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CILOSTAZOL Tablets (2018)

Active ingredients: Cilostazol

Product Name and Form

Cilostazol 100 mg tablets.

Pharmaceutical form

Tablet.

Odourless or almost odourless, white or almost white, round, flat, bevelled edge tablets with no physical faults, no spots and no extraneous matters on the surface of tablet. The tablets are with stylized E engraving and 602 code on one side and no sign on the other side. The diameter of tablets is about 8 mm. The height of tablets is about 3.05 mm.

Qualitative and Quantitative Composition

One tablet contains 100 mg of cilostazol.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Cilostazol

Cilostazol and several of its metabolites are phosphodiesterase III inhibitors which suppress cyclic AMP degradation, resulting in increased cAMP in a variety of tissues including platelets and blood vessels. Studies in animals and in man (in vivo and ex vivo) have shown that cilostazol causes reversible inhibition of platelet aggregation.

List of excipients

Cellulose, microcrystalline
Maize starch
Carmellose calcium
Hypromellose 2910
Magnesium stearate

Pack sizes and Marketing

28 (2x14) or 56 (4x14) tablets in PVC/PVdC//Aluminium blisters in carton box with package leaflet. Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Consilient Health Limited, 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

24/04/2014

Marketing authorization number:

PL 24837/0048