Pantoprazole Sodium and Domperidone Tablets Technical Specification:
| Product Name: | Pantoprazole Sodium and Domperidone Tablets |
| Brand Name: | Generic |
| Strength: | 40mg + 30mg |
| Dosage Form: | Enteric coated Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Proton pump inhibitor, Anti-emetic |
| Indication: | To treat Gastroesophageal reflux disease & Peptic ulcer disease |
| Storage: | Store below 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Pantoprazole Sodium and Domperidone Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Pantoprazole Sodium and Domperidone Tablets
Each Enteric Coated Tablet Contains:
Pantoprazole Sodium USP
eq. to Pantoprazole ……………40mg
Domperidone BP…………………30mg
Excipients……………………………Q.S.
Colour: Yellow Oxide of Iron & Titanium Dioxide BP
THERAPEUTIC INDICATIONS:
This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD); a condition where the acid in the stomach flows back up into the esophagus.
CAUTION & WARNING:
Keep all medicines out of reach of children.
Do not chew or crush the tablet.
STORAGE & DOSAGE:
STORAGE: Store at a temperature below 25°C. Protect from light and moisture.
DOSAGE: As directed by the Physician.