Medication info
Painclear Tablets

Painclear Tablets

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

MFDS item code 201403740 · Approved 2014.08.12 · Insurance code 670103660

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be at least 6 hours apart but not exceeding 16 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use beyond necessary, and if long-term use is needed due to the characteristics and severity of the disease, conduct regular monitoring to assess the continued use of this medication. Elderly Administer the usual adult dosage. However, in patients over 75 years, the elimination half-life of tramadol increased by 17% upon oral administration, so dosing should be spaced at least 6 hours apart. Renal Impairment For moderate renal impairment patients (creatinine clearance 10-30ml/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance below 10ml/min), this medication is not recommended. Tramadol is eliminated very slowly by hemodialysis and filtration, so there is no need to readminister this medicine after dialysis for pain relief maintenance. Hepatic Impairment For moderate hepatic impairment patients, careful consideration should be given to extend the dosing interval. This medication should not be administered to patients with severe hepatic impairment.
Child dose
Children aged 12 and older and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be at least 6 hours apart, but not exceeding daily.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to alleviate acute or chronic pain from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be at least 6 hours apart but not exceeding 16 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use beyond necessary, and if long-term use is needed due to the characteristics and severity of the disease, conduct regular monitoring to assess the continued use of this medication. Elderly Administer the usual adult dosage. However, in patients over 75 years, the elimination half-life of tramadol increased by 17% upon oral administration, so dosing should be spaced at least 6 hours apart. Renal Impairment For moderate renal impairment patients (creatinine clearance 10-30ml/min), extend the dosing interval to 12 hours. For severe renal impairment patients (creatinine clearance below 10ml/min), this medication is not recommended. Tramadol is eliminated very slowly by hemodialysis and filtration, so there is no need to readminister this medicine after dialysis for pain relief maintenance. Hepatic Impairment For moderate hepatic impairment patients, careful consideration should be given to extend the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children aged 12 and older and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be at least 6 hours apart, but not exceeding daily.

Precautions

This medication may burden the liver, so those who consume more than three alcoholic drinks daily must consult a physician or pharmacist before use. If any abnormal reactions such as skin rash or itching occur while taking this medication, discontinue use immediately and consult a healthcare provider. Due to the risk of seizures, patients with a history of seizures or risk factors for seizures should use this medication with caution, and the risk of seizures may increase when combined with certain antidepressants or opioid analgesics. This drug can rarely cause serious allergic reactions; if symptoms such as difficulty breathing or hives occur, immediate medical treatment is necessary. Patients with acute and severe asthma are at risk of respiratory suppression when taking this medication, so it should only be used in a properly equipped environment. Taking this medication with alcohol or benzodiazepines can lead to severe drowsiness or respiratory suppression, so concurrent use should be avoided or done with extreme caution. Patients with head injuries or brain diseases should be cautious, as this medication can increase intracranial pressure. This drug can lead to physical and psychological dependence, so prolonged use should only occur under a doctor’s guidance. Patients with impaired liver function must consult a physician before taking this medication, as it contains acetaminophen which poses a risk of liver damage. Patients with certain genetic profiles may metabolize this drug rapidly, increasing the risk of respiratory suppression; such patients require special medical management. This medication should not be administered to children under 12 years or to adolescents under 18 years following certain surgeries. Patients with sleep apnea should be closely monitored, as symptoms may worsen while using this medication. Electrolyte imbalances such as hyponatremia may occur, so elderly patients or those with risk factors should undergo blood testing to assess their condition. Patients with hypersensitivity to this medication or those prohibited from taking certain drugs should not take this product. Patients in a state of severe respiratory suppression, those with head injuries, or those taking MAO inhibitors should not use this medication. This drug may cause drowsiness or dizziness, so caution is needed during driving or the operation of hazardous machinery. In cases of overdose, serious respiratory suppression, seizures, or liver damage may occur, so prescribed dosages must be strictly followed, and immediate emergency treatment is necessary in case of overdose. This medication can interact with various drugs, so inform healthcare providers of any other medications being taken. Pregnant or breastfeeding women should consult a physician before using this medication, as it may affect the fetus or newborn. This medication must be kept out of reach of children and managed carefully to prevent drug misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, 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
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • sensory disturbance
  • excitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • sensations

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

Storage

This product should be stored in a tightly sealed container to prevent air and moisture from entering. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow rectangular film-coated tablets

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.