Medication info

Extra Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle
Approval status
Expired

MFDS item code 201905069 · Approved 2019.07.19

This product's status changed to Expired on 2024.07.19. 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 · Children
Adult dose
A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, not to exceed 8 tablets in one day. Administer the effective minimum dose for the shortest duration possible. In elderly patients, the usual adult dosage is administered but elderly patients aged 75 and older should have a minimum dosing interval of 6 hours. In cases of moderate renal impairment, the dosing interval should be extended to 12 hours; for severe renal impairment, administration is not recommended.
Child dose
Children aged 12 and older should have their dosage adjusted based on the level of pain and treatment response like in adults. A starting dose of 2 tablets is recommended. Subsequent dosing intervals should be at least 6 hours apart.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • severe acute pain
  • moderate chronic pain
  • severe chronic pain
View approved original text

This medicine is used for the relief of acute and chronic pain that ranges from moderate to severe.

How to take

Adult dose

A starting dose of 2 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, not to exceed 8 tablets in one day. Administer the effective minimum dose for the shortest duration possible. In elderly patients, the usual adult dosage is administered but elderly patients aged 75 and older should have a minimum dosing interval of 6 hours. In cases of moderate renal impairment, the dosing interval should be extended to 12 hours; for severe renal impairment, administration is not recommended.

Child dose

Children aged 12 and older should have their dosage adjusted based on the level of pain and treatment response like in adults. A starting dose of 2 tablets is recommended. Subsequent dosing intervals should be at least 6 hours apart.

Precautions

This medication can burden the liver, so those who regularly consume alcohol over a certain amount daily should consult a doctor or pharmacist before taking it. Serious rashes or allergic reactions may occur while using this medication. If unusual symptoms appear, discontinue use immediately and consult a healthcare provider. The components of this medication may pose a risk of seizures, so patients with a history of seizures or those at high risk should be monitored closely during use. Rarely, life-threatening allergic reactions may occur while taking this medication, so if symptoms appear, visit a medical facility immediately. Patients with severe respiratory diseases may experience difficulty breathing while taking this medication, so it should be administered under medical supervision. Taking this medication with alcohol or sedatives may lead to dangerous side effects such as severe drowsiness or respiratory depression, so it is advised to avoid or be cautious when combining them. Patients with head injuries or brain diseases should use this medication with caution as it may increase intracranial pressure. This medication may cause psychological and physical dependence, so long-term use should be directed by a physician, and sudden discontinuation may lead to withdrawal symptoms. Patients with diminished liver function should consult with a physician before taking this medication and must not exceed the recommended dosage to prevent liver damage. Patients with specific genotypes may have rapid metabolism of this medication, increasing the risk of side effects. Therefore, dosage adjustment and monitoring according to a doctor's instructions may be necessary. This medication should not be administered to children under 12 years of age and should be used cautiously in adolescents aged 12 to 18, only in special cases. This medication may cause sleep apnea or hypoxia, so if these symptoms occur or worsen, consult a physician to adjust the dosage or discontinue use. Elderly patients and those at risk of hyponatremia should carefully monitor for symptoms of hyponatremia while taking this medication. Patients with hypersensitivity to this medication, serious respiratory depression, or those taking specific medications should not take this medication. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may affect the fetus or newborn. Drowsiness, dizziness, and other symptoms may occur while taking this medication, so it is advisable to avoid driving or handling dangerous machinery. In case of overdose, severe respiratory depression and liver damage may occur; therefore, it's vital to adhere strictly to the prescribed dosage, and in case of overdose, seek emergency treatment immediately. This medication can interact with other drugs, so it is crucial to inform healthcare providers of any other medications being taken. Keep this medication out of reach of children to prevent accidental ingestion.

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 mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • sense of direction impairment
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensory alteration

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

Storage

Store this medication in a tightly sealed container to protect from air and moisture, and keep it at room temperature between 1 to 30 degrees Celsius. By doing so, the effectiveness of the medication can be maintained safely.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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.