Telmisartan Actavis

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 20 mg tablets 
Telmisartan Actavis 40 mg tablets 
Telmisartan Actavis 80 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Telmisartan Actavis 20 mg tablets 
Each tablet contains 20 mg telmisartan 
 
Telmisartan Actavis 40 mg tablets 
Each tablet contains 40 mg telmisartan 
 
Telmisartan Actavis 80 mg tablets 
Each tablet contains 80 mg telmisartan 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
Telmisartan Actavis 20 mg tablets 
White, round, flat tablets with logo T on one side. 
 
Telmisartan Actavis 40 mg tablets 
White, oval, biconvex tablets with a break line and logo T on one side. The tablet can be divided into 
equal halves. 
 
Telmisartan Actavis 80 mg tablets 
White, oval, biconvex tablets with logo T1 on one side. 
 
 
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 



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increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination 
with thiazidetype 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. 
 
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 Actavis 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 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 trimesters of pregnancy (see sections 4.4 and 4.6) 
- Biliary obstructive disorders 
- Severe hepatic impairment 
 
The concomitant use of Telmisartan Actavis 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 



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be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 
4.6). 
 
Hepatic impairment 
Telmisartan Actavis 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 Actavis 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. 
 
Renal impairment and kidney transplantation 
When Telmisartan Actavis 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 Actavis in patients with recent kidney transplantation. 
 
Intravascular hypovolaemia 
Symptomatic hypotension, especially after the first dose of Telmisartan Actavis, 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 Actavis . 
Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Actavis . 
 
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 



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

- Intercurrent events, in particular 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). 
 
Ethnic differences 
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin 
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. 
 
Excipient(s) 
 
Sodium 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
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. 



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Concomitant use not recommended 
 
Potassium sparing diuretics or potassium supplements 
Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss. 
Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium 
supplements, or potassium-containing salt substitutes may lead to a significant increase in serum 
potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used 
with caution and with frequent monitoring of serum potassium. 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with 
angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, 
careful monitoring of serum lithium levels is recommended. 
 
Concomitant use requiring caution 
 
Non-steroidal anti-inflammatory medicinal products 
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and 
nonselective 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. 
 
Corticosteroids (systemic route) 
Reduction of the antihypertensive effect. 



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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 Actavis 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, 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 anti-hypertensive 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 Actavis during breast-feeding, 
Telmisartan Actavis 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 Actavis. 
 
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 placebo 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 



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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 list of adverse reactions 
 
Adverse reactions have been ranked under headings of frequency using the following convention: 
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); 
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Infections and infestations  
 Uncommon: 
 
 Rare: 

Urinary tract infection including cystitis, upper respiratory tract 
infection including pharyngitis and sinusitis 
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: 
 Rare: 
 

Hyperkalaemia 
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: Interstitial lung disease4 

  
Gastrointestinal disorders  
 Uncommon: 
 Rare: 

Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting 
Dry mouth, stomach discomfort, dysgeusia 



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Hepatobiliary disorders  
 Rare: Hepatic function abnormal/liver disorder3 

 
Skin and subcutaneous tissue disorders 
 Uncommon: 
 Rare: 
  

Pruritus, hyperhidrosis, rash 
Angioedema (also with fatal outcome), eczema, erythema, 
urticaria, drug eruption, toxic skin eruption 
 

Muscoloskeletal and connective tissue disorders 
 Uncommon: 
 Rare: 
  

Back pain (e.g. sciatica), muscle spasms, myalgia 
Arthralgia, pain in extremity, tendon pain (tendinitis like 
symptoms) 
 

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

 
General disorders and administration site conditions 
 Uncommon: 
 Rare: 

Chest pain, asthenia (weakness)  
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 
 



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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 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 



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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 
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.  
 
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). 
 
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. 



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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. 
 
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 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 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%. 
 



13 

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 
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 
Gender differences in plasma concentrations were observed, 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 



14 

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. 
 
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 
 
Magnesium stearate 
Croscarmellose sodium 
Mannitol 
Povidone 
Potassium Hydroxide Pellets 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Al/Al blisters:  
Store in the original package in order to protect from light. 
 
