Medication info
Artsemi Tablets

Artsemi Tablets

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

MFDS item code 200705595 · Notified 2007.05.16 · Insurance code 652604190

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 should adjust the dose based on the patient's level of pain and treatment response. The initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours. Do not exceed 16 tablets in one day. Administer the effective minimum dose for the shortest possible duration, avoiding prolonged use beyond necessity. Elderly individuals should generally receive the usual adult dose; however, for those aged 75 and older, dosing intervals should be carefully managed.
Child dose
Children over 12 years should follow the same dosing regimen as adults.

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • 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

Children aged 12 and older and adults should adjust the dose based on the patient's level of pain and treatment response. The initial dose is 4 tablets, with subsequent dosing intervals of at least 6 hours. Do not exceed 16 tablets in one day. Administer the effective minimum dose for the shortest possible duration, avoiding prolonged use beyond necessity. Elderly individuals should generally receive the usual adult dose; however, for those aged 75 and older, dosing intervals should be carefully managed.

Child dose

Children over 12 years should follow the same dosing regimen as adults.

Precautions

This medication may put a strain on the liver, so those who consume more than three alcoholic beverages daily should consult their doctor or pharmacist before use. It contains acetaminophen, which has a risk of causing liver damage, so caution is advised. Serious allergic reactions may occur; if symptoms such as skin rash or itching arise, discontinue use immediately and consult a physician. The tramadol component of this medication can induce seizures, so patients with a history of seizures or at high risk for seizures should be particularly cautious. Tramadol may increase the risk of seizures when taken with certain other medications, so inform your healthcare provider of any other medications being taken. For patients with severe respiratory diseases, this medication can cause significant respiratory depression and should only be used in a monitored medical environment. Co-administration with narcotic analgesics, central nervous system depressants, or alcohol may cause severe drowsiness, respiratory depression, or coma, so such combinations should be avoided. Patients with head injuries or increased intracranial pressure may experience exacerbated symptoms while taking this medication. This medication can cause psychological and physical dependence, so monitoring for dependence is required with long-term use. Patients with impaired liver function must consult with their doctor before using this medication and ensure that the total daily acetaminophen dosage does not exceed 4,000 mg. Certain genotypes (CYP2D6 ultra-rapid metabolizers) may metabolize the active ingredient quickly, which increases the risk of respiratory depression; dose adjustments or alternative medications may be necessary in such cases. This medication should not be used in children under 12 years of age or in adolescents under 18 years of age who have undergone tonsillectomy or adenoidectomy; even between the ages of 12 and 18, use should be avoided in the presence of risk factors. This medication may worsen symptoms in patients with sleep apnea, so careful monitoring is necessary, with dose adjustments or discontinuation as needed. Hypotonic hyponatremia may rarely occur during treatment, so especially elderly patients or those with risk factors should have their serum sodium levels monitored. Patients with hypersensitivity to any component of this medication, severe respiratory depression, head trauma, or those on certain medications should not take this medication. Abrupt discontinuation during use can lead to withdrawal symptoms; it is safest to taper off under a physician's guidance. Drowsiness or dizziness may occur due to this medication when driving or operating machinery, so caution is warranted. In cases of overdose, serious respiratory depression, seizures, liver damage, etc. may occur; emergency treatment should be sought immediately. This medication should be stored out of reach of children and precautions should be taken to prevent misuse or abuse.

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 fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme sedation, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination issues

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
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremor
  • paresthesia
  • attention deficit

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

Storage

This medication should be stored in a closed container to prevent air or moisture from entering, and it should be kept at a temperature between 1 and 30 degrees Celsius, which is safe. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale 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.