Medication info

Gentraset Tablet

Prescription medication경구Expired
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
Pale yellow, oblong film-coated tablet
Packaging
30 Tablets/bottle, 300 Tablets/bottle
Approval status
Expired

MFDS item code 201507361 · Approved 2015.10.23 · Insurance code 644603270

This product's status changed to Expired on 2025.10.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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: Dosage should be adjusted according to the severity of pain and treatment response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours between doses, with a maximum of 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Long-term administration should be avoided unless required by the characteristics and severity of the disease. In such cases, regular monitoring should be performed to confirm whether to continue this medication.
Child dose
Children aged 12 and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours between doses, with a maximum of

Ingredients

Manufacturer
조아제약(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: Dosage should be adjusted according to the severity of pain and treatment response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours between doses, with a maximum of 8 tablets per day. The effective minimum dose should be administered for the shortest duration possible. Long-term administration should be avoided unless required by the characteristics and severity of the disease. In such cases, regular monitoring should be performed to confirm whether to continue this medication.

Child dose

Children aged 12 and older and adults: Dosage should be adjusted according to the severity of pain and treatment response. An initial dose of 2 tablets is recommended, followed by intervals of at least 6 hours between doses, with a maximum of

Precautions

This medication may put strain on the liver, so individuals who regularly consume more than three alcoholic drinks per day should consult a doctor or pharmacist before taking this medication or other analgesics. During treatment with this medication, serious skin reactions such as severe rashes or blisters may occur, so if skin rashes or allergy symptoms develop, discontinue immediately and consult healthcare personnel. The main ingredient, tramadol, may trigger seizures, therefore patients with a history of seizures or those at increased risk should use with caution, as concomitant use with certain antidepressants or other narcotic analgesics may further increase the risk of seizures. Patients with severe respiratory diseases, especially those with acute or severe bronchial asthma, face life-threatening respiratory depression when taking this medication, so it must be administered in an environment where healthcare personnel can monitor. Co-administration of this medication with alcohol or benzodiazepines can lead to severe drowsiness, respiratory depression, coma, or in severe cases, death; therefore, such combinations should be avoided. Patients with elevated intracranial pressure or head injuries require caution with this medication, as respiratory depression may elevate intracranial pressure further. Tramadol may cause physical and psychological dependence, so the duration and dosage should be adjusted to consider the potential for dependence in long-term use. This medication is primarily metabolized in the liver, so patients with severely impaired liver function should not take it or should do so with extreme caution, and due to the acetaminophen component, it is important to ensure that the total daily dose does not exceed 4,000mg. In particular, ultra-rapid metabolizers of CYP2D6 may have increased concentrations of the active metabolite, raising the risk of respiratory depression; therefore, dosage adjustments and symptom monitoring are required. This medication should not be administered to children under 12 years or to individuals under 18 years who have undergone tonsillectomy or adenoidectomy, and also to adolescents aged 12 to 18 years at higher risk of respiratory depression. This medication may induce or exacerbate sleep apnea and hypoxemia, so patients with these symptoms should consistently monitor their condition and reduce or cease the medication dosage as necessary. Hyponatremia may occur, thus older adults or patients at risk for hyponatremia should regularly check their serum sodium levels. Patients allergic to any components of this medication, individuals with central nervous system drug overdose, those with severe respiratory depression, head injury patients, individuals taking or having taken MAO inhibitors within the last 14 days, patients with severe liver, kidney, or heart dysfunction, or nursing mothers should not take this medication. This medication may have side effects such as drowsiness or dizziness, necessitating caution when driving or operating machinery, especially when taken in conjunction with alcohol or other central nervous system depressants. In cases of overdose, dangerous symptoms such as severe respiratory depression, seizures, or liver damage may arise, so the recommended dosage must be strictly adhered to, and in cases of emergency, contact medical services immediately. This medication should be stored in a secure place out of reach of children and care should be taken to prevent accessibility to others to avoid abuse or 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 fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with coughing and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • indigestion
  • abdominal pain
  • discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • impaired sense of direction
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucination
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory disturbance

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, and kept in a cool place at or below room temperature (25 degrees). This storage method helps maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Pale yellow, oblong 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.

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.