Ifirmacombi
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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 150 mg/12.5 mg film-coated tablets
Ifirmacombi 300 mg/12.5 mg film-coated tablets
Ifirmacombi 300 mg/25 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ifirmacombi 150 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg 
hydrochlorothiazide.

Ifirmacombi 300 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg 
hydrochlorothiazide.

Ifirmacombi 300 mg/25 mg film-coated tablets
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg 
hydrochlorothiazide.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet (tablet).

Ifirmacombi 150 mg/12.5 mg film-coated tablets
Pale pink, biconvex, oval, film-coated tablets.

Ifirmacombi 300 mg/12.5 mg film-coated tablets
White, biconvex, capsule shaped, film-coated tablets.

Ifirmacombi 300 mg/25 mg film-coated tablets
Pale pink, biconvex, capsule shaped, film-coated tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately 
controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

4.2 Posology and method of administration

Posology

Ifirmacombi can be taken once daily, with or without food.

Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be 
recommended. 

When clinically appropriate direct change from monotherapy to the fixed combinations may be 
considered:



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- Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not 
adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;

- Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by 
irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg.

- Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by 
Ifirmacombi 300 mg/12.5 mg.

Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. 
When necessary, Ifirmacombi may be administered with another antihypertensive medicinal product 
(see section 4.3, 4.4, 4.5 and 5.1).

Special populations

Renal impairment

Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe 
renal dysfunction (creatinine clearance < 30 ml/min). Loop diuretics are preferred to thiazides in this 
population. No dosage adjustment is necessary in patients with renal impairment whose renal 
creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).

Hepatic impairment

Ifirmacombi is not indicated in patients with severe hepatic impairment. Thiazides should be used with 
caution in patients with impaired hepatic function. No dosage adjustment of Ifirmacombi is necessary 
in patients with mild to moderate hepatic impairment (see section 4.3).

Elderly population

No dosage adjustment of Ifirmacombi is necessary in older people.

Paediatric population

Ifirmacombi is not recommended for use in children and adolescents because the safety and efficacy
have not been established. No data are available.

Method of Administration

For oral use.

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to 
other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance)

- Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
- Severe renal impairment (creatinine clearance < 30 ml/min)
- Refractory hypokalaemia, hypercalcaemia
- Severe hepatic impairment, biliary cirrhosis and cholestasis
- The concomitant use of Ifirmacombi 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

Hypotension - Volume-depleted patients:
Ifirmacombi has been rarely associated with symptomatic hypotension in hypertensive patients 
without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in 



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patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, 
diarrhoea or vomiting. Such conditions should be corrected before initiating therapy with Ifirmacombi.

Renal artery stenosis - 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 angiotensin 
converting enzyme inhibitors or angiotensin II receptor antagonists. While this is not documented with 
Ifirmacombi, a similar effect should be anticipated.

Renal impairment and kidney transplantation:
When Ifirmacombi is used in patients with impaired renal function, a periodic monitoring of 
potassium, creatinine and uric acid serum levels is recommended.
There is no experience regarding the administration of Ifirmacombi in patients with recent kidney 
transplantation.
Ifirmacombi should not be used in patients with severe renal impairment (creatinine clearance 
< 30 ml/min) (see section 4.3). Thiazide diuretic-associated azotaemia may occur in patients with 
impaired renal function. No dosage adjustment is necessary in patients with renal impairment whose 
creatinine clearance is ≥ 30 ml/min. However, in patients with mild to moderate renal impairment 
(creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be 
administered with caution. 

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.

Hepatic impairment:
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver 
disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. There is 
no clinical experience with Ifirmacombi in patients with hepatic impairment.

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 Ifirmacombi is not 
recommended.

Metabolic and endocrine effects:
Thiazide therapy may impair glucose tolerance. In diabetic patients dosage adjustments of insulin or 
oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during 
thiazide therapy.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; 
however at the 12.5 mg dose contained in Ifirmacombi, minimal or no effects were reported.
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide 
therapy.

Electrolyte imbalance:
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be 
performed at appropriate intervals.



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Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, 
hyponatraemia, and hypochloremic alkalosis). Warning signs of fluid or electrolyte imbalance are 
dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, 
muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea 
or vomiting.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with 
irbesartan may reduce diuretic-induced hypokalaemia. The risk of hypokalaemia is greatest in patients 
with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving 
inadequate oral intake of electrolytes and in patients receiving concomitant therapy with 
corticosteroids or ACTH. Conversely, due to the irbesartan component of Ifirmacombi hyperkalaemia 
might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Adequate monitoring of serum potassium in patients at risk is recommended. Potassium-sparing 
diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered 
cautiously with Ifirmacombi (see section 4.5).
There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia. 
Chloride deficit is generally mild and usually does not require treatment.
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of 
serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia 
may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out 
tests for parathyroid function.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in 
hypomagnaesemia.

Lithium:
The combination of lithium and Ifirmacombi is not recommended (see section 4.5).

Anti-doping test:
Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an 
anti-doping test.

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 ischemic cardiopathy or ischemic cardiovascular 
disease could result in a myocardial infarction or stroke.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of 
allergy or bronchial asthma, but are more likely in patients with such a history.

Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide 
diuretics.

Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8). If 
photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a 
re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to 
the sun or to artificial UVA.

Pregnancy:
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).



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Acute Myopia and Secondary Acute Angle-Closure Glaucoma: 
Sulfonamide drugs or sulfonamide derivative drugs can cause an idiosyncratic reaction, resulting in 
transient myopia and acute angle-closure glaucoma. While hydrochlorothiazide is a sulfonamide, only 
isolated cases of acute angle-closure glaucoma have been reported so far with hydrochlorothiazide. 
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within 
hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent 
vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical 
or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk 
factors for developing acute angle-closure glaucoma may include a history of sulfonamide or 
penicillin allergy (see section 4.8).

Non-melanoma skin cancer
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous 
cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has 
been observed in two epidemiological studies based on the Danish National Cancer Registry. 
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. 

Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their 
skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive 
measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate 
protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious 
skin lesions should be promptly examined potentially including histological examinations of biopsies. 
The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC 
(see also section 4.8).

Sodium:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 
"sodium-free".

4.5 Interaction with other medicinal products and other forms of interaction

Other antihypertensive agents:
The antihypertensive effect of Ifirmacombi may be increased with the concomitant use of other 
antihypertensive agents. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg 
hydrochlorothiazide) have been safely administered with other antihypertensive agents including 
calcium channel blockers and beta-adrenergic blockers. Prior treatment with high dose diuretics may 
result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or 
without thiazide diuretics unless the volume depletion is corrected first (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).

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. Furthermore, renal clearance of lithium is 
reduced by thiazides so the risk of lithium toxicity could be increased with Ifirmacombi. Therefore, 
the combination of lithium and Ifirmacombi is not recommended (see section 4.4). If the combination 
proves necessary, careful monitoring of serum lithium levels is recommended.

Medicinal products affecting potassium:
The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of 
irbesartan. However, this effect of hydrochlorothiazide on serum potassium would be expected to be 



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potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other 
kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium). Conversely, based 
on the experience with the use of other medicinal products that blunt 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 sodium) 
may lead to increases in serum potassium. Adequate monitoring of serum potassium in patients at risk 
is recommended (see section 4.4).

Medicinal products affected by serum potassium disturbances:
Periodic monitoring of serum potassium is recommended when Ifirmacombi is administered with 
medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, 
antiarrhythmics).

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 co-administration of irbesartan.

Additional information on hydrochlorothiazide interactions:
When administered concurrently, the following medicinal products may interact with thiazide 
diuretics:

Alcohol: potentiation of orthostatic hypotension may occur;

Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic 
medicinal product may be required (see section 4.4);

Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of 
anionic exchange resins. Ifirmacombi should be taken at least one hour before or four hours after these 
medications;

Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;

Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of 
digitalis-induced cardiac arrhythmias (see section 4.4);

Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug 
may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;

Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not 
sufficiently to preclude their use;



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Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal 
muscle relaxants may be potentiated by hydrochlorothiazide;

Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as 
hydrochlorothiazide may raise the level of serum uric acid. Increase in dosage of probenecid or 
sulfinpyrazone may be necessary. Co-administration of thiazide diuretics may increase the incidence 
of hypersensitivity reactions to allopurinol;

Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion. If 
calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be 
prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;

Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with 
the risk of symptomatic hyponatraemia. Electrolytes should be monitored during concomitant use. If 
possible, another class of diuretics should be used;

Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by 
thiazides.
Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type 
diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Thiazides may increase the risk of adverse effects caused by amantadine.
Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, 
methotrexate) and potentiate their myelosuppressive effects.

4.6 Fertility, pregnancy and lactation

Pregnancy

Angiotensin II Receptor Antagonists (AIIRAs):

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).

Hydrochlorothirazide

There is limited experience with hydrochlorothiazide during pregnancy, especially during the first 
trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the 



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pharmacological mechanism of action of hydrochlorothiazide its use during the second and third 
trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like 
icterus, disturbance of electrolyte balance and thrombocytopenia.

Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or 
preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a 
beneficial effect on the course of the disease. 

Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare 
situations where no other treatment could be used. 

Since Ifirmacombi contains hydrochlorothiazide, it is not recommended during the first trimester of 
pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned 
pregnancy.

Breast-feeding

Angiotensin II Receptor Antagonists (AIIRAs):

Because no information is available regarding the use of Ifirmacombi during breast-feeding, 
Ifirmacombi 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).

Hydrochlorothiazide

Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing 
intense diuresis can inhibit the milk production. The use of Ifirmacombi during breast feeding is not 
recommended. If Ifirmacombi is used during breast feeding, doses should be kept as low as possible. 

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, Ifirmacombi is unlikely to affect the ability to drive and use 
machines. When driving vehicles or operating machines, it should be taken into account that 
occasionally dizziness or weariness may occur during treatment of hypertension.

4.8 Undesirable effects

Irbesartan/hydrochlorothiazide combination

Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide 
(range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients 
experienced adverse reactions. The most commonly reported ADRs were dizziness (5.6%), fatigue 
(4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). In addition increases in blood urea 
nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in 
the trials.

