VASTAREL 20 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-05-2016
Summary of Product characteristics
(SPC)
12-05-2016
Active ingredient:
TRIMETAZIDINE DIHYDROCHLORIDE
Available from:
PCO Manufacturing
ATC code:
C01EB15
INN (International Name):
TRIMETAZIDINE DIHYDROCHLORIDE
Dosage:
20 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other cardiac preparations
Authorization status:
Authorised
Authorization date:
2005-02-04
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VASTAREL
®
20MG FILM-COATED TABLETS
Trimetazidine dihydrochloride
▼This medicine is subject to
additional monitoring. This will allow quick identification of
new safety
information. You can help by reporting any side effects you
may get. See the end of Section 4 for how to
report side effects.
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 Vastarel 20mg is and what it is used for
2.
What you need to know before you take Vastarel 20mg
3.
How to take Vastarel 20mg
4.
Possible side effects
5.
How to store Vastarel 20mg
6.
Contents of the pack and other information
1.
WHAT VASTAREL 20MG IS AND WHAT IT IS USED FOR
This medicine is intended for use in adult patient, in combination
with other medicines to treat angina
pectoris (chest pain caused
by coronary disease). It protects the heart cells from the
effects of a reduced
oxygen supply during an episode of angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VASTAREL 20 MG
DO NOT TAKE VASTAREL 20MG
If you are allergic to trimetazidine or any of the other
ingredients of this medicine (listed in section 6)
If you have a Parkinson disease: disease of the brain affecting
movement (trembling, rigid posture,
slow movements and a shuffling, unbalanced walk)
If you ha
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Vastarel 20mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg trimetazidine dihydrochloride.
Excipients with known effect: Ponceau 4R (E124) and sunset yellow (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece_
Round, red film-coated tablets.
4 CLINICAL PARTICULARS
As per PA0068/010/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0068/010/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Maize Starch
Mannitol
Povidone
Magnesium stearate
Talc
_Film coating:_
Glycerol
Hypromellose
Macrogol 6000
Magnesium stearate
Ponceau 4R aluminium lake (E124)
Sunset yellow FCF aluminium lake (E110)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/04/2016_
_CRN 2175323_
_page number: 1_
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30° C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 60 tablets in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBE
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