Medication info
Olfen Tablets

Olfen Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Light yellow, rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200801284 · Notified 2007.11.12 · Insurance code 646202450

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 and adults: The dosage is adjusted based on the patient's level of pain and treatment response. It is recommended to administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours apart, ensuring that no more than 8 tablets are taken in one day. The effective minimum dosage should be administered for as short a duration as possible. Do not use this drug for extended periods unnecessarily; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the continuation of this medication. Elderly Individuals Administer the usual adult dosage. However, in elderly patients over 75 years of age, oral tramadol administration has been shown to increase the elimination half-life by 17%, so dosing intervals should also be at least 6 hours apart. Patients with Renal Impairment For moderate renal impairment (creatinine clearance between 10-30 ml/min), extend the interval between doses to 12 hours. It is not recommended for severe renal impairment (creatinine clearance less than 10 ml/min). Tramadol is eliminated very slowly during hemodialysis and filtration, so it is not necessary to re-administer this drug after dialysis for pain control. Patients with Hepatic Impairment For moderate hepatic impairment, careful consideration should be given to extending the dosing interval. Do not administer this drug to patients with severe hepatic impairment.
Child dose
Applicable for children over 12 years and adults, with no separate pediatric dosage adjustment mentioned, so this is the dosage for both children and adults.

Ingredients

Manufacturer
(주)셀릭스

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 to relieve moderate to severe acute and chronic pain.

How to take

Adult dose

For children over 12 and adults: The dosage is adjusted based on the patient's level of pain and treatment response. It is recommended to administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours apart, ensuring that no more than 8 tablets are taken in one day. The effective minimum dosage should be administered for as short a duration as possible. Do not use this drug for extended periods unnecessarily; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the continuation of this medication. Elderly Individuals Administer the usual adult dosage. However, in elderly patients over 75 years of age, oral tramadol administration has been shown to increase the elimination half-life by 17%, so dosing intervals should also be at least 6 hours apart. Patients with Renal Impairment For moderate renal impairment (creatinine clearance between 10-30 ml/min), extend the interval between doses to 12 hours. It is not recommended for severe renal impairment (creatinine clearance less than 10 ml/min). Tramadol is eliminated very slowly during hemodialysis and filtration, so it is not necessary to re-administer this drug after dialysis for pain control. Patients with Hepatic Impairment For moderate hepatic impairment, careful consideration should be given to extending the dosing interval. Do not administer this drug to patients with severe hepatic impairment.

Child dose

Applicable for children over 12 years and adults, with no separate pediatric dosage adjustment mentioned, so this is the dosage for both children and adults.

Precautions

This drug may cause liver damage in individuals who regularly consume more than three alcoholic beverages per day, so consultation with a physician or pharmacist is essential. This drug can rarely cause serious skin reactions, and usage should be immediately discontinued if a rash or allergic symptoms occur. The tramadol component increases the risk of seizures if the recommended dosage is exceeded, and the risk of seizures is heightened when combined with certain antidepressants or other central nervous system medications. This drug can rarely trigger serious allergic reactions, so individuals with hypersensitivity should not use it and must immediately inform healthcare personnel if symptoms occur. Patients with severe respiratory conditions may experience life-threatening respiratory depression when using this drug, so it should only be administered in a setting where healthcare personnel are present. Co-administration of this drug with alcohol or benzodiazepines can lead to severe drowsiness or respiratory depression, so caution is advised. Patients with elevated intracranial pressure or head injuries should use this drug carefully, as symptoms may worsen. This drug can lead to mental and physical dependence, so careful monitoring for dependence is required during prolonged use. Due to the presence of acetaminophen, patients with liver dysfunction must consult a physician before taking this drug and must be careful not to exceed the maximum daily dose of 4,000 mg. Particularly, patients with a rapid genetic metabolism, children under 12 years old, and adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy should not take this drug. Patients with sleep apnea or hypoxia may experience exacerbation of symptoms after taking this drug, thus continuous monitoring is necessary. Elderly patients or those at risk of hyponatremia should be closely monitored for the occurrence of hyponatremia while taking this drug. This drug may interact with certain medications, so patients must inform healthcare personnel if they are taking other drugs, particularly when taking MAO inhibitors, antidepressants, antibiotics, and central nervous system depressants, caution should be exercised. Women who are pregnant or breastfeeding should consult a healthcare professional before taking this drug, and breastfeeding mothers are advised to avoid its use. This drug may cause drowsiness or dizziness, requiring caution when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, or liver damage may occur, so recommended dosages should be adhered to, and one should seek immediate medical attention if any suspicious symptoms arise. This drug should be stored in a secure place out of reach of children, and care should be taken to prevent misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), profound drowsiness, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disturbed sense of direction
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnolence
  • sensory loss
  • tremors
  • sensations

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

Storage

This drug should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is best to keep it away from direct sunlight and at room temperature below 25 degrees.

Appearance and packaging

Appearance

Light 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

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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.