Nchi: Armenia
Lugha: Kiingereza
Chanzo: 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
(28/2x14/), in blisters
Prescription
Registered
2019-07-30
1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet SmPCPIL073379_2 02.02.2016 – Updated: 02.02.2016 Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT Nolpaza ® 20 mg gastro-resistant tablets Nolpaza ® 40 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mg gastro-resistant tablet contains 20 mg pantoprazole as 22.55 mg pantoprazole sodium sesquihydrate. Each 40 mg gastro-resistant tablet contains 40 mg pantoprazole as 45.10 mg pantoprazole sodium sesquihydrate. Excipient: Each 20 mg gastro-resistant tablet contains 18 mg sorbitol (E420). Each 40 mg gastro-resistant tablet contains 36 mg sorbitol (E420). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet Light yellowish brown, oval, slightly biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above_ - Symptomatic gastro-oesophageal reflux disease. - For long-term management and prevention of relapse in reflux oesophagitis. - Reflux oesophagitis _Adults_ - Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at high risk with a need for continuous NSAID treatment (see section 4.4). - Eradication of _Helicobacter pylori _(_H. pylori_) in combination with appropriate antibiotic therapy in patients with _H. pylori _associated ulcers. - Gastric and duodenal ulcers. - Zollinger-Ellison syndrome and other pathological hypersecretory conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water. _RECOMMENDED DOSE_ _ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_ CONFIDENTIAL Nolpaza gastro-resistant tablets 20 mg, 40 mg VOL: 1; P: 17 / 27 1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet SmPCPIL073379_2 02.02.2016 – Updated: 02.02.2016 Page 2 of 11 Symptomatic gastro-oesophageal reflux disease The recommended Soma hati kamili