PROGIT Film-coated tablet Ref.[11050] Active ingredients: Itopride

Publisher: PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

Product name and form

PROGIT 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to almost white round biconvex scored film-coated tablets, diameter 7 mm.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg of itopride hydrochloride.

Excipients with known effect: Each film-coated tablet contains 74.68 mg of 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

Lactose monohydrate
Pregelatinised maize starch
Croscarmellose sodium
Silica colloidal anhydrous
Magnesium stearate

Coating composition Opadry II White 85F18422:

Partially hydrolyzed polyvinylalcohol
Titanium dioxide (E171)
Macrogol 4000

Pack sizes and marketing

OPA/Al/PVC/Al blister or transparent PVC/PVdC/Al blister, carton.

Pack size: 10, 20, 30, 40, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic


Drug Countries
PROGIT Lithuania

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