COVERSYL ARGININE PLUS 5/1.25 mg/mg Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PERINDOPRIL ARGININE, INDAPAMIDE

Available from:

Clear Pharmacy

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL ARGININE, INDAPAMIDE

Dosage:

5/1.25 mg/mg

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and diuretics

Authorization status:

Authorised

Authorization date:

2010-11-05

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
One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg
indapamide.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from 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
_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.
_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/min, no dose