Ifirmacombi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan, hydrochlorothiazide

Available from:

Krka, d.d., Novo mesto

ATC code:

C09DA04

INN (International Name):

irbesartan, hydrochlorothiazide

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

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.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2011-03-04

Patient Information leaflet

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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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:
3
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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.
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Ifirmacombi 3