Medication info
Setamadol Tablets

Setamadol Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Light yellow, rectangular Film-coated tablets
Packaging
30 tablets/box[(10 tablets/PTP)×3], 300 tablets/bottle
Approval status
Active

MFDS item code 200804562 · Notified 2008.04.23 · Insurance code 642902710

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. It is recommended to start with an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not use this medication longer than necessary, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be performed to check the continuation of this medication.
Child dose
Children aged 12 years and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. It is recommended to start with an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of 8 tablets per day.

Ingredients

Manufacturer
일동제약(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 moderate to severe acute and chronic pain.

How to take

Adult dose

Children aged 12 years and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. It is recommended to start with an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Do not use this medication longer than necessary, and if long-term use is required due to the nature and severity of the disease, regular monitoring should be performed to check the continuation of this medication.

Child dose

Children aged 12 years and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. It is recommended to start with an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of 8 tablets per day.

Precautions

This medication can cause liver damage, so individuals who regularly consume alcohol above a certain amount daily should consult a doctor or pharmacist before taking this medication. If a rash or hypersensitivity reaction occurs after taking this medication, discontinue use immediately and inform a healthcare professional. This medication has the potential to cause seizures, so patients with a history of seizures or at high risk of seizures should use it with caution. In patients with severe asthma, there is a risk of respiratory depression; therefore, this medication must only be administered in an environment where appropriate monitoring can take place. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness or respiratory depression; extreme caution is advised when co-administering. Patients with elevated intracranial pressure or head injuries should use caution as this medication may exacerbate symptoms. This medication can cause physical and psychological dependence, so long-term use requires careful monitoring for signs of dependence. Patients with impaired liver function should consult a doctor before taking this medication and be careful not to exceed the recommended dosage. Patients with specific genetic metabolic characteristics may produce excessive active metabolites of this medication, increasing the risk of respiratory depression; thus, caution should be exercised. This medication should not be administered to children under 12 years of age or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and should be avoided in children sensitive to respiratory depression. Patients with sleep apnea or hypoxia should continuously monitor for worsening symptoms while taking this medication and consider dosage adjustments or discontinuation if necessary. This medication can cause hyponatremia; therefore, particularly in elderly patients or those with risk factors, regular monitoring of serum sodium levels is advisable. Patients allergic to any components of this medication, those in severe respiratory depression, patients with head injuries or brain lesions, and those taking MAO inhibitors should not use this medication. Patients taking opioid analgesics or central nervous system depressants, patients with severely reduced liver or kidney function, and patients with severe cardiac function failure should use this medication cautiously. Drowsiness or dizziness may occur when taking this medication, so caution is advised when driving or operating machinery. In the case of overdose, severe respiratory depression, seizures, liver damage, etc., may occur, so be sure to adhere to the prescribed dosage and seek medical attention immediately in case of overdose. This medication should be stored out of the reach of children, and care should be taken to prevent misuse and abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

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
  • spatial disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremor
  • sensation

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and moisture, and it is advisable to keep it in a cool place below room temperature (25 degrees Celsius). This storage method helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Light yellow, rectangular Film-coated tablets

Package unit

30 tablets/box[(10 tablets/PTP)×3], 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.