PRINDEX 2 Milligram Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

PERINDOPRIL TERT-BUTYLAMINE

Διαθέσιμο από:

Glenmark Pharmaceuticals Europe Limited

INN (Διεθνής Όνομα):

PERINDOPRIL TERT-BUTYLAMINE

Δοσολογία:

2 Milligram

Φαρμακοτεχνική μορφή:

Tablets

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

0000-00-00

Φύλλο οδηγιών χρήσης

February 2014 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

PERINDOPRIL 2MG TABLETS 

        PERINDOPRIL 4MG TABLETS 

        PERINDOPRIL 8MG 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 or pharmacist.  This includes any possible side 
effects not listed in this leaflet.  See section 4. 
What is in this leaflet: 
1.  What Perindopril is and what is it used for 
2.  What you need to know before you take Perindopril Tablets 
3.  How to take Perindopril Tablets 
4. Possible side effects. 
5.  How to store Perindopril Tablets 
6.  Contents of the pack and other information 

1. WHAT PERINDOPRIL IS AND WHAT IT IS USED FOR 

PERINDOPRIL belongs to a group of medicines called ACE inhibitors.
These work by widening 
the blood vessels. This makes it easier for your heart to pump blood
through the body. 

Perindopril 2 mg or 4 mg tablets are used to: 

•   treat high blood pressure (hypertension) 
•   treat heart failure (a condition where the heart is unable
to pump enough blood to meet the 
body’s needs) 
•    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.  

Perindopril 8 mg

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prindex 2 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril
Excipient(s) with known effect: 31.39 mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, biconvex tablet, smooth on both sides. Tablet dimensions: 5.00 ± 0.10mm
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
Method of administration
It is recommended that Prindex is taken once daily in the morning before a meal.
The dose should be individualised according to the patient profile (see 4.4 “Special warnings and precautions for use”)
and blood pressure response.
Posology
Hypertension
Prindex may be used in monotherapy or in combination with other classes of antihypertensive therapy.
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; this is more lik