País: Malta
Língua: inglês
Origem: Medicines Authority
AMLODIPINE, PERINDOPRIL ARGININE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BB04
AMLODIPINE 10 mg PERINDOPRIL ARGININE 10 mg
TABLET
AMLODIPINE 10 mg PERINDOPRIL ARGININE 10 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2008-12-05
PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERAM 5MG / 5MG TABLETS COVERAM 10MG / 5MG TABLETS COVERAM 5MG / 10MG TABLETS COVERAM 10MG / 10MG TABLETS perindopril arginine / amlodipine 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 Coveram is and what it is used for 2. What you need to know before you take Coveram 3. How to take Coveram 4. Possible side effects 5. How to store Coveram 6. Content of the pack and other information 1. WHAT COVERAM IS AND WHAT IT IS USED FOR Coveram is prescribed for treatment of high blood pressure (hypertension) and/or treatment of stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked). Patients already taking perindopril and amlodipine from separate tablets may instead receive one tablet of Coveram which contains both ingredients. Coveram is a combination of two active ingredients, perindopril and amlodipine. Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they work to widen and relax the blood vessels so that blood passes through them more easily and makes it easier for your heart to maintain a good blood flow. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERAM DO NOT TAKE COVERAM - if you are allergic to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonists, or any of the other ingredients of this medicine (listed in Sec Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Coveram 5mg/5mg tablets [Coveram 5mg/10mg tablets] [Coveram 10mg/5mg tablets] [Coveram 10mg/10mg tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine. [One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine] [One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine] [One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine] Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet, 8.5 mm long and 4.5 mm wide, engraved with 5/5 on one face and on the other face. [White, square-shaped tablet, 8 mm long and 8 mm wide, engraved with 5/10 on one face and on the other face.] [White, triangular-shaped tablet, 9.5 mm x 8.8 mm x 8.8 mm, engraved with 10/5 on one face and on the other face.] [White, round tablet, 8.5 mm diameter, engraved with 10/10 on one face and on the other face.] 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Coveram is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _ _ Oral route. One tablet per day as a single dose, preferably to be taken in the morning and before a meal. The fixed dose combination is not suitable for initial therapy. If a change of posology is required, the dose of Coveram could be modified or individual titration with free combination may be considered. 3 _Special populations _ _ _ _ Leia o documento completo