Irbesartan Teva

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 75 mg film-coated tablets 
Irbesartan Teva 150 mg film-coated tablets 
Irbesartan Teva 300 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Irbesartan Teva 75 mg film-coated tablets 
Each film-coated tablet contains 75 mg of irbesartan 
 
Irbesartan Teva 150 mg film-coated tablets 
Each film-coated tablet contains 150 mg of irbesartan 
 
Irbesartan Teva 300 mg film-coated tablets 
Each film-coated tablet contains 300 mg of irbesartan 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
Irbesartan Teva 75 mg film-coated tablets 
White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number 
“93”. The other side of the tablet debossed with number “7464”.  
 
Irbesartan Teva 150 mg film-coated tablets 
White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number 
“93”. The other side of the tablet debossed with number “7465”.  
 
Irbesartan Teva 300 mg film-coated tablets 
White to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number 
“93”. The other side of the tablet debossed with number “7466”.   
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Irbesartan Teva is indicated in adults for the treatment of essential hypertension. 
 
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 
diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 
and 5.1). 
 
4.2 Posology and method of administration 
 
Posology 
 
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. 
Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control 
than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in 
haemodialysed patients and in the elderly over 75 years. 
 



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In patients insufficiently controlled with 150 mg once daily, the dose of irbesartan can be increased to 
300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In 
particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive 
effect with irbesartan (see section 4.5). 
 
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily 
and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.  
 
The demonstration of renal benefit of irbesartan in hypertensive type 2 diabetic patients is based on 
studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach 
target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). 
 
Special populations 
 
Renal impairment 
 
No dose adjustment is necessary in patients with impaired renal function. A lower starting dose 
(75 mg) should be considered for patients undergoing haemodialysis (see section 4.4). 
 
Hepatic impairment 
 
No dose adjustment is necessary in patients with mild to moderate hepatic impairment. There is no 
clinical experience in patients with severe hepatic impairment. 
 
Elderly population  
 
Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of 
age, dose adjustment is not usually necessary for elderly people. 
 
Paediatric population 
 
The safety and efficacy of Irbesartan Teva in children aged 0 to 18 has not been established. Currently 
available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be 
made. 
 
Method of Administration 
 
For oral use. 
 
4.3 Contraindications 
 

• Hypersensitivity to the active substance or to any of the excipients listed insection 6.1. 
• Second and third trimesters of pregnancy (see section 4.4 and 4.6). 
• The concomitant use of Irbesartan Teva with aliskiren-containing products is contraindicated in 

patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 
and 5.1). 

 
4.4 Special warnings and precautions for use 
 
Intravascular volume depletion 
Symptomatic hypotension, especially after the first dose, 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 irbesartan. 
 
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 



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products that affect the renin-angiotensin-aldosterone system. While this is not documented with 
irbesartan, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
 
Renal impairment and kidney transplantation 
When irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium 
and creatinine serum levels is recommended. There is no experience regarding the administration of 
irbesartan in patients with a recent kidney transplantation. 
 
Hypertensive patients with type 2 diabetes and renal disease 
The effects of irbesartan both on renal and cardiovascular events were not uniform across all 
subgroups, in an analysis carried out in the study with patients with advanced renal disease. In 
particular, they appeared less favourable in women and non-white subjects (see section 5.1). 
 
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. 
 
Hyperkalaemia 
As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia 
may occur during the treatment with irbesartan, especially in the presence of renal impairment, overt 
proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in 
patients at risk is recommended (see section 4.5). 
 
Lithium 
The combination of lithium and irbesartan is not recommended (see section 4.5). 
 
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. 
 
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 irbesartan is not 
recommended. 
 
General 
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 angiotensin converting enzyme inhibitors or 
angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, 
azotaemia, oliguria, or rarely acute renal failure (see section 4.5). As with any antihypertensive agent, 
excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular 
disease could result in a myocardial infarction or stroke. 
As observed for angiotensin converting enzyme inhibitors, irbesartan 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 (see 
section 5.1). 
 
Pregnancy 
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless 
continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to 



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alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. 
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if 
appropriate, alternative therapy should be started (see sections 4.3 and 4.6). 
 
Paediatric population 
Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are 
insufficient to support an extension of the use in children until further data become available (see 
sections 4.8, 5.1 and 5.2). 
 
Excipient 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Diuretics and other antihypertensive agents 
Other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan 
has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting 
calcium channel blockers, and thiazide diuretics. Prior treatment with high dose diuretics may result in 
volume depletion and a risk of hypotension when initiating therapy with irbesartan (see section 4.4). 
 
Potassium supplements and potassium-sparing diuretics 
Based on experience with the use of other medicinal products that affect the renin-angiotensin system, 
concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing 
potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may 
lead to increases in serum potassium and is, therefore, not recommended (see section 4.4). 
 
Lithium 
Reversible increases in serum lithium concentrations and toxicity have been reported during 
concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects 
have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended 
(see section 4.4). If the combination proves necessary, careful monitoring of serum lithium levels is 
recommended. 
 
Non-steroidal anti-inflammatory drugs 
When angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory 
drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), 
attenuation of the antihypertensive effect may occur.   
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an 
increased risk of worsening of renal function, including possible acute renal failure, and an increase in 
serum potassium, especially in patients with poor pre-existing renal function. The combination should 
be administered with caution, especially in the elderly. Patients should be adequately hydrated and 
consideration should be given to monitoring renal function after initiation of concomitant therapy, and 
periodically thereafter. 
 
Additional information on irbesartan interactions 
In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan 
is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant 
pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered 
with warfarin, a medicinal product metabolised by CYP2C9. The effects of CYP2C9 inducers such as 
rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of 
digoxin was not altered by coadministration of irbesartan. 
 
Aliskiren-containing products or ACE-inhibitors 
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 



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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). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The 
use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 
and 4.4). 
 
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 Inhibitors (AIIRAs), similar risks may exist for this class of drugs. Unless continued AIIRAs 
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 AIIRAs should be stopped immediately, and, if appropriate, 
alternative therapy should be started. 
 
