LOPRAZ 20 MG GASTRO-RESISTANT CAPSULES, HARD
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
OMEPRAZOLE
Available from:
Universal Farma S.L.
Dosage:
20 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Authorization date:
2003-11-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lopraz 20 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg omeprazole
Excipients: Contains sucrose, see section 4.4
-Each 20mg omeprazole capsule contains 102 to 116mg of sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard
Opaque yellow capsule containing off-white to cream-white enteric coated 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_
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 Lopraz 20 mg once daily. In most patients healing
occurs within two weeks. For those patients who may not be fully healed after
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