RIVASTIGMINE BROWN & BURK

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 is not available for 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 transdermal patches 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.

Summary of the safety profile Skin reactions at the application site (usually mild to moderate erythema at the application site) are the most common adverse reactions that have been observed with the use of rivastigmine transdermal patch.

The next most common side effects are gastrointestinal in nature, including nausea and vomiting. Adverse reactions in table 1 are listed according to MedDRA system organ class and frequency category.

The assessment of side effects is based on the following frequency specifications:

Very Common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000) Not known (frequency cannot be estimated from the available data) Table with an overview over side effects Table 1 list the adverse drug reactions that occurred in 1,670 Alzheimer’s disease patients who were treated in randomised, double-blind, placebo and drug-controlled clinical trials evaluating rivastigmine transdermal patches for 24 to 48 weeks, and from post-marketing data.

g. g. fatigue, asthenia), pyrexia, weight decreased Rare: Falls *In a 24-week controlled study with Japanese patients, application site erythema, application site oedema, and application site pruritus were reported very frequently. 3 mg/24 h or placebo, suggesting a dose effect relationship.

3 mg/24 h transdermal patch the events did not occur more frequently 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: Feeling unwell, confusion, increased sweating (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).

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.

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).

1. 4).