Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Rabeprazole Sodium
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
Rabeprazole Sodium
30 Tablets; 60 Tablets; 100 Tablets; 28 Tablets
LEK PHARMACEUTICALS D.D.
RABEPRAZOLE SANDOZ ® GASRTO- RESISTANT TABLETS 20MG Rabeprazole sodium (20mg) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET: 1. What Rabeprazole Sandoz is used for 2. How Rabeprazole Sandoz works 3. Before you use Rabeprazole Sandoz 4. How to use Rabeprazole Sandoz 5. While you are using it 6. Side effects 7. Storage and Disposal of Rabeprazole Sandoz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RABEPRAZOLE SANDOZ IS USED FOR Rabeprazole Sandoz is intended for: - Short-term (4 to 8 weeks) treatment in the healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD). For those people who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sandoz may be considered. - For maintaining healing and reduction in relapse rates of heartburn symptoms in people with erosive or ulcerative Gastroesophageal Reflux Disease (GERD maintenance). - Short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. - Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. - Symptomatic treatment of moderate to very severe GERD. - _Helicobacter pylori_ infection eradication to reduce the risk of duodenal ulcer recurrence in adults when used in combination with amoxicillin and clarithromycin as a three- medicine regimen. GERD is a long-term condition where acid from the stomach comes up in to the esophagus (tube connecting your mouth and stomach). HOW RABEPRAZOLE SANDOZ WORKS Rabeprazole Sandoz is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. BEFORE YOU USE RABEPRAZOLE SANDOZ - _When you must not use it _ Do not take Rabeprazole: - if you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (see section on ingredients). - if you are pregnant or breast feeding. PREGNANCY AND BREAST-FEEDING _Pregnancy _ There are no adequate information from Lestu allt skjalið
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Rabeprazole Sandoz ® Gastro-Resistant Tablets 20 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg of rabeprazole sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Rabeprazole Sandoz ® Gastro-Resistant Tablets 20 mg are yellow, round, biconvex, coated tablets containing 20 mg of rabeprazole sodium. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Healing of erosive or ulcerative gastroesophageal reflux disease (GERD) _ Rabeprazole Sandoz is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8 -week course of Rabeprazole Sandoz may be considered. _Maintenance of healing of erosive or ulcerative gastroesophageal reflux disease (GERD) _ Rabeprazole Sandoz is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD maintenance). _Healing of duodenal ulcers _ Rabeprazole Sandoz is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks. _Treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome _ Rabeprazole Sandoz is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. _Symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD) _ Rabeprazole Sandoz is indicated for the symptomatic treatment of moderate to very severe GERD. _Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in adults _ Rabeprazole Sandoz in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with _H Lestu allt skjalið