Medication info
Remitch Oral Disintegrating Tablet 2.5 Micrograms (Nalufan Hydrochloride)

Remitch Oral Disintegrating Tablet 2.5 Micrograms (Nalufan Hydrochloride)

Prescription medicationOrally disintegrating TabletOral
Ingredient · strength
Nalfurafine Hydrochloride›2.5μg / 1 tablet
Manufacturer / importer
SK Chemicals Co., Ltd.
Appearance
Pale purplish-red or cloudy red film-coated oral disintegrating tablet
Packaging
14 tablets/box [14 tablets/PTP X 1], 140 tablets/box [14 tablets/PTP X 10]
Approval status
Active

MFDS item code 202107133 · Approved 2021.10.26

Summary

Main use
Improvement of pruritus inadequately controlled by existing treatment in patients undergoing hemodialysis
Who takes it
Adults
Adult dose
Adults: Take 1 tablet (equivalent to 2.5 ㎍ of nalfurafine hydrochloride) orally once daily after dinner. The maximum daily dose is 5㎍ once daily. Place this medicine on the tongue and allow it to dissolve in saliva before swallowing, or take it with water.

Ingredients

Importer
SK Chemicals Co., Ltd.

Efficacy & effects

Improvement of pruritus inadequately controlled by existing treatment in patients undergoing hemodialysis

  • Pruritus
View approved original text

This medication can help patients receiving dialysis who have insufficient improvement of pruritus with existing treatments. This drug effectively alleviates pruritus symptoms, improving the quality of life for patients. It is used for the relief of itching that occurs during dialysis treatment.

How to take

Adult dose

Adults: Take 1 tablet (equivalent to 2.5 ㎍ of nalfurafine hydrochloride) orally once daily after dinner. The maximum daily dose is 5㎍ once daily. Place this medicine on the tongue and allow it to dissolve in saliva before swallowing, or take it with water.

Precautions

This medication should not be used in certain patients. Those allergic to this drug or its components, children, and individuals with genetic disorders that cannot digest lactose should not take this medication. Patients with moderate to severe liver function impairment, pregnant women or those who may become pregnant, and the elderly should use this medication cautiously. In cases of poor liver function, the drug may remain in the body longer, increasing the risk of side effects. Symptoms such as insomnia, constipation, and drowsiness may appear within the first 2 weeks of taking this medication, so it is important to monitor the condition closely. If liver function test results increase or jaundice symptoms appear, discontinue the medication immediately and consult a physician. This medication may be removed by dialysis, so adequate time must be allowed between administration and dialysis. Additionally, because drowsiness or dizziness may occur, it is advisable to avoid driving or operating machinery. This medication may interact with other drugs, so care should be taken, especially when taken with medications metabolized by the liver, sedatives, or anxiolytics. Changes in condition should be monitored closely during medication use. Pregnant or breastfeeding women are advised against using this medication due to potential effects on the fetus or newborn. Safety and efficacy for children have not been established, and it should not be used by them. The elderly should be more cautious when taking this medication as their bodily functions may be weakened. In case of overdose, symptoms such as hallucinations, anxiety, severe drowsiness, and insomnia may occur, so if these symptoms arise, discontinue the medication immediately and seek medical assistance. This medication should be stored in its original packaging and unopened to protect it from air and moisture. It should be taken quickly after removal from the packaging and care should be taken to avoid moisture. It is also important to keep it out of reach of children.

Side effects

  • Insomnia
  • drowsiness
  • dizziness
  • headache
  • bad mood
  • hallucinations
  • speech disorders
  • restless leg syndrome
  • tremors
  • numbness
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  • anxiety
  • delirium
  • irritability
  • constipation
  • thirst
  • nausea
  • diarrhea
  • vomiting
  • loss of appetite
  • abdominal discomfort
  • gastritis
  • stomatitis
  • exacerbation of itching
  • eczema
  • rash
  • urticaria
  • erythema
  • papules
  • pigmentation
  • total bile acid increase
  • AST increase
  • ALT increase
  • ALP increase
  • γ-GTP increase
  • bilirubin increase
  • LDH increase
  • frequent urination
  • nocturia
  • polyuria
  • palpitations
  • flushing
  • increased blood pressure
  • increased prolactin
  • decreased testosterone
  • decreased thyroid-stimulating hormone
  • increased thyroid-stimulating hormone
  • increased antidiuretic hormone
  • gynecomastia in males
  • increased eosinophils
  • anemia
  • presence of hematuria
  • presence of proteinuria
  • malaise
  • chest discomfort
  • feeling weak
  • vertigo
  • strange sensation
  • edema
  • decreased blood hemoglobin
  • sleep disturbances
  • oral sensory disturbance
  • elevated blood LDH
  • increased blood pressure
  • nasopharyngitis
  • molluscum contagiosum
  • tinea capitis
  • low back pain
  • hemoptysis
  • chest discomfort
  • abnormal sensations
  • cold sensation
  • high fever

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best to store the drug at room temperature between 1 degree and 30 degrees Celsius. Avoid extremely hot or cold places to help maintain the drug's efficacy.

Appearance and packaging

Appearance

Pale purplish-red or cloudy red film-coated oral disintegrating tablet

Package unit

14 tablets/box [14 tablets/PTP X 1], 140 tablets/box [14 tablets/PTP X 10]

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.