Exposure to AIIRAs therapy during the second and third trimesters is known to induce human 
foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal 
toxicity (renal failure, hypotension, hyperkalaemia). (see section 5.3). 
 
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check 
of renal function and skull is recommended. 
 
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also 
sections 4.3 and 4.4). 
 
Breast-feeding 
 
Because no information is available regarding the use of irbersartan during breast-feeding, irbesartan 
is not recommended and alternative treatments with better established safety profiles during 
breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
 
It is unknown whether irbesartan or its metabolites are excreted in human milk.  
Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its 
metabolites in milk (for details see section 5.3). 
 
Fertility 
 
Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing 
the first signs of parental toxicity (see section 5.3).  
 
 
4.7 Effects on ability to drive and use machines 
 
Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use 
machines. When driving vehicles or operating machines, it should be taken into account that dizziness 
or weariness may occur during treatment. 
 
4.8 Undesirable effects 
 
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did 
not differ between the irbesartan (56.2 %) and the placebo groups (56.5 %). Discontinuation due to 



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any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3 %) than 
for placebo-treated patients (4.5 %). The incidence of adverse events was not related to dose (in the 
recommended dose range), gender, age, race, or duration of treatment. 
 
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic 
dizziness and orthostatic hypotension were reported in 0.5 % of the patients (i.e., uncommon) but in 
excess of placebo. 
 
The following presents the adverse drug reactions that were reported in placebo-controlled trials in 
which 1,965 hypertensive patients received irbesartan. Terms marked with a star (*) refer to the 
adverse reactions that were additionally reported in > 2 % of diabetic hypertensive patients with 
chronic renal insufficiency and overt proteinuria and in excess of placebo. 
 
The frequency of adverse reactions listed below is defined 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, undesirable effects are presented 
in order of decreasing seriousness. 
 
Adverse reactions additionally reported from post–marketing experience are also listed. These adverse 
reactions are derived from spontaneous reports.  
 
Blood and lymphatic system disorders 
 
Not known:  thrombocytopenia 
 
Immune system disorders 
 
Not known:  hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, 

anaphylactic shock 
 
Metabolism and nutrition disorders 
 
Not known:  hyperkalaemia 
 
Nervous system disorders 
 
Common: dizziness, orthostatic dizziness* 
Not known: vertigo, headache 
 
Ear and labyrinth disorder 
 
Not known: tinnitus 
 
Cardiac disorders 
 
Uncommon: tachycardia 
 
Vascular disorders 
 
Common: orthostatic hypotension* 
Uncommon: flushing 
 
Respiratory, thoracic and mediastinal disorders 
 
Uncommon: cough 
 



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Gastrointestinal disorders 
 
Common: nausea/vomiting 
Uncommon: diarrhoea, dyspepsia/heartburn 
Not known: dysgeusia 
 
Hepatobiliary disorders 
 
Uncommon: jaundice 
Not known: hepatitis, abnormal liver function 
 
Skin and subcutaneous tissue disorders 
 
Not known: leukocytoclastic vasculitis 
 
Musculoskeletal and connective tissue disorders 
 
Common: musculoskeletal pain* 
Not known: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase 
  levels), muscle cramps 
 
Renal and urinary disorders 
 
Not known: impaired renal function including cases of renal failure in patients at risk (see section 4.4) 
 
Reproductive system and breast disorders 
 
Uncommon: sexual dysfunction 
 
General disorders and administration site conditions 
 
Common: fatigue 
Uncommon: chest pain 
 
Investigations 
 
Very common:  Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan 

than with placebo. In diabetic hypertensive patients with microalbuminuria and 
normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4 % of the 
patients in the irbesartan 300 mg group and 22 % of the patients in the placebo 
group. In diabetic hypertensive patients with chronic renal insufficiency and overt 
proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3 % of the patients in the 
irbesartan group and 26.3 % of the patients in the placebo group. 

Common:   significant increases in plasma creatine kinase were commonly observed (1.7 %) in 
irbesartan treated subjects. None of these increases were associated with 
identifiable clinical musculoskeletal events. In 1.7 % of hypertensive patients with 
advanced diabetic renal disease treated with irbesartan, a decrease in 
haemoglobin*, which was not clinically significant, has been observed. 

 
 
Paediatric population  
 
In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following 
adverse reactions occurred in the 3-week double-blind phase: headache (7.9 %), hypotension (2.2 %), 
dizziness (1.9 %), cough (0.9 %). In the 26-week open-label period of this trial the most frequent 
laboratory abnormalities observed were creatinine increases (6.5 %) and elevated CK values in 2 % of 
child recipients. 



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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 
 
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most 
likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might 
also occur from overdose. No specific information is available on the treatment of overdose with 
irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and 
supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal 
may be useful in the treatment of overdose. Irbesartan is not removed by haemodialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Angiotensin-II antagonists, plain. 
ATC code: C09C A04 
 
Mechanism of action 
 
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is 
expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source 
or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors 
results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma 
aldosterone concentration. Serum potassium levels are not significantly affected by irbesartan alone at 
the recommended doses. Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates 
angiotensin-II and also degrades bradykinin into inactive metabolites. Irbesartan does not require 
metabolic activation for its activity. 
 
Clinical efficacy 
 
Hypertension 
 
Irbesartan lowers blood pressure with minimal change in heart rate. The decrease in blood pressure is 
dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 
150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by 
an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo. 
 
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood 
pressure lowering effect is maintained for at least 24 hours. At 24 hours the reduction of blood 
pressure was 60-70 % of the corresponding peak diastolic and systolic responses at the recommended 
doses. Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice 
daily dosing on the same total dose. 
 
The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect 
occurring by 4-6 weeks after start of therapy. The antihypertensive effects are maintained during long 
term therapy. After withdrawal of therapy, blood pressure gradually returns toward baseline. Rebound 
hypertension has not been observed. 
 

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The efficacy of irbesartan is not influenced by age or gender. As is the case with other medicinal 
products that affect the renin-angiotensin system, black hypertensive patients have notably less 
response to irbesartan monotherapy. There is no clinically important effect on serum uric acid or 
urinary uric acid secretion. 
 
