Země: Tanzanie
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
*PERINDOPRIL 10MG AND AMLODIPINE 5MG TABLET
LES LABORATOIRES SERVIER, FRANCE
*PERINDOPRIL 10MG AND AMLODIPINE 5MG TABLET
10+ 5
Oral tablet
SERVIER (IRELAND) INDUSTRIES LIMITED, REPUBLIC OF IRELAND
Physical description: White triangular-shaped tablet (9.5 mm x 8.8 mm x 8.8 mm), engraved with "10/5" on one face and break line on the other face; Local technical representative: MAHIMBI ABBAS MAHIMBI (2472)
Registered/Compliant
2022-10-07
SUMMARY OF PRODUCT CHARACTERISTICS 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 Prescription Only Medicine _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. _Special populations_ _Renal impairment and elderly (see sections 4.4 and 5.2)_ Elimination of perindoprilat is decr Přečtěte si celý dokument