SPC Rabeprazole Sodium 10mg (Rabeprazole Sodium)

Adult dose

Gastric ulcer, duodenal ulcer: Usually, administer 10 mg orally once daily as rabeprazole sodium to adults. Depending on symptoms, 20 mg can be taken orally once daily. Generally, treatment lasts for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily for 4 to 8 weeks. If treatment is not successful after 8 weeks, further treatment may be needed.

This medication should not be used by patients who have an allergy to specific components or have a history of hypersensitivity to this medication or similar drugs. Especially, patients with allergies to penicillin or macrolide antibiotics, as well as those taking certain heart-related medications, should avoid this medication. It is safest not to use this medicine in pregnant or breastfeeding women. Caution is needed when using this medication in patients with poor liver function, elderly patients, and those with a history of drug allergies. If symptoms of allergy, such as rash or itching, occur during the medication, it should be discontinued immediately. Regular blood tests and liver function tests should be conducted, and if abnormalities are found, appropriate measures should be taken. Various side effects may appear in the heart, gastrointestinal, nervous system, skin, respiratory system, muscles, and bones, so medical consultation should be sought if symptoms occur. Long-term use of this medication may increase the risk of side effects such as osteoporosis or hypomagnesemia, thus periodic testing is necessary and supplementation may be required if needed. This medication suppresses gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract; therefore, if diarrhea persists, diagnosis and treatment are needed. Caution is warranted when driving or operating machinery due to potential drowsiness. There could be interactions with other medications, so particularly when taking antibiotics, anticoagulants, antifungals, immunosuppressants, etc., medical professionals should be informed, and dose adjustment or monitoring may be necessary. This medication should be swallowed whole in tablet form and not chewed or crushed, and should be stored out of reach of children. It should not be used during pregnancy or breastfeeding, and elderly patients should be cautious due to the possibility of side effects from decreased liver function. Safety in pediatric patients has not been established; thus, it is advisable not to use it. There is no specific antidote for overdose, so appropriate treatment should be administered according to symptoms. Long-term use of this medication may mask malignant tumor symptoms, so regular monitoring of the condition is required.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, migraine, seizures, confusion of consciousness, visual impairment, paralysis, severe edema, urinary disturbances, pulmonary embolism, acute interstitial nephritis, anaphylaxis, shock, angioedema, systemic allergic reactions, interstitial pneumonia, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, sudden death, coma, high ammonia levels

Mild side effects

• Rash
• itching
• decreased red blood cells
• decreased white blood cells
• increased white blood cells
• eosinophilia
• neutrophilia
• decreased lymphocytes
• anemia
• petechiae

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to maintain the efficacy and safety of the medication.

Appearance

Light yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/AluAlu packaging x 2)