Enteric Coated Pantoprazole Sodium and Domperidone Sustained-release Capsules Technical Specification:
| Product Name: | Enteric Coated Pantoprazole Sodium and Domperidone Sustained-release Capsules |
| Brand Name: | Generic |
| Strength: | 40mg + 30mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| 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 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Enteric Coated Pantoprazole Sodium and Domperidone Sustained-release Capsules 40mg + 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
A. Enteric Coated Pantoprazole Sodium and Domperidone Sustained-release Capsules
Each Hard Gelatin Capsule Contains:
Pantoprazole Sodium USP
eq. to Pantoprazole ……………40mg
(As Enteric-coated Pellets)
Domperidone BP…………………30mg
(As Sustained-release Pellets)
Excipients……………………………Q.S.
Approved colours used in empty capsule shells and pellets.
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 capsule. Capsule should be swallowed whole with water.
STORAGE & DOSAGE:
STORAGE: Store in a dry place at a temperature below 30°C. Protect from light and moisture.
DOSAGE: As directed by the Physician.