Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
irbesartan, hydrochlorothiazide
Krka, d.d., Novo mesto
C09DA04
irbesartan, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
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.
Revision: 15
Authorised
2011-03-04
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 Прочетете целия документ
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 - 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 3 Прочетете целия документ