VASTAREL Ref.[4409] Active ingredients: Trimetazidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2014  Publisher: Servier Laboratories (Ireland) Limited Block 2 West Pier Business Campus Old Dunleary Road Dun Laoghaire Co. Dublin.

Product name and form

VASTAREL 20 mg Film-coated Tablets.

Pharmaceutical Form

Qualitative and quantitative composition

Each tablet contains 20mg trimetazidine dihydrochloride.

Excipients:

Ponceau 4R (E124): 0.369 mg per tablet.
Sunset yellow (E110): 0.042 mg per tablet.

For full list of excipients, see section 6.1.

Active Ingredient Description
Trimetazidine

In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels.

List of Excipients

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)

Pack sizes and marketing

Cartons of 30, 60 and 90 tablets in PVC/Aluminium blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Servier Laboratories (Ireland) Limited
Block 2
West Pier Business Campus
Old Dunleary Road
Dun Laoghaire
Co. Dublin.

Marketing authorization dates and numbers

PA 68/10/1

Date of first authorisation: 8th April 1987

Date of last renewal: 8th April 2007

Drugs

Drug Countries
VASTAREL Austria, Brazil, Cyprus, Ecuador, France, Hong Kong, Ireland, Japan, Malta, Singapore, Tunisia, Turkey

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.