OMEPRAZOLE Tablets Gastro-Resistant 20 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
OMEPRAZOLE
Available from:
Rowa Pharmaceuticals Limited
Dosage:
20 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Authorization date:
2009-06-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 20mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant, film-coated tablet contains 20mg omeprazole
Also contains Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-Resistant Tablet
White, round, gastro-resistant, film-coated tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole gastro-resistant tablets are indicated for:
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 ofNSAID-associated gastric and duodenal ulcers
•
Prevention ofNSAID-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 _2: _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 in 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 p
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