Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RANITIDINE HYDROCHLORIDE
IMEKS PHARMA SDN. BHD.
RANITIDINE HYDROCHLORIDE
100Tablet Tablets; 50Tablet Tablets; 60 Tablet Tablets
Salutas pharma GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RANITIC ® TABLET Ranitidine hydrochloride (150mg) WHAT IS IN THIS LEAFLET 1. What Ranitic ® is used for 2. How Ranitic ® works 3. Before you use Ranitic ® 4. How to use Ranitic ® 5. While you are using it 6. Side effects 7. Storage and Disposal of Ranitic ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT RANITIC ® IS USED FOR Ranitic ® contains the active ingredient Ranitidine hydrochloride. Ranitic ® is used in: • Prevention and management of duodenal and stomach ulcers • Management of Zollinger – Ellison syndrome (a rare condition where the stomach produces very large amounts of acids) • Management of reflux oesophagitis (inflammation of oesophagus accompanied by the regurgitating of stomach acid) • Management of people at risk of stress – related ulceration HOW RANITIC ® WORKS Ranitidine hydrochloride belongs to a group of medicines called H 2 -receptor antagonist. Ranitidine works by reducing the amount of acid produced in the stomach, relieving the pain and allows the ulcers or reflux disease to heal. BEFORE YOU USE RANITIC ® _- When you must not use it_ • Have ever had any allergic reactions or been told that you are allergic to Ranitidine hydrochloride, the active ingredients or to any of the other ingredients listed in this leaflet. _- Before you start to use it_ Tell your doctor if you: • Have allergies to any other medicines, food, preservatives or dyes • Suffer from stomach cancer • Have any kidney disease • Suffer from acute porphyria (hereditary disorder that affect the nervous system) • Are pregnant, planning to become pregnant or are breastfeeding If you are not sure whether you should start taking this medicine, consult your doctor. _- Taking other medicines_ Some medicines and Ranitic ® may interfere with each other. It is important to tell your doctor or pharmacist if you are taking: • Sucralfate, used to treat ulcers • Procainamide or N-acetylprocainamide , Perskaitykite visą dokumentą
P LEASE READ CAREFULLY! DIRECTIONS FOR USE Ranitic ® 150 Film‐Coated Tablets DESCRIPTIONS RANITIC® 150 TABLET: Yellow, round, biconvex tablet with score notch on one side. Each tablet contains 150mg of ranitidine . INDICATIONS - Prophylaxis and management of duodenal and gastric ulcers - Management of Zollinger‐Ellison syndrome - Management of reflux oesophagitis - Management of patient at risk of stress related ulceration RECOMMENDED DOSAGES DUODENAL ULCER AND BENIGN GASTRIC ULCERS Take 150mg twice daily or 300mg at bedtime. Ulcer should heal within four weeks. In cases where the ulcer is not fully healed after four weeks, treatment should be continued for another four weeks. The usual dosage for long term management of duodenal ulcer and benign gastric ulcers is 150mg at bedtime. ZOLLINGER‐ELLISON SYNDROME The initial dosage regimen for Zollinger‐Ellison syndrome is 150mg three times a day, but this may be increased as necessary. Doses up to 6g/day have been reported as well tolerated. GASTRO‐OESOPHAGEAL REFLUX DISEASE Acute reflux Gastro‐oesophageal Take 150mg twice daily or 300mg at bedtime. Treatment should be continued for 8 weeks, or if necessary, up to 12 weeks MODERATE TO SEVERE GASTRO‐OESOPHAGEAL Take 150mg two to four times a day for up to 12 weeks. The recommended dosage for long term management of reflux oesophagitis is 150mg twice a day. STRESS RELATED ULCER Take 150mg twice a day. RENAL IMPAIRMENT For patients with creatinine clearance <50ml/min, daily dosage used should be 75mg (half of 150mg) twice daily. For patient with creatinine clearance >50ml/min, daily dosage used should be 150mg twice daily. Ranitidine is dialyzable. Therefore, with dialysis patient the recommended dose should be administered only after the dialysis. PAEDIATRIC In general, this patient group should not be treated with Ranitic® 150 tablet. The drug should be administered only in cases where the use of ranitidine is absolutely indicated, and should be restricted to short‐term treatment only. The daily dos Perskaitykite visą dokumentą