Medication info

Gimuradol Semi-Sustained Release Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Light yellow round sustained release film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201908243 · Approved 2019.12.05

This product's status changed to Approval withdrawn on 2024.01.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Initially, 2 tablets are administered, with subsequent dosing intervals of at least 12 hours. Do not exceed 8 tablets in one day and do not use for a longer period than necessary. If long-term use is necessary, regular monitoring should be conducted. For elderly patients, the adult dosage may be given, but for those over 75 years, intervals of at least 12 hours should be observed.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to relieve acute pain from moderate to severe levels as well as chronic pain.

How to take

Adult dose

Initially, 2 tablets are administered, with subsequent dosing intervals of at least 12 hours. Do not exceed 8 tablets in one day and do not use for a longer period than necessary. If long-term use is necessary, regular monitoring should be conducted. For elderly patients, the adult dosage may be given, but for those over 75 years, intervals of at least 12 hours should be observed.

Precautions

This medication may put a strain on the liver, so individuals who consume large amounts of alcohol daily should consult a doctor or pharmacist before taking it. Due to the acetaminophen component, there may be rare occurrences of severe skin rashes or allergic reactions; if any skin abnormalities occur, discontinue use immediately. The tramadol component can increase the risk of seizures in case of overdose, and the risk may increase when taken with certain antidepressants or other narcotic analgesics, so caution is advised. In patients with severe respiratory diseases, severe respiratory depression may occur when administered, thus it should only be given in a medical facility. This medication can cause severe drowsiness or respiratory depression when taken in combination with alcohol or benzodiazepines; thus, it is advisable not to take them together. Patients with brain injury or increased intracranial pressure should be cautious due to the risk of respiratory depression and increased intracranial pressure when taking this medication. The tramadol component can induce physical and mental dependence, so the potential for dependence should be carefully monitored with long-term use. Patients with compromised liver function may experience liver damage due to the acetaminophen component of this medication, so they must follow a doctor's prescription. In patients with a rapid genetic metabolic rate, the effects of this drug may be excessive, increasing the risk of respiratory depression, thus dosage adjustment or alternative medications may be necessary. This medication is not to be administered to children under 12 years old or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. During use, electrolyte disturbances such as hyponatremia can occur; particularly elderly patients or those with risk factors should undergo blood tests to monitor their condition. Individuals with a history of allergy to this medication's components, severe respiratory depression, severe liver or kidney impairment, pregnant or nursing women, or those taking certain medications should not use this medication. This medication can cause drowsiness or dizziness, so caution is needed while driving or operating machinery. In case of overdose, severe respiratory depression or liver damage may occur, so it is crucial to adhere strictly to the prescribed dosage and visit a medical institution immediately if any suspicious symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), severe drowsiness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • tension
  • migraine
  • worsening migraine
  • involuntary muscle contractions
  • abnormal sensations
  • confusion
  • dizziness
  • nausea
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • vomiting
  • dysphagia
  • hematochezia
  • tongue swelling
  • appetite loss
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness
  • drowsiness

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Storage temperature should be maintained between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Light yellow round sustained release film-coated tablets

Package unit

30 tablets/bottle, 100 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.