Active ingredient(s) and Contents

• Effective components

  • - Wondron Patch 5: Rivastigmine 9 mg
    - Wondron Patch 10: Rivastigmine 18 mg
    - Wondron Patch 15: Rivastigmine 27mg

• Other

  • Silicone Adhesive, Polyester Film, Acrylate Adhesive, Acrylate Copolymer, Fluoro-coated Polyester Film

Dosage and administration

• The amount of release per 24 hours according to the unit area of ··the rivastigmine patch is as follows.
  

  Unit area(cm2)	Contents of active ingredient(s)	Emissions per 24 hours
  5	9mg	4.6mg
  10	18mg	9.5mg
  15	27mg	13.3mg

  
  
  • dose
    
    • 1) Conservative therapy of mild-to-moderate dementia of the Alzheimer’s type or dementiaassociated with Parkinson’s disease.
      • - Initial dose: Treatment begins with patch 5 applied once daily. If well tolerated by the patient, the minimum four week treatment should be followed by an increase to patch 10, which is the recommended effective dose.
      • - Maintenance dose: The daily recommended maintenance dose is patch 10. After a minimum of four weeks of treatment and if well tolerated, the dose should be increased, which should be continued for as long as the patient continues to demonstrate therapeutic benefit. If patients have demonstrated significant cognitive deterioration and/or functional decline since 6 months of administering patch 10, the dose can be increased to patch 15.
    • 2) Conservative therapy of severe dementia of the Alzheimer’s type.
      • - Treatment begins with patch 5 once daily. After, the dose can be increased to patch 10, and then continuously increased to patch 15. If the current dose is well tolerated, the dose may be increased or may be considered after the previous dose is administered for at least four weeks.
      • - The effective dose for severe dementia of the Alzheimer’stype is patch 15.
    • 3) Discontinuation of administration
      If gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, loss of appetite) and/or exacerbation of extrapyramidal symptoms (e.g., tremor) are observed, administration should be temporarily discontinued until these adverse reactions disappear. If administration has been discontinued for less than 3 days, administration is resumed at the same or lower dose. If administration has been discontinued for more than several days, administration is resumed at the lowest dose and increased again.
      If the adverse reaction persists after resumption of administration, it should be temporarily reduced to the previously tolerated dose.
    • 4) Switching from capsules to transdermal patches
      Patients treated with Rivastigmine capsules can switch to transdermal patches as follows. The patch is to be applied the day after oral medication was last administered.
      • - 6 mg daily oral Rivastigmine: patch 5
      • - 6 mg to 12 mg daily oral Rivastigmine: patch 10
  • Method of administration
    One patch should be applied once daily. Patches should be applied to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by clothing. The patch should be replaced by a new one every 24 hours.
    Patients and caregivers should be instructed on following administration instructions before administration.
    
    • 1) The previous day's patch must be removed before applying a new one every day.
    • 2) The patch should be replaced by a new one every 24 hours. Only one patch should be worn at a time.
    • 3) The patch should not be applied to skin that is red, irritated or wounded. Patches can be applied to the same physical location in succession, but it is recommended that each patch be applied to a different site every day to avoid potential irritation. (e.g., other locations on the upper back) Reapplication to the exact same skin location within 14 days should be avoided.
    • 4) The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
    • 5) If the patch falls off, apply a new patch should be applied for the rest of the day, then replaced at around the same time of usual application.
    • 6) The patch can be used in everyday situations including while bathing and in hot weather.
    • 7) The patch should not be exposed to any external heat sources (e.g., excessive sunlight, saunas, solarium and etc.) for long periods.
    • 8) The patch should not be cut into pieces.
    • 9) Hands should be washed with soap and water after removing the patch. In case of contact with the eyes, or if the eyes become red after handling the patch, immediately rinse with plenty of water and seek medical advice if symptoms do not resolve.
  • Patients with body weight below 50 kg
    As they may experience more adverse reactions, particular caution should be exercised in titrating patients with body weight below 50 kg. Carefully increase the dose and monitor for adverse events (e.g., severe nausea or vomiting) and consider dose reduction if such adverse events occur.
    
  • Patients with renal impairment
    No dose adjustment is necessary for patients with renal impairment.
    
  • Patients with hepatic impairment
    Patients with clinically significant hepatic impairment may experience more adverse reactions. For these types of patients, exercise caution when adjusting to a dose higher than patch 10, which is the maintenance dose.
    Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dose titration according to individual tolerability should be closely followed. Patients with severe hepatic impairment have not been studied, so do not administer.
    

Storage and handling

• Airtight container, keep at a temperature below 30°C