Perindopril Arginine Clonmel 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine

Available from:

Clonmel Healthcare Ltd

ATC code:

C09AA04

INN (International Name):

Perindopril arginine

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

perindopril

Authorization status:

Not marketed

Authorization date:

2024-03-15

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

Health Products Regulatory Authority
20 March 2024
CRN00CV3V
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Arginine Clonmel 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg perindopril arginine equivalent
to 6.790 mg perindopril.
Excipient with known effect
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.
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.
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure response.
Hypertension
Perindopril Arginine Clonmel may be used in monotherapy or in
combination with other classes of antihypertensive therapy
(see sections 4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone
system (in particular, renovascular hypertension, salt and/or
volume depletion, cardiac decompensation or severe hypertension) may
experience an excessive drop in blood pressure
following the initial dose. A starting dose of 2.5 mg is recommended
in such patients and the initiation of treatment should
take place under medical supervision.
The dose may be increased to 10 mg once daily after 1 month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with
Perindopril Arginine Clonmel; this is more likely in
patients who are being treated concurrently with diuretics. Caution is
therefore recommended since these patients may be
volume and/or salt depleted.
If possi