País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LANSOPRAZOLE
John Wyeth & Brother Limited
30 Milligram
Capsules Gastro-Resistant
1994-11-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoton 30mg Gastro-resistant Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of lansoprazole Excipient(s): Each 30 mg capsule contains 59.8 mg of sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule. Opaque, lilac/purple, size 1 (elongated) gastro-resistant capsules, printed ‘Zoton’ and ‘30 mg’ in black ink. Each capsule contains white to off-white gastro-resistant spheroidal granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Treatment of duodenal and gastric ulcer o Treatment of reflux oesophagitis o Prophylaxis of reflux oesphagitis o Eradication of Helicobacter pylori (_H.pylori_) concurrently given with appropriate antibiotic therapy for treatment of _H.pylori_- associated ulcers o Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment o Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy o Symptomatic gastroesophageal reflux disease o Zollinger-Ellison syndrome 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For optimal effect, Zoton should be taken once daily in the morning, except when used for _H. pylori _eradication when treatment should be twice a day, once in the morning and once in the evening. Zoton should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid. For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease admi Leer el documento completo