Medication info

Samsung Rasagiline Tablet 0.5 mg (Rasagiline Mesylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Rasagiline Mesylate›0.78mg / 1 tablet
Manufacturer / importer
Samsung Pharmaceutical Co., Ltd.
Appearance
Flat, round tablets with edges, white or almost white in color
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 202000579 · Approved 2020.02.04

This product's status changed to Expired on 2025.02.04. 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 once daily to adults 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 it is well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Ingredients

Manufacturer
Samsung 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 idiopathic Parkinson's disease. Initially, it is used as monotherapy or in combination with dopamine agonists to relieve symptoms. Additionally, it can be used as an adjunct therapy with levodopa in patients experiencing motor fluctuations, particularly 'end of dose fluctuations' that appear when the effect wears off. This helps improve the patient's motor function and contributes to enhancing quality of life.

How to take

Adult dose

This medicine is administered orally once daily to adults 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 it is well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Precautions

This medication should not be used in certain patients. Individuals allergic to the active ingredient or other components of this medication should not take it. Furthermore, it can be dangerous when taken with other MAO inhibitors or certain analgesics, cold medications, etc. Therefore, it should not be used in patients currently taking these medications or those who have stopped using them within the last 2 weeks. Patients with moderate to severe liver function impairment should also not take this medication. Side effects can occur when taking this medication. Symptoms such as headache, dizziness, nausea, insomnia, muscle pain, joint pain, skin rash, rhinitis, and angina are commonly reported. Moreover, psychological symptoms such as depression or hallucinations have also been noted. Other adverse reactions may include blood disorders, infections, gastrointestinal issues, and kidney problems. Consult a healthcare professional immediately if any symptoms appear. This medication should be used with caution in patients with liver dysfunction, and severe liver impairment patients should not take it. For patients with slight kidney dysfunction, dosage adjustment is not necessary; however, safety has not been confirmed in severe renal impairment cases. Drowsiness or sudden sleep symptoms may occur during treatment; therefore, avoid driving or operating machinery during these symptoms. Additionally, this medication may cause increased drowsiness when taken with other central nervous system depressants or alcohol, so caution is advised. This medication has many drug interactions; particularly, it can be dangerous when taken with other MAO inhibitors, specific analgesics, antidepressants, cold medicines, and sympathomimetics. Therefore, it is crucial to inform your doctor or pharmacist of any other medications you are taking. Pregnant or breastfeeding women should take caution when using this medication. If breastfeeding, it may affect milk production; therefore, consult a professional for guidance. The safety and efficacy in children under 18 have not been established, and no special dosage adjustment is necessary for individuals over 65. In the case of overdose, severe side effects may occur, and appropriate treatment should be sought immediately at a medical facility. This medication should be kept out of reach of children and stored in a sealed container to protect it from air and moisture. Additionally, it should be stored in a cool place at temperatures between 1 to 25 degrees Celsius and should not be transferred to another container.

Side effects

  • Influenza
  • skin cancer
  • leukopenia
  • allergy
  • loss of appetite
  • depression
  • hallucinations
  • 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
  • fatigue
  • peripheral edema
  • falling
  • arthralgia
  • low back pain
  • cough
  • insomnia
  • upper respiratory infection
  • orthostatic hypotension
  • nausea
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • dyspepsia
  • hernia
  • infection
  • gingivitis
  • accidental injury
  • weight loss
  • tendinitis
  • dyskinesia
  • drowsiness
  • sensory disturbances
  • ataxia
  • muscle tension abnormalities
  • myasthenia
  • appetite loss
  • abnormal dreams
  • respiratory distress
  • rash
  • hyperhidrosis
  • petechiae
  • melanoma
  • confusion
  • carpal tunnel syndrome
  • balance disorders
  • hypotension
  • hypertension
  • pathological gambling
  • increased libido
  • hypersexuality
  • compulsive buying or spending
  • binge eating
  • compulsive eating
  • impulse control disorder
  • excessive drowsiness
  • acute kidney failure
  • malignant hyperthermia
  • spinal fracture
  • rib fracture
  • tendon injury
  • pelvic fracture
  • leg fracture
  • upper extremity fracture
  • back pain
  • knee arthroplasty
  • herniated disc
  • hypoglycemia
  • weight loss
  • dysuria
  • orthostatic hypotension
  • systemic weakness
  • pulmonary tuberculosis
  • hallucinations
  • semicoma
  • gait disturbance
  • ocular movement seizures
  • facial paralysis
  • spinal canal stenosis
  • exacerbation of Parkinson's disease
  • subdural hematoma
  • pneumonia
  • myalgia
  • osteoporosis
  • limb weakness
  • thirst
  • hematuria
  • frequency
  • vaginitis
  • conjunctival injection
  • diplopia
  • visual impairment
  • skin thickening
  • palpitations
  • arrhythmia
  • heartburn
  • fatigue
  • delusions
  • sleep disorders
  • aggression
  • amnesia
  • memory impairment
  • lethargy
  • sleep talking
  • psychosexual disorder
  • skin paresthesia
  • tremors
  • freezing phenomenon
  • limb tremors
  • cataplexy
  • leg cramps
  • polyuria
  • tremors
  • stuttering
  • vocal disabilities
  • vocal cord paralysis
  • language disabilities
  • localized inflammation
  • itching
  • urticaria
  • boils
  • hair loss
  • bruising
  • abnormal sputum
  • increased sputum
  • cold
  • bronchitis

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. Furthermore, it should be kept in a cool place between 1 to 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Flat, round tablets with edges, white or almost white in color

Package unit

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.