Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Perindopril arginine; Indapamide
Servier Laboratories Ltd
C09BA04
Perindopril arginine; Indapamide
5mg ; 1.25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5017476171405
1739_05.04.indd 1 21/03/2017 09:41 1739_05.04.indd 2 21/03/2017 09:41 1739_05.04.indd 3 21/03/2017 09:41 1739_05.04.indd 4 21/03/2017 09:41 1739_05.04.indd 5 21/03/2017 09:41 1739_05.04.indd 6 21/03/2017 09:41 Read the complete document
OBJECT 1 COVERSYL ARGININE PLUS 5 MG/1.25 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 21-Mar-2017 | Servier Laboratories Limited 1. Name of the medicinal product Coversyl Arginine Plus 5mg/1.25mg film-coated tablets 2. Qualitative and quantitative composition One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide. Excipient with known effect: 71.33 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, rod-shaped film-coated tablet. 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension in adults, Coversyl Arginine Plus 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 Posology and method of administration Posology One Coversyl Arginine Plus 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. Coversyl Arginine Plus 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablet (where available). When clinically appropriate, direct change from monotherapy to Coversyl Arginine Plus 5mg/1.25mg film-coated tablet may be considered. Special populations _Elderly (see section 4.4)_ Treatment should be initiated after considering blood pressure response and renal function. _Renal impairment (see section 4.4)_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contra-indicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination. In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of Read the complete document