Medication info
Lansomel Capsule 15 mg (Lansoprazole Granules)

Lansomel Capsule 15 mg (Lansoprazole Granules)

Prescription medicationHard capsuleOral
Ingredient · strength
Lansoprazole Granules›176.5mg / 1 capsule
Manufacturer / importer
Il Sung IS Co., Ltd.
Appearance
White to light brown granules in a hard capsule with a white upper and lower body
Packaging
28 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 202001364 · Approved 2020.02.26 · Insurance code 655404440

Summary

Main use
Treatment of gastric and duodenal ulcers (including eradication therapy), gastroesophageal reflux disease, and pathological gastric acid hypersecretion
Who takes it
Adults · Children
Adult dose
This medicine should be taken before meals. For patients who have difficulty swallowing the medicine, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and take immediately. To ensure the entire dose is taken, rinse the glass with twice as much juice or more and drink immediately. Do not chew or crush this medicine after opening the capsule. ○ Adults 1. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 1) Administer lansoprazole 30 mg with clarithromycin 250 ∼ 500 mg and amoxicillin 1,000 mg twice daily (every 12 hours) for 7 days. If necessary, treatment may continue for up to 14 days. 2) Administer lansoprazole 30 mg with amoxicillin 1,000 mg 3 times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. Comparative clinical trials did not exceed 12 months. 5. Treatment of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. Comparative clinical trials did not exceed 8 weeks. 6. Reduction of the risk of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. Comparative clinical trials did not exceed 12 weeks. 7. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks. 8. Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. 10. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The lansoprazole dosage for pathological hypersecretory conditions varies from patient to patient. Treatment is usually initiated in adults at 60 mg once daily. The dosage should be adjusted according to the patient's needs and may be continued for as long as it is clinically effective. Doses of 90 mg per dose up to twice daily have been administered. If the daily dose exceeds 120 mg, it should be divided. ○ Older adults Since clearance of this medicine is reduced in older adults, dosage adjustment is required. Do not exceed a daily dose of 30 mg. ○ Patients with hepatic impairment Use with caution, including dosage adjustment, in patients with hepatic impairment because metabolism and excretion of this medicine may be delayed.
Child dose
○ Children and adolescents aged 12 ∼ 17 years — Short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks ○ Children and adolescents aged 12 ∼ 17 years — Short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks ○ Children aged 1 ∼ 11 years, weighing 30 kg or less — Short-term treatment of symptoms associated with gastroesophageal reflux disease and erosive reflux esophagitis: 15 mg once daily for 12 weeks ○ Children aged 1 ∼ 11 years, weighing more than 30 kg — Short-term treatment of symptoms associated with gastroesophageal reflux disease and erosive reflux esophagitis: 30 mg once daily for 12 weeks

Ingredients

Manufacturer
Il Sung IS Co., Ltd.

Efficacy & effects

Treatment of gastric and duodenal ulcers (including eradication therapy), gastroesophageal reflux disease, and pathological gastric acid hypersecretion

  • Active duodenal ulcers
  • active benign gastric ulcers
  • duodenal ulcers
  • NSAID-induced gastric ulcers
  • symptoms related to gastroesophageal reflux disease
  • erosive esophagitis
  • Zollinger-Ellison syndrome
  • pathological hypersecretion conditions
View approved original text

This medicine is used for the short-term treatment of active duodenal ulcers and active benign gastric ulcers. Additionally, it helps to eradicate Helicobacter pylori to prevent the recurrence of duodenal ulcers. It is also used for maintenance therapy after treatment to effectively prevent recurrence. It is effective for the treatment of NSAID-induced gastric ulcers and reducing the risk of occurrence. It is also indicated for the short-term treatment and maintenance therapy of symptoms related to gastroesophageal reflux disease and erosive esophagitis. Finally, it helps to improve pathological hypersecretion conditions such as Zollinger-Ellison syndrome.

How to take

Adult dose

This medicine should be taken before meals. For patients who have difficulty swallowing the medicine, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and take immediately. To ensure the entire dose is taken, rinse the glass with twice as much juice or more and drink immediately. Do not chew or crush this medicine after opening the capsule. ○ Adults 1. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 1) Administer lansoprazole 30 mg with clarithromycin 250 ∼ 500 mg and amoxicillin 1,000 mg twice daily (every 12 hours) for 7 days. If necessary, treatment may continue for up to 14 days. 2) Administer lansoprazole 30 mg with amoxicillin 1,000 mg 3 times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. Comparative clinical trials did not exceed 12 months. 5. Treatment of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. Comparative clinical trials did not exceed 8 weeks. 6. Reduction of the risk of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. Comparative clinical trials did not exceed 12 weeks. 7. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks. 8. Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. 10. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The lansoprazole dosage for pathological hypersecretory conditions varies from patient to patient. Treatment is usually initiated in adults at 60 mg once daily. The dosage should be adjusted according to the patient's needs and may be continued for as long as it is clinically effective. Doses of 90 mg per dose up to twice daily have been administered. If the daily dose exceeds 120 mg, it should be divided. ○ Older adults Since clearance of this medicine is reduced in older adults, dosage adjustment is required. Do not exceed a daily dose of 30 mg. ○ Patients with hepatic impairment Use with caution, including dosage adjustment, in patients with hepatic impairment because metabolism and excretion of this medicine may be delayed.

