RIVASTIGMINE CRESCENT

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. The diagnosis must be made according to the currently valid guidelines. Like every 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.

6 mg/24h. 5 mg/24h. This should be continued for as long as the patient continues to demonstrate therapeutic benefit. 5 mg/24 h is the recommended daily effective dose. This 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. A discontinuation should be considered when there is no longer any evidence of a therapeutic effect at the optimal dose. Treatment should be temporarily interrupted if gastrointestinal side effects are observed until the symptoms resolve.

If the interruption did not last longer than three days, the treatment with the transdermal patch can be continued at the same dose. 6 mg/24h. 6 mg/24h transdermal patches. 6 mg/24h transdermal patches. 5 mg/24h transdermal patches. 6 mg/24h transdermal patches is recommended.

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

Special populations • Paediatric population:

There is no relevant benefit of rivastigmine in children and adolescents in the therapeutic area of Alzheimer's dementia. 4). These patients may experience more side effects and may be more likely to discontinue the treatment due to adverse reactions.

• Hepatic impairment: Due to the increased exposure in mild to moderate hepatic impairment that has also been observed with the oral dosage forms, the recommendations for dose titration should be strictly followed according to individual tolerance.

Patients with clinically significant hepatic impairments can experience more dose-dependent side effects. 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, unbroken healthy skin on the upper or lower back, upper arm or chest, in a place that will not be affected by rubbing of tight clothing.

It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine in these areas. Do not apply the transdermal patch to skin that is red, irritated or injured. To minimise the potential risk of skin irritations the patch should not be applied to the same area of the body within 14 days.

9). • After 24 hours the patch must be replaced through a new one. 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 comes off, apply a new one for the rest of the day.

On the following day, replace it at the usual time. • The patch can be worn in everyday situations, including showering/bathing and during hot weather. g. excessive sunlight, saunas, solarium) for extended periods of time. • The patch should not be cut into pieces.

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 lists 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 loss 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/24h or placebo, suggesting a dose effect relationship.

3 mg/24h 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).

Skin irritation In double-blind, controlled clinical trials the reactions at the application site were mostly mild to moderate. 3%. 9%). In two 24-week double-blind, placebo-controlled clinical trials skin reactions were measured at each visit using a skin irritation scale.

In patients treated with rivastigmine transdermal patch it was observed that the skin reactions were mostly negligible or mild. 7% of the patients who had been treated with rivastigmine transdermal patch. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple Store.

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

2). 8). These side effects are more common in women. Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and a dose reduction or discontinuation if recognised and treated promptly.

Dehydration can have severe consequences. Weight loss Patients with Alzheimer’s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine. During the treatment with rivastigmine the patients’ weight should be monitored.

8); • Patients with a tendency for urinary obstruction and seizures because cholinomimetics may induce or exacerbate these; • Patients with a history of asthma or obstructive pulmonary disease. Skin reactions at the application site Rivastigmine patches can cause skin reactions at the application site that are usually mild or moderate in intensity.

Patients and caregivers should be instructed accordingly. These reactions by themselves are not yet a sign for a sensitisation. However, the use of rivastigmine patches may lead to allergic contact dermatitis. g. increasing erythema, oedema, blistering) and if symptoms do not significantly improve within 48 hours after removing the patch.

3). Patients who develop reactions at the application site that are suggestive of allergic contact dermatitis to rivastigmine patches 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 who have become sensitised to rivastigmine through the exposure to the rivastigmine patches may not be able to take rivastigmine in any form. There have been rare post-marketing reports of patients with allergic dermatitis (disseminated) after the administration of rivastigmine irrespective of the route of administration (oral, transdermal).

3). Other warnings and precautions Rivastigmine can exacerbate or induce extrapyramidal symptoms. Rivastigmine may cause bradycardia which is a risk factor for the occurrence of torsade de pointes, especially in patients with risk factors.

8). 3). Hands should be washed with soap and water after removing the patch. In case of contact with eyes or if the eyes turn red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

2). g. excessive nausea or vomiting). 6 mg/24h transdermal patch. • Patients with hepatic impairment: Patients with clinically significant hepatic impairments might experience more adverse reactions. The recommendations for dose titration should be strictly followed according to individual tolerance.

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

1. 4).