Medication info

Soul Tracetablets

Prescription medicationTablet경구Expired
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
주식회사더유제약
Appearance
Pale yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202000542 · Approved 2020.02.03

This product's status changed to Expired on 2025.02.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults A starting dose of 4 tablets is recommended, with the subsequent dosing interval at least 6 hours apart, not to exceed 16 tablets per day. Administer the lowest effective dose possible for the shortest duration necessary. For elderly patients, administer the usual adult dose, but for those aged 75 or older, ensure that the dosing interval is at least 6 hours apart. In patients with renal impairment, moderate renal impairment (creatinine clearance).
Child dose
Children aged 12 and older and adults A starting dose of 4 tablets is recommended, with the subsequent dosing interval at least 6 hours apart, not to exceed 16 tablets per day. Administer the lowest effective dose possible.

Ingredients

Manufacturer
주식회사더유제약

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 ranging from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults A starting dose of 4 tablets is recommended, with the subsequent dosing interval at least 6 hours apart, not to exceed 16 tablets per day. Administer the lowest effective dose possible for the shortest duration necessary. For elderly patients, administer the usual adult dose, but for those aged 75 or older, ensure that the dosing interval is at least 6 hours apart. In patients with renal impairment, moderate renal impairment (creatinine clearance).

Child dose

Children aged 12 and older and adults A starting dose of 4 tablets is recommended, with the subsequent dosing interval at least 6 hours apart, not to exceed 16 tablets per day. Administer the lowest effective dose possible.

Precautions

This medication may put stress on the liver, so individuals who frequently consume alcohol in amounts exceeding a certain limit should consult a physician or pharmacist before use. This medication can rarely cause severe skin reactions; if rashes or allergic symptoms appear, discontinue use immediately and consult a healthcare provider. One of the ingredients in this medication, tramadol, may increase the risk of seizures if taken in excess of the recommended dose, and the seizure risk can further increase when taken with certain antidepressants or narcotic analgesics. This medication may be dangerous for patients with breathing difficulties or severe asthma; such patients should use it under medical supervision. This medication affects the central nervous system and may cause drowsiness or dizziness; caution is advised when driving or operating machinery. Pregnant or breastfeeding women should always consult a physician before taking this medication as it may transfer to breast milk and pose risks to the baby. This medication can interact with other analgesics or drugs, so patients should inform healthcare providers of any other medications they are taking. Overdose can result in severe respiratory depression or liver damage, so it is essential to adhere to the prescribed dosage and avoid exceeding the recommended amount. Elderly patients or those with compromised liver or kidney function may have an increased risk of side effects; special caution is required during use. This medication can cause dependence and withdrawal symptoms, so long-term users should gradually adjust or discontinue the dosage under medical guidance.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and very severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urinary 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
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnolence
  • sensation loss
  • tremors
  • paresthesia
  • attention deficit.

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 exposure to air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's efficacy for a longer time.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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.