Ifirmasta

1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



2

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 75 mg film-coated tablets
Ifirmasta 150 mg film-coated tablets
Ifirmasta 300 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ifirmasta 75 mg film-coated tablets
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).

Ifirmasta 150 mg film-coated tablets
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).

Ifirmasta 300 mg film-coated tablets
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).

Excipient with known effect
Ifirmasta 75 mg film-coated tablets
Each film-coated tablet contains 4 mg castor oil.

Ifirmasta 150 mg film-coated tablets
Each film-coated tablet contains 8 mg castor oil.

Ifirmasta 300 mg film-coated tablets
Each film-coated tablet contains 16 mg castor oil.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

White, oval tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Ifirmasta 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.
Ifirmasta 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.



3

In patients insufficiently controlled with 150 mg once daily, the dose of Ifirmasta can be increased to 
300 mg, or other antihypertensive 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 Ifirmasta (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 Ifirmasta 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
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 older people.

Paediatric population
The safety and efficacy of Ifirmasta 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 in section 6.1.

Second and third trimesters of pregnancy (see sections 4.4 and 4.6).

The concomitant use of Ifirmasta 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 Ifirmasta.

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 



4

products that affect the renin-angiotensin-aldosterone system. While this is not documented with 
Ifirmasta, a similar effect should be anticipated with angiotensin-II receptor antagonists.

Renal impairment and kidney transplantation
When Ifirmasta 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 
Ifirmasta 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.

Hyperkalemia
As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia 
may occur during the treatment with Ifirmasta, 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 Ifirmasta 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 Ifirmasta 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



5

Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless 
continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to 
alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 
When pregnancy is diagnosed, treatment with 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).

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 Ifirmasta
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 Ifirmasta (see section 4.4).

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 
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).

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:
Rreversible 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 medicinal products:
When angiotensin II antagonists are administered simultaneously with non-steroidal anti-
inflammatory medicinal products (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 



6

rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of 
digoxin was not altered by coadministration of irbesartan.

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 Antagonists (AIIRAs), similar risks may exist for this class of drugs. Unless continued 
AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative 
antihypertensive treatments which have an established safety profile for use in pregnancy. When 
pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, 
alternative therapy should be started.

Exposure to AIIRA 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 
sections 4.3 and 4.4).

Breast-feeding

Because no information is available regarding the use of Ifirmasta during breast-feeding, Ifirmasta 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 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 any 
clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for 



7

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 table presents the adverse medicinal product 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

Gastrointestinal disorders:
Common: nausea/vomiting
Uncommon: diarrhoea, dyspepsia/heartburn
Not known: dysgeusia

Hepatobiliary disorders:
Uncommon: jaundice
Not known: hepatitis, abnormal liver function



8

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.

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 overdosage are expected to be hypotension and tachycardia; bradycardia 
might also occur from overdose. No specific information is available on the treatment of overdosage 
with Ifirmasta. 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 overdosage. Irbesartan is not removed by haemodialysis.



9

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code: C09CA04.

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.

The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive. In patients 
not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide 
(12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at 
trough of 7-10/3-6 mm Hg (systolic/diastolic).

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. When irbesartan is administered concomitantly with a low dose 
of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches 
that of white patients.
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 



10

blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (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 mmHg (low dose), 3.2 mmHg (medium 
dose), 5.6 mmHg (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 mmHg 
in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg 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 mmHg 
or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg. 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 placebo-
based 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 
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 mmHg. 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 



11

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. 

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-



12

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 older subjects (≥ 65 years) than those of young subjects (18-40 years). However the terminal 
halflife was not significantly altered. No dosage adjustment is necessary in older 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 
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.



13

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:
Mannitol
Hydroxypropylcellulose
Low-substituted Hydroxypropyl Cellulose (LH-21)
Low-substituted Hydroxypropyl Cellulose (LH-11)
Talc
Macrogol 6000
Castor oil, hydrogenated

Film coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3000
Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

Do not store above 30C. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available.
Blister (PVC/PE/PVDC/Alu): 56 x 1 film-coated tablets in perforated unit dose blisters in box.
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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. MARKETING AUTHORISATION NUMBER(S)



14

Ifirmasta 75 mg film-coated tablets
14 tablets: EU/1/08/480/001
28 tablets: EU/1/08/480/002
30 tablets: EU/1/08/480/019
56 tablets: EU/1/08/480/003
56 x 1 tablets: EU/1/08/480/004
84 tablets: EU/1/08/480/005
90 tablets: EU/1/08/480/020
98 tablets: EU/1/08/480/006

Ifirmasta 150 mg film-coated tablets
14 tablets: EU/1/08/480/007
28 tablets: EU/1/08/480/008
30 tablets: EU/1/08/480/021
56 tablets: EU/1/08/480/009
56 x 1 tablets: EU/1/08/480/010
84 tablets: EU/1/08/480/011
90 tablets: EU/1/08/480/022
98 tablets: EU/1/08/480/012

Ifirmasta 300 mg film-coated tablets
14 tablets: EU/1/08/480/013
28 tablets: EU/1/08/480/014
30 tablets: EU/1/08/480/023
56 tablets: EU/1/08/480/015
56 x 1 tablets: EU/1/08/480/016
84 tablets: EU/1/08/480/017
90 tablets: EU/1/08/480/024
98 tablets: EU/1/08/480/018

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1 December 2008
Date of latest renewal: 26 August 2013

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



15

ANNEX II

A. MANUFACTURER 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



16

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

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 requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates 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.



