Medication info
Mighty Set Tablets (Tramadol Hydrochloride, Acetaminophen)

Mighty Set Tablets (Tramadol Hydrochloride, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Light yellow, oval-shaped film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200804952 · Notified 2008.04.30 · Insurance code 647301350

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: It is recommended to take an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, not exceeding 8 tablets per day. Use the lowest effective dose for the shortest duration possible. Elderly: Administer the usual adult dose; however, for those over 75 years, doses should be at least 6 hours apart. Renal impairment: Moderate renal impairment patients (creatinine clearance)
Child dose
Children over 12 years and adults: It is recommended to take an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, not exceeding 8 tablets per day. Use the lowest effective dose for the shortest duration possible.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute and chronic pain
View approved original text

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

How to take

Adult dose

Children over 12 years and adults: It is recommended to take an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, not exceeding 8 tablets per day. Use the lowest effective dose for the shortest duration possible. Elderly: Administer the usual adult dose; however, for those over 75 years, doses should be at least 6 hours apart. Renal impairment: Moderate renal impairment patients (creatinine clearance)

Child dose

Children over 12 years and adults: It is recommended to take an initial dose of 2 tablets, and subsequent dosing intervals should be at least 6 hours apart, not exceeding 8 tablets per day. Use the lowest effective dose for the shortest duration possible.

Precautions

This medication may burden the liver; individuals who regularly consume more than three drinks of alcohol per day should consult a doctor or pharmacist before taking it. The acetaminophen ingredient may rarely cause serious skin reactions; discontinue use immediately if skin rash or hypersensitivity reactions occur. Exceeding the recommended dose of tramadol increases the risk of seizures, and taking it with certain antidepressants or narcotics may further heighten this risk. Rarely, severe allergic reactions such as anaphylaxis may occur; inform medical personnel immediately if allergy symptoms appear. Patients with severe asthma are at risk of significant respiratory suppression when using this medication, so it should only be administered in a medically equipped setting, and alternative analgesics should be considered. Taking this medication with alcohol or central nervous system depressants may cause significant sedation and respiratory suppression; caution is advised when using with such drugs. Patients with head injuries or elevated intracranial pressure should be cautious as respiratory suppression from this medication may raise intracranial pressure. This medication can cause physical and psychological dependence; long-term use should consider dependence risk, and withdrawal symptoms may occur upon discontinuation. An overdose of acetaminophen can result in severe liver damage; total daily dosages should not exceed 4,000mg, and patients with impaired liver function should consult a doctor. Some patients may metabolize this medication rapidly, increasing the risk of respiratory suppression; these cases may require dose adjustments and close monitoring. Children under 12 years or adolescents under 18 who have undergone tonsillectomy or adenoidectomy should not be administered this medication, and special caution is necessary for patients in this age group. In patients with sleep apnea, this medication may worsen symptoms; continuous monitoring of sleep state is required during use, and dose reduction or discontinuation may be needed. Elderly patients or those at risk of hyponatremia should periodically check for occurrences of hyponatremia during use of this medication. This medication may interact with certain drugs, increasing the risk of seizures, serotonin syndrome, respiratory suppression, etc.; patients on other medications must inform healthcare personnel. Drowsiness and dizziness may occur when driving or operating machinery, so caution is advised. In cases of overdose, severe respiratory suppression, seizures, liver damage may occur; contact medical institutions immediately for treatment in emergencies. This medication should be stored safely out of reach of children, and careful management is required to prevent misuse or 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 fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, lightning headache, seizures, confusion of consciousness, visual disturbances, 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
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraines
  • drowsiness
  • sensory impairment
  • tremor
  • paresthesia
  • attention disturbances

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

Storage

Store this medication in a tightly closed container to prevent air ingress, at a temperature between 1 to 30 degrees Celsius. This storage method helps maintain the medication's efficacy.

Appearance and packaging

Appearance

Light yellow, oval-shaped 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.