Omeprazole 20mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Omeprazole

Available from:

NorthStar Healthcare Unlimited Company

ATC code:

A02BC01

INN (International Name):

Omeprazole

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 05051089990459

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole 20mg hard gastro-resistant capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of omeprazole.
Excipient(s) with known effect:
•
Each 20mg capsule contains 102 to 116mg of sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard (gastro-resistant capsule).
Omeprazole 20 mg capsules: hard gelatine capsules with opaque
yellow
capsule containing off-white to cream-white spherical microgranules.
4.1 THERAPEUTIC INDICATIONS
_ _
Omeprazole capsules is indicated for in:
Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
•
In combination with appropriate antibiotics, _Helicobacter pylori_ (H.
pylori_) _
•
Eradication in peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in
patients at
risk
• Treatment of reflux esophagitis
• Long-term management of patients with healed reflux esophagitis
• Treatment of symptomatic gastro-esophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
_Children over 1 year of age and _
≥
_ 10 kg _
• Treatment of reflux esophagitis
•. Symptomatic treatment of heartburn and acid regurgitation in
gastro-
esophageal reflux disease
_ _
_Children and adolescents over 4 years of age _
• In combination with antibiotics in treatment of duodenal ulcer
caused by _H. _
_pylori _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults
_ _
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is
Omeprazole 20 mg once daily. In most patients healing occurs within
two
weeks. For those patients who may not be fully healed after the
initial course,
healing usually occurs during a further two weeks treatment period. In
patients
with poorly responsive duodenal ulce