Paediatric population 
 
Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target 
titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of 
hypertension) children and adolescents aged 6 to 16 years over a three week period. At the end of the 
three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic 
blood pressure (SeSBP) was 11.7 mm Hg (low dose), 9.3 mm Hg (medium dose), 13.2 mm Hg (high 
dose). No significant difference was apparent between these doses. Adjusted mean change of trough 
seated diastolic blood pressure (SeDBP) was as follows: 3.8 mm Hg (low dose), 3.2 mm Hg (medium 
dose), 5.6 mm Hg (high dose). Over a subsequent two week period where patients were re-randomized 
to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mm Hg 
in SeSBP and SeDBP compared to +0.1 and -0.3 mm Hg changes respectively in those on all doses of 
irbesartan (see section 4.2). 
 
Hypertension and type 2 diabetes with renal disease 
 
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression 
of renal disease in patients with chronic renal insufficiency and overt proteinuria. IDNT was a double 
blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo. In 1,715 
hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging 
from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal 
disease and all-cause mortality were examined. Patients were titrated from 75 mg to a maintenance 
dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated. Patients in all 
treatment groups typically received between 2 and 4 antihypertensive agents (e.g., diuretics, beta 
blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mm Hg or a 
10 mm Hg reduction in systolic pressure if baseline was > 160 mm Hg. Sixty per cent (60 %) of 
patients in the placebo group reached this target blood pressure whereas this figure was 76 % and 
78 % in the irbesartan and amlodipine groups respectively. Irbesartan significantly reduced the relative 
risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) 
or allcause mortality. Approximately 33 % of patients in the irbesartan group reached the primary 
renal composite endpoint compared to 39 % and 41 % in the placebo and amlodipine groups [20 % 
relative risk reduction versus placebo (p = 0.024) and 23 % relative risk reduction compared to 
amlodipine (p = 0.006)]. When the individual components of the primary endpoint were analysed, no 
effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a 
significant reduction in doubling of serum creatinine were observed. 
 
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum 
creatinine, and albumin excretion rate were assessed for treatment effect. In the female and black 
subgroups which represented 32 % and 26 % of the overall study population respectively, a renal 
benefit was not evident, although the confidence intervals do not exclude it. As for the secondary 
endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups 
in the overall population, although an increased incidence of non-fatal MI was seen for women and a 
decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased 
regimen. An increased incidence of non-fatal MI and stroke was seen in females in the 
irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart 
failure was reduced in the overall population. However, no proper explanation for these findings in 
women has been identified. 
 
The study of the “Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in 
patients with microalbuminuria. IRMA 2 was a placebo-controlled double blind morbidity study in 



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590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function 
(serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females). The study examined the long-term 
effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin 
excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30 % from baseline). The 
predefined blood pressure goal was ≤ 135/85 mm Hg. Additional antihypertensive agents (excluding 
ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added 
as needed to help achieve the blood pressure goal. While similar blood pressure was achieved in all 
treatment groups, fewer subjects in the irbesartan 300 mg group (5.2 %) than in the placebo (14.9 %) 
or in the irbesartan 150 mg group (9.7 %) reached the endpoint of overt proteinuria, demonstrating a 
70 % relative risk reduction versus placebo (p = 0.0004) for the higher dose. An accompanying 
improvement in the glomerular filtration rate (GFR) was not observed during the first three months of 
treatment. The slowing in the progression to clinical proteinuria was evident as early as three months 
and continued over the 2 year period. Regression to normoalbuminuria (< 30 mg/day) was more 
frequent in the irbesartan 300 mg group (34 %) than in the placebo group (21 %). 
 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) 
 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in 
combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs 
Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an 
angiotensin II receptor blocker. 
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular 
disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D 
was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. 
 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and 
mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as 
compared to monotherapy was observed. Given their similar pharmacodynamic properties, these 
results are also relevant for other ACE- inhibitors and angiotensin II receptor blockers. 
 
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in 
patients with diabetic nephropathy. 
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) 
was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor 
or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney 
disease, cardiovascular disease, or both. The study was terminated early because of an increased risk 
of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the 
aliskiren group than in the placebo group and adverse events and serious adverse events of interest 
(hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren 
group than in the placebo group. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of 
approximately 60-80 %. Concomitant food intake does not significantly influence the bioavailability 
of irbesartan.  
 
Distribution 
 
Plasma protein binding is approximately 96 %, with negligible binding to cellular blood components. 
The volume of distribution is 53-93 litres.  
 



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Biotransformation 
 
Following oral or intravenous administration of 14C irbesartan, 80-85 % of the circulating plasma 
radioactivity is attributable to unchanged irbesartan. Irbesartan is metabolised by the liver via 
glucuronide conjugation and oxidation. The major circulating metabolite is irbesartan glucuronide 
(approximately 6 %). In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome 
P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect. 
 
Linearity/non-linearity 
 
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. 
A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal 
recommended dose) was observed; the mechanism for this is unknown. Peak plasma concentrations 
are attained at 1.5-2 hours after oral administration. The total body and renal clearance are 157-176 
and 3-3.5 ml/min, respectively. The terminal elimination half-life of irbesartan is 11-15 hours. 
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing 
regimen. Limited accumulation of irbesartan (< 20 %) is observed in plasma upon repeated once-daily 
dosing. In a study, somewhat higher plasma concentrations of irbesartan were observed in female 
hypertensive patients. However, there was no difference in the half-life and accumulation of 
irbesartan. No dosage adjustment is necessary in female patients. Irbesartan AUC and Cmax values 
were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years). 
However the terminal half-life was not significantly altered. No dosage adjustment is necessary in 
elderly people. 
 
Elimination 
 
Irbesartan and its metabolites are eliminated by both biliary and renal pathways. After either oral or IV 
administration of 14C irbesartan, about 20 % of the radioactivity is recovered in the urine, and the 
remainder in the faeces. Less than 2 % of the dose is excreted in the urine as unchanged irbesartan. 
 
