VASTAREL 20 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

TRIMETAZIDINE DIHYDROCHLORIDE

可用日期:

PCO Manufacturing

ATC代码:

C01EB15

INN（国际名称）:

TRIMETAZIDINE DIHYDROCHLORIDE

剂量:

20 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Other cardiac preparations

授权状态:

Authorised

授权日期:

2005-02-04

资料单张

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

产品特点

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