17

ANNEX III

LABELLING AND PACKAGE LEAFLET



18

A. LABELLING



19

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 75 mg film-coated tablets

Irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
56 film-coated tablets
56x1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 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



20

9. SPECIAL STORAGE CONDITIONS

Do not store above 30C. Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets: EU/1/08/480/001
28 tablets: EU/1/08/480/002
30 tablets: EU/1/08/480/019
56 tablets: EU/1/08/480/003
56 x 1 tablets: EU/1/08/480/004
84 tablets: EU/1/08/480/005
90 tablets: EU/1/08/480/020
98 tablets: EU/1/08/480/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmasta 75 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.
Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>



21

Safety features will be implemented until 9/2/2019.



22

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PE/PVDC/Alu

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 75 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



23

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 150 mg film-coated tablets

Irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
56 film-coated tablets
56x1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 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 AND OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



24

9. SPECIAL STORAGE CONDITIONS

Do not store above 30C. Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets: EU/1/08/480/007
28 tablets: EU/1/08/480/008
30 tablets: EU/1/08/480/021
56 tablets: EU/1/08/480/009
56 x 1 tablets: EU/1/08/480/010
84 tablets: EU/1/08/480/011
90 tablets: EU/1/08/480/022
98 tablets: EU/1/08/480/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmasta 150 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.
Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>



25

Safety features will be implemented until 9/2/2019.



26

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PE/PVDC/Alu

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 150 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



27

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 300 mg film-coated tablets

Irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
56 film-coated tablets
56x1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 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



28

9. SPECIAL STORAGE CONDITIONS

Do not store above 30C. Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets: EU/1/08/480/013
28 tablets: EU/1/08/480/014
30 tablets: EU/1/08/480/023
56 tablets: EU/1/08/480/015
56 x 1 tablets: EU/1/08/480/016
84 tablets: EU/1/08/480/017
90 tablets: EU/1/08/480/024
98 tablets: EU/1/08/480/018

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmasta 300 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.
Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>
Safety features will be implemented until 9/2/2019.



29

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PE/PVDC/Alu

1. NAME OF THE MEDICINAL PRODUCT

Ifirmasta 300 mg film-coated tablets

Irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



30

B. PACKAGE LEAFLET



31

Package leaflet: Information for the patient

Ifirmasta 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 Ifirmasta is and what it is used for
2. What you need to know before you take Ifirmasta
3. How to take Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta 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. Ifirmasta prevents the binding of angiotensin-II 
to these receptors, causing the blood vessels to relax and the blood pressure to lower. Ifirmasta slows 
the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Ifirmasta 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 Ifirmasta

Do not take Ifirmasta
- if you are allergic to irbesartan or 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 Ifirmasta 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 or pharmacist before taking Ifirmasta 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 Ifirmasta 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,



32

- 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 Ifirmasta”.

You must tell your doctor if you think you are (or might become) pregnant. Ifirmasta 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 medicine should not be used in children and adolescents (< 18 years) because the safety and 
efficacy have not yet been fully established.

Other medicines and Ifirmasta
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 Ifirmasta” 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Ifirmasta before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Ifirmasta. Ifirmasta 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. Ifirmasta 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
Ifirmasta 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.



33

3. How to take Ifirmasta

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

Method of administration
Ifirmasta is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
You can take Ifirmasta 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 Ifirmasta until your doctor tells you otherwise.

- Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 
300 mg (four tablets a day) 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 (four tablets a day) 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.

Use in children and adolescents
Ifirmasta should not be given to children under 18 years of age. If a child swallows some tablets, 
contact your doctor immediately.

If you take more Ifirmasta than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Ifirmasta
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 and contact your doctor 
immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with irbesartan were:

- 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.



34

- Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, and 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 renal 
disease, dizziness when getting up from a 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.

Some undesirable effects have been reported since marketing of irbesartan. Undesirable effects where 
the frequency is not known are: 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 renal 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 Ifirmasta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after 
EXP. The expiry date refers to the last day of that month.

Do not store above 30C.
Store in the original package in order to protect from moisture.

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 Ifirmasta contains
- The active substance is irbesartan. Each film-coated tablet contains 75 mg irbesartan (as 

hydrochloride).
- The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl 

cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, 
castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), 
macrogol 3000 and talc in film-coating.