Paediatric population 
 
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration 
of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for 
four weeks. Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults 
(twelve children over 12 years, nine children between 6 and 12 years). Results showed that Cmax, AUC 
and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan 
daily. A limited accumulation of irbesartan (18 %) in plasma was observed upon repeated once daily 
dosing. 
 
Renal impairment 
 
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters 
of irbesartan are not significantly altered. Irbesartan is not removed by haemodialysis. 
 
Hepatic impairment 
 
In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not 
significantly altered. Studies have not been performed in patients with severe hepatic impairment. 
 
5.3 Preclinical safety data 
 
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses. In 
non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in 
macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit). 
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial 



13 

nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and 
creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the 
hypotensive effects of the medicinal product which led to decreased renal perfusion. Furthermore, 
irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in 
macaques at ≥ 10 mg/kg/day). All of these changes were considered to be caused by the 
pharmacological action of irbesartan. For therapeutic doses of irbesartan in humans, the 
hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance. 
 
There was no evidence of mutagenicity, clastogenicity or carcinogenicity. 
 
Fertility and reproductive performance were not affected in studies of male and female rats even at 
oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including 
mortality at the highest dose. No significant effects on the number of corpora lutea, implants, or live 
foetuses were observed. Irbesartan did not affect survival, development, or reproduction of offspring. 
Studies in animals indicate that the radiolabelled irbesartan is detected in rat and rabbit foetuses. 
Irbesartan is excreted in the milk of lactating rats. 
 
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, 
hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth. In rabbits, 
abortion or early resorption were noted at doses causing significant maternal toxicity, including 
mortality. No teratogenic effects were observed in the rat or rabbit. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet Core: 
Povidone 
Pregelatinized starch (maize) 
Poloxamer 188 
Microcrystalline cellulose 
Croscarmellose sodium 
Silica, colloidal hydrated   
Magnesium stearate 
 
Film coating: 
Polydextrose (E1200) 
Titanium dioxide (E171) 
Hypromellose (E464) 
Macrogol 4000 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
PVC/PVdC white opaque – aluminium blisters.   



14 

Pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, 100 film-coated tablets in non-perforated blisters. 
Pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters. 
Pack size of 28 film-coated tablets in non-perforated calendar blisters. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
Any unused  medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Irbesartan Teva 75 mg film-coated tablets 
EU/1/09/576/001  7 tablets 
EU/1/09/576/002  14 tablets 
EU/1/09/576/003  28 tablets 
EU/1/09/576/004  30 tablets 
EU/1/09/576/005  56 tablets 
EU/1/09/576/006  60 tablets 
EU/1/09/576/007  80 tablets 
EU/1/09/576/008  84 tablets 
EU/1/09/576/009  90 tablets 
EU/1/09/576/010  98 tablets 
EU/1/09/576/011  100 tablets 
EU/1/09/576/012  50 x 1 tablet (unit dose) 
EU/1/09/576/013  56 x 1 tablet (unit dose) 
EU/1/09/576/040  28 tablets (calendar pack) 
 
Irbesartan Teva 150 mg film-coated tablets 
EU/1/09/576/014  7 tablets 
EU/1/09/576/015  14 tablets 
EU/1/09/576/016  28 tablets 
EU/1/09/576/017  30 tablets 
EU/1/09/576/018  56 tablets 
EU/1/09/576/019  60 tablets 
EU/1/09/576/020  80 tablets 
EU/1/09/576/021  84 tablets 
EU/1/09/576/022  90 tablets 
EU/1/09/576/023  98 tablets 
EU/1/09/576/024  100 tablets 
EU/1/09/576/025  50 x 1 tablet (unit dose) 
EU/1/09/576/026  56 x 1 tablet (unit dose) 
EU/1/09/576/041  28 tablets (calendar pack) 
 
Irbesartan Teva 300 mg film-coated tablets 
EU/1/09/576/027  7 tablets 
EU/1/09/576/028  14 tablets 



15 

EU/1/09/576/029  28 tablets 
EU/1/09/576/030  30 tablets 
EU/1/09/576/031  56 tablets 
EU/1/09/576/032  60 tablets 
EU/1/09/576/033  80 tablets 
EU/1/09/576/034  84 tablets 
EU/1/09/576/035  90 tablets 
EU/1/09/576/036  98 tablets 
EU/1/09/576/037  100 tablets 
EU/1/09/576/038  50 x 1 tablet (unit dose) 
EU/1/09/576/039  56 x 1 tablet (unit dose) 
EU/1/09/576/042  28 tablets (calendar pack) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 30 October 2009 
Date of latest renewal: 18 July 2014 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency: http://www.ema.europa.eu 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



17 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
 
Name and address of the manufacturers responsible for batch release 
 
Teva Operations Poland Sp.z.o.o 
ul. Mogilska 80 
31-546 Kraków 
Poland  
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13 
HU-4042 Debrecen 
Hungary 
 
Pharmachemie B.V. 
Swensweg 5, Postbus 552 
2003 RN Haarlem 
The Netherlands 
 
TEVA UK Ltd. 
Brampton Road 
Hampden Park, Eastbourne, 
East Sussex, BN22 9AG 
United Kingdom 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 

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

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
Not applicable. 
 



18 

• Obligation to conduct post-authorisation measures 
 
The MAH shall complete, within the stated timeframe, the below measures: 
 

Conditions to the MA Due date 
The MAH must ensure that the manufacturing processes of the drug substances 
used for their drug products are reviewed for the potential risk of formation of N-
nitrosamines and changed as necessary to minimise nitrosamine contamination as 
much as possible. 

Within 2 
years after 
Commission 
Decision. 

For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the 
MAH must introduce the following specifications for the drug substance:  

After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 
0.03 ppm should be implemented. 

Within 2 
years after 
Commission 
Decision. 

