Vynex Omeprazole Capsule (Omeprazole Delayed-Release Granules)

Adult dose

1. Adults: 1) Gastric ulcer: Administer 20mg of omeprazole orally once daily. Healing occurs within 4 weeks in most patients, although healing time may vary in some patients. If healing is incomplete after the initial 4 weeks, continue treatment for another 4 weeks. In patients who have not responded to other medicines, administration of 40mg once daily generally results in healing within 8 weeks, although healing time may vary in some patients. Repeat treatment if the ulcer recurs. 2) Short-term treatment of duodenal ulcer: Administer 20mg per dose orally once daily. Healing occurs within 2 weeks in most patients, although healing time may vary in some patients. If healing is incomplete after the initial 2 weeks, continue treatment for another 2 weeks. In patients who have not responded to other medicines, administration of 40mg once daily generally results in healing within 4 weeks, although healing time may vary in some patients. Repeat treatment if the ulcer recurs. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): - Reflux esophagitis: Administer 20mg per dose orally once daily. Healing occurs within 4 weeks in most patients, although healing time may vary in some patients. If healing is incomplete after the initial 4 weeks, continue treatment for another 4 weeks. In patients who have not responded to other medicines, administration of 40mg once daily generally results in healing within 8 weeks, although healing time may vary in some patients. Repeat treatment if the condition recurs. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Administer 20mg per dose orally once daily. Treatment for 2～4 weeks is generally sufficient for healing. 4) Maintenance therapy for severe reflux esophagitis and poorly responsive peptic ulcers: Administer 20mg per dose orally once daily. If the condition recurs, the dose may be increased to 40mg per dose once daily. 5) Zollinger-Ellison syndrome: The initial dose is 60mg per dose 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; doses of 80mg or more per day should be divided into 2 doses. 6) Combination therapy with antibiotics to prevent recurrence of duodenal ulcers infected with Helicobacter pylori: - Dual therapy: Administer this medicine 20mg with amoxicillin 750 - 1000mg twice daily for 2 weeks. - Triple therapy: Administer this medicine 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 therapeutic 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 per dose orally once daily. Healing occurs within 4 weeks in most patients, although healing time may vary in some patients. If healing is incomplete after the initial 4 weeks, continue treatment for another 4 weeks. 8) Maintenance therapy to prevent gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAID administration in patients with a history of gastric or duodenal lesions who are receiving long-term NSAID treatment: Administer 20mg per dose orally once daily. 9) Prevention of recurrence of reflux esophagitis: Administer 10mg per dose orally once daily to prevent recurrence of reflux esophagitis. * Take this medicine whole with at least half a cup of water. Adjust the dose as appropriate according to age and symptoms.

This medication should not be used in patients with hypersensitivity to its components or in patients with gastric ulcers that may have a malignant tumor potential. Also, it should not be taken with certain antiviral agents, and patients with lactose intolerance or certain genetic conditions should avoid it. Dosing should be adjusted carefully in patients with impaired liver function or in the elderly. Various side effects such as headache, dizziness, gastrointestinal disturbances, and skin rashes may occur during treatment, so if abnormal symptoms arise, immediate consultation with healthcare personnel is necessary. Long-term use of this medication may increase the risk of fractures and cause metabolic disorders such as hypomagnesemia, so regular check-ups are required. If gastric cancer or other malignancies are suspected, confirmation through testing should be conducted before deciding on the use of this medication, and during long-term use, the minimum effective dose and appropriate duration should be observed. This medication has many interactions with other drugs, so healthcare providers must be informed of all concomitant medications, and co-administration with certain drugs is prohibited. Women who are pregnant or may become pregnant should make a careful decision regarding its use, and breastfeeding mothers should avoid taking it or discontinue breastfeeding. The safety of this medication in children has not been established, so caution should be exercised when administering it to children. In cases of overdose, symptoms such as vomiting, diarrhea, and headache may occur, and in such cases, immediate medical attention should be sought. This medication should be kept out of reach of children, not stored in a different container, and the cap should be tightly closed after use.

Headache, drowsiness, dizziness, insomnia, paresthesia, faintness, vertigo, confusion, agitation, aggression, hallucination, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, constipation, nausea, vomiting, abdominal pain, abdominal bloating, 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, vision impairment, taste disturbance, breast pain in females, 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 fundic polyps, hypocalcemia, hypokalemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, acute interstitial nephritis, nausea, apathy, depression, confusion

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1°C and 30°C. Storing it this way helps maintain its effectiveness.

Appearance

A brown hard capsule with a pink lower part, filled with pale yellow enteric-coated granules

Package unit

30 capsules/bottle