Medication info

Remitch Soft Capsule 2.5 Micrograms (Nalbufin Hydrochloride)

Prescription medicationSoft capsuleOralApproval withdrawn
Ingredient · strength
Nalfurafine Hydrochloride›2.5μg / 1 capsule
Manufacturer / importer
SK Chemicals Co., Ltd.
Appearance
Very light yellow to light yellow oval soft capsule containing a colorless transparent viscous liquid.
Packaging
14 capsules in PTP packaging
Approval status
Approval withdrawn

MFDS item code 201307707 · Approved 2013.06.14

This product's status changed to Approval withdrawn on 2023.11.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of pruritus in hemodialysis patients for whom existing treatments are insufficiently effective
Who takes it
Adults
Adult dose
Adults: Take 1 capsule (equivalent to 2.5㎍ of nalfurafine hydrochloride) orally once daily after the evening meal. The maximum daily dose is 5㎍ once daily.

Ingredients

Importer
SK Chemicals Co., Ltd.

Efficacy & effects

Improvement of pruritus in hemodialysis patients for whom existing treatments are insufficiently effective

  • Pruritus
View approved original text

This medication is used to improve pruritus in patients undergoing hemodialysis who do not have sufficient relief from existing therapies.

How to take

Adult dose

Adults: Take 1 capsule (equivalent to 2.5㎍ of nalfurafine hydrochloride) orally once daily after the evening meal. The maximum daily dose is 5㎍ once daily.

Precautions

This medicine should not be used by individuals who are allergic to this medicine or its components, or by children under 18 years of age. Patients with moderately to severely impaired liver function, pregnant women, or those who might become pregnant, as well as elderly individuals should exercise increased caution when using this medicine. This medication can frequently cause symptoms such as insomnia, constipation, and drowsiness, so the patient's condition should be carefully monitored after administration. Liver function test results may rise, or jaundice symptoms may appear; if these symptoms occur, immediately stop taking the medicine and consult a doctor. Since this medicine can be removed by hemodialysis, patients undergoing dialysis should take this medication at least 8 hours apart from their dialysis sessions. Drowsiness or dizziness may occur while taking this medicine, so it is advisable to avoid driving or operating hazardous machinery. If the medicine is taken without any noticeable effect, care should be taken to not use it for an extended period of time. When taken with drugs that inhibit certain liver metabolic enzymes or with some sedatives, anxiolytics, etc., the side effects may be more severe, so it is essential to consult a doctor or pharmacist when taking this medicine with others. Pregnant women are advised not to take this drug, and nursing mothers should also avoid it as it can be passed through breast milk. In the case of children or the elderly, since the safety and efficacy of this medicine have not been sufficiently confirmed or bodily functions may be impaired, greater caution is necessary when administering it. In case of overdose, symptoms such as hallucinations, anxiety, severe drowsiness, and insomnia may occur; if such symptoms are present, stop taking the medicine immediately and seek appropriate treatment. This medicine must be stored in its original packaging, out of reach of children, and kept away from direct sunlight. Once the blister pack is opened, it should be taken immediately, and transferring it to another container may cause degradation in quality or accidents.

Side effects

  • Insomnia
  • constipation
  • drowsiness
  • increased prolactin
  • dizziness
  • restlessness
  • headache
  • hallucination
  • tremor
  • numbness
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  • anxiety
  • delirium
  • vomiting
  • diarrhea
  • loss of appetite
  • abdominal discomfort
  • thirst
  • worsening of itching
  • rash
  • eczema
  • urticaria
  • erythema
  • pigmentation
  • papules
  • AST elevation
  • ALT elevation
  • ALP elevation
  • γ-GTP elevation
  • bilirubin elevation
  • lactate dehydrogenase (LDH) elevation
  • palpitations
  • flushing
  • decreased testosterone
  • decreased thyroid-stimulating hormone
  • increased thyroid-stimulating hormone
  • gynecomastia
  • eosinophilia
  • fatigue
  • chest discomfort
  • lethargy
  • vertigo
  • sleep disturbances
  • oral sensory abnormalities
  • elevated blood LDH
  • increased blood pressure
  • nasopharyngitis
  • molluscum contagiosum
  • tinea capitis
  • low back pain
  • hemoptysis
  • dysesthesia
  • cold sensation
  • high fever

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

Storage

This medicine is sensitive to light; it should be stored in a container that does not allow light to enter. Additionally, it is important to store it at room temperature, between 1 to 30 degrees Celsius, until use. This will help maintain the efficacy of the medicine.

Appearance and packaging

Appearance

Very light yellow to light yellow oval soft capsule containing a colorless transparent viscous liquid.

Package unit

14 capsules in PTP packaging

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.