Osera Capsule (Omeprazole)

Adult dose

1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most cases can be healed within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to treatment with other agents, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the condition recurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most cases can be healed within 2 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to treatment with other agents, administration of 40mg once daily generally results in healing within 4 weeks, although the healing period may vary from patient to patient. Repeat treatment if the condition recurs. 3) Reflux esophagitis: Administer 20mg orally once daily. Most cases can be healed within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to treatment with other agents, administration of 40mg once daily generally results in healing within 8 weeks, although the healing period may vary from patient to patient. Repeat treatment if the condition recurs. 4) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment with the dose adjusted as appropriate for the individual. More than 90% of patients respond to doses of 20 - 120mg per day. If doses above 80mg per day are administered, divide the dose into 2 doses per day. 5) Maintenance treatment of severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. If the condition recurs, the dose may be increased to 40mg once daily. 6) Concomitant antibiotic therapy to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this drug 20mg and amoxicillin 750 - 1000mg twice daily for 2 weeks. - Triple therapy: Administer this drug 40mg once daily or 20mg twice daily in combination with the following antibiotics. ① Administer clarithromycin 250mg and metronidazole 400mg twice daily for 1 week, or ② Administer amoxicillin 1g and clarithromycin 500mg twice daily for 1 week. If the treatment effect is insufficient, omeprazole monotherapy may be continued. 7) Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg orally once daily. Healing is generally possible after 2-4 weeks of treatment. 8) Treatment of gastric or duodenal ulcers or erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases can be healed within 4 weeks, although the healing period may vary from patient to patient. If healing is not achieved after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 9) Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID administration in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Administer 20mg orally once daily. * Swallow this drug whole with at least half a glass of water. Adjust the dose as appropriate according to age and symptoms.

This medication should not be administered to certain patients. First, individuals with an allergy to any of its components should not take it. Second, patients with gastric ulcers who may have malignant tumors should be cautious as the medication might mask symptoms or delay diagnosis. Third, it should not be combined with the drug atazanavir. Fourth, patients taking rilpivirine should not take this medication together. Fifth, patients with lactose intolerance or genetic lactose metabolism disorders should avoid this medication due to the lactose it contains. Patients with poor liver function or elderly individuals should take this medication cautiously. In particular, those with severe liver impairment should take a reduced dose, ensuring it does not exceed 20mg per day. While taking this medication, various side effects may occur. For example, neurological symptoms such as headaches, drowsiness, dizziness, and insomnia can occur frequently. As it may cause liver function abnormalities, discontinuation is necessary if enzyme levels increase. Gastrointestinal side effects may include diarrhea, constipation, nausea, and abdominal pain. Skin reactions such as rashes and itching, or in rare cases, serious skin reactions may occur, and if symptoms worsen, medication should be stopped immediately. Allergic reactions, such as angioedema or anaphylaxis, may rarely occur. Additionally, various side effects have been reported, including arrhythmias, reduction in blood cells, myalgia, gynecomastia, and visual disturbances. Regular check-ups are required when taking this medication for long periods, especially if taken for more than a year, as there may be an increased risk of fractures. Periodic checks for magnesium levels are also needed as hypomagnesemia may occur. This medication may interact with other drugs, so particularly with warfarin, diazepam, phenytoin, cyclosporine, and methotrexate, it should be taken according to a doctor’s instructions. It must not be combined with atazanavir or rilpivirine, and caution is required when taken with certain antibiotics. Women who are pregnant or may become pregnant should carefully weigh the benefits and risks when using this medication, whereas breastfeeding women should ideally avoid it or discontinue breastfeeding while using it. The safety in children has not been sufficiently established, and its use is not recommended. In case of overdose, symptoms such as nausea, vomiting, dizziness, abdominal pain, diarrhea, and headaches may occur, and if severe symptoms arise, immediate medical attention must be sought. This medication should be kept out of the reach of children, not transferred to another container, and must be securely capped after use to maintain its integrity. Lastly, animal studies have reported a risk of tumors in the stomach with long-term use, so it is advisable to use this medication only for the minimum necessary duration.

Headache, drowsiness, dizziness, insomnia, paresthesia, fainting sensation, vertigo, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, abdominal pain, constipation, nausea, vomiting, abdominal pain, abdominal bloating, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticaria, itching, dermatitis, vesicular rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity, alopecia, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, chest pain, tachycardia, bradycardia, palpitations, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, back pain, joint pain, muscle weakness, myalgia, gynecomastia, cough, asthenia, fatigue, peripheral edema, increased sweating, blurred vision, visual impairment, taste disturbance, breast pain, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyp

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the efficacy and safety of the medication.

Appearance

An upper reddish-brown, lower pink hard capsule filled with pale yellow enteric-coated granules

Package unit

28 capsules/bottle