HDPE tablet container with LDPE lid:  
Keep the container tightly closed in order to protect from light. 
 
6.5 Nature and contents of container 
 
Telmisartan Actavis 20 mg tablets 
Telmisartan Actavis 40 mg tablets 



15 

Telmisartan Actavis 80 mg tablets 
Al/Al blisters:  
Pack sizes: 14, 28, 30, 56, 84, 90, 98 or 100 tablets. 
 
HDPE container with LDPE lid and desiccant 
Pack sizes: 30 or 250 tablets 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Telmisartan Actavis 20 mg tablets 
EU/1/10/639/001 (14 tablets blister) 
EU/1/10/639/002 (28 tablets blister) 
EU/1/10/639/003 (30 tablets blister) 
EU/1/10/639/004 (56 tablets blister) 
EU/1/10/639/005 (84 tablets blister) 
EU/1/10/639/006 (90 tablets blister) 
EU/1/10/639/007 (98 tablets blister) 
EU/1/10/639/008 (100 tablets blister) 
EU/1/10/639/009 (30 tablets container) 
EU/1/10/639/010 (250 tablets container) 
 
Telmisartan Actavis 40 mg tablets 
EU/1/10/639/011 (14 tablets blister) 
EU/1/10/639/012 (28 tablets blister) 
EU/1/10/639/013 (30 tablets blister) 
EU/1/10/639/014 (56 tablets blister) 
EU/1/10/639/015 (84 tablets blister) 
EU/1/10/639/016 (90 tablets blister) 
EU/1/10/639/017 (98 tablets blister) 
EU/1/10/639/018 (100 tablets blister) 
EU/1/10/639/019 (30 tablets container) 
EU/1/10/639/020 (250 tablets container) 
 
Telmisartan Actavis 80 mg tablets 
EU/1/10/639/021 (14 tablets blister) 
EU/1/10/639/022 (28 tablets blister) 
EU/1/10/639/023 (30 tablets blister) 
EU/1/10/639/024 (56 tablets blister) 
EU/1/10/639/025 (84 tablets blister) 
EU/1/10/639/026 (90 tablets blister) 
EU/1/10/639/027 (98 tablets blister) 
EU/1/10/639/028 (100 tablets blister) 



16 

EU/1/10/639/029 (30 tablets container) 
EU/1/10/639/030 (250 tablets container) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 30.09.2010 
Date of latest renewal: 19.06.2015 
 
 
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/. 
 



17 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE  
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORIZATION 
 

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



18 

A. MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Actavis Ltd 
BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000 
Malta 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

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

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton for blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 20 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets  
56 tablets  
84 tablets  
90 tablets  
98 tablets  
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



22 

 
 
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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/001 (14 tablets blister) 
EU/1/10/639/002 (28 tablets blister) 
EU/1/10/639/003 (30 tablets blister) 
EU/1/10/639/004 (56 tablets blister) 
EU/1/10/639/005 (84 tablets blister) 
EU/1/10/639/006 (90 tablets blister) 
EU/1/10/639/007 (98 tablets blister) 
EU/1/10/639/008 (100 tablets blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS  
 
Blister 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 20 mg tablets 
 
telmisartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis logo 
  
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
 
  



24 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Carton for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 20 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg telmisartan. 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 
 



25 

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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/009 (30 tablets container) 
EU/1/10/639/010 (250 tablets container) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 20 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



26 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Label for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 20 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 
 



27 

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 
 
Actavis logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/009 (30 tablets container) 
EU/1/10/639/010 (250 tablets container) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton for blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 40 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets  
56 tablets  
84 tablets  
90 tablets  
98 tablets  
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



29 

 
 
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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/011 (14 tablets blister) 
EU/1/10/639/012 (28 tablets blister) 
EU/1/10/639/013 (30 tablets blister) 
EU/1/10/639/014 (56 tablets blister) 
EU/1/10/639/015 (84 tablets blister) 
EU/1/10/639/016 (90 tablets blister) 
EU/1/10/639/017 (98 tablets blister) 
EU/1/10/639/018 (100 tablets blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 40 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS  
 
