Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; PERINDOPRIL ARGININE
SERVIER MALAYSIA SDN BHD
AMLODIPINE BESILATE; PERINDOPRIL ARGININE
30Tablet Tablets
SERVIER ( IRELAND) INDUSTRIES LTD
_Consumer Medication Information Leaflet (RIMUP)_ COVERAM TABLET Perindopril arginine / amlodipine (5mg/5mg, 5mg/10mg, 10mg/5mg & 10mg/10mg) 1 WHAT IS IN THIS LEAFLET 1. What is Coveram used for 2. How Coveram works 3. Before you use Coveram 4. How to use Coveram 5. While you are using Coveram 6. Side effects 7. Storage and Disposal of Coveram 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT COVERAM 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. HOW COVERAM WORKS 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. BEFORE YOU USE COVERAM - _When you must not use it _ 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 Section 8), - if you are more than 3 months pregnant (It is also better to avoid Coveram in early pregnancy – see pregnancy section), - if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema), - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing a Прочетете целия документ
Final PI_Coveram_16.12.2022 1 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 engraved with 5/5 on one face and on the other face. White, square-shaped tablet engraved with 5/10 on one face and on the other face. White, triangular-shaped tablet engraved with 10/5 on one face and on the other face. White, round tablet 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. Final PI_Coveram_16.12.2022 2 _Special populations _ _ _ _Renal impairment and elderly (see sections 4.4 and 5.2) _ Elimination of perindoprilat is decrease Прочетете целия документ