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VASTAREL (2014)

Active ingredients: Trimetazidine

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.

Chemical substance
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
Authorization dates

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

Date of first authorisation: 8th April 1987

Date of last renewal: 8th April 2007

Marketing authorization number:

PA 68/10/1