Perindosyl 4mg Tablets

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

PERINDOPRIL,TERT-BUTYLAMINE

Dostupné s:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Mezinárodní Name):

PERINDOPRIL,TERT-BUTYLAMINE

Jednotky v balení:

30Tablet Tablets

Výrobce:

LEK PHARMACEUTICALS D.D.

Informace pro uživatele

PERINDOSYL
(Perindopril tert-butylamine 4 mg)
________________________________________________________________________________________________________
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is PERINDOSYL used for
2.
How PERINDOSYL works
3.
Before you take PERINDOSYL
4.
How to take PERINDOSYL
5.
While you are using
PERINDOSYL
6.
Side effects
7.
Storage and disposal of
PERINDOSYL
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS PERINDOSYL USED
FOR
PERINDOSYL is used to treat:
•
high blood pressure
(hypertension)
•
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.
HOW PERINDOSYL WORKS
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.
BEFORE YOU USE
PERINDOSYL
-
_When you must not use it _
•
if you are allergic
(hypersensitive) to Perindopril
or any of the other ingredients
in the tablet or any other ACE
inhibitor;
•
if you have had symptoms such
as wheezing, swelling of the
face, tongue or throat, intense
itching, skin rashes, fainting or
dizziness with previous ACE
inhibitor treatment or have had
these symptoms in any other
circumstances (this condition is
called
angioedema);
•
if you have hereditary tendency
to tissue swelling of unknown
origin (hereditary or idiopathic
angioedema);
•
if you are pregnant;
•
if you are taking aliskiren and
have Type 2 diabetes;
•
if you are taking concomitant
medicine (sacubitril/valsartan);
•
if you are having extracorporeal
treatments;
•
if you have significant kidney
artery na

Charakteristika produktu

1.
NAME OF THE MEDICINAL PRODUCT
Perindosyl 4 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg perindopril tert-butylamine, equivalent to
3.338 mg perindopril.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
4 mg: white, round, biconvex tablet scored on one side and debossed
with 4 on the reverse side. The
tablet can be divided into equal halves.
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
It is recommended that Perindopril tert-butylamine is taken once daily
in the morning before a meal
with sufficient amount of fluid (e.g., water).
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure
response.
Hypertension
Perindopril tert-butylamine 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.
After one month of treatment, the daily dose may be increased to 8 mg
once daily.
Symptomatic hypotension may occur following initiation of therapy with
Perindopril tert-butylamine;
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 disc