Medication info
Paracetamol/Tramadol Extended Release Tablet

Paracetamol/Tramadol Extended Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
동아에스티(주)
Appearance
Pale yellow rectangular extended-release film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201502631 · Approved 2015.04.30 · Insurance code 642507230

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
It is recommended to administer 1 tablet as an initial dose, then maintain a minimum dosing interval of at least 12 hours, not exceeding 4 tablets per day. This medication should not be taken longer than necessary, and regular monitoring should be conducted if prolonged use is needed. For the elderly, the usual adult dose is prescribed, but those aged 75 years or older should be given at least a 12-hour interval.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

This medication is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

It is recommended to administer 1 tablet as an initial dose, then maintain a minimum dosing interval of at least 12 hours, not exceeding 4 tablets per day. This medication should not be taken longer than necessary, and regular monitoring should be conducted if prolonged use is needed. For the elderly, the usual adult dose is prescribed, but those aged 75 years or older should be given at least a 12-hour interval.

Precautions

This medication may put strain on the liver, so individuals who regularly consume more than three cups of alcohol daily should consult a doctor or pharmacist before taking this or other antipyretic analgesics. Rarely, this medication may cause serious skin allergic reactions; if symptoms such as a rash or hypersensitivity occur, discontinue use immediately and consult a specialist. One of the ingredients in this medication can increase the risk of seizures, so those with a history of seizures or a higher risk of seizures should be particularly cautious, especially when taken with certain antidepressants or other medications, as the risk of seizures may increase. This medication can rarely cause serious allergic reactions; if allergy symptoms occur, discontinue use immediately. Patients with acute and severe asthma may experience difficulty breathing when taking this medication, hence it must be administered in a medically equipped facility. Concurrent use of this medication with alcohol or central nervous system depressants may result in severe drowsiness, respiratory depression, or coma, so co-administration should be avoided or monitored closely. Patients with head injuries or elevated intracranial pressure may experience worsened symptoms due to respiratory depression, so caution is advised in such cases. This medication can cause physical and psychological dependence, thus monitoring for dependency is necessary during long-term use. Patients with impaired liver function should consult a doctor before taking this medication as its components are metabolized by the liver, and they should take care not to exceed the recommended dosage. Patients with certain genetic metabolic profiles may experience excessive accumulation of the active ingredients, leading to severe respiratory depression; alternative medications or dose adjustments may be needed for these patients. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone certain surgeries, and adolescents aged 12 to 18 with special risk factors should also avoid its use. During treatment with this medication, electrolyte imbalances such as hyponatremia may occur, hence especially elderly patients or those with risk factors should undergo regular blood tests to monitor their condition. This medication could lead to severe side effects when combined with other opioid analgesics, alcohol, sedatives, or central nervous system depressants; hence consultation with a specialist is essential. If pregnant or breastfeeding, it is critical to consult a doctor before taking this medication, and nursing mothers should avoid use as this medication can transfer to breast milk and cause serious side effects in infants. Additionally, this medication may cause drowsiness or dizziness, so caution is advised when driving or operating hazardous machinery. Overdose may result in severe side effects such as respiratory depression or liver damage, necessitating immediate contact with a medical facility for appropriate treatment. During the course of this medication, do not exceed the recommended dosage, follow the doctor’s instructions, and consult a specialist immediately if abnormal reactions occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, urination problems

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • aggravation of hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • vertigo
  • headache
  • tremor
  • ataxia
  • hypertonia
  • migraine
  • worsening of migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • hematochezia
  • tongue swelling
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness

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. Additionally, it is best to store the medication at a cool room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow rectangular extended-release 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

No questions yet.

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.