Страна: Малта
Език: английски
Източник: Medicines Authority
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09DA06
CANDESARTAN CILEXETIL 8 mg HYDROCHLOROTHIAZIDE 12.5 mg
TABLET
CANDESARTAN CILEXETIL 8 mg HYDROCHLOROTHIAZIDE 12.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2015-07-03
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN/HYDROCHLOROTHIAZIDE 8 MG/12.5 MG TABLETS CANDESARTAN/HYDROCHLOROTHIAZIDE 16 MG/12.5 MG TABLETS CANDESARTAN/HYDROCHLOROTHIAZIDE 32 MG/12.5 MG TABLETS CANDESARTAN/HYDROCHLOROTHIAZIDE 32 MG/25 MG TABLETS Candesartan cilexetil/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 Candesartan/Hydrochlorothiazide is and what it is used for 2. What you need to know before you take Candesartan/Hydrochlorothiazide 3. How to take Candesartan/Hydrochlorothiazide 4. Possible side effects 5. How to store Candesartan/Hydrochlorothiazide 6. Contents of the the pack and other information 1. WHAT CANDESARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan/ Hydrochlorothiazide. It is used for treating high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure. • Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure. • Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure. Your doctor may prescribe Candesartan/Hydrochlorothiazide if your blood pressure has not been properly controlled by candesart Прочетете целия документ
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets: Each tablet contains 8 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 110.000 mg lactose monohydrate. Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets: Each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 101.925 mg lactose monohydrate. Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets: Each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 216.000 mg lactose monohydrate. Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets: Each tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 203.850 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets: White to off-white, uncoated capsule shaped tablets [diameter 9.8 mm x 4.6 mm], debossed with ‘J’ and ‘04’ separated by score line on one side and plain with score line on the other side. The tablet can be divided into equal doses. Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets: Pink, uncoated capsule shaped tablets [size 9.8 mm x 4.6 mm], debossed with ‘J’ and ‘05’ separated by score line on one side and plain with score line on the other side The tablet can be divided into equal doses. Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets: Yellow, uncoated oval shaped tablets [size 11.3 mm x 6.6 mm], debossed with ‘J’ and ‘07’ separated by score line on one side a Прочетете целия документ