Medication info
Encitrasem Tablet (Tramadol Hydrochloride, Acetaminophen)

Encitrasem Tablet (Tramadol Hydrochloride, Acetaminophen)

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

MFDS item code 200707222 · Notified 2007.06.22 · Insurance code 645301170

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years old and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, but not exceed 16 tablets in a day. The effective lowest dose should be administered for the shortest period possible. Avoid administering this medication for a longer duration than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly Administer the typical adult dosage. However, in elderly patients over 75 years old, the elimination half-life of tramadol increases by 17% when administered orally, so doses should be given with at least a 6-hour interval. Renal impairment patients For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. Administering this medication is not recommended for severe renal impairment patients (creatinine clearance less than 10 ml/min). Tramadol is removed very slowly during hemodialysis and filtration, so there is no need for re-administration of this medication after dialysis to maintain analgesic effects. Hepatic impairment patients For moderate hepatic impairment patients, carefully consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.
Child dose
Children over 12 years old and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, but not exceed 16 tablets in a day.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children over 12 years old and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, but not exceed 16 tablets in a day. The effective lowest dose should be administered for the shortest period possible. Avoid administering this medication for a longer duration than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly Administer the typical adult dosage. However, in elderly patients over 75 years old, the elimination half-life of tramadol increases by 17% when administered orally, so doses should be given with at least a 6-hour interval. Renal impairment patients For moderate renal impairment patients (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. Administering this medication is not recommended for severe renal impairment patients (creatinine clearance less than 10 ml/min). Tramadol is removed very slowly during hemodialysis and filtration, so there is no need for re-administration of this medication after dialysis to maintain analgesic effects. Hepatic impairment patients For moderate hepatic impairment patients, carefully consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children over 12 years old and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. An initial dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, but not exceed 16 tablets in a day.

Precautions

This medication may put stress on the liver, so individuals who drink alcohol heavily on a daily basis should consult a doctor or pharmacist before taking it. The acetaminophen included in this medication can rarely cause serious skin reactions, so if a rash or allergic symptoms occur, the medication should be stopped immediately and medical advice sought. Exceeding the recommended dosage of tramadol may increase the risk of seizures, and taking it with certain antidepressants or other central nervous system medications may further increase this risk. Caution is advised for patients with severe respiratory diseases as this medication may suppress breathing, and if necessary, it should be administered in an environment equipped for cardiopulmonary resuscitation. Taking this medication with alcohol or other central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma, so concurrent use should be avoided. Patients with brain injury or increased intracranial pressure may experience worsening symptoms while taking this medication, so caution is necessary. This medication can lead to physical and mental dependence, so it should be taken according to a physician's guidance for prolonged use. Patients with compromised liver function must consult a healthcare provider before taking this medication, as its components are metabolized in the liver. This medication is not to be administered to children under 12 years old or to children after certain surgeries, and adolescents aged 12 to 18 with special risk factors should also avoid taking it. Various side effects such as drowsiness, dizziness, insomnia, nausea, constipation may occur during use, and patients should consult a doctor if symptoms become severe. Women who are pregnant or breastfeeding should discuss the potential effects on the fetus or newborn with their medical provider before taking this medication, and it is advised not to use during breastfeeding. Caution is required when driving or operating machinery as this medication may cause drowsiness or dizziness. In case of overdose, severe respiratory depression, seizures, or liver damage may occur, so the prescribed dosage must be adhered to, and if overdose is suspected, immediate medical attention should be sought. This medication has numerous interactions with other drugs, so patients should inform their healthcare provider of any other medications being taken, especially when taken with antidepressants, antibiotics, sedatives, anticoagulants, etc. Children and the elderly may be at higher risk for side effects, so careful monitoring before and after administration is necessary. This medication should be stored in a safe place out of reach of children, and measures should be taken to prevent misuse or abuse by ensuring it is not easily accessible to others.

Side effects and when to seek care immediately

Serious side effects

Hives, anaphylactic reaction, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash accompanied by fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, respiratory distress, severe respiratory issues.

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
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disorders
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremor
  • sensitivity.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is best kept in a cool place below 25 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication 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.