Medication info
Setadol Tablet

Setadol Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
동성제약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200710808 · Notified 2007.09.27 · Insurance code 643200540

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and treatment response. It is recommended to take an initial dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, not exceeding 8 tablets per day. The effective minimum dosage should be administered for as short a period as possible. Avoid administering this drug for longer than necessary, and if long-term treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued use of this medication.
Child dose
For children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and treatment response. It is recommended to take an initial dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, not exceeding 8 tablets per day.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

For children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and treatment response. It is recommended to take an initial dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, not exceeding 8 tablets per day. The effective minimum dosage should be administered for as short a period as possible. Avoid administering this drug for longer than necessary, and if long-term treatment is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the continued use of this medication.

Child dose

For children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and treatment response. It is recommended to take an initial dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, not exceeding 8 tablets per day.

Precautions

This medication may burden the liver; thus, individuals who consume a lot of alcohol daily should consult a doctor or pharmacist before taking it. If severe rash or allergic reactions occur during use of this medication, it should be discontinued immediately, and medical attention should be sought. One of the main ingredients, Tramadol, can trigger seizures; therefore, patients with a history of seizures or those at high risk for seizures should be particularly cautious. This medication may be dangerous to patients with severe respiratory distress, so those with severe asthma or respiratory diseases should consult a specialist. This drug can affect the central nervous system, leading to drowsiness or dizziness; therefore, caution is needed when driving or operating machinery. Women who are pregnant or breastfeeding should consult a doctor before using this medication, and breastfeeding mothers should avoid taking it. This drug can interact with other medications, so it is essential to inform your healthcare provider of any other medications being taken, especially when used in conjunction with antidepressants, anticonvulsants, or narcotic analgesics. This medication should not be administered to children, particularly those under 12 years or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Do not exceed the recommended dosage of this medication; overdose can lead to severe side effects, and immediate contact with a medical institution is necessary. Patients with impaired liver or kidney function may require dosage adjustments and should follow their doctor's instructions. Withdrawal symptoms or dependence may occur; therefore, do not abruptly discontinue use without consulting a doctor to gradually reduce the dosage. This medication should be stored out of the reach of children, and caution should be taken to prevent drug abuse and misuse.

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 high fever, blisters, peeling of skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination issues

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
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • orientation disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor

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

Storage

This medication should be stored in a tightly closed container to prevent air from entering and kept at a temperature below 25 degrees Celsius. This way, the drug's effect can be maintained for a longer duration and prevent deterioration.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

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.