Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
AMLODIPINE BESILATE 13.87 mg EQV AMLODIPINE; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE
SERVIER (S) PTE LTD
C09BB04
10mg
TABLET
AMLODIPINE BESILATE 13.87 mg EQV AMLODIPINE 10mg; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE 5 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE [LSI]
ACTIVE
2010-07-08
1 _ _ 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 COVERAM 5mg/5mg tablets: One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine COVERAM 5mg/10mg tablets: One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine COVERAM 10mg/5mg tablets: One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine COVERAM 10mg/10mg tablets: 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 : lactose monohydrate For the complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. COVERAM 5mg/5mg tablets: White, rod-shaped tablet engraved with 5/5 on one face and on the other face. COVERAM 5mg/10mg tablets: White, square-shaped tablet engraved with 5/10 on one face and on the other face. COVERAM 10mg/5mg tablets: White, triangular-shaped tablet engraved with 10/5 on one face and on the other face. COVERAM 10mg/10mg tablets: White, round tablet engraved with 10/10 on one face and on the other face. 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS COVERAM is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease Perskaitykite visą dokumentą
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 Coveram 5mg/5mg tablets: One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine Coveram 5mg/10mg tablets: One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine Coveram 10mg/5mg tablets: One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine Coveram 10mg/10mg tablets: 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 complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Coveram 5mg/5mg tablets: White, rod-shaped tablet engraved with 5/5 on one face and on the other face. Coveram 5mg/10mg tablets: White, square-shaped tablet engraved with 5/10 on one face and on the other face. Coveram 10mg/5mg tablets: White, triangular-shaped tablet engraved with 10/5 on one face and on the other face. Coveram 10mg/10mg tablets: White, round tablet engraved with 10/10 on one face and on the other face. 4. CLINICAL DATA 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 Perskaitykite visą dokumentą