Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Indapamide; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE
SERVIER (S) PTE LTD
C09BA04
1.25mg
TABLET, FILM COATED
Indapamide 1.25mg; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE 5 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE [LSI]
ACTIVE
2009-04-24
EU SPC 08.2012 (French MA amendment: 21st August 2012) Page 1 of 17 PACKAGE INSERT COVERSYL PLUS 2.5MG/0.625MG COVERSYL PLUS 5MG/1.25MG COVERSYL PLUS 10MG/2.5MG 1. NAME OF THE MEDICINAL PRODUCT COVERSYL PLUS 2.5mg/0.625mg film-coated tablets COVERSYL PLUS 5mg/1.25mg film-coated tablets COVERSYL PLUS 10mg/2.5mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COVERSYL PLUS 2.5mg/0.625mg One film-coated tablet contains 1.6975 mg perindopril corresponding to 2.5 mg perindopril arginine and 0.625 mg indapamide. COVERSYL PLUS 5mg/1.25mg One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide. COVERSYL PLUS 10mg/2.5mg One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide. Excipient: lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. COVERSYL PLUS 5mg/1.25mg: White, rod-shaped film-coated tablet. COVERSYL PLUS 2.5mg/0.625mg: White, rod-shaped film-coated tablet with an embossed line on both faces. COVERSYL PLUS 10mg/2.5mg: White, round film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COVERSYL PLUS 2.5mg/0.625mg Essential hypertension. COVERSYL PLUS 5mg/1.25mg Treatment of essential hypertension, COVERSYL PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. COVERSYL PLUS 10mg/2.5mg COVERSYL PLUS 10mg/2.5mg tablet is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ EU SPC 08.2012 (French MA amendment: 21st August 2012) Page 2 of 17 _Oral Olvassa el a teljes dokumentumot
PACKAGE INSERT COVERSYL PLUS 5MG/1.25MG COVERSYL PLUS 10MG/2.5MG 1. NAME OF THE MEDICINAL PRODUCT COVERSYL PLUS 5mg/1.25mg film-coated tablets COVERSYL PLUS 10mg/2.5mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COVERSYL PLUS 5mg/1.25mg One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide. COVERSYL PLUS 10mg/2.5mg One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. COVERSYL PLUS 5mg/1.25mg: White, rod-shaped film-coated tablet. COVERSYL PLUS 10mg/2.5mg: White, round film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COVERSYL PLUS 5mg/1.25mg Treatment of essential hypertension in adults, COVERSYL PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. COVERSYL PLUS 10mg/2.5mg COVERSYL PLUS 10mg/2.5mg tablet is indicated as substitution therapy for treatment of essential hypertension, in adult patients already controlled with perindopril and indapamide given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology COVERSYL PLUS 5mg/1.25mg One COVERSYL PLUS 5mg/1.25mg tablet per day as a single dose, preferably to be taken in the morning and before a meal. When clinically appropriate, direct change from monotherapy to COVERSYL PLUS 5mg/1.25mg film-coated tablet may be considered. COVERSYL PLUS 10mg/2.5mg One COVERSYL PLUS 10mg/2.5mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. _ _ Special populations _ _ _Elderly (see section 4.4) _ Treatment should be initiated after considering blood pressure response and renal function. In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with COVERSYL PL Olvassa el a teljes dokumentumot