| Product Name: | Omeprazole Gastro-resistant Capsules BP 20mg |
| Brand Name: | Prilosid |
| Strength: | 20mg, 40mg |
| Dosage Form: | Capsules (Hard Gelatin) |
| Route Of Administration: | Via oral route |
| Packing: | 10s, 20s, 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics). |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Ulcer, proton-pump inhibitor |
| Indication: | It’s widely used to treat indigestion and heartburn, and acid reflux. |
| Storage: | Store below 25°C. Preserve in a tight container. Keep in a cool & dry place. Protect from Light & Moisture. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Omeprazole Gastro-resistant Capsules BP 20mg
- Omeprazole Gastro-resistant Capsules BP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Omeprazole Gastro-resistant Capsules BP 20mg
Each Hard Gelatin Capsules contains:
Omeprazole BP……………………20mg
(As enteric coated granules)
Excipients……………………………q.s.
Approved colors used in empty capsule shell. - Omeprazole Gastro-resistant Capsules BP 40mg
Each Hard Gelatin Capsules contains:
Omeprazole BP……………………40mg
(As enteric coated granules)
Excipients……………………………q.s.
Approved colors used in empty capsule shell.
THERAPEUTIC INDICATIONS:
Omeprazole capsules are used in
treatment of duodenal ulcers
prevention of relapse of duodenal ulcers
treatment of gastric ulcers
prevention of relapse of gastric ulcers
treatment of reflux esophagitis.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 3 years.
Treatment of symptomatic GERD.
Read the enclosed leaflet before use.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Keep medicine out of reach of children
STORAGE & DOSAGE:
Storage: Store below 25°C. Preserve in a tight container. Keep in a cool & dry place.
Protect from Light and moisture.
Do not freeze.
Dosage:
Recommended dose: 20mg orally once a day.
Duration of therapy: 4 weeks
Treatment of active duodenal ulcer
Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence.