Medication info

Simetidin Tablet (Cimetidine)

Prescription medicationTabletExpired
Ingredient · strength
Cimetidine›200mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pale green-green round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 1000 tablets/bottle
Approval status
Expired

MFDS item code 201905607 · Approved 2019.08.08

This product's status changed to Expired on 2024.08.08. 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 (erosions, bleeding, etc.)
Who uses it
Adults · Children
Adult dosage
Adults: Administer Cimetidine as a single dose of 400 mg twice daily (morning, bedtime) orally, or 800 mg once daily (bedtime). Additionally, administer 300 mg four times daily (after meals, at bedtime) orally. The dose may be increased to 400 mg four times daily (after meals, at bedtime) (total 1.6 g). For improvement of gastric mucosal lesions: In cases of acute gastritis and acute exacerbation of chronic gastritis, administer 200 mg twice daily.
Children's dosage
Children: Administer orally in divided doses of 20-40 mg per kg of body weight per day.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

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

This medication is used for the treatment of various gastrointestinal related diseases including gastric ulcers, duodenal ulcers, gastroesophageal reflux disease, recurrent ulcers, anastomotic ulcers, and Zollinger-Ellison syndrome. It is also effective in improving gastric mucosal lesions such as erosions, bleeding, redness, and swelling that occur during acute exacerbations of acute gastritis and chronic gastritis. This drug helps protect the gastric mucosa and heals damaged areas, aiding in the restoration of gastric health. It plays an important role in alleviating discomfort caused by gastrointestinal diseases and preventing recurrence. Therefore, it is used for the effective management and treatment of gastrointestinal diseases.

Dosage and Administration

Adult dosage

Adults: Administer Cimetidine as a single dose of 400 mg twice daily (morning, bedtime) orally, or 800 mg once daily (bedtime). Additionally, administer 300 mg four times daily (after meals, at bedtime) orally. The dose may be increased to 400 mg four times daily (after meals, at bedtime) (total 1.6 g). For improvement of gastric mucosal lesions: In cases of acute gastritis and acute exacerbation of chronic gastritis, administer 200 mg twice daily.

Children's dosage

Children: Administer orally in divided doses of 20-40 mg per kg of body weight per day.

Precautions

This medication contains the ingredient cimetidine and is used to inhibit gastric acid secretion for the treatment of peptic ulcers or gastroesophageal reflux disease. This drug should not be administered to patients with allergic reactions to cimetidine or other ingredients, or those at risk of specific cardiac arrhythmias. Additionally, patients with lactose intolerance or hereditary glucose absorption disorders should avoid taking this medication. Patients with impaired renal or liver function, elderly patients, individuals under 19 years of age, and patients undergoing dialysis should use this medication with caution, and may require dosage adjustments or longer dosing intervals. During the course of this medication, it is important to regularly conduct blood tests, liver function tests, and kidney function tests to detect any adverse reactions early. Various side effects may occur such as decreased blood cell counts, hepatitis, elevated AST and ALT, interstitial nephritis, urinary retention, increased BUN, gynecomastia, excessive milk secretion, increased vaginal discharge, erectile dysfunction, abdominal bloating, constipation, diarrhea, headaches, dizziness, limb numbness, stiffness, drowsiness, hypochondriac symptoms, and weakness. Particular attention is needed as neurological abnormal symptoms such as confusion or seizures can occur especially in elderly patients or those with renal failure. This medication may interact with various other drugs, so it is crucial to inform healthcare professionals if you are taking other medications as some may require dose adjustments. Women who are pregnant or nursing should carefully consider the impact of this medication on the fetus or newborn, and it is recommended to discontinue breastfeeding while taking this medication. In case of overdose, serious symptoms such as respiratory depression may occur, and immediate emergency treatment should be sought. Keep this medication out of reach of children, and do not change the container.

Side effects and when to seek care immediately

Serious side effects

  • General malaise, weakness, subcutaneous hemorrhage, mucosal hemorrhage, fever (early signs of blood system abnormalities)
  • Jaundice, hepatic dysfunction
  • Fever, abnormal kidney function tests (elevated BUN, creatinine level, etc.)
  • Shock, anaphylactic-like reactions, respiratory distress
  • Altered consciousness, convulsions
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, epidermal necrosis, erythema multiforme, exfoliative dermatitis, generalized exfoliative erythema edema
  • Respiratory depression accompanied by cyanosis of the lips

Mild side effects

  • Leukopenia
  • granulocytopenia
  • agranulocytosis
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • immune hemolytic anemia
  • hepatitis
  • elevation of AST and ALT
  • hepatic fibrosis
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  • interstitial seizures
  • acute renal failure
  • interstitial nephritis
  • urinary retention
  • increased BUN
  • gynecomastia
  • hyperlactation
  • increased vaginal discharge
  • erectile dysfunction
  • abdominal bloating
  • constipation
  • diarrhea
  • headache
  • dizziness
  • limb numbness
  • stiffness
  • drowsiness
  • hypochondriac symptoms
  • weakness
  • nausea

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

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it is important to maintain a room temperature between 1°C and 30°C when storing the medication. Doing so will help safely preserve its effectiveness.

Appearance and packaging

Appearance

Pale green-green round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 1000 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.