| Product Name: | Esomeprazole (EC) and Domperidone (SR) Capsules |
| Brand Name: | Generic |
| Strength: | 20mg+30mg, 40mg+30mg |
| Dosage Form: | Film-coated Oral Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-ulcer |
| Indication: | Domperidone+Esomeprazole is a combination of two medicines: Domperidone and Esomeprazole. This combination is used to treat acidity and heartburn or gastroesophageal reflux disease (GERD); a condition where the acid in the stomach flows back up into the food pipe (esophagus). |
| Storage: | Store in a cool & dry place below 25°C temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT
- Esomeprazole (EC) and Domperidone (SR) Capsules 20mg +30mg
- Esomeprazole (EC) and Domperidone (SR) Capsules 40mg +30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Esomeprazole (EC) and Domperidone (SR) Capsules 20mg +30mg
Esomeprazole Magnesium Trihydrate IP.
equivalent to Esomeprazole ……………20 mg.
(as enteric coated tablet)
Domperidone Maleate I.P.00
equivalent to Domperidone ……………30 mg
(as uncoated bilayered sustained release tablet)
Colors: Red Oxide of Iron and Titanium Dioxide LP
Approved colors used in hard gelatin capsule shell
- Esomeprazole (EC) and Domperidone (SR) Capsules 40mg +30mg
Esomeprazole Magnesium Trihydrate IP.
equivalent to Esomeprazole ……………40 mg.
(as enteric coated tablet)
Domperidone Maleate I.P.
equivalent to Domperidone ……………30 mg
(as uncoated bilayered sustained release tablet)
Colors: Red Oxide of Iron and Titanium Dioxide LP
Approved colors used in hard gelatin capsule shell
THERAPEUTIC INDICATIONS:
Domperidone+Esomeprazole is a combination of two medicines: Domperidone and Esomeprazole. This combination is used to treat acidity and heartburn or gastroesophageal reflux disease (GERD); a condition where the acid in the stomach flows back up into the food pipe (esophagus).
SCHEDULE:
SCHEDULE: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Store in in cool & Dry place. Protect from light & moisture
Dosage: As directed by the Physician.