Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
14-07-2022
Summary of Product characteristics
(SPC)
14-07-2022
Active ingredient:
Perindopril arginine; Indapamide
Available from:
Les Laboratoires Servier
ATC code:
C09BA; C09BA04
INN (International Name):
Perindopril arginine; Indapamide
Dosage:
2.5/0.625
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors and diuretics; perindopril and diuretics
Authorization status:
Marketed
Authorization date:
2007-05-11
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL ARGININE PLUS 2.5MG/0.625MG FILM-COATED TABLETS
perindopril arginine/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Coversyl Arginine Plus 2.5mg/0.625mg is and what it is used for
2.
What you need to know before you take Coversyl Arginine Plus
2.5mg/0.625mg
3.
How to take Coversyl Arginine Plus 2.5mg/0.625mg
4.
Possible side effects
5.
How to store Coversyl Arginine Plus 2.5mg/0.625mg
6.
Contents of the pack and other information
1.
WHAT COVERSYL ARGININE PLUS 2.5MG/0.625MG IS AND WHAT IT IS USED FOR
Coversyl Arginine Plus 2.5mg/0.625mg 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) in
adults.
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 by 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 control your blood
pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL ARGININE PLUS
2.5MG/0.625MG
DO NOT TAKE COVERSYL ARGININE PLUS 2.5MG/0.625MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides
o
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
12 July 2022
CRN00CNLG
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1.6975 mg perindopril corresponding to
2.5 mg perindopril arginine and 0.625 mg indapamide.
Excipient with known effect: 74.455 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 with an embossed line on both
faces.
The scoreline is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Coversyl Arginine Plus 2.5mg/0.625mg is indicated in essential
hypertension in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose isone Coversyl Arginine Plus 2.5mg/0.625mg film-coated
tablet per day as a single dose, preferably to be taken
in the morning and before a meal. If blood pressure is not controlled
after one month of treatment, the dose can be doubled_._
Special populations
_Elderly (see section 4.4)_
Treatment should be started at the normal dose of one Coversyl
Arginine Plus 2.5mg/0.625mg film-coated tablet per day.
_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), the maximum dose should be one tablet of
Coversyl Arginine Plus 2.5mg/0.625mg per day.
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 creatinine
and potassium.
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_Paediatric population_
The safety and efficacy of perindopril arginine/indapamide in the
paediatric popul
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