 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 75 mg film-coated tablets 
Irbesartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 75 mg irbesartan 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
7 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
80 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
50 x 1 film-coated tablets 
56 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use.  Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 



22 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/576/001  7 tablets 
EU/1/09/576/002  14 tablets 
EU/1/09/576/003  28 tablets 
EU/1/09/576/004  30 tablets 
EU/1/09/576/005  56 tablets 
EU/1/09/576/006  60 tablets 
EU/1/09/576/007  80 tablets 
EU/1/09/576/008  84 tablets 
EU/1/09/576/009  90 tablets 
EU/1/09/576/010  98 tablets 
EU/1/09/576/011  100 tablets 
EU/1/09/576/012  50 x 1 tablet (unit dose) 
EU/1/09/576/013  56 x 1 tablet (unit dose) 
EU/1/09/576/040  28 tablets (calendar pack) 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Irbesartan Teva 75 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



23 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



24 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 75 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
 
 
  



25 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
CALENDAR BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 75 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
 
 



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 150 mg film-coated tablets 
Irbesartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 150 mg irbesartan 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
7 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
80 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
50 x 1 film-coated tablets 
56 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use.  Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 



27 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/576/014  7 tablets 
EU/1/09/576/015  14 tablets 
EU/1/09/576/016  28 tablets 
EU/1/09/576/017  30 tablets 
EU/1/09/576/018  56 tablets 
EU/1/09/576/019  60 tablets 
EU/1/09/576/020  80 tablets 
EU/1/09/576/021  84 tablets 
EU/1/09/576/022  90 tablets 
EU/1/09/576/023  98 tablets 
EU/1/09/576/024  100 tablets 
EU/1/09/576/025  50 x 1 tablet (unit dose) 
EU/1/09/576/026  56 x 1 tablet (unit dose) 
EU/1/09/576/041  28 tablets (calendar pack) 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Irbesartan Teva 150 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 



28 

2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



29 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 150 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
 
  



30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
CALENDAR BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 150 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
 
 



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 300 mg film-coated tablets 
Irbesartan 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 300 mg irbesartan 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablets 
 
7 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
80 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
50 x 1 film-coated tablets 
56 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use.  Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 



32 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/576/027  7 tablets 
EU/1/09/576/028  14 tablets 
EU/1/09/576/029  28 tablets 
EU/1/09/576/030  30 tablets 
EU/1/09/576/031  56 tablets 
EU/1/09/576/032  60 tablets 
EU/1/09/576/033  80 tablets 
EU/1/09/576/034  84 tablets 
EU/1/09/576/035  90 tablets 
EU/1/09/576/036  98 tablets 
EU/1/09/576/037  100 tablets 
EU/1/09/576/038  50 x 1 tablet (unit dose) 
EU/1/09/576/039  56 x 1 tablet (unit dose) 
EU/1/09/576/042  28 tablets (calendar pack) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Irbesartan Teva 300 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



33 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



34 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 300 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
  



35 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
CALENDAR BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Irbesartan Teva 300 mg film-coated tablets 
Irbesartan 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
LOT 
 
 

5. OTHER 
 
Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
 
 
  



36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



37 

 Package leaflet: information for the user 
 

Irbesartan Teva 75 mg Film-Coated Tablets 
Irbesartan 

 
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 Irbesartan Teva is and what it is used for 
2. What you need to know before you take Irbesartan Teva 
3. How to take Irbesartan Teva 
4. Possible side effects 
5. How to store Irbesartan Teva 
6. Contents of the pack and other information 
 
 
1. What Irbesartan Teva is and what it is used for 
 
Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists.  
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing 
them to tighten.  This results in an increase in blood pressure. Irbesartan Teva prevents the binding of 
angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.  
Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 
diabetes.      
 
Irbesartan Teva is used in adult patients 
 to treat high blood pressure (essential hypertension) 
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory 

evidence of impaired kidney function. 
 
 
2.  What you need to know before you take Irbesartan Teva 
 
Do not take Irbesartan Teva 
 If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in 

section 6). 
 If you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early 

pregnancy - see pregnancy section). 
  if you have diabetes or impaired kidney function and you are treated with a blood pressure 

lowering medicine containing aliskiren 
 

Warnings and precautions 
Talk to your doctor before taking Irbesartan Teva and if any of the following apply to you: 
 if you get excessive vomiting or diarrhoea 
 if you suffer from kidney problems   
 if you suffer from heart problems   
 if you receive Irbesartan Teva for diabetic kidney disease.  In this case your doctor may 

perform regular blood tests, especially for measuring blood potassium levels in case of poor 
kidney function.   

 if you are going to have an operation (surgery) or be given anaesthetics.  



38 

 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 Irbesartan Teva”. 

  
 
You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section).   
 
Children and adolescents 
This medicinal product should not be given to children under 18 years of age because the safety and 
efficacy have not yet been fully established. If a child swallows some tablets, contact your doctor 
immediately. 
 
Other medicines and Irbesartan Teva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Your doctor may need to change your dose and/or to take other precautions: 
 
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Irbesartan Teva” and “Warnings and precautions”). 
 
You may need to have blood checks if you take: 
 potassium supplements 
 salt substitutes containing potassium 
 potassium-sparing medicines (such as certain diuretics) 
 medicines containing lithium 
 
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan 
may be reduced.   
 
 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think that you are (or might become) pregnant.  Your doctor will 
normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you 
know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva.  
Irbesartan Teva is not recommended in early pregnancy, and must not be taken when more than 3 
months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.   
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding.  Irbesartan Teva is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.   
 
Driving and using machines 
Irbesartan Teva is unlikely to affect your ability to drive or use machines.  However, occasionally 
dizziness or weariness may occur during treatment of high blood pressure.  If you experience these, 
talk to your doctor before attempting to drive or use machines. 
 



39 

Irbesartan Teva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take Irbesartan Teva 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
Method of administration 
Irbesartan Teva is for oral use.  Swallow the tablets with a sufficient amount of fluid (e.g. one glass of 
water).  You can take Irbesartan Teva with or without food.  Try to take your daily dose at about the 
same time each day. It is important that you continue to take Irbesartan Teva until your doctor tells 
you otherwise. 
 
 Patients with high blood pressure  

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily 
depending on blood pressure response. 

 
 Patients with high blood pressure and type 2 diabetes with kidney disease 

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred 
maintenance dose for the treatment of associated kidney disease. 