What Ifirmasta looks like and contents of the pack
Ifirmasta 75 mg film-coated tablets are: white, oval film-coated tablets.

Ifirmasta 75 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated 
tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.

IJ



35

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
ELOGIS PHARMA
Τηλ: + 30 210 4101670

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501



36

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
Kipa Pharmacal Ltd.
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in .

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



37

Package leaflet: Information for the patient

Ifirmasta 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 Ifirmasta is and what it is used for
2. What you need to know before you take Ifirmasta
3. How to take Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta 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. Ifirmasta prevents the binding of angiotensin-II 
to these receptors, causing the blood vessels to relax and the blood pressure to lower. Ifirmasta slows 
the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Ifirmasta 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 Ifirmasta

Do not take Ifirmasta
- if you are allergic to irbesartan or 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 Ifirmasta 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 or pharmacist before taking Ifirmasta 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 Ifirmasta 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 Ifirmasta”.

You must tell your doctor if you think you are (or might become) pregnant. Ifirmasta 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 medicine should not be used in children and adolescents (< 18 years) because the safety and 
efficacy have not yet been fully established.

Other medicines and Ifirmasta
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 Ifirmasta” 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Ifirmasta before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Ifirmasta. Ifirmasta 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. Ifirmasta 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
Ifirmasta 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

3. How to take Ifirmasta

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

Method of administration
Ifirmasta is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
You can take Ifirmasta 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 Ifirmasta 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 (two tablets a 
day) 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 (two tablets a day) 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.

Use in children and adolescents
Ifirmasta should not be given to children under 18 years of age. If a child swallows some tablets, 
contact your doctor immediately.

If you take more Ifirmasta than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Ifirmasta
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 and contact your doctor 
immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with irbesartan were:

- 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.



40

- Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, and 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 renal 
disease, dizziness when getting up from a 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.

Some undesirable effects have been reported since marketing of irbesartan. Undesirable effects where 
the frequency is not known are: 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 renal 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 Ifirmasta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after 
EXP. The expiry date refers to the last day of that month.

Do not store above 30C.
Store in the original package in order to protect from moisture.

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 Ifirmasta contains
- The active substance is irbesartan. Each film-coated tablet contains 150 mg irbesartan (as 

hydrochloride).
- The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl 

cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, 
castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), 
macrogol 3000 and talc in film-coating.

What Ifirmasta looks like and contents of the pack
Ifirmasta 150 mg film-coated tablets are: white, oval film-coated tablets.

Ifirmasta 150 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated 
tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.

IJ



41

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
ELOGIS PHARMA
Τηλ: + 30 210 4101670

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501



42

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
Kipa Pharmacal Ltd.
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in .

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



43

Package leaflet: Information for the patient

Ifirmasta 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 Ifirmasta is and what it is used for
2. What you need to know before you take Ifirmasta
3. How to take Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta 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. Ifirmasta prevents the binding of angiotensin-II 
to these receptors, causing the blood vessels to relax and the blood pressure to lower. Ifirmasta slows 
the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Ifirmasta 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 Ifirmasta

Do not take Ifirmasta
- if you are allergic to irbesartan or 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 Ifirmasta 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 or pharmacist before taking Ifirmasta 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 Ifirmasta 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 Ifirmasta”.

You must tell your doctor if you think you are (or might become) pregnant. Ifirmasta 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 medicine should not be used in children and adolescents (< 18 years) because the safety and 
efficacy have not yet been fully established.

Other medicines and Ifirmasta
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 Ifirmasta” 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Ifirmasta before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Ifirmasta. Ifirmasta 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. Ifirmasta 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
Ifirmasta 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

3. How to take Ifirmasta

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

Method of administration
Ifirmasta is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
You can take Ifirmasta 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 Ifirmasta 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.

Use in children and adolescents
Ifirmasta should not be given to children under 18 years of age. If a child swallows some tablets, 
contact your doctor immediately.

If you take more Ifirmasta than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Ifirmasta
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 and contact your doctor 
immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with irbesartan were:

- 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.



46

- Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, and 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 renal 
disease, dizziness when getting up from a 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.

Some undesirable effects have been reported since marketing of irbesartan. Undesirable effects where 
the frequency is not known are: 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 renal 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 Ifirmasta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after 
EXP. The expiry date refers to the last day of that month.

Do not store above 30C.
Store in the original package in order to protect from moisture.

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 Ifirmasta contains
- The active substance is irbesartan. Each film-coated tablet contains 300 mg irbesartan (as 

hydrochloride).
- The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl 

cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, 
castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), 
macrogol 3000 and talc in film-coating.

What Ifirmasta looks like and contents of the pack
Ifirmasta 300 mg film-coated tablets are: white, oval film-coated tablets.

Ifirmasta 300 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated 
tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.

IJ



47

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
ELOGIS PHARMA
Τηλ: + 30 210 4101670

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501



48

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
Kipa Pharmacal Ltd.
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in .

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


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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