COVERSYL ARGININE PLUS 5MG/1.25MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
PERINDOPRIL ARGININE INDAPAMIDE
Available from:
Profind Wholesale Ltd.
Dosage:
5/1.25 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-07-31
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine Plus 5mg/1.25mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3.395 mg perindopril corresponding to 5mg perindopril arginine and 1.25 mg
indapamide.
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK and Hungary:_
White, rod-shaped film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension, 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
Oral route
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.
_Elderly (see section 4.4)_
Treatment should be initiated after considering blood pressure response and renal function.
_Patients with renal impairment (see section 4.4)_
In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated.
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
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