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled 
trials.



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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)
- Not known (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Investigations Common:

Uncommon:

increases in blood urea nitrogen (BUN), creatinine 
and creatine kinase
decreases in serum potassium and sodium

Cardiac disorders Uncommon syncope, hypotension, tachycardia, oedema

Nervous system disorders Common:
Uncommon:
Not known:

dizziness
orthostatic dizziness
headache

Ear and labyrinth disorders Not known: tinnitus

Respiratory, thoracic and 
mediastinal disorders

Not known: cough

Gastrointestinal disorders Common:
Uncommon:
Not known:

nausea/vomiting
diarrhoea
dyspepsia, dysgeusia

Renal and urinary disorders: Common:
Not known

abnormal urination
impaired renal function including isolated cases of 
renal failure in patients at risk (see section 4.4)

Musculoskeletal and 
connective tissue disorders

Uncommon:
Not known:

swelling extremity
arthralgia, myalgia

Metabolism and nutrition
disorders

Not known: hyperkalaemia

Vascular disorders Uncommon: flushing

General disorders and 
administration site conditions

Common: fatigue

Immune system disorders Not known: cases of hypersensitivity reactions such as 
angioedema, rash, urticaria

Hepatobiliary disorders Uncommon:
Not known:

jaundice
hepatitis, abnormal liver function

Reproductive system and 
breast disorders

Uncommon: sexual dysfunction, libido changes

Additional information on individual components: in addition to the adverse reactions listed above for 
the combination product, other adverse reactions previously reported with one of the individual 
components may be potential adverse reactions with Ifirmacombi. Tables 2 and 3 below detail the 
adverse reactions reported with the individual components of Ifirmacombi.

Table 2: Adverse reactions reported with the use of irbesartan alone
Blood and lymphatic system
disorders

Not known: thrombocytopenia

General disorders and 
administration site conditions:

Uncommon: chest pain

Immune system disorders: Not known: Anaphylactic reaction including anaphylactic 
shock



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Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Investigations Not known: electrolyte imbalance (including hypokalaemia 

and hyponatraemia, see section 4.4), 
hyperuricaemia, glycosuria, hyperglycaemia, 
increases in cholesterol and triglycerides

Neoplasms benign, malignant 
and unspecified (incl cysts and 
polyps)

Not known Non-melanoma skin cancer (Basal cell carcinoma 
and Squamous cell carcinoma)1

Cardiac disorders Not known: cardiac arrhythmias

Blood and lymphatic system 
disorders:

Not known: aplastic anaemia, bone marrow depression, 
neutropenia/agranulocytosis, haemolytic anaemia, 
leucopenia, thrombocytopenia

Nervous system disorders Not known: vertigo, paraesthesia, light-headedness, 
restlessness

Eye disorders Not known: transient blurred vision, xanthopsia, acute myopia 
and secondary acute angle-closure glaucoma

Respiratory, thoracic and 
mediastinal disorders

Not known: respiratory distress (including pneumonitis and 
pulmonary oedema)

Gastrointestinal disorders Not known: pancreatitis, anorexia, diarrhoea, constipation, 
gastric irritation, sialadenitis, loss of appetite

Renal and urinary disorders Not known: interstitial nephritis, renal dysfunction 

Skin and subcutaneous tissue 
disorders

Not known: anaphylactic reactions, toxic epidermal necrolysis, 
necrotizing angitis (vasculitis, cutaneous 
vasculitis), cutaneous lupus erythematosus-like 
reactions, reactivation of cutaneous lupus 
erythematosus, photosensitivity reactions, rash, 
urticaria

Musculoskeletal and 
connective tissue disorders

Not known: weakness, muscle spasm

Vascular disorders Not known: postural hypotension

General disorders and 
administration site conditions

Not known: fever

Hepatobiliary disorders: Not known: jaundice (intrahepatic cholestatic jaundice)

Psychiatric disorders: Not known: depression, sleep disturbances

1 Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative 
dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 
5.1).

The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may 
increase when titrating the hydrochlorothiazide.

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

No specific information is available on the treatment of overdose with Ifirmacombi. The patient 
should be closely monitored, and the treatment should be symptomatic and supportive. Management 
depends on the time since ingestion and the severity of the symptoms. Suggested measures include 



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induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of 
overdose. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the 
patient should be placed in a supine position, with salt and volume replacements given quickly.

The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; 
bradycardia might also occur.

Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, 
hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis. The most common 
signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle 
spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis 
glycosides or certain anti-arrhythmic medicinal products.

Irbesartan is not removed by haemodialysis. The degree to which hydrochlorothiazide is removed by 
haemodialysis has not been established.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA04.

Mechanism of action

Ifirmacombi is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide 
diuretic, hydrochlorothiazide. The combination of these ingredients has an additive antihypertensive 
effect, reducing blood pressure to a greater degree than either component alone.

Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) 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 in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5). 
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.

Hydrochlorothiazide is a thiazide diuretic. The mechanism of antihypertensive effect of thiazide 
diuretics is not fully known. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, 
directly increasing excretion of sodium and chloride in approximately equivalent amounts. The 
diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, 
increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, 
and decreases in serum potassium. Presumably through blockade of the renin-angiotensin-aldosterone 
system, co-administration of irbesartan tends to reverse the potassium loss associated with these 
diuretics. With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at 
about 4 hours, while the action persists for approximately 6-12 hours.

