PERINDOPRIL TERT-BUTYLAMINE 4 Milligram Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

PERINDOPRIL TERT-BUTYLAMINE

Tillgänglig från:

Arrow Generics Limited

ATC-kod:

C09AA04

INN (International namn):

PERINDOPRIL TERT-BUTYLAMINE

Dos:

4 Milligram

Läkemedelsform:

Tablets

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

ACE inhibitors, plain

Bemyndigande status:

Authorised

Tillstånd datum:

2008-05-23

Bipacksedel

Renewal
August 2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL TERT-BUTYLAMINE 4 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 4mg tablets is and what it is used
for
2.
What you need to know before you take Perindopril tert-butylamine 4mg
tablets
3.
How to take Perindopril tert-butylamine 4mg tablets
4.
Possible side effects
5.
How to store Perindopril tert-butylamine 4mg tablets
6
Contents of the pack and other information
1.
WHAT PERINDOPRIL TERT-BUTYLAMINE 4MG TABLETS IS AND WHAT IT IS USED
FOR
Perindopril tert-butylamine 4mg 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 4mg tablets 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)
-
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 4MG
TABLETS
DO NOT TAKE PERINDOPRIL TERT-BUTYLAMINE 4MG TABLETS:
-
if you are allergic to perindopril or any of the ot

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine 4mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg of perindopril tert-butylamine equivalent to
3.338mg of perindopril
Excipient with known effect: 70mg 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 ‘4’ 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.
Heart failure:
Treatment of symptomatic heart failure.
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 4 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 4 mg tablets; this
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