PERCARNIL PLUS 4/1.25 mg/mg Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE

Disponível em:

Arrow Generics Limited

Código ATC:

C09BA04

DCI (Denominação Comum Internacional):

PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE

Dosagem:

4/1.25 mg/mg

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

ACE inhibitors and diuretics

Status de autorização:

Authorised

Data de autorização:

2009-01-09

Folheto informativo - Bula

V019
June 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL PLUS 4MG/1.25MG TABLETS
(perindopril _tert_-butylamine/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 PERCARNIL PLUS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCARNIL PLUS
3.
HOW TO TAKE PERCARNIL PLUS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PERCARNIL PLUS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PERCARNIL PLUS IS AND WHAT IT IS USED FOR
WHAT ARE PERCARNIL PLUS TABLETS?
Percarnil plus is a combination of two active substances, perindopril
and indapamide. It is an anti-hypertensive
medicine used in the treatment of high blood pressure (hypertension).
WHAT ARE PERCARNIL PLUS TABLETS USED FOR?
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 substances reduces blood pressure
and they work together to control your blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCARNIL PLUS
DO NOT TAKE PERCARNIL PLUS:
•
if you are allergic to perindopril, indapamide or any of the other
ingredients of this medicine (listed in
section 6)
•
if you are allergic to other ACE inhibitors or sulphonamides
•
if you have experien

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Percarnil plus 4mg/1.25mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril_ tert_-butylamine and 1.25 mg indapamide.
Excipient with known effect: 68.75 mg lactose monohydrate/tablet.
For
the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule-shaped tablet, embossed with ‘I 4’ on
one side and ‘>’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension, Percarnil plus 4mg/1.25mg tablets
is indicated in patients whose blood pressure is
not adequately controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one Percarnil plus 4mg/1.25mg 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.
Percarnil plus 4mg/1.25mg tablet should be used when blood pressure is
not adequately controlled on Percarnil plus
2mg/0.625mg tablets (where available).When clinically appropriate,
direct change from monotherapy to Percarnil plus
4mg/1.25mg tablets may be considered.
_Elderly (see section 4.4)_
Treatment 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 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.
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, treatment is contraindicated.
In patients wit