Medication info
Trasetsem Tablet

Trasetsem Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
(주)휴온스메디텍
Appearance
Pale yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201603985 · Approved 2016.06.27 · Insurance code 670401240

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. Starting dose of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours, not exceeding 16 tablets per day. The effective minimal dosage should be administered for the shortest duration possible. Avoid unnecessary long-term use of this medication, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether this medication should be continuously administered.
Child dose
Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. Starting dose of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours, not exceeding 16 tablets per day.

Ingredients

Manufacturer
(주)휴온스메디텍

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

This medication is used to relieve acute and chronic pain that is classified as moderate to severe.

How to take

Adult dose

Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. Starting dose of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours, not exceeding 16 tablets per day. The effective minimal dosage should be administered for the shortest duration possible. Avoid unnecessary long-term use of this medication, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether this medication should be continuously administered.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. Starting dose of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours, not exceeding 16 tablets per day.

Precautions

This medication may put stress on the liver, so individuals who drink alcohol regularly more than three glasses a day should consult a physician or pharmacist before taking this medication. This medication can rarely cause serious skin reactions, so if a skin rash or hypersensitivity occurs, it should be discontinued immediately and medical attention should be sought. The active ingredient, tramadol, may increase the risk of seizures if the recommended dosage is exceeded, and the risk of seizures may be higher if taken with certain antidepressants or narcotic pain relievers. Rarely, serious allergic reactions can occur during the use of this medication, so if symptoms such as difficulty breathing, hives, or facial swelling occur, immediate medical help should be sought. Patients with acute and severe bronchial asthma may experience great difficulty in breathing while taking this medication, so it must be administered in a properly equipped medical environment. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, or even coma, so concurrent use should be avoided. Patients with head injuries or brain diseases may experience increased intracranial pressure or worsening of breathing problems while using this medication, thus caution is necessary. This medication can cause psychological and physical dependence, so it should be taken under a physician's guidance for prolonged use, and sudden discontinuation may cause withdrawal symptoms. Patients with liver dysfunction or liver disease should consult medical personnel before taking this medication, and should not take it with other acetaminophen products. Children, especially those under 12 years of age and certain pediatric patients under 18 years of age after specific surgeries, should not be given this medication, and adolescents between 12 and 18 years of age should also avoid it if there are special risk factors. This medication can cause sleep apnea or hypoxia, so if such symptoms occur or worsen, patients should consult medical personnel to consider dosage adjustment or discontinuation. Hypoatremia may occur while taking this medication, so elderly patients or patients with risk factors should carefully monitor their symptoms. This medication can interact with certain drugs, so patients must inform medical personnel of any other medications they are taking, especially concerning the combined use of MAO inhibitors, antidepressants, antibiotics, and central nervous system depressants. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, especially breastfeeding mothers should avoid it due to the risk of transmission to the baby through breast milk. This medication may cause drowsiness or dizziness, so precautions are necessary when driving or operating machinery. In cases of overdose, serious risks of severe respiratory depression, seizures, and liver damage exist, therefore the prescribed dosage must be strictly adhered to, and immediate emergency treatment should be sought if abnormal symptoms occur. This medication should be stored in a safe place out of reach of children to prevent accidental ingestion or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), sweating, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma, respiratory distress, severe respiratory depression, liver abnormalities (jaundice), acute liver failure, sudden and very severe headache, seizures, confusion, visual disturbances, paralysis, severe edema accompanied by high blood pressure, urinary abnormalities, severe swelling, loss of consciousness, myocardial infarction

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • sweating
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremor
  • paresthesia
  • attention deficit
  • fainting

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

Storage

This medication should be stored in a sealed container to prevent air from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 500 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.