País: Malta
Língua: inglês
Origem: Malta Medicines Authority
HYDROCHLOROTHIAZIDE, IRBESARTAN
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
C09DA04
HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2012-08-22
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ IRBESARTAN HCTZ FAIR-MED 150 MG/12.5 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Irbesartan HCTZ Fair-Med is and what it is used for 2. What you need to know before you take Irbesartan HCTZ Fair-Med 3. How to take Irbesartan HCTZ Fair-Med 4. Possible side effects 5. How to store Irbesartan HCTZ Fair-Med 6. Contents of the pack and other information 1. WHAT IRBESARTAN HCTZ FAIR-MED IS AND WHAT IT IS USED FOR Irbesartan HCTZ Fair-Med 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 Irbesartan HCTZ Fair-Med work together to lower blood pressure further than if either was given alone. IRBESARTAN HCTZ FAIR-MED 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 Leia o documento completo
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan HCTZ Fair-Med 150 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each tablet contains 114 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Peach coloured, oval shaped, biconvex, film coated tablet, debossed with “L183” on one side and plain on other side. 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 Irbesartan HCTZ Fair-Med 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: Irbesartan HCTZ Fair-Med 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan HCTZ Fair-Med 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan HCTZ Fair-Med 150 mg/12.5 mg. Irbesartan HCTZ Fair-Med 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan HCTZ Fair-Med 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan HCTZ Fair-Med may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1). Page 2 of 17 Special Populations _Renal impairment:_ due to the hydrochlorothiazide component, Irbesartan HCTZ Fair-Med is not recommende Leia o documento completo