البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
PAHANG PHARMACY SDN. BHD.
PANTOPRAZOLE SODIUM SESQUIHYDRATE
28Tablet Tablets
KRKA
1.3.1 Pantoprazole sodium sesquihydrate SPC, Labeling and Package Leaflet MY SmPCPIL160254_3 10.11.2020 – Updated: 25.01.2021 Page 1 of 10 NOLPAZA _Pantoprazole _ NAME OF THE MEDICINAL PRODUCT Nolpaza gastro-resistant tablets 40 mg PRODUCT DESCRIPTION AND COMPOSITION Each gastro-resistant tablet contains 40 mg pantoprazole as pantoprazole sodium sesquihydrate. The tablets are light brownish yellow, oval, slightly biconvex, film-coated tablets. Each gastro-resistant tablet contains 36 mg sorbitol (E420). DOSAGE FORM Oral Gastro-resistant tablet. THERAPEUTIC INDICATIONS - In combination with two appropriate antibiotics (see ,,Posology") for the eradication of Helicobacter pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism - Duodenal ulcer - Gastric ulcer - Moderate and severe cases of inflammation of the esophagus (reflux esophagitis). - Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions POSOLOGY AND METHOD OF ADMINISTRATION The following information applies unless Nolpaza 40 mg has been otherwise prescribed by your doctor. Please follow these instructions, as otherwise Nolpaza 40 mg may not have the desired effect! ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE Treatment of moderate and severe reflux oesophagitis_ _ One tablet of Nolpaza 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets Nolpaza 40 mg daily) especially when there has been no response to other treatment. ADULTS Eradication of H. pylori in combination with two appropriate antibiotics In cases of duodenal or gastric ulcer in which infection with Helicobacter pylori has been confirmed, the microorganism should be eradicated by combination treatment. Depending on the resistance pattern, the following combinations are recommended: a) Twice daily one tablet Nolpaza 40 mg gastro-resistant tablet + twice daily 1000 mg amoxicillin + twice daily_ _500 mg clarithromycin b) Twice daily one tablet Nolpaza 40 mg اقرأ الوثيقة كاملة