Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lansoprazole
KRKA d.d.
A02BC03
lansoprazole
30mg
capsules
(14/2x7/) in blister
Prescription
Registered
2023-05-25
PI_Text051441_1 – Updated: Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT Lansoptol 30 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg lansoprazole. Excipient: 30 mg capsules sucrose 149.11 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule White capsules containing white to slightly brown or slightly pink pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lansoprazole is indicated in adults: - Treatment of duodenal and gastric ulcer. - Treatment and prophylaxis of reflux oesophagitis. - Eradication of _Helicobacter pylori_ (_H. pylori_) concurrently given with appropriate antibiotic therapy for treatment of _H.pylori_-associated ulcers. - Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment. - Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued NSAID treatment. - Symptomatic gastroesophageal reflux disease. - Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment of duodenal ulcer: The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another 2 weeks. Treatment of gastric ulcer: The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks. Reflux oesophagitis: CONFIDENTIAL Lansoptol capsules 30 mg VOL: 1; P: 7 / 29 PI_Text051441_1 – Updated: Page 2 of 12 The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. Prophylaxis of reflux oesophagitis: 15 mg once daily. The dose may be increased up to 30 mg daily as necessary. Eradication of _Helicobacter pylori:_ When selecting appropriate combination therapy, considerat Прочитать полный документ