Child dose

○ Children and adolescents aged 12 ∼ 17 years — Short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks ○ Children and adolescents aged 12 ∼ 17 years — Short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks ○ Children aged 1 ∼ 11 years, weighing 30 kg or less — Short-term treatment of symptoms associated with gastroesophageal reflux disease and erosive reflux esophagitis: 15 mg once daily for 12 weeks ○ Children aged 1 ∼ 11 years, weighing more than 30 kg — Short-term treatment of symptoms associated with gastroesophageal reflux disease and erosive reflux esophagitis: 30 mg once daily for 12 weeks

Precautions

This medication should not be administered to patients with allergies or hypersensitivity to certain ingredients. Pregnant or breastfeeding women should consult a doctor before using this medication. Patients with impaired liver function or elderly patients should use this medication with caution. There may be serious allergic reactions such as anaphylaxis, skin rash, or respiratory distress while taking this medication; if any unusual symptoms occur, stop using it immediately and consult a healthcare professional. Long-term use may lead to vitamin B12 deficiency, so regular testing is necessary. Since this medication inhibits gastric acid secretion, the risk of gastrointestinal infections may be slightly increased, and if symptoms like diarrhea or abdominal pain occur, they should be reported to a healthcare professional. As there may be interactions with other drugs, patients currently taking other medications should inform their healthcare provider. Particular caution is required when used in combination with certain antibiotics, HIV treatments, or anticoagulants, and it should be taken under the guidance of a specialist. Dizziness or drowsiness may occur, so caution is advised when driving or operating machinery. In the event of overdose, gastric lavage or symptomatic treatment may be required, and it should be stored out of the reach of children. Regular check-ups and observation by healthcare professionals are necessary for long-term use of this medication.

Side effects

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, generalized rash, facial swelling, dyspnea, shock, pancytopenia, agranulocytosis, hemolytic anemia, granulocytopenia, thrombocytopenia, anemia, jaundice, elevated AST, elevated ALT, toxic liver dysfunction, toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS syndrome, interstitial pneumonia, fever, cough, abnormal lung sounds, interstitial nephritis, acute renal failure, membranous colitis, bloody stool, abdominal pain, frequent diarrhea, headache, diarrhea, abdominal distension, allergic reaction, back pain, weakness, candidiasis, carcinoma, chills, chest pain, edema, fever, flu-like symptoms, halitosis, infection, lethargy, neck stiffness, pelvic pain, angina, arrhythmia, bradycardia, tachycardia, cerebrovascular accident, cerebral infarction, hypertension, hypotension, migraine, myocardial infarction, palpitations, shock, vasodilation, fainting, abnormal stool, enteritis, gastritis, gastrointestinal abnormalities, gastrointestinal diseases, gastrointestinal hemorrhage, loss of appetite, gastric stone, pyloric spasm, cholelithiasis, constipation, polydipsia, thirst, dyspepsia, dysphagia, belching, esophageal stricture, esophageal ulcer, esophagitis, stool discoloration, bloating, gastric nodule, gastric adenomatous polyp, gastroenteritis, upper gastrointestinal bleeding, hematemesis, increased appetite, increased salivation, rectal bleeding, stomatitis, tongue disorders, glossitis, gum bleeding, hypergastrointestinal motility, colitis, vomiting, nausea, gastric candidiasis, rectal disorders, rectal bleeding, diabetes mellitus, goiter, hypothyroidism, anemia, bleeding, lymphadenopathy, vitamin deficiency, gout, hyperglycemia, hypoglycemia, dehydration, weight gain, weight loss, peripheral edema, bone disease, joint disease, leg cramps, arthritis, arthralgia, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis, anxiety, amnesia, anxiety, apathy, confusion, depression, dizziness, fainting, hallucinations, hemiplegia, exacerbation of hostility, decreased libido, increased libido, neurosis, paresthesia, abnormal thinking, convulsions, dementia, depersonalization, diplopia, hyperactivity, hypertonicity, sensory loss syndrome, insomnia, sleep disorders, drowsiness, tremors, asthma, bronchitis, increased cough, epistaxis, hemoptysis, hiccups, pneumonia, upper respiratory tract infection, laryngeal tumor, pulmonary fibrosis, pharyngitis, pleural disorder, respiratory disorder, rhinitis, sinusitis, wheezing, acne, hair loss, pruritus, rash, urticaria, contact dermatitis, dry skin, nail disorders, skin cancer, skin diseases, sweating, abnormal vision, amblyopia, blepharitis, cataract, conjunctivitis, dry eyes, ear diseases, eye diseases, glaucoma, olfactory dysfunction, photophobia, retinal degeneration, loss of taste, blurred vision, deafness, eye pain, otitis media, taste disturbance, tinnitus, visual field narrowing, urination disorders, kidney pain, penile disorders, testicular disorders, urethral pain, polyuria, frequent urination, urinary retention, menstrual irregularities, chest tenderness, chest expansion, gynecomastia, diabetes, hematuria, erectile dysfunction, nephrolithiasis, hepatotoxicity, pancreatitis, taste abnormalities, aplastic anemia, thrombocytopenic purpura, eosinophilia, hypomagnesemia, Clostridium difficile-associated diarrhea, fracture, myositis, erythema multiforme, speech disorder, urinary retention, elevated ALP, elevated LDH, elevated γ-GTP, weakness, hyponatremia, elevated total cholesterol, decreased total cholesterol, tongue paralysis, lip paralysis, limb paralysis, abdominal pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White to light brown granules in a hard capsule with a white upper and lower body

Package unit

28 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.