 
The doctor may advise a lower dose, especially when starting treatment in certain patients such as 
those on haemodialysis, or those over the age of 75 years. 
 
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. 
 
 
If you take more Irbesartan Teva than you should: 
If you accidentally take too many tablets, contact your doctor immediately. 
 
If you forget to take Irbesartan Teva 
If you accidentally miss a daily dose, just take the next dose as normal.  Do not take a double dose to 
make up for a forgotten dose.   
  
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 of 
these effects may be serious and may require medical attention.   
 
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised 
swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any 
of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor 
immediately. 
  
 
List of side effects: 
 Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and 

type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
 
 Common (may affect up to 1in 10 people): dizziness, feeling sick/vomiting, fatigue and blood 

tests may show raised levels of an enzyme that measures the muscle and heart function (creatine 



40 

kinase enzyme).  In patients with high blood pressure and type 2 diabetes with kidney disease, 
dizziness when getting up from  lying or sitting position, low blood pressure when getting up 
from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the 
red blood cells (haemoglobin) were also reported. 

 
 Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, 

indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
 
Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, 
taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of 
platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, 
inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic 
vasculitis) and severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing 
of the skin and/or whites of the eyes) have also been reported. 
 
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 Irbesartan Teva 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.  The 
expiry date refers to the last day of that month. 
  
This medicinal product does not require any special storage conditions.  
 
Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Irbesartan Teva contains 
 The active substance is irbesartan.   

• Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan. 
 The other ingredients are: 

• Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline 
cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.   

• Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000. 
 
What Irbesartan Teva looks like and contents of the pack 
Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet. One side 
of the tablet debossed with the number “93”. The other side of the tablet debossed with number 
“7464”.  
 
Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated 
tablets in non-perforated blisters; pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters 
and pack size of 28 film-coated tablets in non-perforated calendar blisters.      
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder: 
Teva B.V. 

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


41 

Swensweg 5 
2031GA Haarlem 
The Netherlands 
   
Manufacturers: 
Teva Operations Poland Sp.z.o.o 
ul. Mogilska 80 
31-546 Kraków 
Poland  
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13 
Debrecen H-4042 
Hungary 
 
TEVA UK Ltd 
Brampton Road 
Hampden Park 
Eastbourne, East Sussex 
BN22 9AG UK 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A/AG  
Tél/Tel: +32 38207373  

Luxembourg/Luxemburg  
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
  

България  
Актавис ЕАД 
Teл: +359 24899582 

Magyarország  
Teva Gyógyszergyár Zrt.  
Tel: +36 12886400 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251007111  

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Τel: +353 51321740 

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44985511  

 
Nederland  
Teva Nederland B.V. 
Tel: +31 8000228400  

 
Deutschland 
Teva GmbH 
Tel: +49 73140208 

 
Norge 
Teva Norway AS 
Tlf: +47 66775590 

 
Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 

 
Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 



42 

Τηλ: +30 2107279099 Tel.: +48 223459300 

 
España 
TevaPharma, S.L.U. 
Tel: +34 913873280 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos, 
Lda 
Tel: 351 214235910 

 
France 
Teva Santé 
Tél: +33 155917800 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +40 212306524 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: +385 13720000 
 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51321740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 

 
Ísland 
ratiopharm Oy  
Finnland  
Sími: +358 201805900 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 

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

 
Sverige 
Teva Sweden AB 
Tel: +46 42121100 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Τηλ: +30 2107279099 

 
United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67323666 

 
 

 
Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 

 

 
 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 



43 

 Package leaflet: information for the user 
 

Irbesartan Teva 150 mg Film-Coated Tablets 
Irbesartan 

 
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 Irbesartan Teva is and what it is used for 
2. What you need to know before you take Irbesartan Teva 
3. How to take Irbesartan Teva 
4. Possible side effects 
5.       How to store Irbesartan Teva 
6. Contents of the pack and other information 
 
 
1.  What Irbesartan Teva is and what it is used for 
 
Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists.  
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing 
them to tighten.  This results in an increase in blood pressure.  Irbesartan Teva prevents the binding of 
angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.  
Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 
diabetes.      
 
Irbesartan Teva is used in adult patients 
 to treat high blood pressure (essential hypertension) 
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory 

evidence of impaired kidney function. 
 
 
2. What you need to know before you take Irbesartan Teva 
 
Do not take Irbesartan Teva 
 If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in 

section 6). 
 If you are more than 3 months pregnant (It is also better to avoid Irbesartan Teva in early 

pregnancy - see pregnancy section). 
 if you have diabetes or impaired kidney function and you are treated with a blood pressure 

lowering medicine containing aliskiren. 
 
Warnings and precautions 
Talk to your doctor before taking Irbesartan Teva and if any of the following apply to you: 
 if you get excessive vomiting or diarrhoea 
 if you suffer from kidney problems   
 if you suffer from heart problems   
 if you receive Irbesartan Teva for diabetic kidney disease.  In this case your doctor may 

perform regular blood tests, especially for measuring blood potassium levels in case of poor 
kidney function   

 if you are going to have an operation (surgery) or be given anaesthetics  



44 

 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 Irbesartan Teva”.  
 
You must tell your doctor if you think that you are (or might become) pregnant.  Irbesartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section).   
 
Children and adolescents 
This medicinal product should not be given to children under 18 years of age because the safety and 
efficacy have not yet been fully established. If a child swallows some tablets, contact your doctor 
immediately. 
 
Other medicines and Irbesartan Teva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Your doctor may need to change your dose and/or to take other precautions: 
 
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Irbesartan Teva” and “Warnings and precautions”). 
You may need to have blood checks if you take: 
 potassium supplements 
 salt substitutes containing potassium 
 potassium-sparing medicines (such as certain diuretics) 
 medicines containing lithium 
 
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan 
may be reduced.   
 
 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think that you are (or might become) pregnant.  Your doctor will 
normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you 
know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva.  
Irbesartan Teva is not recommended in early pregnancy, and must not be taken when more than 3 
months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.   
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding.  Irbesartan Teva is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.   
 
