Medication info
Danophen Tablet

Danophen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201903793 · Approved 2019.06.10 · Insurance code 658106360

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children 12 years and older and adults: It is recommended to administer 2 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets in one day. The effective lowest dose should be administered for the shortest period possible. Elderly: Administer the usual adult dose, but for individuals over 75 years, the dosing interval should be at least 6 hours. Patients with renal impairment: Moderate renal impairment patients should extend dosing intervals to 12 hours.
Child dose
For children 12 years and older and adults: It is recommended to administer 2 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets in one day. The effective lowest dose should be administered for the shortest period possible.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This drug is used to relieve moderate to severe acute and chronic pain.

How to take

Adult dose

For children 12 years and older and adults: It is recommended to administer 2 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets in one day. The effective lowest dose should be administered for the shortest period possible. Elderly: Administer the usual adult dose, but for individuals over 75 years, the dosing interval should be at least 6 hours. Patients with renal impairment: Moderate renal impairment patients should extend dosing intervals to 12 hours.

Child dose

For children 12 years and older and adults: It is recommended to administer 2 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets in one day. The effective lowest dose should be administered for the shortest period possible.

Precautions

This medication may pose a risk of liver damage if taken by individuals who regularly consume more than three alcoholic drinks daily; therefore, consultation with a physician or pharmacist is essential. This medication may rarely cause serious skin reactions, and if rash or allergic symptoms occur after taking the drug, discontinue use immediately and consult a healthcare professional. The tramadol ingredient in this medication can increase the risk of seizures if the recommended dosage is exceeded or if taken with certain medications, so caution is required. When administered to patients with acute and severe asthma, there is an increased risk of respiratory depression, so it should be used in a monitored environment, and consideration should be given to using other non-narcotic analgesics. The concomitant use of this medication with alcohol or central nervous system depressants can cause severe sedation and respiratory depression, so caution is advised if used together. Patients with increased intracranial pressure or head injuries may experience worsening symptoms when taking this medication, so it should be used cautiously. This drug can cause psychological and physical dependence, so long-term use should be closely monitored for signs of dependency. Patients with impaired liver function must consult with their physician before taking this medication, as acetaminophen overdose can lead to severe liver damage. In particular, patients who are ultra-rapid metabolizers of CYP2D6 may rapidly produce the active metabolite of this drug, increasing the risk of respiratory depression, necessitating dosage adjustments and monitoring. This medication should not be administered to children under 12 years of age or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy. For patients with sleep apnea, this drug may exacerbate symptoms, requiring careful evaluation and, if necessary, dosage adjustment or discontinuation. For patients at risk of hyponatremia, it is recommended to periodically monitor blood sodium levels during the use of this medication. This drug is contraindicated or requires cautious administration in certain patient populations, so consultation with a healthcare professional before use is mandatory, and directions must be followed. Possible adverse effects during use include nausea, vomiting, dizziness, drowsiness, rash, etc.; report any severe symptoms immediately to a healthcare provider. This medication may cause drowsiness or dizziness while driving or operating machinery, so caution is necessary during such activities. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur, hence it is crucial to adhere to the prescribed dosage, and immediate emergency treatment is required in the event of overdose. This medication should be stored safely out of reach of children to prevent drug misuse and 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 fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty or shortness of breath, asthma attack, respiratory complications with cough and fever, yellowing of skin or eyes (jaundice), profound fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, etc.

Mild side effects

  • Loss of 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 disorders
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • etc.

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 or moisture from entering. It is best to maintain a storage temperature between 1 degree to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

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

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.