| Product Name: | Levosulpiride Tablet |
| Brand Name: | Generics |
| Strength: | (50mg), (100mg) |
| Dosage Form: | Tablet (Uncoated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Ulcer, Anti-Psychotic |
| Indication: | Levosulpiride is used for the treatment of upper abdominal pain and bloating, nausea, vomiting, irritable bowel movement, irregular emptying of the stomach in diabetic patients, it is also used for the treatment of depression and schizophrenia in adults. |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
Levosulpiride Tablet Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Levosulpiride Tablet 50mg
B) Levosulpiride Tablet 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Levosulpiride Tablet 50mg
Each Uncoated tablet contains:
Levosulpiride…………………………50mg
Excipients…………………………q.s.
Colours: Oxide Yellow USP NF
b) Levosulpiride Tablet 100mg
Each Uncoated tablet contains:
Levosulpiride…………………………100mg
Excipients…………………………q.s.
Colours: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Levosulpiride is used for the treatment of upper abdominal pain and bloating, nausea, vomiting, irritable bowel movement, irregular emptying of the stomach in diabetic patients, it is also used for the treatment of depression and schizophrenia in adults.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.