PERINDOPRIL TERT-BUTYLAMINE 8 Milligram Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PERINDOPRIL TERT-BUTYLAMINE

Disponível em:

Arrow Generics Limited

Código ATC:

C09AA04

DCI (Denominação Comum Internacional):

PERINDOPRIL TERT-BUTYLAMINE

Dosagem:

8 Milligram

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

ACE inhibitors, plain

Status de autorização:

Authorised

Data de autorização:

2008-05-23

Folheto informativo - Bula

1
RENEWAL
AUG 2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS
perindopril tert-butylamine
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Perindopril tert-butylamine 8 mg tablets is and what it is used
for
2.
What you need to know before you take Perindopril tert-butylamine 8 mg
tablets
3.
How to take Perindopril tert-butylamine 8 mg tablets
4.
Possible side effects
5.
How to store Perindopril tert-butylamine 8 mg tablets
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS IS AND WHAT IT IS USED
FOR
Perindopril tert-butylamine 8 mg tablets 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 tert-butylamine 8 mg tablets is used:
-
to treat high blood pressure (hypertension)
-
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 TERT-BUTYLAMINE 8 MG
TABLETS
DO NOT TAKE PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS:
-
if you are allergic to perindopril or any of the other ingredients of
this medicine (listed in section 6)
-
if you are allergic to other ACE inhibitors
-
if you ar

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine 8mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg of perindopril tert-butylamine equivalent to
6.676mg of perindopril
Excipient with known effect: 140mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule-shaped convex tablet, embossed with
‘PI’ bisect ‘8’ on one side and ‘>’ on the other side.
The tablet can be divided into equal doses.
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 tert-butylamine 8 mg tablets 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 4 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 mg is
recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with
Perindopril tert-butylamine 8 mg tablets; 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 should be discontinued 2 to 3 days before
beg