Medication info
Gontrasetsemi Sustained Release Tablet

Gontrasetsemi Sustained Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pale yellow round sustained release film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Active

MFDS item code 202002522 · Approved 2020.04.09 · Insurance code 073000350

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
It is recommended to start with a dose of 2 tablets, and subsequent doses should be given at intervals of at least 12 hours, not to exceed 8 tablets per day. This medication should not be administered for longer than necessary. If long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether continued administration is warranted. In elderly patients, standard adult dosages are advised; however, in patients over 75 years old, it is important to ensure a dosing interval of at least 12 hours.

Ingredients

Manufacturer
건일바이오팜주식회사

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

It is recommended to start with a dose of 2 tablets, and subsequent doses should be given at intervals of at least 12 hours, not to exceed 8 tablets per day. This medication should not be administered for longer than necessary. If long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether continued administration is warranted. In elderly patients, standard adult dosages are advised; however, in patients over 75 years old, it is important to ensure a dosing interval of at least 12 hours.

Precautions

This medication may put a burden on the liver, so individuals who regularly consume more than a certain amount of alcohol daily should consult with a doctor or pharmacist before use. If unusual symptoms such as rash or allergic reactions occur while taking this medication, discontinue use immediately and consult a healthcare professional. One of the ingredients in this medication may increase the risk of seizures, so caution is necessary for those with a history of seizures or those taking other medications that may trigger seizures. There is a rare risk of severe allergic reactions during the use of this medication; if difficulty breathing or severe skin reactions occur, immediate emergency measures should be taken. For patients with acute asthma, this medication may suppress breathing, so it should only be administered in an environment where healthcare professionals can monitor the patient. Taking this medication with alcohol or central nervous system depressants can lead to excessive drowsiness or respiratory depression, and coma; therefore, it should be avoided or used with great caution. Patients with head injuries or brain diseases should be careful as this medication may increase intracranial pressure or worsen respiratory issues. This medication may lead to physical or psychological dependence in some individuals, so it should be used with caution considering the potential for dependence if taken over a long period. Patients with impaired liver function are at a greater risk of liver damage when using this medication, so it should only be taken after consulting with a doctor. Individuals with a certain genetic metabolism rate may experience excessive effects of the active ingredient, leading to respiratory depression; in such cases, dosage adjustments or alternative medications may be necessary. This medication should not be administered to children under 12 years of age or children after certain surgeries; adolescents should also avoid use in the presence of risk factors. Elderly patients or those with reduced kidney and liver function should be even more cautious when taking this medication, and dosage adjustments may be needed. Pregnant or breastfeeding women should consult with a healthcare professional before taking this medication, as it may pose risks to the fetus or newborn. This medication can cause drowsiness or dizziness, so caution is necessary when driving or operating machinery. In cases of overdose, there is a risk of severe respiratory depression or liver damage, so the prescribed dosage should be strictly adhered to, and medical attention should be sought immediately in case of overdose.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output,

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • fainting
  • withdrawal symptoms
  • hypertension
  • aggravated hypertension
  • hypotension
  • arrhythmia
  • palpitations
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  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • tension
  • migraines
  • involuntary muscle contractions
  • sensory abnormalities
  • confusion
  • dizziness
  • nausea
  • constipation
  • diarrhea
  • indigestion
  • flatulence
  • dry mouth
  • vomiting
  • difficulty swallowing
  • bloody stools
  • tongue swelling
  • loss of appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness
  • drowsiness
  • forgetfulness
  • depersonalization

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 exposure to air or moisture. Additionally, it should be kept at room temperature between 1°C and 30°C, avoiding extremely hot or cold conditions.

Appearance and packaging

Appearance

Pale yellow round sustained release film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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

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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.