Medication info
Acetralset Semi Tablets

Acetralset Semi Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Pale yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200705597 · Notified 2007.05.16 · Insurance code 649000140

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, with a maximum of 16 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Avoid prolonged administration beyond what is necessary. If prolonged administration is required due to the nature and severity of the disease, regular monitoring should be conducted.
Child dose
Children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, with a maximum of 16 tablets per day.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • 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

Children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, with a maximum of 16 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Avoid prolonged administration beyond what is necessary. If prolonged administration is required due to the nature and severity of the disease, regular monitoring should be conducted.

Child dose

Children aged 12 and older and adults: The dosage should be adjusted based on the level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, with a maximum of 16 tablets per day.

Precautions

This medication can put stress on the liver, so individuals who consume large amounts of alcohol daily should consult a physician or pharmacist before taking it. If a rash or allergic reaction occurs during treatment, stop taking this medicine immediately and seek medical attention. The ingredients in this medication may provoke seizures, so patients with a history of seizures or those at risk should take it with caution. Serious allergic reactions can occasionally occur while taking this medicine, so if you experience difficulty breathing or severe skin reactions, seek emergency treatment immediately. Patients with severe respiratory diseases are at risk of breathing suppression from this medication; therefore, it should only be administered in facilities equipped with appropriate medical equipment. Taking this medication with alcohol or sedatives may cause severe drowsiness, respiratory depression, and altered consciousness; thus, co-administration should be avoided or consulted with a doctor. Patients who have head injuries or elevated intracranial pressure should exercise caution when taking this medication as it may exacerbate symptoms due to respiratory suppression. This medication can lead to physical and psychological dependence, so it should be taken according to a physician's instructions for long-term use. Patients with impaired liver function should consult a physician before taking this medication and should not take it with other acetaminophen-containing products. Patients with certain genotypes may metabolize this medication quickly, increasing the risk of respiratory depression; special management by a physician may be necessary. This medication should not be given to children under 12 years or to pediatric patients following certain surgeries; also, teens aged 12 to 18 should avoid taking it if there are special risk factors. This medication may cause sleep apnea or hypoxia, so symptoms should be monitored continuously, and consideration should be given to dosage adjustment or discontinuation as necessary. Elderly patients or those at risk for hyponatremia should closely observe for symptoms of hyponatremia while taking this medication. This medication may interact with specific drugs; therefore, inform a doctor or pharmacist if you are taking other medications. Women who are pregnant or breastfeeding should consult a specialist before taking this medication, as it may affect the fetus or newborn. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. Overdose can lead to severe respiratory depression, seizures, liver damage, etc., so it is crucial to adhere to the prescribed dosage. This medication should be stored out of reach of children, and care should be taken to prevent misuse or abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, vision disturbances, paralysis, urinary retention

Mild side effects

  • Reduced 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 sex drive
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremor
  • sensory disturbances

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, at a temperature between 1 to 30 degrees Celsius at room temperature. This will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablets

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

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.