The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in 
blood pressure across their therapeutic dose ranges. The addition of 12.5 mg hydrochlorothiazide to 
300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted 
in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 
6.1 mmHg. The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an 
overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mmHg.



13

Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 
300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg. In these patients, an 
incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and 
diastolic blood pressure (DBP) (13.3 and 8.3 mmHg, respectively).

Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic 
mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg 
in patients with mild-to-moderate hypertension. Peak effects occurred at 3-6 hours. When assessed by 
ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg 
hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours 
period with mean 24-hour placebo-subtracted systolic/diastolic reductions of 15.8/10.0 mmHg. When 
measured by ambulatory blood pressure monitoring, the trough to peak effects of Ifirmacombi 
150 mg/12.5 mg were 100%. The trough to peak effects measured by cuff during office visits were 
68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively. These 
24-hour effects were observed without excessive blood pressure lowering at peak and are consistent 
with safe and effective blood-pressure lowering over the once-daily dosing interval.

In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan 
gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mmHg.

The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent 
after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-
8 weeks. In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained 
for over one year. Although not specifically studied with the Ifirmacombi, rebound hypertension has 
not been seen with either irbesartan or hydrochlorothiazide.

The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has 
not been studied. Epidemiological studies have shown that long term treatment with 
hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.

There is no difference in response to Ifirmacombi, regardless of 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 non-black patients.

Clinical efficacy and safety

Efficacy and safety of the combination of irbesartan and hydrochlorothiazide as initial therapy for 
severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, 
double-blind, active-controlled, 8-week, parallel-arm study. A total of 697 patients were randomized 
in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and 
systematically force titrated (before assessing the response to the lower dose) after one week to 
irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.

The study recruited 58% males. The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, 
and just 2% were ≥ 75 years of age. Twelve percent (12%) of patients were diabetic, 34% were 
hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of 
the participants.

The primary objective of this study was to compare the proportion of patients whose SeDBP was 
controlled (SeDBP < 90 mmHg) at Week 5 of treatment. Forty-seven percent (47.2%) of patients on 
the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan 
(p = 0.0005). The mean baseline blood pressure was approximately 172/113 mmHg in each treatment 
group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for 
irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001).



14

The types and incidences of adverse events reported for patients treated with the combination were 
similar to the adverse event profile for patients on monotherapy. During the 8-week treatment period, 
there were no reported cases of syncope in either treatment group. There were 0.6% and 0% of 
patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported 
in the combination and monotherapy groups, respectively.

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.

Non-melanoma skin cancer

Based on available data from epidemiological studies, cumulative dosedependent association between 
HCTZ and NMSC has been observed. One study included a population comprised of 71,533 cases of 
BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. 
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-
1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship 
was observed for both BCC and SCC. Another study showed a possible association between lip cancer 
(SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, 
using a risk-set sampling strategy. A cumulative doseresponse relationship was demonstrated with an 
adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 
7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).

5.2 Pharmacokinetic properties

Concomitant administration of hydrochlorothiazide and irbesartan has no effect on the 
pharmacokinetics of either medicinal product.

Absorption

Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for 
their activity. Following oral administration of Ifirmacombi, the absolute oral bioavailability is 60-
80% and 50-80% for irbesartan and hydrochlorothiazide, respectively. Food does not affect the 



15

bioavailability of Ifirmacombi. Peak plasma concentration occurs at 1.5-2 hours after oral 
administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.

Distribution

Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood 
components. The volume of distribution for irbesartan is 53-93 litres. Hydrochlorothiazide is 68% 
protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.

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 was observed; the 
mechanism for this is unknown. The total body and renal clearance are 157-176 and 3.0-3.5 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 older 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 older people. The mean 
plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours.

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. 

Elimination

Irbesartan and its metabolites are eliminated by both biliary and renal pathways. After either oral or 
intravenous 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. Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys. At least 
61% of the oral dose is eliminated unchanged within 24 hours. Hydrochlorothiazide crosses the 
placental but not the blood-brain barrier, and is excreted in breast milk.

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. In patients with 
creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to 
increase to 21 hours.

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

Irbesartan/hydrochlorothiazide

The potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was 
evaluated in rats and macaques in studies lasting up to 6 months. There were no toxicological findings 



16

observed of relevance to human therapeutic use. The following changes, observed in rats and 
macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, 
were also seen with one of the two medicinal products alone and/or were secondary to decreases in 
blood pressure (no significant toxicologic interactions were observed):
- kidney changes, characterized by slight increases in serum urea and creatinine, and 

hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the 
interaction of irbesartan with the renin-angiotensin system;

- slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);
- stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in 

a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and 
irbesartan/hydrochlorothiazide 10/10 mg/kg/day. These lesions were not observed in macaques;

- decreases in serum potassium due to hydrochlorothiazide and partly prevented when 
hydrochlorothiazide was given in combination with irbesartan.

Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan 
(blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing 
cells) and occur also with angiotensin converting enzyme inhibitors. These findings appear to have no 
relevance to the use of therapeutic doses of irbesartan/hydrochlorothiazide in humans.

No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at 
doses that produced maternal toxicity. The effects of the irbesartan/hydrochlorothiazide combination 
on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on 
fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone. 
However, another angiotensin-II antagonist affected fertility parameters in animal studies when given 
alone. These findings were also observed with lower doses of this other angiotensin-II antagonist 
when given in combination with hydrochlorothiazide.

There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide 
combination. The carcinogenic potential of irbesartan and hydrochlorothiazide in combination has not 
been evaluated in animal studies.

Irbesartan

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 kidneys (such as interstitial 
nephritis, tubular distention, 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, 



17

abortion or early resorption was noted at doses causing significant maternal toxicity, including 
mortality. No teratogenic effects were observed in the rat or rabbit.

Hydrochlorothiazide

Although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental 
models, the extensive human experience with hydrochlorothiazide has failed to show an association 
between its use and an increase in neoplasms.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:
Mannitol
Hydroxypropylcellulose
Hydroxypropylcellulose, low-substituted
Sodium starch glycolate
Talc
Macrogol 6000
Castor oil, hydrogenated

Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets
Film coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide, yellow (E172)
Iron oxide, red (E172)

Ifirmacombi 300 mg/12.5 mg film-coated tablets
Film coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blister (OPA/Aluminium/PVC//Aluminium): 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets, 
in a box.

Not all pack sizes may be marketed.



18

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)

Ifirmacombi 150 mg/12.5 mg film-coated tablets
EU/1/11/673/001-008

Ifirmacombi 300 mg/12.5 mg film-coated tablets
EU/1/11/673/009-016

Ifirmacombi 300 mg/25 mg film-coated tablets
EU/1/11/673/017-024

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 March 2011
Date of latest renewal: 19 November 2015

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu



19

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



20

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

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

TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

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 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.



21

ANNEX III

LABELLING AND PACKAGE LEAFLET



22

A. LABELLING



23

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 150 mg/12.5 mg film-coated tablets
Irbesartan/Hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg 
hydrochlorothiazide.

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
56 x 1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



24

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

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/673/001 (14 film-coated tablets)
EU/1/11/673/002 (28 film-coated tablets)
EU/1/11/673/003 (30 film-coated tablets)
EU/1/11/673/004 (56 film-coated tablets)
EU/1/11/673/005 (56 x 1 film-coated tablets)
EU/1/11/673/006 (84 film-coated tablets)
EU/1/11/673/007 (90 film-coated tablets)
EU/1/11/673/008 (98 film-coated tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmacombi 150 mg/12.5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>



25

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 150 mg/12.5 mg tablets
Irbesartan/Hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



26

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 300 mg/12.5 mg film-coated tablets
Irbesartan/Hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg 
hydrochlorothiazide.

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
56 x 1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



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

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/673/009 (14 film-coated tablets)
EU/1/11/673/010 (28 film-coated tablets)
EU/1/11/673/011 (30 film-coated tablets)
EU/1/11/673/012 (56 film-coated tablets)
EU/1/11/673/013 (56 x 1 film-coated tablets)
EU/1/11/673/014 (84 film-coated tablets)
EU/1/11/673/015 (90 film-coated tablets)
EU/1/11/673/016 (98 film-coated tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmacombi 300 mg/12.5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>



28

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 300 mg/12.5 mg tablets
Irbesartan/Hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



29

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 300 mg/25 mg film-coated tablets
Irbesartan/Hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg 
hydrochlorothiazide.

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
56 x 1 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



30

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

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

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/673/017 (14 film-coated tablets)
EU/1/11/673/018 (28 film-coated tablets)
EU/1/11/673/019 (30 film-coated tablets)
EU/1/11/673/020 (56 film-coated tablets)
EU/1/11/673/021 (56 x 1 film-coated tablets)
EU/1/11/673/022 (84 film-coated tablets)
EU/1/11/673/023 (90 film-coated tablets)
EU/1/11/673/024 (98 film-coated tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ifirmacombi 300 mg/25 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:
SN:
NN:>



31

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ifirmacombi 300 mg/25 mg tablets
Irbesartan/Hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



32

B. PACKAGE LEAFLET



33

Package leaflet: Information for the patient

Ifirmacombi 150 mg/12.5 mg film-coated tablets
Ifirmacombi 300 mg/12.5 mg film-coated tablets
Ifirmacombi 300 mg/25 mg film-coated tablets

Irbesartan/Hydrochlorothiazide

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

1. What Ifirmacombi is and what it is used for

Ifirmacombi is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing 
them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of 
angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased 
urine output and so causes a lowering of blood pressure.
The two active ingredients in Ifirmacombi work together to lower blood pressure further than if either 
was given alone.

Ifirmacombi is used to treat high blood pressure, when treatment with irbesartan or 
hydrochlorothiazide alone did not provide adequate control of your blood pressure.

