Medication info

Simetene Tablets (Cimetidine)

Prescription medicationTablet경구Expired
Ingredient · strength
Cimetidine›200mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Pale green round film-coated tablet
Packaging
500 tablets/bottle
Approval status
Expired

MFDS item code 201405796 · Approved 2014.12.08

This product's status changed to Expired on 2024.12.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of gastric and duodenal ulcers and gastric mucosal lesions (erosion, bleeding, etc.)
Who takes it
Adults · Children
Adult dose
Adults: Cimetidine as a single dose of 400 mg 2 times a day (morning and bedtime) or 800 mg once daily (at bedtime). Additionally, a single dose of 300 mg 4 times a day (after meals and at bedtime) can be administered. The dose can be increased up to 400 mg 4 times a day (after meals and at bedtime) (total 1.6 g). For acute gastritis and acute exacerbation of chronic gastritis, administer 200 mg 2 times a day or 400 mg once daily.
Child dose
Children: Administer divided doses of 20 to 40 mg per kg of body weight per day.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of gastric and duodenal ulcers and gastric mucosal lesions (erosion, bleeding, etc.)

  • Gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease
  • recurrent ulcer
  • anastomotic ulcer
  • Zollinger-Ellison syndrome
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute gastritis
View approved original text

This medication is used for various gastrointestinal disorders such as gastric ulcers, duodenal ulcers, gastroesophageal reflux disease, recurrent ulcers, anastomotic ulcers, and Zollinger-Ellison syndrome. It is also effective for improving gastric mucosal erosion, bleeding, redness, and swelling that occurs during acute exacerbations of acute gastritis and chronic gastritis. Therefore, this drug helps alleviate symptoms and promote recovery from various gastrointestinal disorders.

How to take

Adult dose

Adults: Cimetidine as a single dose of 400 mg 2 times a day (morning and bedtime) or 800 mg once daily (at bedtime). Additionally, a single dose of 300 mg 4 times a day (after meals and at bedtime) can be administered. The dose can be increased up to 400 mg 4 times a day (after meals and at bedtime) (total 1.6 g). For acute gastritis and acute exacerbation of chronic gastritis, administer 200 mg 2 times a day or 400 mg once daily.

Child dose

Children: Administer divided doses of 20 to 40 mg per kg of body weight per day.

Precautions

This drug contains the ingredient cimetidine and should not be used by certain patients. First, individuals who are allergic to this drug or have experienced hypersensitive reactions to its ingredients should not take it. Additionally, patients taking dofetilide, which can increase the risk of cardiac arrhythmias, should not use this drug. Patients with kidney or liver function issues should be cautious when using this drug. In cases of reduced kidney function, serum drug concentration may increase, necessitating a reduction in dose or an increase in dosing interval. Patients with liver dysfunction should also use this drug with caution. Patients with a history of drug allergies, the elderly, children under 19 years of age, and patients receiving hemodialysis should be particularly careful when using this drug. For hemodialysis patients, it is advisable to administer the medication after dialysis. As this drug may mask symptoms of gastric cancer, it should only be used after confirming that it is not a malignant condition. Patients with gastric or duodenal ulcers with Helicobacter pylori infection should also undergo treatment to eradicate the bacteria. Rarely, this drug may cause decreased blood cell counts, liver dysfunction, kidney problems, allergic reactions, endocrine disturbances, gastrointestinal symptoms, neurological symptoms, and skin reactions. If abnormalities are found in blood tests, administration should be stopped immediately, and appropriate treatment should be received. It is advisable to closely monitor the course of the illness while using this drug, and if there is no effect, consider switching to another treatment method. The elderly or those with chronic diseases may have an increased risk of pneumonia, so caution is necessary. This drug can interact with various other medications, and caution or dosage adjustment may be necessary when taken with warfarin, midazolam, diazepam, theophylline, etc. Pregnant or breastfeeding women should carefully consider the risks and benefits of using this drug, as the medication can be transmitted to breast milk, and it is advisable to discontinue breastfeeding. Overdose may result in serious side effects such as respiratory depression, and appropriate treatment should be sought immediately. This drug should be kept out of reach of children, and transferring it to another container is not recommended.

Side effects and when to seek care immediately

Serious side effects

General malaise, weakness, subcutaneous bleeding, mucosal bleeding, fever (blood system abnormal symptoms), jaundice, generalized rash, dyspnea, shock, anaphylactoid reaction, rash (hypersensitivity), consciousness disturbance, seizures, confusion (agitation, psychosis, depression, excitement, hallucinations, disorientation), Stevens-Johnson syndrome, toxic epidermal necrolysis, epidermal necrosis, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, elevated serum creatinine, agitation, psychosis, depression.

Mild side effects

  • Leukopenia
  • agranulocytosis
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • immune hemolytic anemia
  • hepatitis
  • elevated AST and ALT
  • liver dysfunction
  • interstitial nephritis
Show 18 more
  • acute renal failure
  • interstitial nephritis
  • urinary retention
  • elevated BUN
  • gynecomastia
  • excessive lactation
  • increased vaginal discharge
  • erectile dysfunction
  • abdominal bloating
  • constipation
  • diarrhea
  • headache
  • dizziness
  • limb numbness
  • drowsiness
  • hypochondriacal symptoms
  • weakness
  • bradycardia.

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

Storage

This drug should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is best to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication and ensure its safe use.

Appearance and packaging

Appearance

Pale green round film-coated tablet

Package unit

500 tablets/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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.