Driving and using machines 
Irbesartan Teva is unlikely to affect your ability to drive or use machines.  However, occasionally 
dizziness or weariness may occur during treatment of high blood pressure.  If you experience these, 
talk to your doctor before attempting to drive or use machines. 
 



45 

Irbesartan Teva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take Irbesartan Teva 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
Method of administration 
Irbesartan Teva is for oral use.  Swallow the tablets with a sufficient amount of fluid (e.g. one glass of 
water).  You can take Irbesartan Teva with or without food.  Try to take your daily dose at about the 
same time each day. It is important that you continue to take Irbesartan Teva until your doctor tells 
you otherwise. 
 
 Patients with high blood pressure  

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily 
depending on blood pressure response. 

 
 Patients with high blood pressure and type 2 diabetes with kidney disease 

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred 
maintenance dose for the treatment of associated kidney disease. 

 
The doctor may advise a lower dose, especially when starting treatment in certain patients such as 
those on haemodialysis, or those over the age of 75 years. 
 
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. 
 
 
If you take more Irbesartan Teva than you should: 
If you accidentally take too many tablets, contact your doctor immediately. 
 
If you forget to take Irbesartan Teva 
If you accidentally miss a daily dose, just take the next dose as normal.  Do not take a double dose to 
make up for a forgotten dose.   
  
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 of 
these effects may be serious and may require medical attention.   
 
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised 
swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any 
of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor 
immediately. 
  
 
List of side effects: 
 Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and 

type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
 
 Common (may affect up to 1in 10 people): dizziness, feeling sick/vomiting, fatigue and blood 

tests may show raised levels of an enzyme that measures the muscle and heart function (creatine 



46 

kinase enzyme).  In patients with high blood pressure and type 2 diabetes with kidney disease, 
dizziness when getting up from  lying or sitting position, low blood pressure when getting up 
from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the 
red blood cells (haemoglobin) were also reported. 

 
 Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, 

indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
 
Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, 
taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of 
platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, 
inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic 
vasculitis) and severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing 
of the skin and/or whites of the eyes) have also been reported. 
 
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 Irbesartan Teva 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.  The 
expiry date refers to the last day of that month. 
  
This medicinal product does not require any special storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Irbesartan Teva contains 
 
 The active substance is irbesartan.   

• Each Irbesartan Teva 150 mg film-coated tablet contains 150 mg irbesartan. 
 The other ingredients are: 

• Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline 
cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.   

• Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000. 
 
What Irbesartan Teva looks like and contents of the pack 
Irbesartan 150 mg film-coated tablets are white to off white capsule shaped, film coated tablet. One 
side of the tablet debossed with the number “93”. The other side of the tablet debossed with number 
“7465”.    
 
Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated 
tablets in non-perforated blisters; pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters 
and pack size of 28 film-coated tablets in non-perforated calendar blisters. 
 
Not all pack sizes may be marketed. 
 

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


47 

Marketing Authorisation Holder: 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
The Netherlands 
   
Manufacturers: 
Teva Operations Poland Sp.z.o.o 
ul. Mogilska 80 
31-546 Kraków 
Poland  
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13 
Debrecen H-4042 
Hungary 
 
TEVA UK Ltd 
Brampton Road 
Hampden Park 
Eastbourne, East Sussex 
BN22 9AG UK 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A/AG  
Tél/Tel: +32 38207373  

Luxembourg/Luxemburg  
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
  

България  
Актавис ЕАД 
Teл: +359 24899582 

Magyarország  
Teva Gyógyszergyár Zrt.  
Tel: +36 12886400 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251007111  

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Τel: +353 51321740 

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44985511  

 
Nederland  
Teva Nederland B.V. 
Tel: +31 8000228400  

 
Deutschland 
Teva GmbH 
Tel: +49 73140208 

 
Norge 
Teva Norway AS 
Tlf: +47 66775590 

 
Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 

 
Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 



48 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 2107279099 

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 223459300 

 
España 
TevaPharma, S.L.U. 
Tel: +34 913873280 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos, 
Lda 
Tel: 351 214235910 

 
France 
Teva Santé 
Tél: +33 155917800 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +40 212306524 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: +385 13720000 
 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51321740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 

 
Ísland 
ratiopharm Oy  
Finnland  
Sími: +358 201805900 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 

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

 
Sverige 
Teva Sweden AB 
Tel: +46 42121100 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Τηλ: +30 2107279099 

 
United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67323666 

 
 

 
Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 

 

 
 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 



49 

Package leaflet: information for the user 
 

Irbesartan Teva 300 mg Film-Coated Tablets 
Irbesartan 

 
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 Irbesartan Teva is and what it is used for 
2. What you need to know before you take Irbesartan Teva 
3. How to take Irbesartan Teva 
4. Possible side effects 
5.       How to store Irbesartan Teva 
6. Contents of the pack and other information 
 
 
1.  What Irbesartan Teva is and what it is used for 
 
Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists.  
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing 
them to tighten.  This results in an increase in blood pressure.  Irbesartan Teva prevents the binding of 
angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.  
Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 
diabetes.      
 
Irbesartan Teva is used in adult patients  
 to treat high blood pressure (essential hypertension) 
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory 

evidence of impaired kidney function. 
 
 
2. What you need to know before you take Irbesartan Teva 
 
Do not take Irbesartan Teva 
 if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in 

section 6). 
 if you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early 

pregnancy - see pregnancy section). 
 if you have diabetes or impaired kidney function and you are treated with a blood pressure 

lowering medicine containing aliskiren 
 
 

Warnings and precautions 
Talk to your doctor before taking Irbesartan Teva and if any of the following apply to you: 
 If you get excessive vomiting or diarrhoea 
 If you suffer from kidney problems   
 If you suffer from heart problems   
 If you receive Irbesartan Teva for diabetic kidney disease.  In this case your doctor may 

perform regular blood tests, especially for measuring blood potassium levels in case of poor 
kidney function   



50 

 If you are going to have an operation (surgery) or be given anaesthetics   
 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 Irbesartan Teva”. 
You must tell your doctor if you think that you are (or might become) pregnant.  Irbesartan Teva is not 
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it 
may cause serious harm to your baby if used at that stage (see pregnancy section).   
 
