COVERSYL ARGININE PLUS

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

PERINDOPRIL ARGININE; INDAPAMIDE

から入手可能:

B & S Healthcare

ATCコード:

C09BA04

INN（国際名）:

PERINDOPRIL ARGININE; INDAPAMIDE

投薬量:

5/1.25 Milligram

医薬品形態:

Film-coated tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

perindopril and diuretics

認証ステータス:

Authorised

承認日:

2009-11-06

情報リーフレット

PACKAGE LEAFLET : INFORMATION FOR THE USER 
COVERSYL
®
 ARGININE PLUS 5MG/1.25MG 
FILM-COATED TABLETS 
(perindopril arginine/indapamide) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 
THIS MEDICINE. 
•  Keep this leaflet. You may need to read it again. 
•  If you have any further questions, ask your doctor or 
pharmacist. 
•  This medicine has been prescribed for you. Do not pass it 
on to others. It may harm them, even if their symptoms 
are the same as yours. 
•  If any of the side effects get serious, or if you notice
any 
side effects not listed in this leaflet, please tell your
doctor 
or pharmacist. 

The name of your medicine is Coversyl Arginine Plus 
5mg/1.25mg film-coated tablets but will be referred to as 
Coversyl Arginine Plus throughout this leaflet.  

IN THIS LEAFLET 
1.  What Coversyl Arginine Plus is and what it is used for 
2.  Before you take Coversyl Arginine Plus 
3.  How to take Coversyl Arginine Plus 
4.  Possible side effects 
5.  How to store Coversyl Arginine Plus 
6.  Further information  

1.  WHAT COVERSYL ARGINIE PLUS IS AND WHAT IT 
IS USED FOR 
WHAT IS COVERSYL ARGININE PLUS? 
Coversyl Arginine Plus is a combination of two active 
ingredients, perindopril and indapamide. It is an anti-
hypertensive and is used in the treatment of high blood 
pressure (hypertension).  

WHAT IS COVERSYL ARGININE PLUS USED FOR? 
Perindopril belongs to a class of medicines called ACE 
inhibitors. These work by widening the blood vessels, which 
makes it easier for your heart to pump blood through them. 
Indapamide is a diuretic. Diuretics increase the amount of 
urine produced in the kidneys. However, indapamide is 
different from other diuretics, as it only causes a slight 
increase in the amount of urine produced. Each of the active 
ingredients reduces blood pressure and they work together to

製品の特徴

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 3.395mg perindopril corresponding to 5mg perindopril arginine and 1.25mg
indapamide.
Excipients: Contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK and Poland:_
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