Ramep 20 Mg 28 Tablet

Product Description:

• Each gastro-resistant tablet contains 20 mg rabeprazole sodium.
• Proton-pump inhibitor.

How to use:

• Once-daily treatment Ramep tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance.
• Adults/Elderly
• Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on inpidual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require pided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
• Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended.

Ramep 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

Caution & Warnings:

• Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Ramep.
• Ramep is contra-indicated in patients with known hypersensitivity to the active substance or to any of the excipients.
• Ramep is contra-indicated in pregnancy and during breast-feeding.
• Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
• A risk of cross-hypersensitivity reactions with other proton pump inhibitors or substituted benzimidazoles cannot be excluded.
• Patients should be cautioned that Ramep tablets should not be chewed or crushed, but should be swallowed whole.
• There have been post-marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• Co-administration of atazanavir with Ramep is not recommended
• Treatment with proton pump inhibitors, including Ramep, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
• Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

Hypomagnesaemia

• Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like rabeprazole sodium for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

Concomitant use of Rabeprazole with Methotrexate

• Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.

Influence on vitamin B12 absorption

• Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a-chlorhydria. This should be considered in patients with reducedbody stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE)

• Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping Ramep. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Renal impairment

• Acute tubulointerstitial nephritis (TIN) has been observed in patients taking rabeprazole and may occur at any point during rabeprazole therapy.

Interference with laboratory tests

• Increased Chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, Ramep treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Ingredients:

• Each gastro-resistant tablet contains 20 mg rabeprazole sodium.

Product Details:

• Manufacturer: Ramep
• Product Form: Tablets
• Product Type: Tablets
• Quantity: 28 Tablets