TOPRISAN Film-coated tablet Ref.[51160] Active ingredients: Itopride

Source: Medicines Authority (MT)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Toprisan, 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, biconvex, film-coated tablets with diameter 7mm.

Qualitative and quantitative composition

Each film-coated tablet contains itopride hydrochloride 50 mg.

Excipient with known effect: lactose. Each film-coated tablet contains 58.7 mg of lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description

Itopride activates the gastrointestinal propulsive motility by dopamine D2 receptors antagonistic action and acetylcholine esterase inhibitory action. Itopride activates acetylcholine release and inhibits its degradation.

List of Excipients

Tablet core:

Lactose monohydrate
Starch, pregelatinised
Silica, colloidal anhydrous
Magnesium stearate


Hypromellose 2910
Titanium dioxide E171
Macrogol 6000

Pack sizes and marketing

Clear PVC/PE/PVDC-Alu blisters and Clear PVC/PVDC-Alu blisters.

The available pack sizes are: 20, 30, 40 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers


Date of first authorisation: 23rd May 2016
Date of renewal: 16th October 2020


Drug Countries
TOPRISAN Cyprus, Malta

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