2. What you need to know before you take Ifirmacombi

Do not take Ifirmacombi
- if you are allergic  to irbesartan or any of the other ingredients of this medicine (listed in 

section 6)
- if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines
- if you are more than 3 months pregnant. (It is also better to avoid Ifirmacombi in early 

pregnancy – see pregnancy section)
- if you have severe liver or kidney problems
- if you have difficulty in producing urine
- if your doctor determines that you have persistently high calcium or low potassium levels in 

your blood
- if you have diabetes or impaired kidney function and you are treated with a blood pressure 

lowering medicine containing aliskiren



34

Warnings and precautions
Talk to your doctor before taking Ifirmacombi and if any of the following apply to you:
- if you get excessive vomiting or diarrhoea
- if you suffer from kidney problems or have a kidney transplant
- if you suffer from heart problems
- if you suffer from liver problems
- if you suffer from diabetes
- if you suffer from lupus erythematosus (also known as lupus or SLE)
- if you suffer from primary aldosteronism (a condition related to high production of the 

hormone aldosterone, which causes sodium retention and, in turn, an increase in blood 
pressure).

- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. 
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase 
the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin 
from sun exposure and UV rays while taking Ifirmacombi.

- 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 Ifirmacombi”.

You must tell your doctor if you think you are (or might become) pregnant. Ifirmacombi 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).

You should also tell your doctor:
- if you are on a low-salt diet
- if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle 

pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an 
excessive effect of hydrochlorothiazide (contained in Ifirmacombi)

- if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn 
(such as redness, itching, swelling, blistering) occurring more quickly than normal

- if you are going to have an operation (surgery) or be given anaesthetics
- if you have changes in your vision or pain in one or both of your eyes while taking 

Ifirmacombi. This could be a sign that you are developing glaucoma, increased pressure in your 
eye(s). You should discontinue Ifirmacombi treatment and seek medical attention.

The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping 
test.

Children and adolescents
Ifirmacombi should not be given to children and adolescents (under 18 years).

Other medicines and Ifirmacombi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Diuretic agents such as the hydrochlorothiazide contained in Ifirmacombi may have an effect on other 
medicines. Preparations containing lithium should not be taken with Ifirmacombi without close 
supervision by your doctor.

Your doctor may need to change your dose and/or to take other precautions:



35

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

You may need to have blood checks if you take:
- potassium supplements
- salt substitutes containing potassium
- potassium sparing medicines or other diuretics (water tablets)
- some laxatives
- medicines for the treatment of gout
- therapeutic vitamin D supplements
- medicines to control heart rhythm
- medicines for diabetes (oral agents or insulins)
- carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, 
steroids, and medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol 
resins for lowering blood cholesterol.

Ifirmacombi with food, drink and alcohol
Ifirmacombi can be taken with or without food.

Due to the hydrochlorothiazide contained in Ifirmacombi, if you drink alcohol while on treatment with 
this medicine, you may have an increased feeling of dizziness on standing up, specially when getting 
up from a sitting position.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 
advise you to stop taking Ifirmacombi before you become pregnant or as soon as you know you are 
pregnant and will advise you to take another medicine instead of Ifirmacombi. Ifirmacombi is not 
recommended during 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. Ifirmacombi 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
Ifirmacombi 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.

Ifirmacombi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-
free".

3. How to take Ifirmacombi

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

Dosage of Ifirmacombi 150 mg/12.5 mg
The recommended dose of Ifirmacombi 150 mg/12.5 mg is one tablet a day. Ifirmacombi 
150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not 



36

reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous 
treatment to Ifirmacombi. 
If this dose does not help to reduce your blood pressure as required, the doctor may prescribe 
Ifirmacombi 300 mg/12.5 mg to you. 

Dosage of Ifirmacombi 300 mg/12.5 mg
The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day. 
Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment 
did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the 
previous treatment to Ifirmacombi.
If this dose does not help to reduce your blood pressure as required, the doctor may prescribe 
Ifirmacombi 300 mg/25 mg to you.

Dosage of Ifirmacombi 300 mg/25 mg
The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet a day. This dose should not be 
increased. Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous 
treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch 
from the previous treatment to Ifirmacombi. 
If this medicine does not help to reduce your blood pressure as required, the doctor will prescribe 
additional treatment to you.

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

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

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

Children should not take Ifirmacombi
Ifirmacombi should not be given to children under 18 years of age. If a child swallows some tablets, 
contact your doctor immediately.

If you forget to take Ifirmacombi
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.

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 the above symptoms or get short of breath, stop taking Ifirmacombi and contact 
your doctor immediately.

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



37

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

Common side effects (may affect up to 1 in 10 people):
- nausea/vomiting
- abnormal urination
- fatigue
- dizziness (including when getting up from a lying or sitting position)
- blood tests may show raised levels of an enzyme that measures the muscle and heart function 

(creatine kinase) or raised levels of substances that measure kidney function (blood urea 
nitrogen, creatinine).

If any of these side effects causes you problems, talk to your doctor.

Uncommon side effects (may affect up to 1 in 100 people):
- diarrhoea
- low blood pressure
- fainting
- heart rate increased
- flushing
- swelling
- sexual dysfunction (problems with sexual performance)
- blood tests may show lowered levels of potassium and sodium in your blood.
If any of these side effects causes you problems, talk to your doctor.

Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide
Some undesirable effects have been reported since marketing of Ifirmacombi. Undesirable effects 
where the frequency is not known are:
- headache,
- ringing in the ears,
- cough,
- taste disturbance,
- indigestion,
- pain in joints and muscles,
- liver function abnormal and impaired kidney function,
- increased level of potassium in your blood and
- allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
- uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been 

reported.

As for any combination of two active substances, side effects associated with each individual 
component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock),
and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also 
been reported.

Side effects associated with hydrochlorothiazide alone
Skin and lip cancer (non-melanoma skin cancer); loss of appetite; stomach irritation; stomach cramps; 
constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas 
characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; 
depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; 
decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased 
number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when 
exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-
up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a 
skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, 
which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness 



38

and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling 
of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of 
blood fat; high uric acid levels in the blood, which may cause gout.

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of 
hydrochlorothiazide.

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 Ifirmacombi

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 packaging after EXP. The expiry 
date refers to the last day of that month.

This medicine 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 Ifirmacombi contains
- The active substances are irbesartan and hydrochlorothiazide.

Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan 
hydrochloride) and 12.5 mg hydrochlorothiazide.
Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan 
hydrochloride) and 12.5 mg hydrochlorothiazide.
Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan 
hydrochloride) and 25 mg hydrochlorothiazide.

- The other ingredients are:
Ifirmacombi 150 mg/12.5 mg:
mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch 
glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, 
titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in 
the film-coating. See section 2 "Ifirmacombi contains sodium".

Ifirmacombi 300 mg/12.5 mg:
mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch 
glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, 
titanium dioxide (E171), macrogol, talc in the film-coating. See section 2 "Ifirmacombi contains 
sodium".

Ifirmacombi 300 mg/25 mg:
mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch 
glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, 
titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in 
the film-coating. See section 2 "Ifirmacombi contains sodium".

What Ifirmacombi looks like and contents of the pack



39

Ifirmacombi 150 mg/12.5 mg
Pale pink, biconvex, oval, film-coated tablets (tablets).

Ifirmacombi 300 mg/12.5 mg
White, biconvex, capsule shaped, film-coated tablets (tablets).

Ifirmacombi 300 mg/25 mg
Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).

Boxes of 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.

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

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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
QUALIA PHARMA S.A.
Τηλ: + 30 210 6256177

