Esomeprazole (EC) & Itopride Hydrochloride (SR) Capsules Technical Specification:
| Product Name: | Esomeprazole (EC) & Itopride Hydrochloride (SR) Capsules |
| Brand Name: | Generic |
| Strength: | 40mg + 150mg |
| Dosage Form: | SR Capsules |
| 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: | Anti-ulcer, Proton Pump Inhibitor, gastroprokinetic agent |
| Indication: | To treat gastroesophageal reflux disease (acid reflux) and peptic ulcer disease |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Esomeprazole (EC) & Itopride Hydrochloride (SR) Capsules 40mg + 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Esomeprazole (EC) & Itopride Hydrochloride (SR) Capsules 40mg + 150mg
Each Hard Gelatin Capsule Contains:
Esomeprazole Magnesium Trihydrate BP
eq. to Esomeprazole …………………………40mg
(As enteric coated pellets)
Itopride Hydrochloride ..………………….150mg
(As sustained release pellets)
Excipients……………………………………………Q.S.
Approved colours used in empty capsule shells and pellets.
THERAPEUTIC INDICATIONS:
This medication is used in the treatment of gastroesophageal reflux disease (acid reflux), Heart burns and peptic ulcer disease.
CAUTION & WARNING:
Keep medicine out of reach of children.
SR Capsules should be swallowed whole; not to be opened, chewed or crushed.
To be sold by retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store below 30°C in cool and dry place. Protect from direct light & moisture.
Dosage: As directed by the Physician.