Shinil Omeprazole Capsule

Adult dose

◎ Adults 1) Gastric ulcer: Administer omeprazole 20mg orally once daily. Most ulcers may heal within 4 weeks, although the healing period may vary occasionally between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administration of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary occasionally between patients. Repeat treatment if recurrence occurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg orally once daily. Most ulcers may heal within 2 weeks, although the healing period may vary occasionally between patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. In patients who have not responded to other medications, administration of 40mg once daily usually results in healing within 4 weeks, although the healing period may vary occasionally between patients. Repeat treatment if recurrence occurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (such as heartburn and regurgitation): - Reflux esophagitis: Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary occasionally between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. In patients who have not responded to other medications, administration of 40mg once daily usually results in healing within 8 weeks, although the healing period may vary occasionally between patients. Repeat treatment if recurrence occurs. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (such as heartburn and regurgitation): Administer 20mg orally once daily. Treatment for 2～4 weeks is generally sufficient for healing. 4) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Administer 20mg orally once daily. If recurrence occurs, the dose may be increased to 40mg once daily. 5) Zollinger-Ellison syndrome: The initial dose is 60mg orally once daily. Continue treatment, adjusting the dose as appropriate for the individual patient. More than 90% of patients respond to doses of 20 - 120mg per day. If doses of 80mg or more per day are administered, divide the daily dose into 2 doses. 6) Antibiotic combination 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 gastric or duodenal ulcers or erosions caused by administration of nonsteroidal anti-inflammatory drugs (NSAIDs): Administer 20mg orally once daily. Most cases may heal within 4 weeks, although the healing period may vary occasionally between patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. 8) 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. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, administer 10mg 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 drug should not be used in patients with hypersensitivity to the ingredients or in patients with gastric ulcers that may be malignant. Caution is needed, particularly in malignant tumor patients, as symptom relief may delay diagnosis. Additionally, certain antiviral drugs cannot be co-administered, so patients must inform their healthcare provider about any medications they are taking. For patients with impaired liver function, the dosage should be adjusted as metabolism of this drug may be slowed, and it should be administered cautiously in elderly patients. Neurological symptoms such as headaches, drowsiness, dizziness may occur while taking this medication; in severe cases, hallucinations or confusion may rarely occur. Regular monitoring of liver enzyme levels is important as there may be liver function abnormalities. Gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain may commonly occur, and allergic reactions such as skin rash or itching may also appear. In rare cases, serious skin reactions or kidney disorders may occur; if any abnormal symptoms appear, medical consultation should be sought immediately. Long-term use may lead to an increased risk of fractures and metabolic disorders such as hypomagnesemia, necessitating regular check-ups. This medication suppresses gastric acid secretion, which may increase the number of bacteria in the stomach, slightly increasing the risk of gastrointestinal infections. Pregnant or breastfeeding women should use this medication cautiously, and breastfeeding mothers are advised to avoid its use if possible. Safety in children has not been established, so it is preferable to avoid use in children. In cases of overdose, symptoms such as vomiting, diarrhea, and headaches may occur, and in severe cases, changes in mental state may occur, warranting immediate hospital visit. This medication should be kept out of reach of children, and transferring to another container should be avoided; the container should be tightly closed after use.

Headache, drowsiness, dizziness, insomnia, paresthesia, feeling faint, lightheadedness, confusion, agitation, aggression, hallucinations, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, bowel movement, constipation, nausea, vomiting, abdominal pain, abdominal distension, dry mouth, stomatitis, gastrointestinal candidiasis, erythema, rash, urticaria, pruritus, 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, arthralgia, muscle weakness, myalgia, gynecomastia, cough, asthenia, malaise, peripheral edema, increased sweating, blurred vision, visual impairment, taste disturbance, mastalgia, breast lump, hyponatremia, erectile dysfunction, Clostridium difficile-associated diarrhea, hypomagnesemia, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia

This drug is susceptible to air and moisture, so it should be stored in a sealed container. It is also advisable to store it at room temperature, avoiding extremes of hot or cold.

Appearance

A hard capsule with an upper part of reddish-brown and a lower part of pink, filled with white to light brown enteric-coated granules.

Package unit

28 capsules/bottle, 100 capsules/bottle