Medication info
Orphenesemi Controlled-release Tablet

Orphenesemi Controlled-release Tablet

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

MFDS item code 202002826 · Approved 2020.04.21

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
The dosage should be adjusted based on the patient’s level of pain and treatment response. An initial dose of 2 tablets is recommended, and thereafter the dosing interval should be at least 12 hours apart, not exceeding 8 tablets per day. To avoid prolonged use of this medication beyond what is necessary, if prolonged treatment is required due to the nature and severity of the disease, regular monitoring should be performed to confirm the continuation of this medication.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain of moderate to severe intensity
  • 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

The dosage should be adjusted based on the patient’s level of pain and treatment response. An initial dose of 2 tablets is recommended, and thereafter the dosing interval should be at least 12 hours apart, not exceeding 8 tablets per day. To avoid prolonged use of this medication beyond what is necessary, if prolonged treatment is required due to the nature and severity of the disease, regular monitoring should be performed to confirm the continuation of this medication.

Precautions

This medication may burden the liver, so individuals who usually consume alcohol daily should consult a physician or pharmacist before taking it. If severe rashes, blisters, or red spots appear on the skin during treatment, discontinue use immediately and inform healthcare personnel. The ingredients in this medication can cause seizures, so patients with a history of seizures or at high risk of seizures should use it cautiously. Additionally, taking this medication with certain antidepressants or other pain relievers, narcotic drugs may increase the risk of seizures, so it is essential to consult a professional. Patients with asthma who have weak respiratory function are at risk of severe respiratory suppression when taking this medication, so it should be administered in a facility equipped with medical equipment. Using this medication with alcohol or sedatives, which also depress the central nervous system, can lead to severe drowsiness, respiratory suppression, or even coma; caution is necessary. Patients with head injuries or brain diseases should use this medication carefully as it may increase intracranial pressure. This medication has the potential for dependence; thus, dosages and duration should be adjusted according to a physician's instructions when used for a long time. Especially, patients with weak liver function are at risk of liver damage, so they must consult healthcare personnel before taking this medication. Children, especially those under 12 years old or adolescents under 18 years old who have undergone tonsillectomy, should not use this medication. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may pose risks to the fetus or newborn. Caution is advised when driving or operating machinery, as drowsiness or dizziness may occur. In cases of overdose, severe respiratory suppression or liver damage may occur, so immediate emergency treatment is required if symptoms appear. During the use of this medication, care must be taken to avoid taking other pain relievers or medications containing acetaminophen concurrently.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, skin peeling, painful mucous membranes of the mouth/eyes, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, liver abnormalities (jaundice), sudden and severe reactions

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • increased muscle tension
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • perceptual disturbances
  • confusion
  • dizziness
  • nausea
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • vomiting
  • dysphagia
  • bloody stools
  • swelling of the tongue
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervousness
  • drowsiness

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is best to store the medication at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pale yellow round controlled-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.