Medication info

GanaMed Tablet (Itofride Hydrochloride)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Itopride Hydrochloride›50mg / 1 tablet
Manufacturer / importer
Ildong Pharmaceutical Co., Ltd.
Appearance
[Domestic] White film-coated tablet, [Export] White, biconvex, round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 1000 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200803702 · Notified 2008.04.04

This product's status changed to Approval withdrawn on 2025.02.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of functional dyspepsia symptoms (e.g., abdominal bloating, upper abdominal pain, and nausea)
Who uses it
Adults
Adult dosage
○Adults: Administer 50 mg of itopride hydrochloride orally per dose, 3 times daily before meals. Reduce the dose as appropriate according to symptoms.

Ingredients

Manufacturer
Ildong Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of functional dyspepsia symptoms (e.g., abdominal bloating, upper abdominal pain, and nausea)

  • Abdominal bloating
  • upper abdominal pain
  • loss of appetite
  • heartburn
  • nausea
  • vomiting
View approved original text

This medication is used to relieve gastrointestinal symptoms caused by functional dyspepsia, such as abdominal bloating, upper abdominal pain, loss of appetite, heartburn, nausea, and vomiting.

Dosage and Administration

Adult dosage

○Adults: Administer 50 mg of itopride hydrochloride orally per dose, 3 times daily before meals. Reduce the dose as appropriate according to symptoms.

Precautions

This medication should not be administered to patients who have had allergic reactions to this medication or any of its components. It should also not be used in patients for whom gastrointestinal stimulation could be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. Severe allergic reactions like shock or anaphylaxis may occur during the use of this medication, so symptoms must be closely monitored. If there is a drop in blood pressure or difficulty breathing, and if skin rash or hives occur, the medication should be stopped immediately and appropriate treatment should be administered. Due to the potential for liver function issues, liver enzyme levels (AST, ALT, γ-GTP, etc.) should be checked regularly, and if abnormalities are found, the medication should be discontinued. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur; if discomfort persists, consultation with a healthcare professional is advisable. Neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may occur, so attention should be paid to these symptoms. Gynecomastia or elevated prolactin levels may occur, so if any abnormality is noticed, discontinuation of the medication is necessary. Platelet or white blood cell counts may decrease, so regular blood tests should be performed, and if abnormalities are found, the medication should be stopped. Renal function may be affected, so BUN and creatinine levels should be monitored with caution. Adverse reactions related to elevated liver enzymes may also occur, necessitating regular liver function tests. Allergic reactions such as itching, rash, and redness may rarely occur; if such symptoms present themselves, medication should be discontinued. Symptoms of movement disorders such as tremors may occur, so attention should be paid to changes in symptoms. Chest or back pain and fatigue may occasionally occur, so if symptoms are severe, healthcare professionals should be informed. This medication enhances the action of the neurotransmitter acetylcholine; this should be taken into consideration during use. If gastrointestinal symptoms do not improve, long-term use should be avoided. The effectiveness of this medication may be reduced when taken with anticholinergics; therefore, dosing intervals should be adjusted or caution should be applied when used together. The safety during pregnancy has not been established, so it should only be used when necessary, and women of childbearing potential should be cautioned. During breastfeeding, this medication may be excreted in breast milk, so it should be avoided if possible, and if unavoidable, breastfeeding should be stopped. The safety in children has not been sufficiently confirmed, so caution is needed in use. Elderly patients may have reduced physiological function, increasing the likelihood of adverse reactions; symptoms should be carefully monitored, and doses should be adjusted if necessary. This medication should be stored out of the reach of children, and transferring it to other containers should be avoided to maintain quality and prevent accidents.

Side effects

  • Shock
  • anaphylaxis-like symptoms
  • hypotension
  • dyspnea
  • laryngeal edema
  • urticaria
  • pallor
  • sweating
  • liver dysfunction
  • jaundice
Show 29 more
  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • increased salivation
  • headache
  • feelings of anxiety
  • sleep disturbances
  • dizziness
  • gynecomastia
  • elevated prolactin
  • thrombocytopenia
  • leukopenia
  • elevated BUN
  • elevated creatinine
  • elevated AST
  • elevated ALT
  • elevated γ-GTP
  • elevated ALP
  • rash
  • erythema
  • itching
  • tremor
  • chest pain
  • back pain
  • fatigue
  • heartburn
  • thirst
  • abdominal bloating

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

Storage

This medication should be stored in a well-sealed container to prevent air or moisture from entering, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the efficacy of the medication and prevent deterioration.

Appearance and packaging

Appearance

[Domestic] White film-coated tablet, [Export] White, biconvex, round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle, 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.