Medication info
Tramacet Semi Extended-Release Tablet

Tramacet Semi Extended-Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Pale yellow round extended-release film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201506598 · Approved 2015.09.17 · Insurance code 644102740

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
The dosage should be adjusted based on the level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, and subsequent doses should be spaced at least 12 hours apart. The maximum daily dose should not exceed 8 tablets. Regular monitoring should be conducted for patients needing long-term use. Elderly patients should generally be given the standard adult dosage, but those aged over 75 should be dosed at intervals of at least 12 hours.

Ingredients

Manufacturer
제이더블유신약(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 or chronic pain that ranges from moderate to severe.

How to take

Adult dose

The dosage should be adjusted based on the level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, and subsequent doses should be spaced at least 12 hours apart. The maximum daily dose should not exceed 8 tablets. Regular monitoring should be conducted for patients needing long-term use. Elderly patients should generally be given the standard adult dosage, but those aged over 75 should be dosed at intervals of at least 12 hours.

Precautions

This medication may put strain on the liver, so those who frequently consume more than a certain amount of alcohol daily should consult with a doctor or pharmacist. Otherwise, there is a risk of liver damage. The ingredients in this medication can rarely cause serious skin reactions; if a rash or allergic symptoms appear, stop taking the medication immediately and inform a professional. This medication can induce seizures; therefore, individuals with a history of seizures or a high risk of seizures should exercise particular caution. The risk of seizures may increase when taken with certain antidepressants or other narcotic analgesics. Serious allergic reactions can occur rarely; if symptoms like shortness of breath, rash, or swelling appear, seek immediate medical attention. Individuals with severe respiratory diseases should be administered this medication under appropriate equipment in a hospital setting, as there is a risk of suppressed breathing. Taking this medication with alcohol or central nervous system depressants like sedatives can cause severe drowsiness, respiratory depression, and loss of consciousness, so it should be avoided or taken under the guidance of a professional. Patients with head injuries or increased intracranial pressure should be cautious as the risk of respiratory depression may exacerbate their symptoms when taking this medication. This medication can lead to physical and psychological dependency; thus, patients should adjust dosages according to their doctor's instructions for long-term use and gradually reduce dosage when discontinuing. Patients with impaired liver function must consult a doctor before taking this medication and should not take it with other acetaminophen-containing medications to reduce the risk of hepatotoxicity. Individuals with certain genetic metabolic rates may excessively accumulate the active ingredient of this medication, increasing the risk of respiratory depression, necessitating dosage adjustment and symptom monitoring. Children under 12 years old and adolescents under 18 years old who have undergone tonsillectomy should not take this medication. Adolescents aged 12 to 18 should also avoid taking it if there are specific risk factors. This medication can cause hyponatremia, leading to lowered sodium levels in the blood; therefore, especially elderly patients or those with risk factors should monitor symptoms. When taking this medication, ensure to avoid exceeding the recommended dosage, and refrain from taking other tramadol or acetaminophen products simultaneously. Patients with a history of substance abuse or mental illness may face an increased risk of dependency when taking this medication and should be closely monitored. Abrupt cessation of this medication may lead to withdrawal symptoms, so dosage should be gradually reduced according to the doctor's instructions. When combined with certain antidepressants, narcotic analgesics, or other central nervous system depressants, respiratory depression and sedation may worsen, requiring careful monitoring of dosage and the patient. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, as it may affect the fetus. Breastfeeding women should avoid this medication as it may pass through breast milk, potentially causing sedation or respiratory depression in the nursing infant; consultation with a professional is advisable. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In case of overdose, serious respiratory depression or liver damage may occur, so it is critical to adhere strictly to the dosage and seek immediate emergency measures in case of excessive intake.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, breathing problems with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, liver abnormalities (jaundice), sudden onset

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • increased anxiety
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • paresthesia
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stools
  • swelling of the tongue
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • irritability

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness is safely maintained.

Appearance and packaging

Appearance

Pale yellow round extended-release film-coated tablets

Package unit

30 tablets/bottle, 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.