Medication info
Arafen Semi Tablet

Arafen Semi Tablet

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

MFDS item code 200707943 · Notified 2007.07.10 · Insurance code 693900270

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and treatment response. A starting dose of 4 tablets is recommended, followed by intervals of at least 6 hours, but should not exceed 16 tablets per day. Maintain the lowest effective dose for the shortest duration possible. This medication should not be used longer than necessary, and in cases requiring long-term use due to the nature and severity of the disease, regular monitoring of the continued need for this medication should be conducted. Elderly: Administer the usual adult dose. However, for elderly patients over 75, the elimination half-life of tramadol is increased by 17% when taken orally, therefore the intervals between doses should be at least 6 hours. Renal impairment patients: For moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance less than 10 mL/min) are not recommended to take this medication. Tramadol is removed very slowly during dialysis and filtration, therefore re-dosing after dialysis for pain relief is not necessary. Liver impairment patients: Caution is advised in extending the dosing interval for patients with moderate liver impairment. This medication should not be administered to severe liver impairment patients.
Child dose
For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and treatment response. A starting dose of 4 tablets is recommended, followed by intervals of at least 6 hours, but no more than 16 tablets per day.

Ingredients

Manufacturer
(주)셀트리온제약

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 and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and treatment response. A starting dose of 4 tablets is recommended, followed by intervals of at least 6 hours, but should not exceed 16 tablets per day. Maintain the lowest effective dose for the shortest duration possible. This medication should not be used longer than necessary, and in cases requiring long-term use due to the nature and severity of the disease, regular monitoring of the continued need for this medication should be conducted. Elderly: Administer the usual adult dose. However, for elderly patients over 75, the elimination half-life of tramadol is increased by 17% when taken orally, therefore the intervals between doses should be at least 6 hours. Renal impairment patients: For moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance less than 10 mL/min) are not recommended to take this medication. Tramadol is removed very slowly during dialysis and filtration, therefore re-dosing after dialysis for pain relief is not necessary. Liver impairment patients: Caution is advised in extending the dosing interval for patients with moderate liver impairment. This medication should not be administered to severe liver impairment patients.

Child dose

For children aged 12 years and older and adults: Dosage should be adjusted according to the patient's pain level and treatment response. A starting dose of 4 tablets is recommended, followed by intervals of at least 6 hours, but no more than 16 tablets per day.

Precautions

This medicine may affect the liver, so individuals who consume large amounts of alcohol daily must consult a doctor or pharmacist before taking it. If a rash or allergic reaction appears on the skin during the use of this medication, discontinue use immediately and consult a healthcare professional. Due to the risk of seizures, caution is advised if there is a history of seizures or when taking medications that increase the risk of seizures. Patients with severe respiratory conditions may experience respiratory depression while taking this medication, so it should be administered under medical supervision. Taking this medication with alcohol or other central nervous system depressants may cause severe drowsiness or impaired breathing, so co-administration should be avoided or monitored closely. Patients with head injuries or brain disorders should be cautious, as their symptoms may worsen when taking this medication. This medication can cause dependency; therefore, dosages and duration of use must be adjusted according to doctor's advice if used long-term. Patients with poor liver function must consult a doctor before taking this medication, and dose adjustments may be necessary. This medication should not be administered to children under 12 years or specific post-surgical pediatric patients, and caution is required when used in children and adolescents. If pregnant or breastfeeding, it is essential to consult a doctor before taking this medication, and breastfeeding mothers should avoid use if possible. Drowsiness or dizziness may occur when driving or operating machinery while taking this medication, so caution is necessary. Do not exceed the prescribed dosage, and be careful not to take other medications containing acetaminophen or tramadol together. Severe side effects may occur from overdose, so strict adherence to the dosing is required, and if suspected, immediate medical attention is needed. Store this medication in a safe place out of reach of children to prevent accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mouth/eye mucous membranes, difficulty or shortness of breath, asthma attack, cough with fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, vision abnormalities, paralysis, urination problems

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
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensory disturbance

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, and it is recommended to keep it at room temperature between 1°C and 30°C. This storage method helps maintain the effectiveness of the medication and prevents deterioration.

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.