VEZIMED Film-coated tablet Ref.[50942] Active ingredients: Solifenacin

Source: Web Search  Revision Year: 2021  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, Limassol, 3011 Cyprus

Product name and form

Vezimed 5 mg, film-coated tablet.

Vezimed 10 mg, film-coated tablet.

Pharmaceutical Form

Film-coated tablet.

Each 5 mg film-coated tablet is a yellow, round, biconvex film coated tablet with a diameter of 6mm.

Each 10 mg film-coated tablet is a red, round, biconvex film coated tablet with a diameter of 8mm.

Qualitative and quantitative composition

Vezimed 5 mg, film-coated tablet: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.

Vezimed 10 mg film-coated tablet: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Solifenacin

Solifenacin is a competitive, specific cholinergic-receptor antagonist. In vitro and in vivo pharmacological studies indicate that solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor.

List of Excipients

Microcrystalline cellulose
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate
Hypromellose
Macrogol 400
Titanium dioxide E171
Yellow iron oxide E172 (only for 5mg strength)
Red iron oxide E172 (only for 10mg strength)

Pack sizes and marketing

The tablets are packed in transparent PVC/PVDC-Aluminium blisters and cold forming aluminium/push through aluminium blisters.

The available pack sizes are: 10, 20, 30, 50, 60, 90, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos Street, Limassol, 3011 Cyprus

Marketing authorization dates and numbers

5 mg: MA032/10201
10 mg: MA032/10202

10th January 2017 / 06th June 2021

Drugs

Drug Countries
VEZIMED Cyprus, Malta, Romania

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