LOPRAZ 20 MG GASTRO-RESISTANT CAPSULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
OMEPRAZOLE
Available from:
Teva Pharma B.V.
Dosage:
20 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Authorization date:
2010-11-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lopraz 20 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 20 mg of omeprazole.
Excipient: sucrose.
Each 20mg capsule contains 102 to 116mg of sucrose
For 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
Lopraz Capsules 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 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 16/03/2012_
_CRN 2109930_
_page number: 1_
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 20 mg once daily. I
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