Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium sesquihydrate)
KRKA d.d.
A02BC02
pantoprazole (pantoprazole sodium sesquihydrate)
20mg
tablets gastro-resistant
(7/1x7) in blister, (14/2x7) in blister, (14/1x14/) in blister
OTC
Registered
2018-11-27
1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet SmPCPIL112083_1 24.04.2018 – Updated: 24.04.2018 Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Nolpaza ® 20 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablets contains 20 mg pantoprazole as 22.55 mg pantoprazole sodium sesquihydrate. Excipient with known effect: - sorbitol (E420): 18 mg/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Gastro-resistant tablets are light yellowish brown, oval, slightly biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 20 mg pantoprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued. The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. _Special populations_ No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function. _Paediatric population_ Nolpaza is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. Method of administration Nolpaza 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal. 1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet SmPCPIL112083_1 24.04.2018 – Updated: 24.04.2018 Page 2 of 10 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is Прочитать полный документ