Coversyl Arginine Plus 5mg/1.25mg 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:
5/1.25
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 5MG/1.25MG 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 of the 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 5mg/1.25mg is and what it is used for
2.
What you need to know before you take Coversyl Arginine Plus
5mg/1.25mg
3.
How to take Coversyl Arginine Plus 5mg/1.25mg
4.
Possible side effects
5.
How to store Coversyl Arginine Plus 5mg/1.25mg
6.
Contents of the pack and other information
1.
WHAT COVERSYL ARGININE PLUS 5MG/1.25MG IS AND WHAT IT IS USED FOR
Coversyl Arginine Plus 5mg/1.25mg 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
5MG/1.25MG
DO NOT TAKE COVERSYL ARGININE PLUS 5MG/1.25MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides
or any of the other
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 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
Plus5mg/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 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 modification is required. Usual medical
follow-up will include frequent monitoring of creatinine and
potassium.
_Hepatic impairment (see
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