BYSEC Capsules Gastro-Resistant 20 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
OMEPRAZOLE
Available from:
Ergha Healthcare Ltd
Dosage:
20 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Authorization date:
2005-05-13
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BySec 20 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule contains 20 mg of omeprazole.
Excipient: each capsule contains 52.40 mg of sucrose, methyl-p-hydroxybenzoate (E218) and propyl-p-
hydroxybenzoate (E216).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Opaque white capsule with imprint ‘20mg’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BySec 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 BySec 20 mg once daily. In most patients healing
occurs within two weeks. For those patients who may not be fully healed after the
Read the complete document
