Medication info
Craset Semi Tablet (Tramadol, Acetaminophen)

Craset Semi Tablet (Tramadol, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201803636 · Approved 2018.09.07 · Insurance code 649701800

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: Dosage should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to start with a dose of 4 tablets, and thereafter the interval between doses should be at least 6 hours, ensuring not to exceed 16 tablets in a day. The effective lowest dose should be administered for as short a duration as possible. Do not use this medication for longer than necessary; if prolonged treatment is required due to the nature and severity of the condition, regular monitoring should be conducted to assess the need for the continued use of this medication. Elderly Administer the standard adult dosage. However, in elderly individuals over 75 years of age, the oral half-life of tramadol is increased by 17%, so this medication should be administered with intervals of at least 6 hours. Patients with renal failure For patients with moderate renal failure (creatinine clearance of 10-30 ml/min), extend the interval between doses to 12 hours. Administration is not recommended for patients with severe renal failure (creatinine clearance of less than 10 ml/min). Tramadol is removed very slowly during dialysis and filtration; therefore, there is no need to re-administer this medication post-dialysis to maintain analgesic effect. Patients with liver failure Administration intervals should be carefully considered for patients with moderate liver failure. This medication should not be administered to patients with severe liver failure.
Child dose
Included in children aged 12 and older and adults; therefore, there is no separate children’s dosing.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • 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

For children aged 12 and older and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. It is recommended to start with a dose of 4 tablets, and thereafter the interval between doses should be at least 6 hours, ensuring not to exceed 16 tablets in a day. The effective lowest dose should be administered for as short a duration as possible. Do not use this medication for longer than necessary; if prolonged treatment is required due to the nature and severity of the condition, regular monitoring should be conducted to assess the need for the continued use of this medication. Elderly Administer the standard adult dosage. However, in elderly individuals over 75 years of age, the oral half-life of tramadol is increased by 17%, so this medication should be administered with intervals of at least 6 hours. Patients with renal failure For patients with moderate renal failure (creatinine clearance of 10-30 ml/min), extend the interval between doses to 12 hours. Administration is not recommended for patients with severe renal failure (creatinine clearance of less than 10 ml/min). Tramadol is removed very slowly during dialysis and filtration; therefore, there is no need to re-administer this medication post-dialysis to maintain analgesic effect. Patients with liver failure Administration intervals should be carefully considered for patients with moderate liver failure. This medication should not be administered to patients with severe liver failure.

Child dose

Included in children aged 12 and older and adults; therefore, there is no separate children’s dosing.

Precautions

This medication may cause liver damage, therefore individuals who regularly consume more than three drinks a day should consult a doctor or pharmacist before use. The acetaminophen included in this medication can rarely cause severe skin reactions. If any skin rash or hypersensitivity reactions occur, discontinue use immediately and seek medical attention. Taking higher than the recommended dosage of tramadol may increase the risk of seizures, and co-administration with certain antidepressants or narcotics also increases seizure risk. Rarely, fatal allergic reactions can occur during the use of this medication, so if you experience difficulty breathing or severe rashes, seek emergency medical assistance immediately. For patients with acute and severe bronchial asthma, this medication can cause serious respiratory depression and must be used in a medically equipped environment. Co-administration with alcohol or benzodiazepines can lead to severe sedation, respiratory depression, or coma, so concurrent use should be avoided or used very cautiously. Patients with head injuries or neurological conditions should be cautious as this medication may increase intracranial pressure due to respiratory depression. This medication can cause psychological and physical dependence, so it should be taken under medical supervision for prolonged periods, and abrupt cessation may lead to withdrawal symptoms. Patients with impaired liver function should consult a doctor prior to taking this medication, as excessive acetaminophen can lead to severe liver damage. Certain patients with rapid metabolism of tramadol may have an increased risk of respiratory depression after taking this medication; such patients may require dose adjustment or alternative medications. This medication should not be used in children under 12 years or in children under 18 years who have undergone tonsillectomy or adenoidectomy, and administration in adolescents over 12 should be avoided if specific risk factors are present. This medication may induce sleep apnea or hypoxemia, so consider reducing or discontinuing the dose if symptoms appear. Elderly individuals or patients at risk of hyponatremia should be closely monitored for symptoms of hyponatremia while taking this medication. This medication may interact with certain drugs, so inform your doctor or pharmacist if you are taking other medications, especially when combined with MAO inhibitors, serotonin agents, drugs related to CYP3A4 and CYP2D6. Pregnant or breastfeeding women should consult a doctor before use, as this medication can pass into breast milk and may affect the baby, so it is advisable to avoid use while breastfeeding. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating hazardous machinery. In case of overdose, serious respiratory depression, seizures, or liver damage may occur, so adhere strictly to the dosage, and visit a medical institution immediately in case of overdose. This medication should be stored in a safe place, out of reach of children, to prevent misuse or accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin abnormal reactions, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever and breathing abnormalities, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizure

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 disorders
  • confusion
  • spatial disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory

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 air or moisture from entering and is best kept at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 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.