Perindopril Arginine/Indapamide Mylan 5 mg/1.25mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine; Indapamide

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

C09BA; C09BA04

INN (International Name):

Perindopril arginine; Indapamide

Dosage:

5 mg/1.25 milligram(s)

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:

Not marketed

Authorization date:

2011-08-19

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL ARGININE/INDAPAMIDE MYLAN 2.5 MG/0.625 MG FILM-COATED
TABLETS
PERINDOPRIL ARGININE/INDAPAMIDE MYLAN 5 MG/1.25 MG FILM-COATED TABLETS
perindopril arginine and 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 Perindopril Arginine/Indapamide Mylan is and what it is used for
2.
What you need to know before you take Perindopril Arginine/Indapamide
Mylan
3.
How to take Perindopril Arginine/Indapamide Mylan
4.
Possible side effects
5.
How to store Perindopril Arginine/Indapamide Mylan
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE/INDAPAMIDE MYLAN IS AND WHAT IT IS USED FOR
Perindopril Arginine/Indapamide Mylan 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).
Perindopril belongs to a group of medicines known as angiotensin
converting enzyme
(ACE) inhibitors, which widen the blood vessels, and therefore it is
easier for the heart to pump blood
through them. Indapamide is a diuretic, which is a type of medicine
that increases the amount of urine
produced by the kidneys. These two active ingredients work together to
reduce and control your blood
pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE/INDAPAMIDE
MYLAN
DO NOT TAKE PERINDOPRIL ARGININE/INDAPAMIDE MYLAN:

if you are allergic to perindopril or any other ACE inhibitor,
indapamide or any other
sulphona

Summary of Product characteristics

Health Products Regulatory Authority
22 July 2020
CRN009SVR
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Arginine/Indapamide Mylan 5 mg/1.25mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine and 1.25 mg indapamide.
Excipients with known effect: contains lecithin (soya)
_Perindopril Arginine/Indapamide Mylan 5 mg/1.25 mg:_ Each tablet
contains 66.650 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White capsule shaped, biconvex, film-coated tablets debossed with a
‘PI’ on one side and ‘M2’ on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril Arginine/Indapamide Mylan 5 mg/1.25 mg is indicated for
treatment of essential hypertension, in patients whose
blood pressure is not adequately controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril Arginine/Indapamide Mylan 5 mg/1.25 mg film-coated
tablet per day as a single dose.
When possible individual dose titration with the components is
recommended. When clinically appropriate, direct change
from monotherapy to Perindopril Arginine/Indapamide Mylan 5 mg/1.25 mg
may be considered
_Elderly (see section 4.4)_
Treatment with Perindopril Arginine/Indapamide Mylan 5 mg/1.25 mg
film-coated tablets should be initiated after considering
blood pressure response and renal function.
_Patients with 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 the treatment with
an appropriate dose of the free combination. The maximum dose of
perindopril arginine should be 2.5 mg per day.
In patients