Formula Each film-coated tablet contains ranitidine hydrochloride equivalent to ranitidine base 150 mg and excipients q.s. (microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, film coating excipient).
Dosage form Film-coated tablets.
Presentation Box of 3 blisters x 10 film-coated tablets.
Indications - Duodenal ulcer, benign gastric ulcer. - Post-operative ulcer. - Chronic and discontinuous acid indigestion. - Ulcer due to non-steroidal anti-inflammatory drugs (NSAIDs). - Reflux oesophagitis. - Zollinger-Ellison syndrome.
Contra-indications Hypersensitivity to ranitidine.
Precautions - Patients with severe renal impairment, pregnant women and breast-feeding women. - Malignant ulcer should be removed before ranitidine therapy.
Drug interactions Antacids decrease the absorption of ranitidine. Ranitidine alters the bio-availability of dihydropyridine, nifedipine, metoprolol, glipizide, cefuroxime, ketoconazole.
Side effects Headache, dizziness, transient increase of liver enzymes in blood. Hypersensitivity reactions (urticaria, angioneurotic oedema, bronchospasm, hypotension) and leucopenia, thrombocytopenia are rare. The physician should be informed any side effects during the treatment with DUDINE.
Dosage and Administration - Duodenal ulcer, benign gastric ulcer: * 150 mg x 2 times daily or single bedtime dose of 300 mg. * Maintenance dose: 150 mg at bedtime. - Reflux oesophagitis: 150 mg x 2 times daily for not more than 8 weeks. - Zollinger-Ellison syndrome: * Initial dose: 150 mg x 3 times daily. * Severe disease: Dose may be increased to maximum of 6 g daily. - Chronic and discontinuous acid indigestion: 150 mg x 2 times daily for not more than 6 weeks. - Ulcer due to NSAIDs: 150 mg x 2 times daily for not more than 8-12 weeks.
Shelf-life 36 months.
Storage Store in a dry and cool place (below 25 C), protect from light. Keep out of reach of children.
Read leaflet carefully before use. For more information, consult your physician
|