Medication info

Newlect Tablets 0.5 mg (Rasagiline Mesylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Rasagiline Mesylate›0.78mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
White, round tablets
Packaging
30 tablets (10 tablets/PTP × 3), 30 tablets/bottle
Approval status
Expired

MFDS item code 201907616 · Approved 2019.10.31

This product's status changed to Expired on 2024.10.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of idiopathic Parkinson's disease
Who takes it
Adults
Adult dose
This medicine is administered orally to adults once daily as monotherapy or adjunctive therapy. 1) Monotherapy or adjunctive therapy with a dopamine agonist: Administer 1mg orally once daily. 2) Adjunctive therapy with levodopa: The recommended initial dose for patients taking levodopa is 0.5mg once daily. If well tolerated and the clinical response is insufficient, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease

  • Idiopathic Parkinson's disease
  • motor fluctuation symptoms
View approved original text

This medication is used for the treatment of patients with idiopathic Parkinson's disease. It can be used initially as monotherapy or as an adjunctive therapy to dopamine agonists. Additionally, it is effective as an adjunct therapy to levodopa in patients who experience motor fluctuations, particularly during the end of dose fluctuations when the effect of the medication diminishes. This helps to improve Parkinson's disease symptoms and enhances the quality of daily life for patients.

How to take

Adult dose

This medicine is administered orally to adults once daily as monotherapy or adjunctive therapy. 1) Monotherapy or adjunctive therapy with a dopamine agonist: Administer 1mg orally once daily. 2) Adjunctive therapy with levodopa: The recommended initial dose for patients taking levodopa is 0.5mg once daily. If well tolerated and the clinical response is insufficient, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Precautions

This medicine should not be used in patients who are allergic to its active ingredient or any other ingredients. It should also not be administered to patients who are currently taking monoamine oxidase inhibitors (MAO inhibitors) or who have stopped taking them within the last 2 weeks. Particularly, patients taking medications such as pethidine, tramadol, or dextromethorphan should not use this medicine together, and it should be avoided in patients with moderate to severe liver impairment. This medication can cause various adverse reactions, with common symptoms including headache, depression, hallucinations, dizziness, dermatitis, nausea, constipation, and musculoskeletal pain. Rarely, serious side effects such as myocardial infarction, cerebrovascular accidents, malignant hyperthermia, and acute renal failure have been reported, so any unusual symptoms should be discussed with a physician immediately. When used with other dopaminergic treatments, there may be occurrences of hypotension or movement disorders, so caution is advised. Drowsiness or sudden sleep episodes may occur during treatment, so caution should be taken while engaging in activities such as driving or operating machinery. Especially, combining this medication with other MAO inhibitors, antidepressants, or sympathomimetics can lead to serious side effects, so it should be discussed with a physician. During pregnancy or lactation, careful consideration should be given to the use of this medication, and its safety in pediatric patients has not been established. In case of overdose, symptoms such as mild euphoria, hypertensive crisis, and serotonin syndrome may appear, and immediate medical attention should be sought.

Side effects

  • influenza
  • skin cancer
  • leukopenia
  • allergy
  • decreased appetite
  • depression
  • hallucination
  • headache
  • cerebrovascular accident
  • conjunctivitis
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  • dizziness
  • angina
  • myocardial infarction
  • rhinitis
  • abdominal distension
  • dermatitis
  • vesicular rash
  • musculoskeletal pain
  • neck pain
  • arthritis
  • urinary urgency
  • fever
  • malaise
  • nausea
  • peripheral edema
  • falls
  • arthralgia
  • low back pain
  • cough
  • insomnia
  • upper respiratory infection
  • orthostatic hypotension
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • dyspepsia
  • hernia
  • infection
  • gingivitis
  • accidental injury
  • weight loss
  • tendinitis
  • movement disorders
  • drowsiness
  • sensory disturbances
  • ataxia
  • dystonia
  • myasthenia
  • decreased appetite
  • abnormal dreams
  • respiratory distress
  • rash
  • hyperhidrosis
  • hemorrhagic spots
  • bleeding
  • melanoma
  • delirium
  • carpal tunnel syndrome
  • balance disorders
  • stupor
  • gait disturbances
  • oculomotor seizures
  • facial paralysis
  • spinal canal stenosis
  • worsening of Parkinson's disease
  • subdural hematoma
  • pneumonia
  • spinal fracture
  • rib fracture
  • tendon injury
  • pelvic fracture
  • leg fracture
  • upper limb fracture
  • low back pain
  • knee arthroplasty
  • herniated disc
  • hypoglycemia
  • acute renal failure
  • dysuria
  • malignant hyperthermia
  • systemic weakness
  • pulmonary tuberculosis
  • delusions
  • sleep disorders
  • aggression
  • amnesia
  • memory impairment
  • lethargy
  • sleep talking
  • psychosexual disorders
  • skin paresthesia
  • tremor
  • freezing phenomenon
  • limb tremors
  • myotonic dystrophy
  • leg cramps
  • polyuria
  • tremor
  • stuttering
  • speech disorders
  • language disorders
  • localized inflammation
  • itching
  • urticaria
  • abscess
  • hair loss
  • palpitations
  • arrhythmia
  • abnormal sputum
  • increased sputum
  • cold
  • bronchitis
  • heartburn
  • fatigue

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 important to store it at a cool temperature between 1 degree and 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White, round tablets

Package unit

30 tablets (10 tablets/PTP × 3), 30 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.