Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Malta Medicines Authority
HYDROCHLOROTHIAZIDE, IRBESARTAN
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09DA04
HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 300 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 300 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2013-12-03
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 150 MG/ 12.5 MG FILM-COATED TABLETS IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 300 MG/ 12.5 MG FILM-COATED TABLETS IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 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 sideeffects not listed in this leaflet See section 4. WHAT IS IN THIS LEAFLET: 1. What Irbesartan/ Hydrochlorothiazide Aurobindo is and what it is used for 2. What you need to know before you take Irbesartan/ Hydrochlorothiazide Aurobindo 3. How to take Irbesartan/ Hydrochlorothiazide Aurobindo 4. Possible side effects 5. How to store Irbesartan/ Hydrochlorothiazide Aurobindo 6. Contents of the pack and other information 1. WHAT IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED FOR Irbesartan/ Hydrochlorothiazide Aurobindo 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/ Hydrochlorothiazide Aurobin Διαβάστε το πλήρες έγγραφο
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan/ Hydrochlorothiazide Aurobindo 150 mg/ 12.5 mg film-coated tablets Irbesartan/ Hydrochlorothiazide Aurobindo 300 mg/ 12.5 mg film-coated tablets Irbesartan/ Hydrochlorothiazide Aurobindo 300 mg/ 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 150 mg/12.5 mg Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. _Excipient with known effect: _ Each film-coated tablet contains 131.85 mg of lactose monohydrate. 300 mg/12.5 mg Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. _Excipient with known effect: _ Each film-coated tablet contains 276.20 mg of lactose monohydrate. 300 mg/25 mg Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. _Excipient: _ Each film-coated tablet contains 256.50 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 150 mg/ 12.5 mg Peach coloured film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on other side. The size is 14 mm X 7.6 mm. 300 mg/ 12.5 mg Peach coloured film-coated biconvex oval shaped tablets, debossed with “H 36” on one side and plain on other side. The size is 17.7 mm X 9.6 mm. 300 mg/ 25 mg Pink coloured film-coated biconvex oval shaped tablets, debossed with “H 37” on one side and plain on other side. The size is 17.7 mm X 9.6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Page 2 of 20 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/ Hydrochlorothiazide can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When cl Διαβάστε το πλήρες έγγραφο