Medication info
Tramafen Tablets

Tramafen Tablets

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

MFDS item code 200804563 · Notified 2008.04.23 · Insurance code 669803290

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
An initial dose of 2 tablets is recommended, with subsequent doses at least 6 hours apart, not exceeding 8 tablets in one day. The effective minimum dose should be administered for the shortest time possible. For elderly patients, the usual adult dose may be administered, but for those over 75 years of age, doses should be given at least 6 hours apart. For moderate renal impairment, the dosing interval should be extended to 12 hours. For severe renal impairment patients.
Child dose
For children over 12 years old, the adult dosage applies; an initial dose of 2 tablets is recommended, with subsequent doses at least 6 hours apart, not exceeding 8 tablets in one day.

Ingredients

Manufacturer
구주제약(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 effectively alleviate moderate to severe acute and chronic pain.

How to take

Adult dose

An initial dose of 2 tablets is recommended, with subsequent doses at least 6 hours apart, not exceeding 8 tablets in one day. The effective minimum dose should be administered for the shortest time possible. For elderly patients, the usual adult dose may be administered, but for those over 75 years of age, doses should be given at least 6 hours apart. For moderate renal impairment, the dosing interval should be extended to 12 hours. For severe renal impairment patients.

Child dose

For children over 12 years old, the adult dosage applies; an initial dose of 2 tablets is recommended, with subsequent doses at least 6 hours apart, not exceeding 8 tablets in one day.

Precautions

This medication may affect liver function; therefore, individuals who regularly consume more than three alcoholic beverages per day should consult a doctor or pharmacist before use. This medication may rarely cause serious skin reactions, so if you develop a rash or allergic reaction after taking it, you should stop taking it immediately and seek medical attention. The active ingredient tramadol may increase the risk of seizures, so caution should be exercised in patients with a history of seizures or those taking other medications that may increase seizure risk. Serious allergic reactions may occur while taking this medication, so if you experience symptoms such as difficulty breathing or hives, you should visit a medical facility immediately. Patients with acute or severe bronchial asthma may experience difficulty breathing when taking this medication, so it must be administered in a place where medical personnel are available. Concurrent use of this medication with alcohol or central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma, so this should be avoided, and if unavoidable, it should be used at the minimum dosage for the shortest time possible. Patients with elevated intracranial pressure or recent head injury may see their symptoms worsen when taking this medication, so caution is necessary. This medication can lead to psychological and physical dependence; therefore, close monitoring for dependence is warranted during prolonged use. This medication contains acetaminophen, which can cause liver damage in case of overdose, so care should be taken not to exceed a total daily dosage of 4,000 mg. Particularly in cases of ultra-rapid metabolism through CYP2D6, the concentration of the active metabolite may increase, raising the risk of respiratory depression; in such cases, dosage adjustments and symptom monitoring are necessary. This medication should not be administered to children under the age of 12 or to those under 18 who have undergone tonsillectomy or adenoidectomy, and it is advisable to avoid administration to adolescents aged 12 to 18 who have risk factors. Patients with sleep apnea or hypoxemia should continuously assess for worsening of symptoms while taking this medication and should reduce or discontinue the dosage if necessary. This medication may cause hyponatremia; therefore, especially elderly patients or those at risk of hyponatremia should periodically check their serum sodium levels. Care should be taken not to take other opioid analgesics or acetaminophen-containing preparations while using this medication, and you should avoid exceeding the recommended dosage. This medication may result in withdrawal symptoms when abruptly discontinued, so it is safe to taper off in accordance with a physician's instructions when discontinuing use. Drowsiness or dizziness may occur when taking this medication; therefore, caution should be exercised during hazardous activities such as driving or operating machinery. In the case of overdose, serious symptoms such as respiratory depression, seizures, or liver damage may occur, so dosage must be strictly adhered to, and immediate medical attention should be sought in case of overdose.

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 fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or catching breath, asthma attack, respiratory irregularities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • numbness
  • tremors
  • sensory disturbances
  • attention deficit.

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 ingress and should be kept at room temperature, avoiding extreme heat or cold.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablets

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.

Related searches

Search tags

Suggested searches

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.