Medication info
Bielset Semi Tablet

Bielset Semi Tablet

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

MFDS item code 201905420 · Approved 2019.07.31 · Insurance code 664102830

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children and adults aged 12 years and older: Dosage should be adjusted based on the level of patient pain and treatment response. An initial dose of 4 tablets is recommended, after which subsequent doses should be spaced at least 6 hours apart, and not to exceed 16 tablets in one day. The effective minimum dose should be administered for as short a period as possible. Do not use this medication beyond the necessary duration, and if prolonged administration is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the continuation of this medication.

Ingredients

Manufacturer
하이플생명과학(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • 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

Children and adults aged 12 years and older: Dosage should be adjusted based on the level of patient pain and treatment response. An initial dose of 4 tablets is recommended, after which subsequent doses should be spaced at least 6 hours apart, and not to exceed 16 tablets in one day. The effective minimum dose should be administered for as short a period as possible. Do not use this medication beyond the necessary duration, and if prolonged administration is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the continuation of this medication.

Precautions

This medication may cause liver damage in individuals who consume large amounts of alcohol daily; therefore, it should only be taken after consultation with a doctor or pharmacist. Due to the acetaminophen component, serious skin reactions can rarely occur, so if skin rashes or allergic symptoms appear, discontinue use immediately. Tramadol can increase the risk of seizures; the risk may be further elevated when used in conjunction with certain antidepressants or narcotic analgesics. Patients with severe respiratory conditions may experience difficulty in breathing while taking this medication, so it should be administered under professional monitoring. Caution should be exercised when taking this medication with alcohol or central nervous system depressants, as this can lead to severe drowsiness, respiratory depression, and even coma. Patients with head injuries or brain disorders should use this medication cautiously due to the risk of increased intracranial pressure. Tramadol may lead to physical and psychological dependence, so dosages and duration should be adjusted under medical supervision during long-term use. Patients with compromised liver function should consult a doctor before taking this medication and should take care to avoid other acetaminophen preparations. The efficacy and side effects of this medication can vary depending on the metabolic rate of the enzyme CYP2D6; ultra-rapid metabolizers may experience more severe respiratory depression. Children under 12 years of age or adolescents under 18 who have undergone tonsillectomy should not be administered this medication, particularly those with respiratory-related conditions. This medication may cause sleep apnea or hypoxia, so symptoms should be monitored continuously during use. A rare reduction in blood sodium levels known as hyponatremia may occur, so blood tests may be necessary, especially for elderly patients or those with risk factors. Patients with a history of allergic reactions to this medication's components, central nervous system drug abuse, severe respiratory depression, head injuries, or those on MAO inhibitors should not take this medication. Patients currently taking narcotic analgesics or central nervous system depressants may see an increased risk of side effects and should consult with a doctor before use. Abrupt discontinuation during use may lead to withdrawal symptoms such as anxiety, insomnia, sweating, and nausea, so it should be tapered in accordance with a doctor's instructions. Drowsiness or dizziness may occur when taking this medication, so it is advisable to avoid driving or operating hazardous machinery. In cases of overdose, severe respiratory depression, seizures, and liver damage may occur, so the prescribed dosage must be adhered to, and immediate medical attention sought in case of adverse symptoms.

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, peeling skin, mouth/eye mucosal pain, shortness of breath or breathing difficulty, asthma attack, abnormal respiratory symptoms with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered 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
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervous tension
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbance
  • confusion
  • directional sense disorder
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory impairment
  • tremors
  • sensations

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

Storage

This medication should be stored in a tightly sealed container to keep out air and in a cool place at or below room temperature (25 degrees Celsius). Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

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.