Composition: Each tablet contains:
Rabeprazole sodium . . . . . . . . . . . . . . . .10 mg
Box of 3 blisters x 10 enteric film-coated tablets.
Active duodenal ulcer.
Active benign gastric ulcer.
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).
Benign gastric and duodenal ulcers: Combination with appropriate antibiotic therapy for Helicobacter pylori (H. pylori) eradication.
|Dosage and administration||
Hypersensitivity to rabeprazole, benzimidazole derivatives or any excipient of the drug.
|Warnings and precautions for use||
The possibility of malignancy should be excluded prior to commencing treatment with rabeprazole sodium for patients with gastric ulcer since rabeprazole can mask the symptoms and interfere with the diagnosis.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
Patients who drive or operate machinery should use rabeprazole with caution because it may cause headache, dizziness, drowsiness.
|Interactions, incompatibilities of medicine||
Co-administration of rabeprazole sodium with ketoconazole or itraconazole may reduce absorption of ketoconazole or itraconazole. Therefore, patients may need to be monitored when such drugs are taken concomitantly with rabeprazole to adjust the dosage appropriately.
|Undesirable effects (ADRs)||
The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature.
|Overdose and management||
Rabeprazole is a benzimidazole derivative, which acts as a proton pump inhibitor.
Absorption is rapid, with peak plasma levels of rabeprazole occurring approximately 3.5 hours after administration. Oral bioavailability is about 52% due to hepatic first-pass metabolism and are not significantly altered after the administration of single and multiple doses.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.