Medication info

Fenacet Sustained-release Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Light yellow, oblong, sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201900994 · Approved 2019.02.19

This product's status changed to Expired on 2024.02.19. 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 recommended initial dose is one tablet, with subsequent doses spaced at least 12 hours apart, not to exceed four tablets per day. Do not administer this medication for longer than necessary, and in cases where prolonged treatment is required due to the nature and severity of the condition, regular monitoring should be conducted to confirm the need for continued administration of this medication. Nausea, vomiting, and itching may occur during administration.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate 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

The recommended initial dose is one tablet, with subsequent doses spaced at least 12 hours apart, not to exceed four tablets per day. Do not administer this medication for longer than necessary, and in cases where prolonged treatment is required due to the nature and severity of the condition, regular monitoring should be conducted to confirm the need for continued administration of this medication. Nausea, vomiting, and itching may occur during administration.

Precautions

This medicine can put strain on the liver, so individuals who frequently consume alcohol above a certain amount daily should consult with a doctor or pharmacist before taking this medication. This medication can rarely cause serious skin reactions, so if any rash or allergic symptoms appear, discontinue use immediately and consult healthcare personnel. Tramadol, one of the active ingredients in this medication, can induce seizures; therefore, patients with a history of seizures or those with a high risk of seizures should be particularly cautious. Taking tramadol with certain antidepressants or other central nervous system medications may increase the risk of seizures; anyone taking other medications must inform their healthcare provider. This medication can rarely cause serious allergic reactions, and it may pose life-threatening respiratory difficulties in patients with acute asthma, so such patients should be monitored in a hospital when using this medication. Taking this medication with alcohol or sedatives can lead to severe drowsiness, respiratory depression, coma, etc., so combination should be avoided and, if unavoidable, should be taken at the lowest dose for the shortest duration. Patients with head injuries or brain disorders should be cautious when taking this medication as it may increase intracranial pressure due to respiratory depression. This medication can cause opioid dependence, so long-term use should be managed carefully considering the risks of dependence or abuse. Patients with reduced liver function must consult with a doctor before taking this medication and should be cautious to ensure that the daily dose does not exceed 4,000 mg. Individuals with a genetic predisposition for rapid metabolism of this medication may face severe respiratory depression risk; in such cases, dose adjustments or alternative medications should be considered. This medication should not be administered to children under the age of 12 or adolescents under 18 after certain surgeries, and especially in children at high risk of respiratory depression should be avoided. Elderly patients or those at risk for hyponatremia should be closely monitored for symptoms of hyponatremia while on this medication. This medication should not be administered to individuals with hypersensitivity to its components, to patients with central nervous system drug intoxication, severe respiratory depression, severe liver, kidney, or heart function impairment, or those taking certain medications. Drowsiness or dizziness may occur when taking this medication, so caution is required when driving or operating machinery. In case of overdose, severe respiratory depression or liver damage may occur, hence it is crucial to adhere strictly to the prescribed dosage and to visit a health facility immediately if in doubt. This medication can interact with various drugs, so if any other medications are being taken, healthcare personnel must be informed. Pregnant or breastfeeding women should consult with a doctor before taking this medication, and it is safest to avoid taking it during breastfeeding.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reaction, chest tightness, difficulty breathing, asthma attack, yellowing of the skin or eyes (jaundice), liver abnormalities (jaundice), sudden and severe headache, seizures, confusion, visual disturbances, paralysis, serious neurological symptoms, significantly reduced urine output, severe edema or urination problems, cold sweat, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • exacerbated hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • tension
  • migraine
  • aggravated migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • difficulty swallowing
  • blood in stool
  • swelling of the tongue
  • decreased appetite
  • anxiety
  • confusion
  • intoxication
  • insomnia
  • nervousness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety for a long time.

Appearance and packaging

Appearance

Light yellow, oblong, sustained-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.