Țară: Malta
Limbă: engleză
Sursă: Malta Medicines Authority
CARVEDILOL
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C07AG02
CARVEDILOL 6.25 mg
FILM-COATED TABLET
CARVEDILOL 6.25 mg
POM
BETA BLOCKING AGENTS
Authorised
2012-12-24
PACKAGE LEAFLET: INFORMATION FOR THE USER CARVEDILOL 3.125 MG FILM-COATED TABLETS CARVEDILOL 6.25 MG FILM-COATED TABLETS CARVEDILOL 12.5 MG FILM-COATED TABLETS CARVEDILOL 25 MG FILM-COATED TABLETS Carvedilol 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 Carvedilol is and what it is used for 2. What you need to know before you take Carvedilol 3. How to take Carvedilol 4. Possible side effects 5. How to store Carvedilol 6. Contents of the pack and other information 1. WHAT CARVEDILOL IS AND WHAT IT IS USED FOR Carvedilol belongs to a group of medicines called beta-blockers that work by relaxing and widening the blood vessels. This makes it easier for your heart to pump blood around the body and reduces blood pressure and strain on your heart. CARVEDILOL IS USED: - • for the treatment of high blood pressure (hypertension), • for the treatment of chest pain that occurs when the arteries that supply your heart with blood carrying oxygen are narrowed which results in less oxygen reaching your heart muscles (angina), • for the treatment of weakening of the heart muscle (heart failure), in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL DO NOT TAKE CARVEDILOL: • if you are ALLERGIC to carvedilol or any of the other ingredients of this medicine (listed in section 6). • if you have a history of wheezing due to asthma or other lung diseases, • if you have been told you have very severe heart failure and you have fluid retention (swelling) which is b Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Carvedilol 3.125 mg film-coated tablets Carvedilol 6.25 mg film-coated tablets Carvedilol 12.5 mg film-coated tablets Carvedilol 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Carvedilol 3.125 mg film-coated tablets: _ Each tablet contains 3.125 mg of carvedilol. Excipient(s) with known effect: Each tablet contains 28.625 mg of lactose monohydrate and 0.625 mg of sucrose. _Carvedilol 6.25 mg film-coated tablets: _ Each tablet contains 6.25 mg of carvedilol. Excipient(s) with known effect: Each tablet contains 57.25 mg lactose monohydrate and 1.250 mg of sucrose. _Carvedilol 12.5 mg film-coated tablets: _ Each tablet contains 12.5 mg of carvedilol. Excipient(s) with known effect: Each tablet contains 114.5 mg lactose monohydrate and 2.5 mg of sucrose. _Carvedilol 25 mg film-coated tablets: _ Each tablet contains 25 mg carvedilol. Excipient(s) with known effect: Each tablet contains 229 mg lactose monohydrate and 5 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Carvedilol 3.125 mg film-coated tablets _ Film-coated tablets white to off-white, oval, engraved with "E" on one side and "01" on the other. _Carvedilol 6.25 mg film-coated tablets _ Film-coated tablets white to off-white, oval, engraved with "F57" on one side and scored on the other side. The tablet can be divided into equal doses. _Carvedilol 12.5 mg film-coated tablets _ Film-coated tablets white to off-white, oval, engraved with "F58" on one side and scored on the other side. The tablet can be divided into equal doses. _Carvedilol 25 mg film-coated tablets _ Film-coated tablets white to off-white, oval, engraved with "F59" on one side and scored on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension Chronic stable angina pectoris Adjunctive treatment of moderate to severe stable chronic heart failure 4.2 POSOLOGY AND Citiți documentul complet