
Uncommon side effects (may affect up to 1 in 100 people): 
Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), 
deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad 
(depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood 
pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic 
hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, 
vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney 
impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of 
creatinine in the blood. 
 
Rare side effects (may affect up to 1 in 1,000 people): 
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic 
reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling 
of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, 
impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), 
abnormal liver function (Japanese patients are more likely to experience these side effects), eczema (a skin 
disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon 
pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased 
hepatic enzymes or creatine phosphokinase in the blood. 
 
Very rare side effects (may affect up to 1 in 10,000 people): 
Progressive scarring of lung tissue (interstitial lung disease). 



89 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 
V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
 
5. How to store Telmisartan Teva 
 
Keep this medicineout of the sight and reach of children. 
 
Do not use Telmisartan Teva 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. 
 
This medicinal product does not require any special storage conditions. 
 
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 Telmisartan Teva contains 
 
- The active substance is telmisartan.  Each Telmisartan Teva tablet contains 80 mg telmisartan. 
- The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type 

A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate 
 
What Telmisartan Teva looks like and contents of the pack 
 
Telmisartan Teva 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed 
with the number "93". The other side of the tablet is debossed with the number "7460". 
 
Telmisartan Teva is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated 
unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 
100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. 
Telmisartan Teva is also provided in aluminium-aluminium blister packs of 30 tablets. 
 
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton 
of the peelable blisters. 
 
Marketing Authorisation Holder and Manufacturer 
 
The Marketing Authorisation Holder is: 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
The manufacturer is: 
 
TEVA Pharmaceutical Works Private Limited Company  
H-4042 Debrecen, 
Pallagi út 13,  
Hungary 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


90 

 
Or: 
 
TEVA Pharmaceutical Works Private Limited Company 
H-2100 Gödöllő,  
Táncsics Mihály út 82 
Hungary  
 
Or: 
 
TEVA UK Ltd  
Brampton Road,  
Hampden Park,  
Eastbourne,  
East Sussex,  
BN22 9AG  
United Kingdom 
 
Or: 
 
Pharmachemie B.V.  
Swensweg 5,  
2031 GA, Haarlem, 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the Marketing 
Authorisation Holder 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A.  
Tel/Tél: +32 3 820 73 73  

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 02 03 

 
България  
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 

 
Luxembourg/Luxemburg  
Teva Pharma Belgium S.A.  
Belgien/Belgique 
Tél/Tel: +32 3 820 73 73 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251 007 111 

 
Magyarország  
Teva Gyógyszergyár Zrt. (TPW) 
Tel.: +36 1 288 64 00  

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44 98 55 11 

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321740 

 
Deutschland 
Teva GmbH 
Tel: (49) 731 40208 

 
Nederland  
Teva Nederland B.V. 
Tel: +31 (0) 800 0228400  

 
Eesti 
Teva Eesti esindus UAB Sicor Biotech 
Eesti filiaal 
Tel: +372 661 0801 

 
Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 

 
Österreich 
 ratiopharm Arzneimittel Vertriebs-GmbH 



91 

Τηλ: +30 210 72 79 099 Tel: +43 1 97 00 7 

 
España 
Teva Pharma, S.L.U 
Tél: +(34) 91 387 32 80   

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +(48) 22 345 93 00 

 
France 
Teva Santé 
Tél: +(33) 1 55 91 7800 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos Lda 
Tel: (351) 214 235 910 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 

 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 (0)51 321 740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 

 
Ísland 
ratiopharm Oy 
Finnland 
Sími: + 358 9 180 452 5900 

 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +(421) 2 5726 7911 

 
Italia 
Teva Italia S.r.l. 
Tel: +(39) 028917981 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Ελλάδα 
Τηλ: +30 210 72 79 099 

 
Sverige 
Teva Sweden AB 
Tel: +(46) 42 12 11 00 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67 784 980 

 
United Kingdom 
Teva UK Limited 
Tel: +(44) 1977 628 500 

 
 
This leaflet was last revised in {12/2014}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 
 
 

http://www.emea.europa.eu/

	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 AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET