Medication info

Atradol Semi-Extended Release Tablet

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202002318 · Approved 2020.04.02

This product's status changed to Approval withdrawn on 2025.02.21. 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
Adult dose
The dosage should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, followed by administration at intervals of at least 12 hours, not to exceed 8 tablets per day. Avoid unnecessary long-term use of this medication; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to determine the necessity of continued use of this medication.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • severe acute pain
  • moderate chronic pain
  • severe chronic pain
View approved original text

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

How to take

Adult dose

The dosage should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, followed by administration at intervals of at least 12 hours, not to exceed 8 tablets per day. Avoid unnecessary long-term use of this medication; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to determine the necessity of continued use of this medication.

Precautions

This medication may put a strain on the liver; thus, individuals who regularly consume more than a certain amount of alcohol daily must consult a doctor or pharmacist before taking this medication. The ingredients in this medication can rarely cause serious skin reactions; therefore, if a rash or allergy symptoms appear, stop taking it immediately and notify a healthcare professional. This medication carries a risk of seizures, so patients with a history of seizures or at high risk of seizures should take caution while using it, and the risk of seizures may increase when taken with certain antidepressants or other medications. Severe allergic reactions can occur rarely; if symptoms like difficulty breathing or swelling of the face and neck occur, immediate emergency treatment should be sought. Patients with acute bronchial asthma may experience severe respiratory issues when taking this medication, so it should only be administered in facilities equipped with special medical equipment. Taking this medication with alcohol or central nervous system depressants (sleeping pills, sedatives, etc.) may cause severe drowsiness, respiratory depression, or lead to coma; therefore, it should be avoided or used with extreme caution. Patients with head injuries or brain diseases may have exacerbated symptoms due to respiratory depression and increased intracranial pressure during the use of this medication. This medication may cause dependence; therefore, long-term use should be monitored carefully for signs of dependence, and dosage should be adjusted as necessary. Patients with compromised liver function or liver disease must consult a doctor before taking this medication, as there is a risk of liver damage, and care must be taken not to use it with other acetaminophen products. Patients with specific genetic metabolic characteristics may have excessive accumulation of the active ingredients in this medication, increasing the risk of respiratory depression; therefore, dosage adjustments or alternative medications should be considered for such patients. This medication should not be administered to children under 12 years old or to adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy; special caution is also required for some patients aged 12 to 18 due to potential risks. During the use of this medication, hyponatremia (reduced sodium levels in the blood) may occur; therefore, monitoring of symptoms is necessary, especially for the elderly or patients with risk factors. Do not exceed the recommended dosage when taking this medication and avoid concomitant use with other tramadol or acetaminophen preparations. Sudden discontinuation of this medication may lead to withdrawal symptoms, so dosage should be gradually reduced according to a doctor's instructions. Women who are pregnant or may become pregnant must consult a doctor before taking this medication, and breastfeeding mothers are advised to avoid its use. This medication may cause drowsiness or dizziness, so dangerous activities such as driving or operating machinery should be avoided after taking it. In case of overdose, there is a risk of severe respiratory depression, liver damage, etc., so seek immediate medical attention for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, decreased urine output

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmias
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • hypertonia
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • perceptual abnormalities
  • confusion
  • dizziness
  • headache
  • insomnia
  • sensory disturbances
  • drowsiness
  • taste disturbances
  • involuntary muscle contractions
  • tremors
  • migraine
  • nausea
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is also advisable to store it at room temperature between 1°C and 30°C. Storing it this way can help maintain the efficacy of the medication for a longer duration.

Appearance and packaging

Appearance

Pale yellow round extended-release 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.