Medication info
Traplem Semi Tablet

Traplem Semi Tablet

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

MFDS item code 201405383 · Approved 2014.11.19 · Insurance code 622802150

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
An initial dosage of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, not exceeding 16 tablets per day. The effective minimum dose should be administered for as short a duration as possible. Elderly patients should receive the standard adult dosage; however, for those over 75 years of age, dosing intervals should be at least 6 hours apart. For patients with moderate renal impairment, dosing intervals should be extended to 12 hours. For patients with severe renal impairment:
Child dose
Children aged 12 and older should adjust the dosage as per adult recommendations, beginning with an initial dosage of 4 tablets and ensuring that subsequent dosing intervals are at least 6 hours apart, not exceeding 16 tablets per day.

Ingredients

Manufacturer
(주)마더스제약

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 ranging from moderate to severe.

How to take

Adult dose

An initial dosage of 4 tablets is recommended, with subsequent dosing intervals of at least 6 hours apart, not exceeding 16 tablets per day. The effective minimum dose should be administered for as short a duration as possible. Elderly patients should receive the standard adult dosage; however, for those over 75 years of age, dosing intervals should be at least 6 hours apart. For patients with moderate renal impairment, dosing intervals should be extended to 12 hours. For patients with severe renal impairment:

Child dose

Children aged 12 and older should adjust the dosage as per adult recommendations, beginning with an initial dosage of 4 tablets and ensuring that subsequent dosing intervals are at least 6 hours apart, not exceeding 16 tablets per day.

Precautions

This medication may place a burden on the liver, so individuals who regularly consume more than three drinks a day should consult with a doctor or pharmacist before taking it. This medication can rarely cause severe skin reactions; if a skin rash or hypersensitivity appears, stop taking the medication immediately and inform a medical professional. The ingredients in this medication can potentially induce seizures, so patients with a history of seizures or at risk for seizures should use it cautiously, as the risk of seizures may increase when used in combination with certain other medications. This medication can rarely cause severe allergic reactions; if symptoms like difficulty breathing or hives occur, contact a medical professional immediately. Patients with severe bronchial asthma may experience difficulty breathing while taking this medication, so it should only be administered in an environment where professional supervision is available. Taking this medication with alcohol or central nervous system depressants may cause severe drowsiness or respiratory depression, so such combinations should be avoided or used only for a short duration at the minimum dose. Patients with increased intracranial pressure or head injury should be cautious with this medication, as it may worsen symptoms due to respiratory depression and increased brain pressure. This medication can cause psychological and physical dependence, so careful monitoring for dependence is essential during prolonged use. Patients with impaired liver function should consult with a doctor before taking this medication, as its ingredients may burden the liver. Patients with certain genetic metabolic types may experience increased levels of the active ingredient and a risk of severe respiratory depression; special caution is required in these individuals. This medication is not recommended for children under 12 years of age or adolescents under 18 years after certain surgeries due to a higher risk of respiratory depression. Patients with sleep apnea or hypoxemia may experience worsened symptoms after taking this medication, so any changes in symptoms should be closely monitored. This medication can induce hyponatremia; elderly patients or those at risk for hyponatremia should have their serum sodium levels regularly checked. This medication can interact with specific other medications, so if taking other drugs, be sure to inform a doctor or pharmacist. Pregnant or nursing women should consult with a doctor before taking this medication, as it can affect the fetus or newborn, and it is safest not to use it while breastfeeding. This medication can cause drowsiness or dizziness; caution is advised while driving or operating machinery. In cases of overdose, severe respiratory depression, seizures, or liver damage may occur; therefore, adhere strictly to the prescribed dosage and seek immediate medical attention in case of overdose. This medication should be kept out of reach of children and stored safely to prevent misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylactic reactions, chest tightness, difficulty breathing, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), seizures, liver abnormalities (hepatitis, liver dysfunction, jaundice), severe neurological symptoms (severe headache, confusion, visual disturbances, paralysis, speech disturbances), significantly decreased urine output, generalized severe swelling, increased blood pressure, dyspnea, asthma attack, respiratory issues,

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
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • directional disturbance
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensation

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress, ideally at a temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Light 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.

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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.