| Product Name: | Itopride Hydrochloride Tablets |
| Brand Name: | Generic |
| Strength: | 50mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gastroenterological |
| Indication: | Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating; they have bloating and stomach pain. |
| Storage: | Store at a temperature not exceeding 30℃. Store in a cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itopride Hydrochloride Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Itopride Hydrochloride Tablets
Each film-coated tablet contains:
Itopride Hydrochloride……………………..50mg
Excipients…………………………………………q.s
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating; they have bloating and have stomach pain.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablets to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.