Medication info
Gentraset Semi Tablet

Gentraset Semi Tablet

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

MFDS item code 201507360 · Approved 2015.10.23

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For pediatric patients aged 12 years and older and adults, the dosage should be adjusted according to the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals of at least 6 hours thereafter, ensuring not to exceed 16 tablets in one day. Administer the effective minimum dose for the shortest duration possible. Elderly patients should receive the standard adult dose; however, for those aged 75 years or older, administer with intervals of at least 6 hours. Moderate
Child dose
Pediatric patients aged 12 years and older should be dosed in the same manner as adults.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For pediatric patients aged 12 years and older and adults, the dosage should be adjusted according to the patient's pain level and treatment response. An initial dose of 4 tablets is recommended, with intervals of at least 6 hours thereafter, ensuring not to exceed 16 tablets in one day. Administer the effective minimum dose for the shortest duration possible. Elderly patients should receive the standard adult dose; however, for those aged 75 years or older, administer with intervals of at least 6 hours. Moderate

Child dose

Pediatric patients aged 12 years and older should be dosed in the same manner as adults.

Precautions

This medicine should be discussed with a doctor or pharmacist if you regularly consume three or more alcoholic drinks daily due to the risk of liver damage. Due to the acetaminophen ingredient, serious skin allergic reactions can rarely occur, so if a rash or hypersensitivity reaction develops, discontinue use immediately. Tramadol can increase the risk of seizures, so caution is required for those with a history of seizures or those at risk. Serious allergic reactions can rarely occur while taking this medication, so if symptoms such as hives or difficulty breathing arise, inform medical personnel immediately. In patients with acute bronchial asthma, there is a risk of respiratory depression; thus, it should only be administered in a facility with special equipment. Taking this medicine with alcohol or benzodiazepine medications can lead to severe drowsiness or respiratory depression, so concurrent use should be avoided. Patients with head injuries or brain disorders should be cautious as there is a risk of increased intracranial pressure while taking this medication. This medication can lead to dependence similar to morphine, so the risk of dependence should be considered with long-term use. Patients with reduced liver function should consult a doctor before taking this medication due to the risk of liver toxicity. Individuals genetically predisposed to rapid drug metabolism may experience increased concentrations of the active ingredient, raising the risk of respiratory depression, hence caution is needed. This medication should not be used in children under 12 years or in certain postoperative pediatric patients, and adolescents aged 12 to 18 years should avoid it if risk factors are present. Patients with sleep apnea or hypoxia may experience worsening symptoms after taking this medication, so their condition should be closely monitored. Elderly patients or those at risk of hyponatremia should be carefully monitored for potential occurrence of hyponatremia. This medication should not be administered to certain patients, such as those allergic to its components, those in severe respiratory depression, or those with head injuries. When combined with other central nervous system depressants, the risk of seizures and respiratory depression increases, so it should be used cautiously. Pregnant or breastfeeding women should avoid using this medication or thoroughly consult a physician due to its effects on the fetus and newborn. Drowsiness or dizziness may occur while driving or operating machinery, so caution is necessary. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur, so the dosage must be strictly adhered to, and in emergencies, contact a medical institution immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough accompanied by fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), severe general lethargy, sudden and severe headache, thunderclap headache, seizures, delirium, visual disturbances, paralysis, urinary disturbances.

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
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensory disturbances.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. Also, it is advisable to store it at room temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Pale yellow oblong 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

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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.