Safety Advice
Contraindications:
Razo 20 mg: It is contraindicated in patients with known hypersensitivity to Rabeprazole, or to any of its components or to substituted benzimidazoles.
Razo 40 mg: Hypersensitivity to the active substance, or to any of the excipients. - Pregnancy, and - Breastfeeding.
Special Warnings and Precautions for Use:
Razo 20 mg: Patients on long-term treatment (> 1 year) should be kept under regular surveillance. Co-administration of Atazanavir with Rabeprazole is not recommended. Severe hypomagnesaemia has been reported in patients treated with PPIs like Rabeprazole for at least three months, and in most cases for a year. Concomitant use of PPIs with methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. It may reduce the absorption of vitamin B12 due to hypo- or a-chlorhydria.
Razo 40 mg: 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 Rabeprazole. 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.
Use in specific populations: pregnancy: It is contraindicated during pregnancy.
Breast-feeding: It is not known whether Rabeprazole sodium is excreted in human breast milk. No studies on lactating women have been performed. Rabeprazole sodium is however, excreted in rat mammary secretions. Therefore, Rabeprazole 40mg enteric coated tablet must not be used during breastfeeding.
Use in Children: Rabeprazole tablets are not recommended for use in children due to a lack of data on safety and efficacy.
Paediatric population: Rabeprazole tablets are not recommended for use in children due to a lack of data on safety and efficacy.
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
For the use of a Registered Medical Practitioner, Hospital or Laboratory only. Images appearing herein are for illustration purposes only.
Please refer to the product label for more information
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