GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated extended-release tablet contains:
Acotiamide hydrochloride hydrate…………………300mg
Excipients…………………………………………………………q.s.
Colours: Brilliant blue FCF
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H:TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Protect from Light and moisture.
Dosage: As directed by the Physician
Acotiamide Hydrochloride Hydrate Extended-Release Tablets 300mg Technical Specification:
| Product Name: | Acotiamide Hydrochloride Hydrate Extended-Release Tablets |
| Brand Name: | Generic |
| Strength: | 300mg |
| Dosage Form: | Tablets (Film-Coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anticholinesterase, Gastroenterology |
| Indication: | Acotiamide is primarily used in the treatment of functional dyspepsia (indigestion). |
| Storage: | Store below 30°C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Acotiamide Hydrochloride Hydrate Extended-Release Tablets 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Acotiamide Hydrochloride Hydrate Extended-Release Tablets 300mg
Each film-coated extended-release tablet contains:
Acotiamide hydrochloride hydrate…………………300mg
Excipients…………………………………………………………q.s.
Colours: Brilliant blue FCF
THERAPEUTIC INDICATIONS:
Acotiamide is a medicine used for the treatment of symptoms such as bloating, nausea, burping, stomach pain and discomfort, early satiety (a feeling of being full after eating a small amount of food and unable to eat a full meal), etc., associated with dyspepsia (indigestion).
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H:TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.






