Perindopril arginine Mylan 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

C09AA; C09AA04

INN (International Name):

Perindopril arginine

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; perindopril

Authorization status:

Not marketed

Authorization date:

2011-06-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL ARGININE MYLAN 2.5 MG FILM-COATED TABLETS
PERINDOPRIL ARGININE MYLAN 5 MG FILM-COATED TABLETS
PERINDOPRIL ARGININE MYLAN 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 Mylan is and what it is used for
2. What you need to know before you take Perindopril arginine Mylan
3. How to take Perindopril arginine Mylan
4. Possible side effects
5. How to store Perindopril arginine Mylan
6. Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE MYLAN IS AND WHAT IT IS USED FOR
Perindopril arginine Mylan belongs to a group of medicines known as
angiotensin converting enzyme
(ACE) inhibitors. These work by making your blood vessels wider, which
makes it easier for your heart
to pump blood through them.
Perindopril arginine Mylan 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) [_for 2.5 mg & 5 mg only_]

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE MYLAN
DO NOT TAKE PERINDOPRIL ARGININE MYLAN

if you are allergic to perindopril, any other AC

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2021
CRN008W57
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril arginine Mylan 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of perindopril arginine, equivalent to
6.790 mg of perindopril.
Excipients with known effect:
Contains lecithin (soya)
Each tablet contains 135.80 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Green, round, biconvex, film-coated tablets debossed with “PA3” on
one side and “M” on the other side.
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 Mylan may be used in monotherapy or in
combination with other classes of anti-hypertensive 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 one month of treatment.
Symptomatic hypotension may occur following initiation of therapy with
Perindopril arginine Mylan; 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 possible, the diuretic