Omeprazole Gastro-resistant Capsules BP 20mg Technical Specification:  

Product Name:Omeprazole Gastro-resistant Capsules BP 20mg
Brand Name:Prilosid
Strength:10mg, 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 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

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 colours 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 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 tight container. Keep in a cool & dry place. Protect from Light & 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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Omeprazole Gastro-resistant Capsules BP 10mg
B. Omeprazole Gastro-resistant Capsules BP 20mg
C. Omeprazole Gastro-resistant Capsules BP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Omeprazole Gastro-resistant Capsules BP 10mg
Each Hard Gelatin Capsules contains:
Omeprazole BP…………………...10mg
(As enteric coated granules)
Excipients…………………………...q.s.
Approved colours used in empty capsule shell.

B. Omeprazole Gastro-resistant Capsules BP 20mg
Each Hard Gelatin Capsules contains:
Omeprazole BP…………………...20mg
(As enteric coated granules)
Excipients…………………………...q.s.
Approved colours used in empty capsule shell.


C. Omeprazole Gastro-resistant Capsules BP 40mg
Each Hard Gelatin Capsules contains:
Omeprazole BP…………………...40mg
(As enteric coated granules)
Excipients…………………………...q.s.
Approved colours 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 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 tight container.
Keep in a cool & dry place.
Protect from Light & 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.