ELUDEN

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.

3 mg/24 h dose strength cannot be achieved with this product. 3 mg/24 h strength are available. 6 mg/24 h. 5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.

5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit. g. 1). The clinical benefit of rivastigmine should be reassessed on a regular basis. Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.

Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days.

6 mg/24 h. 6 mg/24 h transdermal patches. 6 mg/24 h transdermal patches. 5 mg/24 h transdermal patches. 6 mg/24 h transdermal patches is recommended. 5 mg/24 h transdermal patches. 5 mg/24 h, which is the recommended effective dose. It is recommended to apply the first transdermal patch on the day following the last oral dose.

Special populations Paediatric population:

There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease. 4). They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.

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. 2). 2). Method of administration 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.

It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body. The transdermal patch should not be applied to skin that is red, irritated or cut.

Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation. 9). • The patch should be replaced by a new one after 24 hours. 9). • 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.

g. excessive sunlight, saunas, solarium) for long periods of time. • The patch should not be cut into pieces.

Summary of the safety profile Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of rivastigmine transdermal patch. The next most common adverse reactions are gastrointestinal in nature including nausea and vomiting.

Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.

Frequency categories are defined using the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Tabulated list of adverse reactions Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer’s dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches for a duration of 24-48 weeks and from post-marketing data.

g. g. fatigue, asthenia), pyrexia, weight decreased Rare Fall * In a 24-week controlled study in Japanese patients, application site erythema, application site oedema and application site pruritus were reported as “very common”. 3 mg/24 h or placebo, suggesting a dose effect relationship.

3 mg/24 h transdermal patches than with placebo. The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: malaise, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).

Skin irritation In double-blind controlled clinical trials, application site reactions were mostly mild to moderate in severity. 3% in patients treated with rivastigmine transdermal patches. 4% in the Chinese and Japanese population respectively.

In two 24-week double-blind, placebo-controlled clinical trials, skin reactions were measured at each visit using a skin irritation rating scale. When observed in patients treated with rivastigmine transdermal patches, skin irritation was mostly slight or mild in severity.

7% of patients treated with rivastigmine transdermal patches in a Japanese study. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes. 6 mg/24 h. 9). Most cases of misuse of the medicinal product and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time.

2). 8). These adverse reactions occur more commonly in women. Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and dose reduction or discontinuation if recognised and treated promptly.

Dehydration can be associated with serious outcomes. Weight loss Patients with Alzheimer’s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine. The patient’s weight should be monitored during therapy with rivastigmine transdermal patches.

Bradycardia Electrocardiogram QT prolongation may occur in patients treated with certain cholinesterase inhibitor products including rivastigmine. Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.

Caution is advised in patients with pre-existing, or a family history of, QTc prolongation or at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes.

8). 8); • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases; • to patients with a history of asthma or obstructive pulmonary disease. Skin application site reactions Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.

Patients and caregivers should be instructed accordingly. These reactions are not in themselves an indication of sensitisation. However, use of rivastigmine patch may lead to allergic contact dermatitis. g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.

3). Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision.

It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form. There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).

3). Other warnings and precautions Rivastigmine may exacerbate or induce extrapyramidal symptoms. 3). Hands should be washed 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.

2). g. 6 mg/24 h transdermal patch if such adverse reactions develop. • Hepatic impairment: Patients with clinically significant hepatic impairment mayexperience more adverse reactions. Dosing recommendations to titrate according to individual tolerability must be closely followed.

Patients with severe hepatic impairment have not been studied. 2).

1 or other carbamate derivatives. 4).