Medication info

Itopul Tablet (Itopride Hydrochloride)

Prescription medicationTabletOralExpired
Ingredient · strength
Itopride Hydrochloride›50mg / 1 tablet
Manufacturer / importer
Hanpung Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201905653 · Approved 2019.08.12

This product's status changed to Expired on 2024.08.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of functional dyspepsia (e.g., abdominal bloating, heartburn, and nausea)
Who takes it
Adults
Adult dose
Adults: Administer itopride hydrochloride 50 mg orally 3 times daily before meals. Adjust the dose as needed according to symptoms.

Ingredients

Manufacturer
Hanpung Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication helps alleviate various gastrointestinal symptoms caused by functional dyspepsia, such as abdominal bloating, upper abdominal pain, loss of appetite, heartburn, nausea, and vomiting. While these symptoms can disrupt daily life, this medication can improve them and normalize digestive function. It is used for comfortable digestion and symptom relief.

How to take

Adult dose

Adults: Administer itopride hydrochloride 50 mg orally 3 times daily before meals. Adjust the dose as needed according to symptoms.

Precautions

This medication should not be used in patients who have had an allergic reaction to this medication or its ingredients. It should be avoided in patients with gastrointestinal bleeding, intestinal obstruction, or perforation, as it may stimulate gastrointestinal motility. Furthermore, this medication contains lactose; therefore, it should not be used in patients with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. During the use of this medication, rare but serious allergic reactions such as shock or anaphylaxis may occur. If symptoms such as hypotension, difficulty breathing, or hives appear, administration should be stopped immediately and appropriate treatment should be initiated. Liver dysfunction or jaundice symptoms may also occur, so liver function tests should be monitored closely. Gastrointestinal symptoms such as abdominal pain, nausea, diarrhea, constipation, and increased salivation may occur, and neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may also be experienced. Gynecomastia or elevated prolactin levels may occur, hence administration should be stopped if any abnormal signs are observed. Blood abnormalities such as thrombocytopenia or leukopenia may also occur, necessitating regular blood tests. There may be an increase in BUN or creatinine levels during kidney function tests, so caution is needed. This medication enhances the action of acetylcholine; therefore, when taken with anticholinergics, its effect may be reduced, so it is advisable to space out the doses if taken together. Pregnant women or those who may become pregnant should use this medication only when the benefits of treatment are judged to outweigh the risks, as its safety has not been established. If breastfeeding, this medication could be excreted into breast milk, so it should be avoided if possible; if necessary, breastfeeding should be discontinued. Due to insufficient safety data or potential for adverse reactions in children or the elderly with diminished physical function, careful observation is required when administering this medication. This medication should be stored out of reach of children, and care should be taken not to transfer it to another container, as this could lead to accidents and negatively impact the quality of the medication.

Side effects

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

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 advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.