Medication info

Phenacetin and Tramadol Extended-Release Tablets

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

MFDS item code 201900993 · 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
Adjust dosage based on the patient's pain level and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 12 hours apart. Do not exceed 8 tablets per day. Avoid prolonged use and conduct regular monitoring where prolonged use is necessary. Monitor closely for side effects such as nausea, vomiting, itching, constipation, dizziness, and drowsiness during administration.

Ingredients

Manufacturer
(주)메디카코리아

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 moderate to severe acute and chronic pain.

How to take

Adult dose

Adjust dosage based on the patient's pain level and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 12 hours apart. Do not exceed 8 tablets per day. Avoid prolonged use and conduct regular monitoring where prolonged use is necessary. Monitor closely for side effects such as nausea, vomiting, itching, constipation, dizziness, and drowsiness during administration.

Precautions

This medication may burden the liver; therefore, individuals who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before taking it. Due to ingredients included in this medication, there is a rare risk of serious skin reactions; therefore, if skin rash or allergic symptoms occur, discontinue use immediately and consult healthcare professionals. Caution is advised if taken with specific antidepressants or other central nervous system medications as this may increase the risk of seizures. This medication can very rarely cause severe allergic reactions; if experiencing difficulty breathing or a severe rash, immediate emergency treatment is necessary. Patients with bronchial asthma may be at risk of respiratory suppression, and if necessary, should be used in a monitored environment. Caution is required when taken with alcohol or benzodiazepine medications, as this may cause severe drowsiness, respiratory suppression, or coma. Patients with head injuries or increased intracranial pressure need to be cautious, as symptoms may worsen with this medication. This medication may cause dependence; therefore, it should be used according to a doctor's guidance for extended periods. Patients with impaired liver function should consult a doctor before use, and care should be taken not to exceed a daily dosage of 4,000 mg. Individuals with specific genotypes may experience faster metabolism of this drug, increasing the risk of side effects; thus, dosage adjustment or monitoring may be necessary according to a doctor's instructions. This medication should not be used in children under 12 years of age or in pediatric patients after certain surgeries, and adolescents aged 12 to 18 with specific risk factors should avoid use. This medication can cause hyponatremia (reduction of sodium concentration in the blood), so elderly patients or those with risk factors should be observed closely for symptoms. Patients allergic to this medication, those with severe respiratory depression, severe liver, kidney, or heart conditions, nursing women, or those currently taking specific medications should not take this medication. During use, drowsiness or dizziness may occur, thus caution is required when driving or operating machinery, and the risk may increase when taking other central nervous system depressants, so consulting a doctor is necessary. In case of overdose, serious respiratory depression or liver damage may occur, so adherence to the prescribed dosage is crucial, and if any unusual symptoms appear, medical attention should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, peeling skin, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination issues

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • exacerbation of hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • restlessness
  • migraine
  • worsening of migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • stupor
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stools
  • tongue swelling
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness
  • mood swings

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

Storage

Store this medication in a tightly sealed container as it may be sensitive to air or moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

Pale yellow, oblong, 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

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.