SPC Rabeprazole Sodium Tablet 20 mg

Adult dose

Gastric ulcer, duodenal ulcer: Typically, 10 mg of rabeprazole sodium is administered orally once daily to adults. Depending on symptoms, 20 mg can be taken orally once daily. Generally, treatment is for up to 8 weeks for gastric ulcer and up to 6 weeks for duodenal ulcer. Erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is given once daily for 4 to 8 weeks. If not resolved after 8 weeks of proton pump inhibitor therapy, an additional 8 weeks of 10 mg or 20 mg can be administered twice daily. However, 20 mg twice daily should only be given to patients with confirmed severe mucosal damage. Symptom relief in gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks of treatment, further evaluation is needed. Once symptoms have resolved, on-demand therapy with 10 mg once daily can be used for subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, 10 mg or 20 mg can be administered orally once daily. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this medication 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg orally once daily. The dosage can be adjusted up to 120 mg daily based on the individual patient's needs. Doses up to 100 mg may be taken as a single daily dose, while the 120 mg dose should be split into two doses of 60 mg each, taken twice daily. There have been experiences administering this medication to Zollinger-Ellison syndrome patients for up to one year. Patients with liver impairment: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. Children: Safety has not been established for pediatric patients. Elderly: Caution should be exercised as liver function may often be impaired.

This medication should not be used in patients who are allergic to certain components or have had hypersensitivity reactions. Additionally, pregnant or breastfeeding women should not take this medication. Patients with poor liver function or elderly patients should use this medication cautiously, and care should be taken if there have been past allergic reactions to medications. If symptoms of an allergic reaction such as skin rash or itching occur while taking this medication, usage should be discontinued immediately and healthcare personnel should be consulted. Regular blood tests and liver function tests are necessary, and if any abnormal findings are discovered, medication should be discontinued and appropriate measures taken. Symptoms related to the heart or blood pressure, digestive issues, and neurological symptoms may occur, so any such symptoms should be reported to a healthcare professional. This medication suppresses gastric acid secretion, and prolonged use may increase the risk of bone fractures, so caution is necessary for long-term use. Also, magnesium levels may decrease, so when used for long periods or in conjunction with certain medications, magnesium levels should be monitored regularly. The risk of gastrointestinal infections may slightly increase, so if diarrhea persists, immediate consultation with a healthcare professional is necessary. Caution should be exercised as drowsiness may occur when driving or operating machinery. There may be interactions with other medications, so it is essential to inform healthcare personnel of any current medications. This is especially important when used with antibiotics, antiviral agents, and anticoagulants. This medication should not be chewed or crushed and must be swallowed whole, and it should be kept out of reach of children. In case of overdose, there is no specific antidote, and appropriate treatment should be provided according to symptoms. Lastly, it is important to undergo regular examinations to check for adverse reactions when using this medication for a long time.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

• Rash
• itching
• decreased red blood cells
• decreased white blood cells
• increased white blood cells
• increased eosinophils
• increased neutrophils
• decreased lymphocytes
• anemia
• petechial hemorrhage

This medicine must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/AluAlu packaging x 2)