Medication info
Widerset Tablets

Widerset Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pale yellow, rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle, 100 tablets (10 tablets/PTP x 10)/box [for export]
Approval status
Active

MFDS item code 200805152 · Notified 2008.05.06 · Insurance code 660702150

Summary

Main use
Moderate to severe acute and chronic pain relief
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: The dosage should be adjusted according to the patient's pain level and treatment response. An initial dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours, with a maximum of 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid administering this drug for longer than necessary; if extended use is needed due to the nature and severity of the illness, regular monitoring should be conducted to determine the necessity of ongoing treatment. Elderly patients Administer the usual adult dose. However, for elderly patients over 75, the elimination half-life of tramadol is increased by 17%, so doses should be administered at least 6 hours apart. Renal impairment patients For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it may not be necessary to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment patients Cautiously consider extending the dosing interval for moderate liver impairment patients. Avoid administering this medication to severe liver impairment patients.
Child dose
Children aged 12 years and older and adults: Dosage should be adjusted based on the severity of the patient's pain and treatment response. An initial dose of 2 tablets is recommended, and the interval between subsequent doses should be at least 6 hours.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Moderate to severe acute and chronic pain relief

  • Moderate to severe 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 years and older and adults: The dosage should be adjusted according to the patient's pain level and treatment response. An initial dose of 2 tablets is recommended, and subsequent dosing intervals should be no less than 6 hours, with a maximum of 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid administering this drug for longer than necessary; if extended use is needed due to the nature and severity of the illness, regular monitoring should be conducted to determine the necessity of ongoing treatment. Elderly patients Administer the usual adult dose. However, for elderly patients over 75, the elimination half-life of tramadol is increased by 17%, so doses should be administered at least 6 hours apart. Renal impairment patients For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it may not be necessary to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment patients Cautiously consider extending the dosing interval for moderate liver impairment patients. Avoid administering this medication to severe liver impairment patients.

Child dose

Children aged 12 years and older and adults: Dosage should be adjusted based on the severity of the patient's pain and treatment response. An initial dose of 2 tablets is recommended, and the interval between subsequent doses should be at least 6 hours.

Precautions

This drug may put strain on the liver, so individuals who consume more than three glasses of alcohol daily should consult a doctor or pharmacist before use. This medication may rarely cause serious skin reactions, and if skin rash or allergic symptoms occur after taking it, discontinue use immediately and consult a healthcare professional. Due to the risk of seizures, do not exceed the recommended dosage, and the possibility of seizures may increase when taken with certain antidepressants or narcotic pain relievers. Rarely, severe allergic reactions may occur; if symptoms such as difficulty breathing or hives appear, seek emergency treatment immediately. Patients with severe respiratory diseases may experience significant respiratory suppression while taking this medication, hence it should only be used in a monitored healthcare setting. Caution is needed when combining this drug with alcohol or central nervous system depressants, as severe drowsiness, respiratory suppression, and coma may occur. Patients with head injuries or increased intracranial pressure should use this medication cautiously, as symptoms may worsen. This drug can cause physical and psychological dependence, so it should be taken following a doctor's instructions for extended periods. Patients with impaired liver function must consult a doctor before taking this medication, as there is a risk of liver damage. Those with genetic characteristics that lead to very rapid metabolism of this drug are at increased risk of respiratory suppression and require special attention. This drug should not be administered to children under 12 years old or adolescents under 18 years old following certain surgeries. Patients with sleep apnea or hypoxemia should continuously monitor for symptom exacerbation while using this medication. Elderly patients or those at risk of hyponatremia should be closely observed for symptoms of low sodium during treatment. Pregnant or breastfeeding women should consult thoroughly with a doctor before using this medication, as it may pose risks to the fetus or newborn. Caution is advised as drowsiness or dizziness may occur while driving or operating machinery. Overdose may result in severe respiratory depression, seizures, liver damage, etc., so strictly adhere to the recommended dosage and seek medical attention immediately if unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), feelings of tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough + fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis, urination problems

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
  • sweating
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory abnormalities
  • attention deficit
  • fainting

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

Storage

Store this medication in a sealed container to prevent air or moisture ingress. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow, rectangular film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle, 100 tablets (10 tablets/PTP x 10)/box [for export]

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.