Medication info
Tramafen Semi Tablet

Tramafen Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201402890 · Approved 2014.06.30 · Insurance code 669804370

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Recommended for children over 12 years of age and adults. Start with an initial dose of 4 tablets, and the interval between doses should be at least 6 hours. Do not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible, and do not administer for a long time beyond necessity. Elderly patients should be treated with the usual adult dosage, but for those over 75 years old, maintain a minimum interval of 6 hours. Patients with moderate renal impairment should have their dosing interval adjusted.
Child dose
Recommended for children over 12 years old. The dosage should be adjusted based on the patient's level of pain and therapeutic response. Start with an initial dose of 4 tablets, and the interval between doses should be at least 6 hours. The maximum dose is 16 tablets per day.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and 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

Recommended for children over 12 years of age and adults. Start with an initial dose of 4 tablets, and the interval between doses should be at least 6 hours. Do not exceed 16 tablets per day. Administer the effective lowest dose for the shortest duration possible, and do not administer for a long time beyond necessity. Elderly patients should be treated with the usual adult dosage, but for those over 75 years old, maintain a minimum interval of 6 hours. Patients with moderate renal impairment should have their dosing interval adjusted.

Child dose

Recommended for children over 12 years old. The dosage should be adjusted based on the patient's level of pain and therapeutic response. Start with an initial dose of 4 tablets, and the interval between doses should be at least 6 hours. The maximum dose is 16 tablets per day.

Precautions

This drug may affect liver function, so individuals who regularly consume three or more alcoholic drinks a day should consult a doctor or pharmacist before taking it. If skin rash or allergic reactions occur during the use of this medication, it should be discontinued immediately and medical assistance should be sought. One of the ingredients in this medication can cause seizures, so caution is particularly needed for those with a history of seizures or at risk of seizures, as the risk may be increased when used with related medications. Individuals with severe respiratory diseases may have difficulty breathing when taking this medication; it should be used under medical supervision. Taking this drug with alcohol or sedatives may cause severe drowsiness or respiratory depression, which can be dangerous, so it is advisable not to combine them. Patients with brain damage or high intracranial pressure should be cautious, as breathing problems may worsen when taking this medication. This medication can lead to physical and psychological dependence; therefore, dosing and duration should be strictly managed as per the doctor's instructions when taking it for a long period. Patients with impaired liver or kidney functions may find it difficult to metabolize and excrete this medication; consultation with a healthcare provider is essential before use. It is not safe to use this medication in children under 12 years old and in adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Pregnant or breastfeeding women should consult a specialist before taking this medication, as it may affect the fetus or baby. Exercise caution when performing activities requiring concentration, such as driving or operating machinery, as this medication may cause drowsiness or dizziness. Overdose of this medication can lead to severe respiratory depression or liver damage; thus, one should adhere to the prescribed dosage and visit an emergency medical facility immediately in case of overdose. This drug may interact with other medications, so it is crucial to inform healthcare providers about any other medications being taken, especially when combined with antidepressants, anticonvulsants, or narcotic pain relievers. When storing this medication, keep it in a safe place out of reach of children to prevent misuse or abuse, and do not share it with others.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin abnormal reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and extremely severe headaches,

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
  • urticaria
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoric state
  • decreased libido
  • sleep disturbances
  • confusion
  • disturbed sense of orientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory disturbances

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

Storage

This drug should be stored in a tightly sealed container to prevent air from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. This helps maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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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.