Percarnil 4mg Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

PERINDOPRIL TERT, BUTYLAMINE SALT

Disponible depuis:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Code ATC:

C09AA04

DCI (Dénomination commune internationale):

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg

forme pharmaceutique:

TABLET

Composition:

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2009-05-04

Notice patient

dimensions: 
pharmacode: 
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black
2
9pt
170x600
07.12.2012
07.12.2012
07.12.2012
K. Mutafchieva
14.01.2013
K. Mutafchieva
Glenmark Pharmaceuticals
Item Number: AAAE6616
Perindopril, All Strengths, PIL, Malta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, consult your 
doctor or pharmacist.
•  This medicine has been prescribed for you. Do 
not pass it on to others. 
It may harm them, even if their symptoms are 
the same as yours.
•  If any of the side effects becomes serious, or if 
you notice any side effects not listed in this leaf-
let, please tell your doctor or pharmacist.
In this leaflet:
1. What Percarnil is and what is it used for.
2.  What you should know before you take 
Percarnil.
3.  How to take Percarnil.
4.  Possible side effects.
5. How to store Percarnil.
6.  Further information.
1. WHAT PERCARNIL 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.
Percarnil 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

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Percarnil 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Perindopril 2 mg: 
Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent
to 1.669 mg perindopril 
Excipient: 31.39 mg of lactose monohydrate 
_ _
Perindopril 4 mg: 
Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent
to 3.338 mg perindopril 
Excipient: 62.78 mg of lactose monohydrate 

Perindopril 8 mg: 
Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent
to 6.676 mg perindopril 
Excipient: 125.56 mg of lactose monohydrate 
_ _
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
Tablet. 
2 mg: 
White, round, biconvex tablet, smooth on both sides. 
4mg: 
White, oblong tablet, with a break-line on both sides, ‘PP’
engraved on one side and ‘4’ on the other.  
The tablet can be divided into equal halves. 
8mg: 
White, circular, biconvex tablet with ‘PP’ debossed on one side
and ‘8’ on the other.  

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Hypertension: 
Treatment of hypertension 
Heart failure (applicable to Percarnil 2mg & 4mg tablets only): 
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 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.  
Page 1 of 14 
Hypertension 
Perindopril 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, renov