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



40

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

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. 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
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{'Title': '2. what you need to know before you take ifirmacombi', 'Section_Content': 'do not take ifirmacombi - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines - if you are more than 3 months pregnant. (it is also better to avoid ifirmacombi in early pregnancy see pregnancy section) - if you have severe liver or kidney problems - if you have difficulty in producing urine - if your doctor determines that you have persistently high calcium or low potassium levels in your blood - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren 34 warnings and precautions talk to your doctor before taking ifirmacombi and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems or have a kidney transplant - if you suffer from heart problems - if you suffer from liver problems - if you suffer from diabetes - if you suffer from lupus erythematosus (also known as lupus or sle) - if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure). - if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). protect your skin from sun exposure and uv rays while taking ifirmacombi. - 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 ifirmacombi". you must tell your doctor if you think you are (or might become) pregnant. ifirmacombi 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). you should also tell your doctor: - if you are on a low-salt diet - if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in ifirmacombi) - if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal - if you are going to have an operation (surgery) or be given anaesthetics - if you have changes in your vision or pain in one or both of your eyes while taking ifirmacombi. this could be a sign that you are developing glaucoma, increased pressure in your eye(s). you should discontinue ifirmacombi treatment and seek medical attention. the hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test. children and adolescents ifirmacombi should not be given to children and adolescents (under 18 years). other medicines and ifirmacombi tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. diuretic agents such as the hydrochlorothiazide contained in ifirmacombi may have an effect on other medicines. preparations containing lithium should not be taken with ifirmacombi without close supervision by your doctor. your doctor may need to change your dose and/or to take other precautions: 35 - if you are taking an ace-inhibitor or aliskiren (see also information under the headings "do not take ifirmacombi" and "warnings and precautions") you may need to have blood checks if you take: - potassium supplements - salt substitutes containing potassium - potassium sparing medicines or other diuretics (water tablets) - some laxatives - medicines for the treatment of gout - therapeutic vitamin d supplements - medicines to control heart rhythm - medicines for diabetes (oral agents or insulins) - carbamazepine (a medicine for the treatment of epilepsy). it is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, and medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol resins for lowering blood cholesterol. ifirmacombi with food, drink and alcohol ifirmacombi can be taken with or without food. due to the hydrochlorothiazide contained in ifirmacombi, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position. pregnancy and breast-feeding pregnancy you must tell your doctor if you think you are (or might become) pregnant. your doctor will normally advise you to stop taking ifirmacombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of ifirmacombi. ifirmacombi is not recommended during 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. ifirmacombi 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 ifirmacombi 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. ifirmacombi contains sodium this medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium- free".', 'Entity_Recognition': [{'Text': 'ifirmacombi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 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{'Title': '3. how to take ifirmacombi', 'Section_Content': 'always take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. dosage of ifirmacombi 150 mg/12.5 mg the recommended dose of ifirmacombi 150 mg/12.5 mg is one tablet a day. ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not 36 reduce your blood pressure enough. your doctor will instruct you how to switch from the previous treatment to ifirmacombi. if this dose does not help to reduce your blood pressure as required, the doctor may prescribe ifirmacombi 300 mg/12.5 mg to you. dosage of ifirmacombi 300 mg/12.5 mg the recomended dose of ifirmacombi 300 mg /12.5 mg is one tablet a day. ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. your doctor will instruct you how to switch from the previous treatment to ifirmacombi. if this dose does not help to reduce your blood pressure as required, the doctor may prescribe ifirmacombi 300 mg/25 mg to you. dosage of ifirmacombi 300 mg/25 mg the recommended dose of ifirmacombi 300 mg/25 mg is one tablet a day. this dose should not be increased. ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. your doctor will instruct you how to switch from the previous treatment to ifirmacombi. if this medicine does not help to reduce your blood pressure as required, the doctor will prescribe additional treatment to you. method of administration ifirmacombi is for oral use. swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). you can take ifirmacombi 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 ifirmacombi until your doctor tells you otherwise. the maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. if you take more ifirmacombi than you should if you accidentally take too many tablets, contact your doctor immediately. children should not take ifirmacombi ifirmacombi should not be given to children under 18 years of age. if a child swallows some tablets, contact your doctor immediately. if you forget to take ifirmacombi 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.', 'Entity_Recognition': [{'Text': 'ifirmacombi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Id': 0, 'BeginOffset': 131, 'EndOffset': 142, 'Score': 0.9967666864395142, 'Text': 'ifirmacombi', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 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{'Title': '4. possible side effects', 'Section_Content': '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. 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 the above symptoms or get short of breath, stop taking ifirmacombi and contact your doctor immediately. the frequency of the side effects listed below is defined using the following convention: common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people 37 side effects reported in clinical studies for patients treated with ifirmacombi were: common side effects (may affect up to 1 in 10 people): - nausea/vomiting - abnormal urination - fatigue - dizziness (including when getting up from a lying or sitting position) - blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine). if any of these side effects causes you problems, talk to your doctor. uncommon side effects (may affect up to 1 in 100 people): - diarrhoea - low blood pressure - fainting - heart rate increased - flushing - swelling - sexual dysfunction (problems with sexual performance) - blood tests may show lowered levels of potassium and sodium in your blood. if any of these side effects causes you problems, talk to your doctor. side effects reported since the launch of the combination of irbesartan and hydrochlorothiazide some undesirable effects have been reported since marketing of ifirmacombi. undesirable effects where the frequency is not known are: - headache, - ringing in the ears, - cough, - taste disturbance, - indigestion, - pain in joints and muscles, - liver function abnormal and impaired kidney function, - increased level of potassium in your blood and - allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. - uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. as for any combination of two active substances, side effects associated with each individual component cannot be excluded. side effects associated with irbesartan alone in addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported. side effects associated with hydrochlorothiazide alone skin and lip cancer (non-melanoma skin cancer); loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build- up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness 38 and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout. it is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide. 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.', 'Entity_Recognition': [{'Text': 'ifirmacombi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 22, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9663403034210205, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6843485832214355}]}, {'Id': 23, 'BeginOffset': 178, 'EndOffset': 201, 'Score': 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{'Title': '5. how to store ifirmacombi', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what ifirmacombi contains - the active substances are irbesartan and hydrochlorothiazide. each ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. each ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. each ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide. - the other ingredients are: ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (e171), macrogol, talc, yellow iron oxide (e172) and red iron oxide (e172) in the film-coating. see section 2 "ifirmacombi contains sodium". ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (e171), macrogol, talc in the film-coating. see section 2 "ifirmacombi contains sodium". ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (e171), macrogol, talc, yellow iron oxide (e172) and red iron oxide (e172) in the film-coating. see section 2 "ifirmacombi contains sodium". what ifirmacombi looks like and contents of the pack 39 ifirmacombi 150 mg/12.5 mg pale pink, biconvex, oval, film-coated tablets (tablets). ifirmacombi 300 mg/12.5 mg white, biconvex, capsule shaped, film-coated tablets (tablets). ifirmacombi 300 mg/25 mg pale pink, biconvex, capsule shaped, film-coated tablets (tablets). boxes of 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets in blisters are available. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'ifirmacombi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 54, 'EndOffset': 64, 'Score': 0.9618518352508545, 'Text': 'irbesartan', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9053176045417786, 'RelationshipScore': 0.8734253644943237, 'RelationshipType': 'FORM', 'Id': 4, 'BeginOffset': 122, 'EndOffset': 126, 'Text': 'film', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 1, 'BeginOffset': 69, 'EndOffset': 88, 'Score': 0.9972645044326782, 'Text': 'hydrochlorothiazide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9053176045417786, 'RelationshipScore': 0.9980865716934204, 'RelationshipType': 'FORM', 'Id': 4, 'BeginOffset': 122, 'EndOffset': 126, 'Text': 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