Medication info
Beaset Semi-Extended Release Tablet

Beaset Semi-Extended Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Light yellow, round extended-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202002520 · Approved 2020.04.09 · Insurance code 694002930

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
It is recommended to administer an initial dose of 2 tablets, thereafter maintaining a minimum interval of 12 hours between doses while not exceeding 8 tablets in a day. Do not use this medication for longer than necessary; where prolonged administration is needed due to disease characteristics and severity, regular monitoring should be performed to assess the need for continued use of this medication. Elderly patients may be given the standard adult dosage, but for those aged 75 and above, care should be taken due to a 17% increase in tramadol elimination half-life, necessitating at least a 12-hour interval between doses.

Ingredients

Manufacturer
대웅바이오(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

It is recommended to administer an initial dose of 2 tablets, thereafter maintaining a minimum interval of 12 hours between doses while not exceeding 8 tablets in a day. Do not use this medication for longer than necessary; where prolonged administration is needed due to disease characteristics and severity, regular monitoring should be performed to assess the need for continued use of this medication. Elderly patients may be given the standard adult dosage, but for those aged 75 and above, care should be taken due to a 17% increase in tramadol elimination half-life, necessitating at least a 12-hour interval between doses.

Precautions

This medication can put strain on the liver, so individuals who regularly consume more than three drinks a day must consult with a doctor or pharmacist before use. Serious skin issues such as severe rashes or pustulosis and major skin problems like Stevens-Johnson syndrome may occur as an allergic reaction, requiring immediate discontinuation if any skin abnormalities appear. One of the active ingredients, tramadol, may increase the risk of seizures, hence caution is advised for those with a seizure history or those at risk of seizures. Additionally, when combined with certain antidepressants or central nervous system depressants, the risk of seizures may increase, thus follow medical advice when used together. Individuals with severe respiratory diseases, particularly those with acute and severe bronchial asthma, may experience difficulties in breathing when taking this medication; therefore, it should only be administered in medically equipped facilities. Concurrent use of this medication with alcohol or benzodiazepines, among other central nervous system depressants, can result in severe sedation, respiratory depression, and coma, so it is advisable to avoid such combinations. Patients with head injuries or brain disorders should exercise caution as this medication may increase intracranial pressure and risk respiratory depression. It has the potential to cause dependence similar to morphine, so it is essential to monitor for signs of dependency and abuse during prolonged use. Patients with compromised liver function have an increased risk of liver toxicity from this medication, thus must consult a doctor before use and should avoid taking it along with other acetaminophen products. In patients where the drug metabolism rate is fast due to CYP2D6 genotype, the concentration of the active metabolite may rise, increasing the risk of respiratory depression. Therefore, dosage adjustments and close monitoring are needed. This medication should not be used in children under 12 years old or in anyone under 18 years old who has undergone tonsillectomy or adenoidectomy, as well as in adolescents between the ages of 12 and 18 who are at risk of respiratory depression. During the use of this medication, hyponatremia may occur rarely; hence older adults or those at risk of hyponatremia should be closely monitored for symptoms. Do not exceed the recommended dosage, and avoid using it together with other tramadol or acetaminophen products; due to possible withdrawal symptoms upon abrupt discontinuation, dosage should be gradually reduced according to a doctor's instructions. Women who are pregnant or breastfeeding should consult healthcare professionals before taking this medication as it may affect the fetus or newborn. Particularly in breastfeeding women, it is crucial to stop breastfeeding while taking this medication or closely monitor the newborn's condition. This medication may cause drowsiness and dizziness, so it is advisable to avoid activities that require alertness, such as driving or operating machinery after taking it. In cases of overdose, serious respiratory depression and liver damage may occur, requiring immediate attendance at an emergency medical facility for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and very severe headaches, lightning bolt headache, seizures, altered consciousness, vision abnormalities, paralysis, urination abnormalities

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmias
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • heightened tension
  • migraines
  • worsening migraines
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stools
  • tongue swelling
  • decreased appetite
  • anxiety
  • delirium
  • euphoria
  • insomnia
  • irritability

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius (room temperature). Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light yellow, round extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 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.