Medication info
Painless Tablets

Painless Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Light yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200712868 · Notified 2007.11.27 · Insurance code 671702200

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 and older and adults, the dosage should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to start with a dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, ensuring not to exceed 8 tablets in one day. The effective minimum dose should be administered for the shortest time possible. This medication should not be taken longer than necessary, and if prolonged administration is needed due to the characteristics and severity of the disease, regular monitoring should be conducted to evaluate the need for continued use of this medication. Elderly patients Aim to administer the usual adult dosage. However, for elderly patients over 75 years, it was found that the elimination half-life of tramadol increased by 17% when administered orally; therefore, ensure a dosing interval of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Administration is not recommended for patients with severe renal impairment (creatinine clearance below 10 mL/min). Tramadol is eliminated very slowly during dialysis and filtration; therefore, it is not necessary to readminister this medication post-dialysis to maintain analgesic effects. Patients with liver impairment Careful consideration should be given to extending the dosing interval for patients with moderate liver impairment. This medication should not be given to patients with severe liver impairment.
Child dose
Children aged 12 and older should receive the same dosage as adults.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

For children aged 12 and older and adults, the dosage should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to start with a dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, ensuring not to exceed 8 tablets in one day. The effective minimum dose should be administered for the shortest time possible. This medication should not be taken longer than necessary, and if prolonged administration is needed due to the characteristics and severity of the disease, regular monitoring should be conducted to evaluate the need for continued use of this medication. Elderly patients Aim to administer the usual adult dosage. However, for elderly patients over 75 years, it was found that the elimination half-life of tramadol increased by 17% when administered orally; therefore, ensure a dosing interval of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Administration is not recommended for patients with severe renal impairment (creatinine clearance below 10 mL/min). Tramadol is eliminated very slowly during dialysis and filtration; therefore, it is not necessary to readminister this medication post-dialysis to maintain analgesic effects. Patients with liver impairment Careful consideration should be given to extending the dosing interval for patients with moderate liver impairment. This medication should not be given to patients with severe liver impairment.

Child dose

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

Precautions

This medication may put a strain on the liver, so individuals who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before taking it. This medication can rarely cause serious skin reactions; hence, if a skin rash or allergic symptoms occur, discontinue use immediately and inform healthcare personnel. The ingredients in this medication may increase the risk of seizures; therefore, patients with a history of seizures or seizure risk factors should exercise caution when taking it. Serious allergic reactions may rarely occur while taking this medication; if symptoms arise, immediate medical attention is required. Patients with acute and severe asthma may experience difficulty breathing when taking this medication; therefore, special caution is advised and it should be taken in a medically equipped environment. Taking this medication with alcohol or central nervous system depressants may cause severe drowsiness, respiratory depression, and coma; thus, co-administration should be avoided. Patients with head injuries or brain diseases may experience worsening symptoms due to respiratory depression and increased intracranial pressure while taking this medication, so caution is necessary. This medication can cause psychological and physical dependence; thus, it should be used according to a doctor's instructions when taken for extended periods. Patients with impaired liver function should always consult a doctor before taking this medication, and care should be taken not to take it with other acetaminophen products. For patients with specific genotypes, the metabolism of this medication may accelerate, increasing the risk of respiratory depression; thus, special monitoring is required. This medication should not be administered to children under 12 years or adolescents under 18 years who have undergone specific surgeries, and adolescents between 12 to 18 years should also be administered with caution. This medication may cause sleep apnea and hypoxia; thus, ongoing monitoring of symptoms during use is essential. Elderly patients or those at risk of hyponatremia should carefully observe for symptoms of hyponatremia while taking this medication. This medication can interact with specific drugs; therefore, inform your doctor or pharmacist of any other medications you are taking. Pregnant or breastfeeding women must consult a doctor before taking this medication, and it is safer not to take this medication while breastfeeding. This medication can cause drowsiness or dizziness; thus, caution is advised when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur; therefore, adhere to the prescribed dosage and contact a medical institution immediately in case of an overdose.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by respiratory abnormalities and fever, skin or eyes turning yellow (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, decreased urine output

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
  • gas
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensory disturbances

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 exposure, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablets

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

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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.