Perindopril Arginine Clonmel 5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL ARGININE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PERINDOPRIL ARGININE 5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2024-01-17

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL ARGININE CLONMEL 2.5 MG FILM-COATED TABLETS
PERINDOPRIL ARGININE CLONMEL 5 MG FILM-COATED TABLETS
PERINDOPRIL ARGININE CLONMEL 10 MG FILM-COATED TABLETS
perindopril arginine
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 Perindopril Arginine Clonmel is and what it is used for
2.
What you need to know before you take Perindopril Arginine Clonmel
3.
How to take Perindopril Arginine Clonmel
4.
Possible side effects
5.
How to store Perindopril Arginine Clonmel
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE CLONMEL IS AND WHAT IT IS USED FOR
Perindopril Arginine Clonmel is an angiotensin converting enzyme (ACE)
inhibitor. These work
by widening the blood vessels, which makes it easier for your heart to
pump blood through them.
Perindopril Arginine Clonmel is used
‒
to treat
HIGH BLOOD PRESSURE
(hypertension).
‒
to treat
HEART FAILURE
(a condition where the heart is unable to pump enough blood to meet
the
body’s needs) (only Perindopril Arginine Clonmel 2.5 mg and 5 mg).
‒
to reduce the risk of cardiac events, such as heart attack, in
patients with
STABLE CORONARY ARTERY
DISEASE
(a condition where the blood supply to the heart is reduced or
blocked) and who have
already had a heart attack and/or an operation to improve the blood
supply to the heart by
widening the vessels that supply it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE CLONMEL
DO NOT TAKE PERINDOPRIL ARGININE

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril Arginine Clonmel 2.5 mg film-coated tablets
Perindopril Arginine Clonmel 5 mg film-coated tablets
Perindopril Arginine Clonmel 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril Arginine Clonmel 2.5 mg: Each film-coated tablet contains
2.5 mg perindopril arginine
equivalent to 1.6975 mg perindopril.
Perindopril Arginine Clonmel 5 mg: Each film-coated tablet contains 5
mg perindopril arginine
equivalent to 3.395 mg perindopril.
Perindopril Arginine Clonmel 10 mg: Each film-coated tablet contains
10 mg perindopril arginine
equivalent to 6.790 mg perindopril.
Excipient with known effect
Perindopril Arginine Clonmel 2.5 mg: Each film-coated tablet contains
58.19 mg lactose (as
monohydrate).
Perindopril Arginine Clonmel 5 mg: Each film-coated tablet contains
116.38 mg lactose (as
monohydrate).
Perindopril Arginine Clonmel 10 mg: Each film-coated tablet contains
232.75 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Perindopril Arginine Clonmel 2.5 mg: White to off-white, rounded,
convex film-coated tablet of
diameter 5.0 ± 0.25 mm.
Perindopril Arginine Clonmel 5 mg: Light-green, oval, biconvex
film-coated tablet with length 10.0 ±
0.50 mm and width 4.75 ± 0.24 mm with both-sided score line. The
tablet can be divided into equal
doses.
Perindopril Arginine Clonmel 10 mg: Green to marble green, rounded,
biconvex film-coated tablet
of diameter 9.0 ± 0.45 mm with one-sided debossing “10”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension.
Heart failure (only Perindopril Arginine Clonmel 2.5 mg and 5 mg)
Treatment of symptomatic heart failure.
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or
revascularisation.
Page 2 of 17
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised