OMEPRAZOLE TEVA 20MG, GASTRO-RESISTANT CAPSULES
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:
Teva Pharma B.V.
Dosage:
20 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Authorization date:
2010-10-29
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Teva 20mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 20 mg of omeprazole
Excipient: sucrose.
Each 20 mg capsule contains 102 to 116 mg of sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque yellow capsule containing off-white to cream-white spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Teva 20 mg gastro-resistant capsules is 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 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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/03/2012_
_CRN 2112710_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in adults
_Treatment of duodenal ulcers_
The recommended dose in pati
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