Blister 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 40 mg tablets 
 
telmisartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis logo 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
 
  



31 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Carton for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 40 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 



32 

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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/019 (30 tablets container) 
EU/1/10/639/020 (250 tablets container) 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 40 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



33 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Label for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 40 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 40 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 
 



34 

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 
 
Actavis logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/019 (30 tablets container) 
EU/1/10/639/020 (250 tablets container) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton for blister 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 80 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 tablets 
28 tablets 
30 tablets  
56 tablets  
84 tablets  
90 tablets  
98 tablets  
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



36 

 
 
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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/021 (14 tablets blister) 
EU/1/10/639/022 (28 tablets blister) 
EU/1/10/639/023 (30 tablets blister) 
EU/1/10/639/024 (56 tablets blister) 
EU/1/10/639/025 (84 tablets blister) 
EU/1/10/639/026 (90 tablets blister) 
EU/1/10/639/027 (98 tablets blister) 
EU/1/10/639/028 (100 tablets blister) 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 80 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



37 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS  
 
Blister 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 80 mg tablets 
 
telmisartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis logo 
 

3. EXPIRY DATE 
 
EXP 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
 
  



38 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Carton for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 80 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reachof children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 
 



39 

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 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/029 (30 tablets container) 
EU/1/10/639/030 (250 tablets container) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Telmisartan Actavis 80 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



40 

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING 
 
Label for tablet container 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Telmisartan Actavis 80 mg tablets 
 
telmisartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 80 mg telmisartan. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
250 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACHOF CHILDREN 
 
Keep out of the sight and reachof children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Contains desiccant, do not eat. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from light. 
 
 



41 

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 
 
Actavis logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/639/029 (30 tablets container) 
EU/1/10/639/030 (250 tablets container) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



43 

Package leaflet: Information for the user 
 

Telmisartan Actavis 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 Actavis is and what it is used for 
2. What you need to know before you take Telmisartan Actavis  
3. How to take Telmisartan Actavis  
4. Possible side effects 
5. How to store Telmisartan Actavis  
6. Contents of the pack and other information 
 
 
1. What Telmisartan Actavis is and what it is used for 
 
Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines 
known as angiotensin II receptor antagonists. 
Angiotensin II is a substance produced in your body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Actavis blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 
 
Telmisartan Actavis tablets are 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 Actavis 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 Actavis 
 
Do not take Telmisartan Actavis  
- 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 Actavis 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 Actavis. 



44 

 
Warning 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 Actavis: 
- 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 Actavis”. 
 
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan Actavis 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 Actavis. 
 
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not 
recommended. 
 
Other medicines and Telmisartan Actavis 
 
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 Actavis 
 
- 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-
converting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists 
(to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin 
or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. 
cyclosporin or tacrolimus), and the antibiotic trimethoprim. 



45 

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

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

- Digoxin. 
 
The effect of Telmisartan Actavis may be reduced when you take NSAIDs (non steroidal 
anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Actavis may increase the blood pressure lowering effect of other medicines used to treat 
high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis. 
 
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 Actavis before you become pregnant or as soon as you know you 
are pregnant and will advise you to take another medicine instead of Telmisartan Actavis. Telmisartan 
Actavis 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 Actavis 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 Actavis. If you feel dizzy or tired, do not 
drive or use machines. 
 
Telmisartan Actavis contains sodium.  
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Telmisartan Actavis 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients 
is one 40 mg tablet once a day to control blood pressure over the 24-hour period. Your 
doctor has recommended a lower dose of one 20 mg tablet daily. Telmisartan Actavis may also 
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. 
 
For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg 
tablet once a day. At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, 
blood pressure should be frequently monitored. 
 
In patients with liver problems the usual dose should not exceed 40 mg once daily. 
 
In patients with kidney problems a lower starting dose of 20 mg is recommended. 



46 

 
Try to take the tablet at the same time each day. You can take Telmisartan Actavis with or without 
food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important 
that you take Telmisartan Actavis every day until your doctor tells you otherwise. If you have 
the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your 
doctor or pharmacist.  
 
If you take more Telmisartan Actavis than you should 
It is important to keep to the dose as prescribed by your doctor. If you accidentally take too many 
tablets ask your doctor what to do or contact your nearest hospital emergency department 
immediately. 
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast 
heart beat (tachycardia). Slow heart beat (bradycardia), dizziness, higher levels of creatinine in the 
blood and sudden kidney failure have also been reported. 
 
If you forget to take Telmisartan Actavis  
If you forget to take your medicine you should take the dose as soon as you remember on the same 
day. 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 a forgotten dose. 
 
If you stop taking Telmisartan Actavis 
Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your 
blood pressure controlled. If you have the impression that the effect of Telmisartan Actavis is too 
strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory 
response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect 
up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see 
their doctor immediately. If these effects are not treated they could be fatal. 
 
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 infections (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):  



47 

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response 
which can lead to death), 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 this side effect), rapid swelling of the skin and 
mucosa which can also lead to death (angioedema also with fatal outcome), 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)**. 
 
* The event may have happened by chance or could be related to a way that telmisartan works that is 
currently not known. 
 
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause. 
 
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 Actavis 
 
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, bottle or blister after 
“EXP”. The expiry date refers to the last day of that month. 
 
Al/Al blisters:  
Store in the original package in order to protect from light. 
 
HDPE tablet container:  
Keep the container tightly closed in order to protect from light. 
 
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 Actavis contains 
- The active substance is telmisartan. Each tablet contains 20 mg telmisartan. 
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, 

potassium hydroxide pellets.  
 
What Telmisartan Actavis looks like and contents of the pack 
20 mg tablets are white, round, flat with logo T on one side 
 
Pack sizes: 



48 

Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets. 
Tablet container: 30 and 250 tablets. 
The tablet container contains a desiccant, do not eat the desiccant. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis Ltd. 
BLB 016 
Bulebel Industrial Estate 
Zejtun 
Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

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

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

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

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Actavis Group PTC ehf. 
IJsland 
Tel: +354 5503300 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 661 0801 
 

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

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 



49 

España 
Actavis Group PTC ehf. 
Islandia 
Tel: +354 5503300 
 

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

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

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

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

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

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 (0)20 180 5900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

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

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271 385257 
 

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



50 

Package leaflet: Information for the user 
 

Telmisartan Actavis 40 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 Actavis is and what it is used for 
2. What you need to know before you take Telmisartan Actavis  
3. How to take Telmisartan Actavis  
4. Possible side effects 
5. How to store Telmisartan Actavis  
6. Contents of the pack and other information 
 
 
1. What Telmisartan Actavis is and what it is used for 
 
Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines 
known as angiotensin II receptor antagonists. 
Angiotensin II is a substance produced in your body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Actavis blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 
 
Telmisartan Actavis tablets are 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 Actavis 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 Actavis 
 
Do not take Telmisartan Actavis  
- 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 Actavis 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 Actavis. 



51 

 
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 Actavis: 
- 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 Actavis”. 
 
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan Actavis 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 Actavis. 
 
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients. 
 
Children and adolescents 
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not 
recommended. 
 
Other medicines and Telmisartan Actavis 
 
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 Actavis 
 
- 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-
converting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists 
(to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin 
or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. 
cyclosporin or tacrolimus), and the antibiotic trimethoprim. 



52 

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

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

- Digoxin. 
 
The effect of Telmisartan Actavis may be reduced when you take NSAIDs (non steroidal 
anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Actavis may increase the blood pressure lowering effect of other medicines used to treat 
high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis. 
 
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 Actavis before you become pregnant or as soon as you know you 
are pregnant and will advise you to take another medicine instead of Telmisartan Actavis. Telmisartan 
Actavis 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 Actavis 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 Actavis. If you feel dizzy or tired, do not 
drive or use machines. 
 
