PERINDOPRIL TOSILATE TEVA 2.5 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

PERINDOPRIL TOSILATE

متاح من:

Teva Pharma B.V.

INN (الاسم الدولي):

PERINDOPRIL TOSILATE

جرعة:

2.5 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2014-04-24

نشرة المعلومات

PRODUCT:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT Harlow
Signed
Signed
29661
PERINDOPRIL TOSILAT TEVA 2.5, 5, 
10MG ALL FC TABS TEI (TPW) V2
26-7-13
120 x 460 mm
2
01-08-13
LT
LT
Leaflet
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
INDESIGN CS6
Last amend:
-
SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds, 
chokes, spreads or other adjustments required for print reproduction
purposes only. If you have any difficulties 
please contact the Teva Artwork Team. We must receive a copy of the
3rd Party Vendors Proof before final 
approval can be made. 
Body: Univers 55 Roman/ 
65 Bold/ 55 Oblique 8pts
Subhead: Univers 65 Bld 9pts
Header: Univers 65 Bld 10pts
PERINDOPRIL TOSILATE 
TEVA 2.5 MG  
FILM-COATED TABLETS
PERINDOPRIL TOSILATE 
TEVA 5 MG  
FILM-COATED TABLETS
PERINDOPRIL  
TOSILATE TEVA 10 MG 
FILM-COATED TABLETS
PERINDOPRIL TOSILATE
PACKAGE LEAFLET:  
INFORMATION FOR THE USER
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
WHAT IS IN THIS LEAFLET: 
1.  WHAT PERINDOPRIL TOSILATE TEVA IS 
AND WHAT IT IS USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE 
YOU TAKE PERINDOPRIL TOSILATE 
TEVA 
3.  HOW TO TAKE PERINDOPRIL TOSILATE 
TEVA 
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE PERINDOPRIL TOSILATE 
TEVA 
6.  CONTENTS OF THE PACK AND OTHER 
INFORMATION
1
   WHAT  PERINDOPRIL 
TOSILATE TEVA IS AND 
WHAT IT IS USED FOR
Perindopril tos

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Tosilate Teva 2.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tosilate
One film-coated tablet contains 1.704 mg perindopril corresponding to 2.5 mg perindopril tosilate converted _in situ _to
perindopril sodium.
Excipient with known effect: 35.981 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, film-coated tablet of approx. 5 mm diameter, debossed “T” on one side and plain on the other.
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 Tosilate is taken once daily in the morning before a meal.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response.
Hypertension:
Perindopril Tosilate may be used in monotherapy or in combination with other classes of antihypertensive therapy.
The recommended starting dose is 5 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 2.5 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 10 mg once daily after one month of treatment.
IR