Land: Malta
Taal: Engels
Bron: Medicines Authority
CANDESARTAN CILEXETIL
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09CA06
CANDESARTAN CILEXETIL 8 mg
TABLET
CANDESARTAN CILEXETIL 8 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2013-08-12
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN CILEXETIL 2 MG TABLETS CANDESARTAN CILEXETIL 4 MG TABLETS CANDESARTAN CILEXETIL 8 MG TABLETS CANDESARTAN CILEXETIL 16 MG TABLETS CANDESARTAN CILEXETIL 32 MG TABLETS candesartan cilexetil 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 cilexetil is and what it is used for 2. What you need to know before you take Candesartan cilexetil 3. How to take Candesartan cilexetil 4. Possible side effects 5. How to store Candesartan cilexetil 6. Contents of the pack and other information 1. WHAT CANDESARTAN CILEXETIL IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan cilexetil. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body. This medicine is used for: • treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years. • Candesartan cilexetil can be used to treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used. (ACE-inhibitors and MRAs are medicines used to treat heart failure). 2. WHAT YOU NEED Lees het volledige document
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Candesartan cilexetil 2 mg tablets Candesartan cilexetil 4 mg tablets Candesartan cilexetil 8 mg tablets Candesartan cilexetil 16 mg tablets Candesartan cilexetil 32 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg candesartan cilexetil. Each tablet contains 4 mg candesartan cilexetil. Each tablet contains 8 mg candesartan cilexetil. Each tablet contains 16 mg candesartan cilexetil. Each tablet contains 32 mg candesartan cilexetil. Excipient with known effect: Lactose monohydrate. Each tablet contains 140 mg lactose monohydrate. Each tablet contains 138 mg lactose monohydrate. Each tablet contains 133.95 mg lactose monohydrate. Each tablet contains 125.60 mg lactose monohydrate. Each tablet contains 251.20 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet _Candesartan cilexetil_ _2 mg tablets _ White to off-white, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets debossed with "CN2" on one side and plain on other side. _Candesartan cilexetil 4 mg tablets _ White to off-white, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets debossed with "CN" and “4” separated by score-line on one side and plain on other side. The tablet can be divided into equal doses. _Candesartan cilexetil 8 mg tablets _ Pale pink, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets debossed with "CN" and “8” separated by score-line on one side and plain on other side. The tablet can be divided into equal doses. _Candesartan cilexetil 16 mg tablets _ Yellow, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets debossed with "CN" and “16” separated by score-line on one side and plain on other side. The tablet can be divided into equal doses. Page 2 of 18 _Candesartan cilexetil 32 mg tablets _ Yellow, biconvex, uncoated, round shaped [diameter 10 mm] tablets debossed with "CN" and “32” separated by score-line on one side and plain on Lees het volledige document