Medication info
Rebaset Tablet (Tramadol Hydrochloride, Acetaminophen)

Rebaset Tablet (Tramadol Hydrochloride, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
(주)바스칸바이오제약
Appearance
Light yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200805144 · Notified 2008.05.06 · Insurance code 656203580

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For individuals aged 12 years and older, it is recommended to start with an initial dose of 2 tablets, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest necessary duration and avoid prolonged usage without need. In the elderly, the usual adult dosage is given, but for those over 75 years, administer at least 6 hours apart. Moderate
Child dose
For children aged 12 years and older, follow the same dosage as adults.

Ingredients

Manufacturer
(주)바스칸바이오제약

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 ranging from moderate to severe.

How to take

Adult dose

For individuals aged 12 years and older, it is recommended to start with an initial dose of 2 tablets, with subsequent doses spaced at least 6 hours apart, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest necessary duration and avoid prolonged usage without need. In the elderly, the usual adult dosage is given, but for those over 75 years, administer at least 6 hours apart. Moderate

Child dose

For children aged 12 years and older, follow the same dosage as adults.

Precautions

This medication may strain the liver, so individuals who consume alcohol frequently should consult a doctor or pharmacist before use. The acetaminophen component in this medication may, rarely, cause severe skin reactions. Stop taking it immediately if you experience a rash or hypersensitivity reaction. Exceeding the recommended dosage of tramadol may increase the risk of seizures, and the risk could be exacerbated when taken with certain antidepressants or other medications. Serious allergic reactions can rarely occur while taking this medication, so if you experience symptoms like difficulty breathing or hives, seek medical attention immediately. Patients with severe respiratory diseases may have difficulty breathing while taking this medication, so careful administration in a medically equipped location is necessary. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, or coma, therefore co-administration should be avoided. Patients with head injuries or brain diseases should be cautious while taking this medication due to the increased risk of elevated intracranial pressure. This medication can cause psychological and physical dependence, so long-term use should be carefully monitored for signs of dependence. Patients with impaired liver function should consult a doctor before using this medication and must avoid concurrent use with other acetaminophen products. Especially those with a fast CYP2D6 enzyme might have excessively increased active components of this medication, posing a risk for severe respiratory depression, warranting dosage adjustments or alternative medications. This medication should not be administered to children under 12 years of age and adolescents under 18 years who have undergone certain surgeries, and it should be avoided in adolescents between 12 to 18 years if there are any risk factors. Patients with sleep apnea or hypoxia may experience a worsening of symptoms after taking this medication, so they should be closely monitored and dosages adjusted or stopped as needed. This medication may cause hyponatremia, a decrease in blood sodium concentration. Therefore, especially elderly patients or those with risk factors should monitor their serum sodium levels. Individuals with hypersensitivity to this medication or those experiencing severe respiratory depression, head injuries, on certain medications, severe liver, kidney, or heart diseases, pregnant or nursing women, and children under 12 years old should not take this medication. Drowsiness or dizziness may occur with use, so caution is advised when driving or operating machinery. In case of overdose, there is a risk of severe respiratory depression, seizures, or liver damage, and immediate medical attention is required for appropriate treatment. This medication interacts with many other drugs, requiring dosage adjustments or monitoring depending on co-administered medications, so all current medications should be disclosed to a doctor or pharmacist. Elderly patients are at higher risk of decreased hepatic, renal, or cardiac function and various coexisting illnesses, necessitating careful observation when taking this medication. Pregnant or nursing women may pose risks to the fetus or newborn, so they must consult a doctor before administration. During the use of this medication, withdrawal symptoms or potential for dependence may arise, thus abrupt cessation should be avoided, and dosages should be gradually reduced according to medical advice. Always store this medication in a safe place out of reach of children, and be cautious not to share it or change the dosage without guidance.

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 oral/ocular mucous membranes, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision 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
  • discomfort
  • flatulence
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors
  • sensations

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

Storage

Store this medication in a sealed container to prevent air ingress and keep it at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the efficacy of the medication and prevents deterioration.

Appearance and packaging

Appearance

Light yellow oblong 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

No questions yet.

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.