Medication info

Simedine 200 mg (Cimetidine)

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

MFDS item code 201907069 · Approved 2019.10.04

This product's status changed to Expired on 2024.10.04. 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
For cimetidine, administer 400 mg orally twice daily (morning and at bedtime) or 800 mg once daily at bedtime. Also, 300 mg can be given orally four times a day (after meals and at bedtime). The dose can be increased to a maximum of 1.6 g (400 mg four times a day). For acute gastritis and acute exacerbations of chronic gastritis, administer 200 mg orally twice daily or 400 mg once daily.
Children's dosage
Administer 20 to 40 mg per kg of body weight daily in divided oral doses.

Ingredients

Manufacturer
한국신텍스제약(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 gastrointestinal diseases such as gastric and duodenal ulcers, gastroesophageal reflux disease, recurrent ulcers, anastomotic ulcers, and Zollinger-Ellison syndrome. It is also effective for improving gastric mucosal lesions like erosions, bleeding, redness, and swelling that occur during acute exacerbations of acute gastritis or chronic gastritis. In other words, it helps protect the stomach lining, heal damaged areas, and alleviate symptoms. This drug is widely used for the treatment and symptom improvement of various gastric diseases.

Dosage and Administration

Adult dosage

For cimetidine, administer 400 mg orally twice daily (morning and at bedtime) or 800 mg once daily at bedtime. Also, 300 mg can be given orally four times a day (after meals and at bedtime). The dose can be increased to a maximum of 1.6 g (400 mg four times a day). For acute gastritis and acute exacerbations of chronic gastritis, administer 200 mg orally twice daily or 400 mg once daily.

Children's dosage

Administer 20 to 40 mg per kg of body weight daily in divided oral doses.

Precautions

This medication contains cimetidine, which is used to inhibit gastric acid secretion for the treatment of gastric ulcers or gastroesophageal reflux disease. This drug should not be administered to patients with an allergy to cimetidine or other ingredients, or those taking dofetilide, as it may increase the risk of cardiac arrhythmias. Patients with decreased kidney or liver function, those with a history of drug allergies, elderly patients, children under 19 years of age, and patients undergoing hemodialysis should use this drug with caution. Particularly, patients with kidney impairment may have elevated drug levels, requiring adjustments in dosage or dosing intervals. This drug may mask symptoms of gastric cancer, so it should be used only after confirming the absence of malignancy, and patients with Helicobacter pylori infection should undergo eradication therapy. While taking this drug, various side effects may occur, including leukopenia, liver dysfunction, kidney problems, allergic reactions, hormonal changes, digestive issues, neurological abnormalities, cardiac rhythm problems, and skin rashes. Therefore, patients should consult a healthcare provider immediately if symptoms arise. Regular blood tests and liver and kidney function tests are important to detect any abnormal signs early. Additionally, this drug may interact with various other medications, including warfarin, antidepressants, antiarrhythmics, calcium channel blockers, and antifungals, so caution is needed when taken together, and dosage or dosing intervals may need to be adjusted. The safety of this drug for use during pregnancy or breastfeeding has not been established; it should be used carefully only if necessary, and breastfeeding should be discontinued as the drug can pass into breast milk. In cases of overdose, serious symptoms such as respiratory depression may occur, requiring immediate emergency care. This drug should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Generalized weakness, lethargy, subcutaneous bleeding, mucosal bleeding, fever, jaundice, abnormal kidney function (elevated BUN, creatinine), shock, anaphylactic-like reactions, generalized rash, difficulty in breathing, rashes, altered consciousness, seizures, confusion (anxiety, psychosis, depression, agitation, hallucinations, disorientation), Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, generalized exfoliative erythema.

Mild side effects

  • Leukopenia
  • granulocytopenia
  • agranulocytosis
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • autoimmune hemolytic anemia
  • hepatitis
  • elevated AST
  • ALT
Show 21 more
  • seizures
  • acute renal failure
  • interstitial nephritis
  • urinary retention
  • elevated BUN
  • gynecomastia
  • excessive lactation
  • increase in vaginal discharge
  • erectile dysfunction
  • abdominal bloating
  • constipation
  • diarrhea
  • headache
  • dizziness
  • limb numbness
  • drowsiness
  • hypochondriac symptoms
  • weakness
  • bradycardia
  • tachycardia
  • palpitations.

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the effectiveness of the drug for a longer period.

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.