Posology : מינונים

4.2    Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to current guidelines. Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.


EXE APL JUL23 V11                            Page 1 of 14                   EU SmPC Apr.2023 Posology

Patches              Rivastigmine base           Rivastigmine in vivo dose load               release rates per 24 h
Exelon patch 5              9 mg                         4.6 mg
Exelon patch 10            18 mg                         9.5 mg
Exelon patch 15            27 mg                        13.3 mg

Mild to moderate dementia of the Alzheimer’s type

Initial dose and dose titration to the effective dose:
Treatment is started with Exelon Patch 5 once a day.
After a minimum of four weeks of treatment and if well tolerated this dose should be increased to Exelon Patch 10, the daily recommended effective dose, which can be continued for as long therapeutic benefit for the patient exists.
Individual responses to rivastigmine may vary and some patients may derive additional benefit from higher doses. Subsequent increases to Exelon Patch 15 should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
Severe dementia of the Alzheimer’s type
Initial dose and dose titration to the effective dose:
Treatment is started with Exelon Patch 5 once a day. Subsequently the dose should be increased to Exelon Patch 10 and then to Exelon Patch 15 which is the demonstrated effective dose. These dose increases should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
Interruption of treatment:
•     Treatment should be temporarily interrupted if gastrointestinal adverse effects and/or worsening of existing extrapyramidal symptoms (e.g. tremor) are observed until these adverse effects resolve.
Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise treatment should be re-initiated with Exelon Patch 5.
•     If adverse effects persist on re-initiation of therapy, the dose should be temporarily reduced to the previous well-tolerated dose.

Switching from capsules to transdermal patches:

Patients treated with Exelon capsules or oral solution can be switched to Exelon patches as follows:
•       A patient who is on a dose < 6 mg per day oral rivastigmine can be switched to Exelon patch 5.
•       A patient on a dose of 6 mg or 12 mg per day oral rivastigmine may be directly switched to Exelon patch 10.
It is recommended to apply the first transdermal patch on the day following the last oral dose.

Special populations

Patients with body weight below 50 kg
Caution should be exercised in titrating these patients as they may experience more adverse reactions.
Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop (see section 4.4).

Hepatic impairment
Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed.
Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions. Patients with severe hepatic impairment have not been studied. Particular caution should be EXE APL JUL23 V11                           Page 2 of 14                      EU SmPC Apr.2023 exercised in titrating these patients (see sections 4.4 and 5.2).

Renal impairment
No dose adjustment is necessary for patients with renal impairment (see section 5.2).

Paediatric population
Children and adolescents (age below 18 years): rivastigmine is not recommended for use in Children.
Method of administration
Exelon transdermal patches should be applied once a day 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 tight clothing.
The patch should be replaced by a new one after 24 hours.

Important administration instructions (patients and caregivers should be instructed):
•    The previous day’s patch must be removed before applying a new one.
•    The patch should be replaced by a new one after 24 hours. Only one patch should be worn at a time (see section 4.9).
•    The patch should not be applied to skin that is red, irritated or cut. It is recommended to change the application site daily to avoid potential irritation, although consecutive patches can be applied to the same general anatomic site (e.g., another spot on the upper back).
•    The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
•    If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
•    The patch can be used in everyday situations, including bathing and during hot weather.
•    The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas, solarium) for long periods of time.
•    The patch should not be cut into pieces.
•    Wash your hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.