Children and adolescents 
This medicinal product should not be given to children under 18 years of age because the safety and 
efficacy have not yet been fully established. If a child swallows some tablets, contact your doctor 
immediately. 
 
Other medicines and Irbesartan Teva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Your doctor may need to change your dose and/or to take other precautions: 
 
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take 
Irbesartan Teva” and “Warnings and precautions”). 
 
You may need to have blood checks if you take: 
 potassium supplements 
 salt substitutes containing potassium 
 potassium-sparing medicines (such as certain diuretics) 
 medicines containing lithium 
 
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan 
may be reduced.   
 
 
Pregnancy and breast-feeding 
Pregnancy 
You must tell your doctor if you think that you are (or might become) pregnant.  Your doctor will 
normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you 
know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva.  
Irbesartan Teva is not recommended in early pregnancy, and must not be taken when more than 3 
months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.   
 
Breast-feeding 
Tell your doctor if you are breast-feeding or about to start breast-feeding.  Irbesartan Teva is not 
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for 
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.   
 
Driving and using machines 
Irbesartan Teva is unlikely to affect your ability to drive or use machines.  However, occasionally 
dizziness or weariness may occur during treatment of high blood pressure.  If you experience these, 
talk to your doctor before attempting to drive or use machines. 
 



51 

Irbesartan Teva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
 
3.  How to take Irbesartan Teva 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
Method of administration 
Irbesartan Teva is for oral use.  Swallow the tablets with a sufficient amount of fluid (e.g. one glass of 
water).  You can take Irbesartan Teva with or without food.  Try to take your daily dose at about the 
same time each day. It is important that you continue to take Irbesartan Teva until your doctor tells 
you otherwise. 
 
 Patients with high blood pressure  

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily 
depending on blood pressure response. 

 
 Patients with high blood pressure and type 2 diabetes with kidney disease 

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred 
maintenance dose for the treatment of associated kidney disease. 

 
The doctor may advise a lower dose, especially when starting treatment in certain patients such as 
those on haemodialysis, or those over the age of 75 years. 
 
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. 
 
 
If you take more Irbesartan Teva than you should 
If you accidentally take too many tablets, contact your doctor immediately.   
 
If you forget to take Irbesartan Teva 
If you accidentally miss a daily dose, just take the next dose as normal.  Do not take a double dose to 
make up for a forgotten dose.   
  
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 of 
these effects may be serious and may require medical attention.   
 
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised 
swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any 
of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor 
immediately. 
  
List of side effects: 
 Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and 

type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. 
 
 Common (may affect up to 1in 10 people): dizziness, feeling sick/vomiting, fatigue and blood 

tests may show raised levels of an enzyme that measures the muscle and heart function (creatine 
kinase enzyme).  In patients with high blood pressure and type 2 diabetes with kidney disease, 



52 

dizziness when getting up from  lying or sitting position, low blood pressure when getting up 
from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the 
red blood cells (haemoglobin) were also reported. 

 
 Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, 

indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
 
Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, 
taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of 
platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, 
inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic 
vasculitis) and severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing 
of the skin and/or whites of the eyes) have also been reported. 
 
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 Irbesartan Teva 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.  The 
expiry date refers to the last day of that month. 
  
This medicinal product does not require any special storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Irbesartan Teva contains 
 
 The active substance is irbesartan.   

• Each Irbesartan Teva 300 mg film-coated tablet contains 300 mg irbesartan. 
 The other ingredients are: 

• Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline 
cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.   

• Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000. 
 
What Irbesartan Teva looks like and contents of the pack 
Irbesartan 300 mg film-coated tablets are white to off white capsule shaped, film coated tablet. One 
side of the tablet debossed with the number “93”. The other side of the tablet debossed with number 
“7466”.   
 
Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated 
tablets in non-perforated blisters; pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters 
and pack size of 28 film-coated tablets in non-perforated calendar blisters. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder: 
Teva B.V. 

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


53 

Swensweg 5 
2031GA Haarlem 
The Netherlands 
   
Manufacturers: 
Teva Operations Poland Sp.z.o.o 
ul. Mogilska 80 
31-546 Kraków 
Poland  
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13 
Debrecen H-4042 
Hungary 
 
TEVA UK Ltd 
Brampton Road 
Hampden Park 
Eastbourne, East Sussex 
BN22 9AG UK 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A/AG  
Tél/Tel: +32 38207373  

Luxembourg/Luxemburg  
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
  

България  
Актавис ЕАД 
Teл: +359 24899582 

Magyarország  
Teva Gyógyszergyár Zrt.  
Tel: +36 12886400 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251007111  

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Τel: +353 51321740 

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44985511  

 
Nederland  
Teva Nederland B.V. 
Tel: +31 8000228400  

 
Deutschland 
Teva GmbH 
Tel: +49 73140208 

 
Norge 
Teva Norway AS 
Tlf: +47 66775590 

 
Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 

 
Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 

 
Ελλάδα 
Teva Ελλάς Α.Ε. 

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 



54 

Τηλ: +30 2107279099 Tel.: +48 223459300 

 
España 
TevaPharma, S.L.U. 
Tel: +34 913873280 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos, 
Lda 
Tel: 351 214235910 

 
France 
Teva Santé 
Tél: +33 155917800 

 
România 
Teva Pharmaceuticals S.R.L 
Tel: +40 212306524 

 
Hrvatska 
Pliva Hrvatska d.o.o 
Tel: +385 13720000 
 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51321740 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 
Slovenská republika 
Teva Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 

 
Ísland 
ratiopharm Oy  
Finnland  
Sími: +358 201805900 

 
Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 

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

 
Sverige 
Teva Sweden AB 
Tel: +46 42121100 

 
Κύπρος 
Teva Ελλάς Α.Ε. 
Τηλ: +30 2107279099 

 
United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 

 
Latvija 
UAB Sicor Biotech filiāle Latvijā  
Tel: +371 67323666 

 
 

 
Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 

 

 
 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 


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