Medication info
Tramiphen Semi Tablet

Tramiphen Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200711885 · Notified 2007.10.29 · Insurance code 657802010

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Administer 4 tablets as the initial dose, and ensure that the dosage interval is at least 6 hours thereafter, not exceeding 16 tablets per day. Administer the effective minimum dose for as short a duration as possible. Elderly patients should typically be given a standard adult dose, but for those over 75 years of age, the dosage interval should be at least 6 hours. For patients with moderate renal impairment, the dosing interval should be extended to 12 hours, and for those with severe renal impairment or severe liver impairment, no dosing recommendation should be made.
Child dose
Pediatric patients aged 12 and older should follow the same dosing as adults.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • moderate to severe chronic pain
View approved original text

This medication is used to relieve acute and chronic pain that ranges from moderate to severe.

How to take

Adult dose

Administer 4 tablets as the initial dose, and ensure that the dosage interval is at least 6 hours thereafter, not exceeding 16 tablets per day. Administer the effective minimum dose for as short a duration as possible. Elderly patients should typically be given a standard adult dose, but for those over 75 years of age, the dosage interval should be at least 6 hours. For patients with moderate renal impairment, the dosing interval should be extended to 12 hours, and for those with severe renal impairment or severe liver impairment, no dosing recommendation should be made.

Child dose

Pediatric patients aged 12 and older should follow the same dosing as adults.

Precautions

This medication may cause liver damage if taken by someone who regularly consumes more than three drinks a day, so it is essential to consult a doctor or pharmacist. If skin rash or hypersensitivity occurs after taking this medication, discontinue use immediately and seek medical attention. Tramadol, the active ingredient in this medication, may increase the risk of seizures if the recommended dosage is exceeded, and the risk of seizures may be heightened when taken with certain antidepressants or narcotic analgesics. Rarely, severe allergic reactions may occur during the use of this medication, so notify medical staff immediately if abnormal symptoms arise. Patients with acute and severe bronchial asthma may experience difficulty breathing when using this medication, so it should only be used in facilities equipped with specialized equipment. Caution is required when using this medication with alcohol or central nervous system depressants as it may lead to excessive drowsiness, respiratory depression, or coma. Caution should be exercised for patients with head trauma or increased intracranial pressure, as respiratory depression may worsen symptoms of increased brain pressure when taking this medication. This medication may cause a dependence similar to that of narcotic analgesics like morphine, so it is important to closely monitor for signs of dependence with long-term use. Patients with impaired liver function should consult a doctor before taking this medication, and should not take it with other acetaminophen products due to the risk of liver damage. Especially in ultra-rapid metabolizers of CYP2D6, the active metabolite of this medication may increase sharply, leading to severe respiratory depression; dosage adjustments and monitoring are advised. This medication should not be administered to children under 12 years of age or adolescents under 18 who have had specific surgeries, nor to children exhibiting symptoms of sleep apnea. This medication can induce hypoxia related to sleep apnea; therefore, ongoing observation of symptoms is necessary, and dosage may need to be reduced or discontinued as required. Elderly patients or those at risk of hyponatremia should be closely monitored for the occurrence of hyponatremia. This medication can interact with certain drugs, so inform a doctor or pharmacist of any other medications being taken, especially caution is needed when combined with MAO inhibitors, antidepressants, or central nervous system depressants. Pregnant or breastfeeding women should consult medical staff before taking this medication; it is safe to discontinue breastfeeding while taking this medication. This medication may cause drowsiness or dizziness, so caution is advised while driving or operating machinery. In the case of an overdose, severe respiratory depression, seizures, or liver damage may occur, so follow the recommended dosage strictly, and seek emergency treatment if overdose is suspected. This medication should be stored in a safe place out of reach of children to avoid misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, breathlessness or difficulty in breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary

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
  • gas
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • neuroticism
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • directional sense disorder
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • daytime sleepiness
  • sensory impairment
  • tremors
  • sensation

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

Storage

This medication should be stored in a tightly sealed container that is air-tight, preferably at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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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.