Opzel Capsule (Omeprazole)

Adult dose

Adults: 1) Gastric ulcer: Take 1 capsule (20mg) of omeprazole once daily. Most ulcers may heal within 4 weeks, although the healing time may vary among patients. If healing is incomplete after the first 4 weeks, continue treatment for an additional 4 weeks. In patients who have not responded to other preparations, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. If the ulcer recurs, repeat treatment. 2) Short-term treatment of duodenal ulcer: Take 1 capsule (20mg) once daily. Most ulcers may heal within 2 weeks, although the healing time may vary among patients. If healing is incomplete after the first 2 weeks, continue treatment for an additional 2 weeks. In patients who have not responded to other preparations, taking 2 capsules (40mg) once daily generally results in healing within 4 weeks, although the healing time may vary among patients. If the ulcer recurs, repeat treatment. 3) Treatment of reflux esophagitis and symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Reflux esophagitis: Take 1 capsule (20mg) once daily. Most cases may heal within 4 weeks, although the healing time may vary among patients. If healing is incomplete after the first 4 weeks, continue treatment for an additional 4 weeks. In patients who have not responded to other preparations, taking 2 capsules (40mg) once daily generally results in healing within 8 weeks, although the healing time may vary among patients. If the condition recurs, repeat treatment. - Treatment of symptoms of gastroesophageal reflux disease (GERD) (heartburn, regurgitation, etc.): Take 1 capsule (20mg) once daily. Treatment for 2-4 weeks generally results in healing. 4) Maintenance therapy for severe reflux esophagitis and peptic ulcers that are difficult to treat: Take 1 capsule (20mg) once daily. If the condition recurs, the dose may be increased to 2 capsules (40mg) once daily. 5) Zollinger-Ellison syndrome: The initial dose is 3 capsules (60mg) once daily. Continue treatment with the dose adjusted appropriately for the individual patient. More than 90% of patients respond to doses of 1-6 capsules (20-120mg) per day. If taking 4 capsules (80mg) or more per day, divide the daily dose into 2 doses. 6) Antibiotic combination therapy to prevent recurrence of duodenal ulcer infected with Helicobacter pylori: - Dual therapy: Take 1 capsule (20mg) of this drug with 750-1000mg of amoxicillin twice daily for 2 weeks. - Triple therapy: Take 2 capsules (40mg) of this drug once daily or 1 capsule (20mg) twice daily in combination with the following antibiotics. ① Take clarithromycin 250mg and metronidazole 400mg twice daily for 1 week, or ② Take 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 nonsteroidal anti-inflammatory drugs (NSAIDs): Take 1 capsule (20mg) once daily. Most cases may heal within 4 weeks, although the healing time may vary among patients. If healing is incomplete after the first 4 weeks, continue treatment for an additional 4 weeks. 8) Maintenance prevention of gastric or duodenal ulcers or erosions and dyspeptic symptoms caused by NSAIDs in patients receiving long-term NSAID treatment who have a history of gastric or duodenal lesions: Take 1 capsule (20mg) once daily. 9) Prevention of recurrence of reflux esophagitis: To prevent recurrence of reflux esophagitis, take 1/2 capsule (10mg) once daily. * Swallow this drug whole with at least half a cup of water. Adjust the dose appropriately according to age and symptoms.

This medication should not be administered to certain patients. First, patients with an allergic reaction to this medication or hypersensitivity to its components should not use it. Second, it should not be given to patients with gastric ulcers who have a possibility of malignant tumors, as it may alleviate symptoms and delay cancer diagnosis. Third, proton pump inhibitors, including this medication, should not be used in conjunction with certain antiviral agents such as atazanavir and should not be combined with drugs containing rilpivirine. Patients with poor liver function or the elderly should use this medication cautiously. Especially in patients with severely impaired liver function, daily dosage should be limited, and careful monitoring is needed due to the possibility of liver function abnormalities. This medication can cause various side effects. Neurological symptoms such as headaches, drowsiness, dizziness, and insomnia may occur commonly, while serious psychiatric symptoms like confusion, hallucinations, and depression can rarely occur. There may be increases in liver enzyme levels or severe liver diseases like hepatitis or liver failure; if abnormal symptoms arise, administration should be stopped immediately. It can also affect the kidneys, and nephritis can rarely occur. Gastrointestinal symptoms such as diarrhea, constipation, nausea, and abdominal pain are commonly reported, and dry mouth or stomatitis can also occur. Skin rashes, itching, and in severe cases, serious skin reactions like Stevens-Johnson syndrome may occur, necessitating immediate cessation of the medication if symptoms develop. Allergic reactions like angioedema, fever, bronchospasm, and anaphylactic shock may occur rarely. Cardiac symptoms may include chest pain, rapid heart rate, and irregular heartbeats. Hematological abnormalities such as leukopenia and thrombocytopenia have been reported rarely, and muscle pain or joint pain may also occur. In women, gynecomastia or breast pain may develop. Long-term use of this medication may lead to electrolyte imbalances such as hypomagnesemia, and diarrhea due to infection with Clostridium difficile may rarely occur, so caution is required. This medication inhibits gastric acid secretion, which may lower gastric acidity, hindering the absorption of certain drugs. Caution is warranted when used with medications such as warfarin or phenytoin, and close monitoring of blood concentration is necessary. Additionally, some antibiotics used in conjunction with this medication are used for eradication therapy for Helicobacter pylori, so the instructions for their use should be carefully followed. Women who are pregnant or may become pregnant should make careful decisions regarding the use of this medication, considering the risks to the fetus. Women who are breastfeeding should avoid using this medication if possible, or discontinue breastfeeding, as it may be excreted into breast milk. The safety in pediatric patients has not been sufficiently established; therefore, it is advisable not to use it in children. In the case of overdose, symptoms such as vomiting, diarrhea, headaches, and confusion may appear, but most are transient, and severe outcomes have been reported infrequently. This medication should be stored out of reach of children, and it should not be transferred to another container; ensure the bottle cap is securely closed after use. Finally, long-term use of this medication may increase the risk of polyps in the stomach; hence, it should only be used at the minimum effective dose for an appropriate duration, and patients should be monitored closely during treatment.

Headache, drowsiness, dizziness, insomnia, paresthesia, faintness, vertigo, confusion, excitement, aggression, hallucination, depression, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, interstitial nephritis, diarrhea, bowel movement changes, 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, eosinophilia, drug reaction with systemic symptoms, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp, hypocalcemia, hypokalemia, alleviation of malignant tumor symptoms, delayed diagnosis, nausea, apathy

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Domestic: A hard capsule with the upper part being dark brown and the lower part pink, filled with a pale yellow enteric-coated granule. Export: A hard capsule with the upper part dark brown and the lower part pink, filled with white to grayish-white enteric-coated granules.

Package unit

Domestic: 30 capsules/bottle, 100 capsules/bottle Export: 100 capsules (10 capsules/PTP × 10)