Telmisartan Actavis contains sodium.  
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Telmisartan Actavis 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 
40 mg tablet once a day to control blood pressure over the 24 hour period.  
However, sometimes your doctor may recommend a lower dose 20 mg or a higher dose of 80 mg. 
Alternatively, Telmisartan Actavis 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. 
 
For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg 
tablet once a day. At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, 
blood pressure should be frequently monitored. 
 
In patients with liver problems the usual dose should not exceed 40 mg once daily. 
 



53 

In patients with kidney problems a lower starting dose of 20 mg is recommended. 
 
Try to take the tablet at the same time each day. You can take Telmisartan Actavis with or without 
food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important 
that you take Telmisartan Actavis every day until your doctor tells you otherwise. If you have 
the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your 
doctor or pharmacist.  
 
If you take more Telmisartan Actavis than you should 
It is important to keep to the dose as prescribed by your doctor. If you accidentally take too many 
tablets ask your doctor what to do or contact your nearest hospital emergency department 
immediately. 
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast 
heart beat (tachycardia). Slow heart beat (bradycardia), dizziness, higher levels of creatinine in the 
blood and sudden kidney failure have also been reported. 
 
If you forget to take Telmisartan Actavis  
If you forget to take your medicine you should take the dose as soon as you remember on the same 
day. 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 a forgotten dose. 
 
If you stop taking Telmisartan Actavis 
Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your 
blood pressure controlled. If you have the impression that the effect of Telmisartan Actavis is too 
strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory 
response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect 
up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see 
their doctor immediately. If these effects are not treated they could be fatal. 
 
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 infections (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. 
 



54 

Rare side effects (may affect up to 1 in 1,000 people):  
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response 
which can lead to death), 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 this side effect), rapid swelling of the skin and 
mucosa which can also lead to death (angioedema also with fatal outcome), 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)**. 
 
*The event may have happened by chance or could be related to a way that telmisartan works that is 
currently not known. 
 
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause. 
 
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 Actavis 
 
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, bottle or blister after 
“EXP”. The expiry date refers to the last day of that month. 
 
Al/Al blisters:  
Store in the original package in order to protect from light. 
 
HDPE tablet container:  
Keep the container tightly closed in order to protect from light. 
 
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 Actavis contains 
- The active substance is telmisartan. Each tablet contains 40 mg telmisartan. 
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, 

potassium hydroxide pellets.  
 
What Telmisartan Actavis looks like and contents of the pack 
40 mg tablets are white, oval, biconvex, with a break line and logo T on one side. The tablet can be 
divided into equal halves. 



55 

 
Pack sizes: 
Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets. 
Tablet container: 30 and 250 tablets. 
The tablet container contains a desiccant, do not eat the desiccant. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis Ltd. 
BLB 016 
Bulebel Industrial Estate 
Zejtun 
Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

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

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

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

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Actavis Group PTC ehf. 
IJsland 
Tel: +354 5503300 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 661 0801 
 

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

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 



56 

España 
Actavis Group PTC ehf. 
Islandia 
Tel: +354 5503300 
 

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

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

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

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

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

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 (0)20 180 5900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

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

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271 385257 
 

 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  



57 

Package leaflet: Information for the user 
 

Telmisartan Actavis 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 possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Telmisartan Actavis is and what it is used for 
2. What you need to know before you take Telmisartan Actavis  
3. How to take Telmisartan Actavis  
4. Possible side effects 
5. How to store Telmisartan Actavis  
6. Contents of the pack and other information 
 
 
1. What Telmisartan Actavis is and what it is used for 
 
Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines 
known as angiotensin II receptor antagonists. 
Angiotensin II is a substance produced in your body, which causes your blood vessels to narrow, thus 
increasing your blood pressure. Telmisartan Actavis blocks the effect of angiotensin II so that the 
blood vessels relax, and your blood pressure is lowered. 
 
Telmisartan Actavis tablets are 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 Actavis 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 Actavis 
 
Do not take Telmisartan Actavis  
- 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 Actavis 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 Actavis. 



58 

 
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 Actavis: 
- 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 Actavis”. 
 
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan 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 Actavis. 
 
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.  
 
