Rabeprazole sodium EC & Levosulpiride SR capsule is indicated in management of GERD.

Rabeprazole (20 mg) + Levosulpiride SR (75 mg) to be taken once daily before meal.

Hypersensitivity to the active substance or to any of the excipients. Epilepsy, Pheochromocytoma, manic states, Hyperprolactinaemias, Porphyria, Mammary dysplasia, Malignant mastopathies, Cardiac impairment, Pregnancy and lactation. 

Symptomatic response to therapy with PPIs does not preclude the presence of gastric malignancy. Patients treated with a proton pump inhibitor and warfarin may need to be monitored for increase in INR and prothrombin time due to risk of abnormal bleeding. Long-term and multiple daily dose PPI therapy may be associated with an increased
risk for osteoporosis-related fractures of the hip, wrist or spine. Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Patient may experience drowsiness, dizziness and dyskinesia with the use of Levosulpiride; hence patients under treatment should be advised to avoid driving vehicles or operation machinery. Levosulpiride should not be used when stimulation of gastrointestinal motility could be harmful, e.g., in the presence of gastrointestinal bleeding, mechanical obstruction or perforation. Cautious use is advised in patients with cardiovascular disease or a family history of QT prolongation. Concomitant use of alcohol should be avoided. Levosulpiride should be used with caution in patients with risk factors for stroke. During treatment with antipsychotic drugs, potentially fatal complex symptoms called “Neuroleptic Malignant Syndrome” (NMS) have been reported. Avoid concomitant therapy with other neuroleptics.

The most common side effects are diarrhea, nausea, vomiting, constipation, rash and headaches. Dizziness, nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, water retention and Acute Kidney Injury rarely occur. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated. Adverse effects reported with Levosulpiride include drowsiness, amenorrhoea, gynaecomastia, galactorrhoea, change in libido. Serious side effects include neuroleptic malignant syndrome, drug-induced movement disorders.