Medication info
Tramadol Semi Tablet

Tramadol Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201310117 · Approved 2013.11.13 · Insurance code 645404160

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
It is recommended to administer an initial dose of 4 tablets, followed by subsequent dosing intervals of at least 6 hours apart, not exceeding 16 tablets in a day. The effective minimum dose should be given for the shortest duration possible. Elderly patients should receive the usual adult dose, but those over 75 should have intervals of at least 6 hours between doses. In moderate renal impairment, intervals should be extended to 12 hours, while in severe renal and hepatic impairment...
Child dose
Children over 12 years should adjust the dosage according to the degree of the patient's pain and treatment response, recommending an initial dose of 4 tablets. The subsequent dosing interval should be at least 6 hours apart, but not exceeding 1...

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

This medication is used to relieve acute and chronic pain from moderate to severe.

How to take

Adult dose

It is recommended to administer an initial dose of 4 tablets, followed by subsequent dosing intervals of at least 6 hours apart, not exceeding 16 tablets in a day. The effective minimum dose should be given for the shortest duration possible. Elderly patients should receive the usual adult dose, but those over 75 should have intervals of at least 6 hours between doses. In moderate renal impairment, intervals should be extended to 12 hours, while in severe renal and hepatic impairment...

Child dose

Children over 12 years should adjust the dosage according to the degree of the patient's pain and treatment response, recommending an initial dose of 4 tablets. The subsequent dosing interval should be at least 6 hours apart, but not exceeding 1...

Precautions

This medication may put a strain on the liver; therefore, individuals who consume large amounts of alcohol daily should consult a doctor or pharmacist before taking it. If skin rashes or itching occur while taking this medication, stop taking it immediately and inform your doctor. Exceeding the recommended dosage may increase the risk of seizures, so ensure you follow the prescribed dose. Taking it alongside certain antidepressants or other narcotic analgesics may increase seizure risk, so consult a doctor. Patients with asthma who have difficulty breathing may be at risk of life-threatening situations when taking this medication, and it should only be used in a facility equipped for such situations. Care should be taken as combining this medication with alcohol or sedatives may lead to severe drowsiness, respiratory depression, or coma. Patients with head injuries or brain disorders should use this medication cautiously as symptoms may worsen. This medication may cause physical and psychological dependence, so it should be taken under a doctor's guidance if used for a long time. Patients with poor liver function should consult a doctor before taking this medication and should not take it with other acetaminophen-containing medications. Children, especially those under 12 years, or adolescents under 18 who have undergone certain surgeries should not use this medication due to increased respiratory depression risk. This medication may induce sleep apnea or hypoxemia; thus, symptoms should be periodically checked. Sodium deficiency may occur, so elderly patients or those with risk factors should have their condition monitored through blood tests. This medication may interact with certain drugs; therefore, if you are taking other medications, inform your doctor, as caution is required when used together. Women who are pregnant or breastfeeding should consult a doctor before taking this medication as it may affect the fetus or newborn, and decisions should be made cautiously. Drowsiness or dizziness may occur when taking this medication, so care should be taken when driving or operating machinery. In case of overdose, there is a risk of severe respiratory depression, seizures, or liver damage, so always adhere to the prescribed dosage, and if unusual symptoms occur, visit a medical institution immediately. This medication should be stored out of reach of children to prevent misuse or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), severe allergic reactions (anaphylaxis), liver abnormalities (hepatitis, liver dysfunction, jaundice), respiratory issues (life-threatening respiratory depression, worsening of asthma, shortness of breath), seizures, severe neurological symptoms (delirium, speech disorders, confusion, worsening migraines, stupor, loss of consciousness), severe swelling, high blood pressure, cardiovascular issues (myocardial infarction)

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
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • paresthesia
  • attention issues

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, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain its effectiveness for a longer time.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

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.