Children and adolescents 
The use of Telmisartan Actavis in children and adolescents up to the age of 18 years is not 
recommended. 
 
Other medicines and Telmisartan Actavis 
 
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 Actavis 
 
- 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-
converting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists 
(to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin 
or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. 
cyclosporin or tacrolimus), and the antibiotic trimethoprim. 



59 

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

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

- Digoxin. 
 
The effect of Telmisartan Actavis may be reduced when you take NSAIDs (non steroidal 
anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids. 
 
Telmisartan Actavis may increase the blood pressure lowering effect of other medicines used to treat 
high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). 
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or 
antidepressants. You may notice this as dizziness when standing up. You should consult with your 
doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis. 
 
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 Actavis before you become pregnant or as soon as you know you 
are pregnant and will advise you to take another medicine instead of Telmisartan Actavis. Telmisartan 
Actavis 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 Actavis 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 Actavis. If you feel dizzy or tired, do not 
drive or use machines. 
 
Telmisartan Actavis contains sodium.  
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Telmisartan Actavis 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 
40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes 
your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg.  
Alternatively, Telmisartan Actavis 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. 
 
For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg 
tablet once a day. At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, 
blood pressure should be frequently monitored. 
 
In patients with liver problems the usual dose should not exceed 40 mg once daily. 
 



60 

In patients with kidney problems a lower starting dose of 20 mg is recommended. 
 
Try to take the tablet at the same time each day. You can take Telmisartan Actavis with or without 
food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important 
that you take Telmisartan Actavis every day until your doctor tells you otherwise. If you have 
the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your 
doctor or pharmacist.  
 
If you take more Telmisartan Actavis than you should 
It is important to keep to the dose as prescribed by your doctor. If you accidentally take too many 
tablets ask your doctor what to do or contact your nearest hospital emergency department 
immediately. 
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast 
heart beat (tachycardia). Slow heart beat (bradycardia), dizziness, higher levels of creatinine in the 
blood and sudden kidney failure have also been reported. 
 
If you forget to take Telmisartan Actavis  
If you forget to take your medicine you should take the dose as soon as you remember on the same 
day. 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 a forgotten dose. 
 
If you stop taking Telmisartan Actavis 
Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your 
blood pressure controlled. If you have the impression that the effect of Telmisartan Actavis is too 
strong or too weak, talk to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Some side effects can be serious and need immediate medical attention: 
You should see your doctor immediately if you experience any of the following symptoms: 
 
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory 
response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect 
up to 1 in1,000 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. 
 
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 infections (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. 
 



61 

Rare side effects (may affect up to 1 in 1,000 people): 
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response 
which can lead to death), 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 this side effect), rapid swelling of the skin and 
mucosa which can also lead to death (angioedema also with fatal outcome), 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)**. 
 
* The event may have happened by chance or could be related to a way that telmisartan works that is 
currently not known. 
 
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. 
However, it is not known whether telmisartan was the cause. 
 
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 Actavis 
 
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, bottle or blister after 
“EXP”. The expiry date refers to the last day of that month. 
 
Al/Al blisters:  
Store in the original package in order to protect from light. 
 
HDPE tablet container:  
Keep the container tightly closed in order to protect from light. 
 
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 Actavis contains 
- The active substance is telmisartan. Each tablet contains 80 mg telmisartan. 
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, 

potassium hydroxide pellets.  
 
What Telmisartan Actavis looks like and contents of the pack 
80 mg tablets are white, oval, biconvex with logo T1 on one side 
 



62 

Pack sizes: 
Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets. 
Tablet container: 30 and 250 tablets. 
The tablet container contains a desiccant, do not eat the desiccant. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis Ltd. 
BLB 016 
Bulebel Industrial Estate 
Zejtun 
Malta 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

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

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

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

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Actavis Group PTC ehf. 
IJsland 
Tel: +354 5503300 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 661 0801 
 

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

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0 
 



63 

España 
Actavis Group PTC ehf. 
Islandia 
Tel: +354 5503300 
 

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

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

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

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

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

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 (0)20 180 5900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

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

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271 385257 
 

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


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