Medication info
Ranofen Tablet

Ranofen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
한국코러스(주)
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200804702 · Notified 2008.04.25 · Insurance code 647201840

Summary

Main use
Management of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older as well as adults should adjust the dosage based on the patient’s level of pain and therapeutic response. An initial dose of two tablets is administered, and the interval between doses should be at least 6 hours. Do not exceed a maximum of 8 tablets in one day. The effective minimum dosage should be administered for the shortest duration possible, and prolonged use beyond necessity should be avoided. For elderly patients aged 75 and older, the interval between doses should be at least 6 hours.
Child dose
Children aged 12 and older should follow the same dosage and administration as adults.

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

Management of moderate to severe acute and chronic pain

  • Moderate pain
  • severe 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

Children aged 12 and older as well as adults should adjust the dosage based on the patient’s level of pain and therapeutic response. An initial dose of two tablets is administered, and the interval between doses should be at least 6 hours. Do not exceed a maximum of 8 tablets in one day. The effective minimum dosage should be administered for the shortest duration possible, and prolonged use beyond necessity should be avoided. For elderly patients aged 75 and older, the interval between doses should be at least 6 hours.

Child dose

Children aged 12 and older should follow the same dosage and administration as adults.

Precautions

This medication may burden the liver, so individuals who regularly consume more than three glasses of alcohol daily must consult a physician or pharmacist before use. During the use of this medication, there may be severe rashes or allergic reactions on the skin; if symptoms such as rashes or hypersensitivity occur, discontinue use immediately and consult with medical personnel. One of the main ingredients, tramadol, can induce seizures; therefore, patients with a history of seizures or those at high risk for seizures should use it cautiously, as the risk of seizures may increase when combined with certain antidepressants or opioid analgesics. Rarely, a severe allergic reaction known as anaphylaxis may occur during the use of this medication; if symptoms such as difficulty breathing or severe rash appear, visit a medical institution immediately. Patients with severe respiratory diseases, particularly acute and severe bronchial asthma, may face a risk of respiratory suppression while using this medication, hence it should be used under medical supervision. Taking this medication with alcohol or central nervous system depressants like benzodiazepines can cause dangerous side effects such as severe drowsiness, respiratory depression, or coma; thus, co-administration should be avoided or closely monitored. Patients with elevated intracranial pressure or head injuries should be cautious in using this medication as respiratory suppression following intake may worsen their condition. This medication can result in psychological and physical dependency; prolonged use should be monitored for signs of dependency. Patients with impaired liver function face increased risks for liver damage while using this medication; they must consult a physician before use and ensure that the total daily intake of acetaminophen does not exceed 4,000 mg. Patients who genetically metabolize this medication rapidly are at a higher risk for severe side effects, including respiratory suppression; dosage adjustments and symptom monitoring are necessary. Children under 12 years old or those recovering from certain surgeries should not be administered this medication, and it is advisable to avoid its use in adolescents aged 12 to under 18 if there are risk factors. This medication may cause sleep apnea or hypoxia; if these symptoms occur or worsen, consideration should be given to reducing or discontinuing the drug dosage. Elderly patients or those at risk for hyponatremia may experience sodium level abnormalities during use, necessitating regular testing. While taking this medication, do not exceed the recommended dosage, and it should not be taken with other medications that contain tramadol or acetaminophen. Suddenly stopping this medication may lead to withdrawal symptoms such as anxiety, insomnia, or sweating; following a doctor's guidance for tapering is advisable. When combined with certain antidepressants, antipsychotics, or opioid analgesics, the risks for seizures and serotonin syndrome increase, so caution is required. Pregnant women or those who may become pregnant must consult a physician, as the administration of this medication can affect the fetus. This medication can be secreted in breast milk and may cause serious side effects in breastfeeding infants, so nursing mothers are advised not to take it. Drowsiness or dizziness may occur while taking this medication, so caution is needed while driving or operating machinery. In case of overdose, severe respiratory depression, seizures, or liver damage may occur, so it is crucial to adhere strictly to the prescribed dose and seek immediate medical attention in emergencies. This medication should be stored out of reach of children, and care must be taken to prevent 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, pallor, severe rash accompanied by fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty in breathing, asthma attack, abnormal breathing accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and extremely severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • paresthesia
  • attention deficit

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally kept at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a prolonged period.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 500 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.