Labela Tablet 20 mg (Rabeprazole Sodium)

Adult dose

For gastric ulcer and duodenal ulcer: Administer 10 mg orally once daily, and based on symptoms, may increase to 20 mg orally once daily. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily for 4 to 8 weeks. If treatment is not effective after 8 weeks of proton pump inhibitors, the dose of 10 mg or 20 mg may be administered orally twice daily for an additional 8 weeks. For symptoms of gastroesophageal reflux disease, administer 10 mg once daily. If symptoms are not controlled after 4 weeks of treatment, further evaluation is necessary. After symptoms resolve, on-demand therapy with 10 mg once daily may be used to manage any subsequent occurrences. For long-term maintenance therapy of gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should receive eradication therapy. It is recommended to co-administer this medication (20 mg) with clarithromycin (500 mg) and amoxicillin (1 g) twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg once daily according to individual patient needs. Doses of 100 mg may be administered once daily, while 120 mg should be divided into two doses of 60 mg. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. The use in patients with liver disease should be approached with caution, as adverse reactions related to hepatic encephalopathy have been reported in cirrhotic patients. The safety in children has not been established. Caution should be taken in elderly patients as they often experience decreased liver function.

This medication should not be administered to patients with hypersensitivity to specific ingredients or those who have experienced allergic reactions. Additionally, pregnant or nursing women should not use this medication. Patients with hepatic impairment or elderly patients should use this medication with caution, and patients with a history of drug hypersensitivity should also be careful. This medication can cause various side effects; if symptoms like skin rash or itching occur, use should be stopped immediately. Regular blood tests and liver function tests should be conducted, and appropriate measures taken if abnormal signs are detected. Side effects may occur in various body systems including cardiovascular, gastrointestinal, neurological, respiratory, musculoskeletal, skin, eyes, and urinary systems, so patients should be aware of symptoms. Prolonged use of this medication may increase the risk of fractures and lead to electrolyte imbalances like hypomagnesemia. This medication suppresses gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract; therefore, if symptoms like diarrhea continue, consult with a healthcare professional. Caution is necessary as drowsiness may occur while driving or operating machinery. There is potential for interaction with other medications; if taking other medications, it is essential to inform and consult with healthcare professionals. Caution is especially required when used in combination with antibiotics or antiviral drugs, as concurrent use is prohibited with some medications. This medication should be swallowed whole and not chewed or crushed, and it should be stored out of reach of children. If any unusual symptoms occur during use, it is important to stop taking the medication and consult with healthcare professionals.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, fever, interstitial pneumonia, hepatitis, jaundice, fulminant hepatitis, liver dysfunction, hepatic encephalopathy, myocardial infarction, fainting, angina, pulmonary embolism, ventricular tachycardia, thrombophlebitis, toxic epidermal necrolysis (Lyell's syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), severe neurological symptoms (headache, seizures, confusion, visual disturbances, paralysis), acute interstitial nephritis, sudden death.

Mild side effects

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

Pale yellow, round enteric-coated tablet

Package unit

28 tablets (14 tablets/AluAlu packaging x 2)