Medication info
Hyperset Semi Tablet

Hyperset Semi Tablet

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

MFDS item code 200710628 · Notified 2007.09.19 · Insurance code 651600790

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The recommended initial dose is 4 tablets, with subsequent doses spaced at least 6 hours apart, but not exceeding 16 tablets in one day. Administer the lowest effective dose for the shortest duration possible. Avoid unnecessary prolonged administration of this medication; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to determine the need for continued administration of this medication. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years of age, the elimination half-life of tramadol increased by 17% after oral administration, therefore, doses should be administered at intervals of at least 6 hours. Renal impairment For moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance below 10 mL/min) should not be recommended this medication. Tramadol is eliminated very slowly during hemodialysis, therefore there is no need to re-administer this medication after dialysis to maintain analgesic effect. Hepatic impairment For moderate hepatic impairment patients, carefully consider extending the dosing interval. Do not administer this medication to patients with severe hepatic impairment.
Child dose
Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The recommended initial dose is 4 tablets, with subsequent doses spaced at least 6 hours apart, but not exceeding 16 tablets in one day.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe 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 over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The recommended initial dose is 4 tablets, with subsequent doses spaced at least 6 hours apart, but not exceeding 16 tablets in one day. Administer the lowest effective dose for the shortest duration possible. Avoid unnecessary prolonged administration of this medication; if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to determine the need for continued administration of this medication. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years of age, the elimination half-life of tramadol increased by 17% after oral administration, therefore, doses should be administered at intervals of at least 6 hours. Renal impairment For moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Severe renal impairment patients (creatinine clearance below 10 mL/min) should not be recommended this medication. Tramadol is eliminated very slowly during hemodialysis, therefore there is no need to re-administer this medication after dialysis to maintain analgesic effect. Hepatic impairment For moderate hepatic impairment patients, carefully consider extending the dosing interval. Do not administer this medication to patients with severe hepatic impairment.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the degree of pain and therapeutic response. The recommended initial dose is 4 tablets, with subsequent doses spaced at least 6 hours apart, but not exceeding 16 tablets in one day.

Precautions

This medicine may put strain on the liver, so individuals who consume large amounts of alcohol daily should consult with a physician or pharmacist before using it. If severe rashes, blisters, or red spots appear on the skin while taking this medication, discontinue use immediately and seek medical attention. One of the ingredients in this medication may trigger seizures, so caution is necessary for individuals with a history of seizures or those at high risk for seizures. Particularly when taken with certain antidepressants or other narcotic analgesics, the risk of seizures may increase, so consulting with a healthcare professional is essential. This medication can rarely cause severe allergic reactions, so if symptoms like difficulty breathing or hives occur, visit a medical institution immediately. Patients with severe respiratory diseases may find it harder to breathe when taking this medication, hence it should only be taken under medical supervision. Taking this medication with alcohol or sedatives may cause severe drowsiness, respiratory depression, or coma, so it is best to avoid such combinations. Patients with head injuries or brain disorders need to be cautious as this medication may increase intracranial pressure. This medication may induce physical and psychological dependence, so the dosage and duration should be adjusted under a doctor's guidance during prolonged use. Patients with impaired liver or kidney function must consult their physician before taking this medication, and dosage adjustments may be necessary. This medication is not for use in children under 12 years of age or adolescents under 18 who have undergone certain surgeries. This medication may exacerbate sleep apnea or hypoxia; thus, patients with related symptoms should continuously monitor their condition while taking it. Rarely, hyponatremia may occur with this medication; therefore, elderly patients or those with related risk factors require regular testing. Women who are pregnant or may become pregnant should carefully consider the impact on the fetus when taking this medication. Nursing mothers should consult with their doctor as the medication may be passed to the baby through breast milk, necessitating either cessation of breastfeeding or medical advice. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In case of overdose, serious respiratory depression or seizures may occur; therefore, the prescribed dose must be strictly followed, and immediate emergency actions should be taken in the event of overdose.

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 the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination changes

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
  • irritability
  • mood instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory disturbances

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering and should be kept at a temperature between 1°C and 30°C (33°F and 86°F). Storing it this way helps maintain its efficacy and prevents degradation.

Appearance and packaging

Appearance

Light yellow oblong film-coated tablets

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.