VOLEZE

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.

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 maintenance 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 Renal impairment:

No dose adjustment is necessary for patients with renal impairment. 2). Paediatric population There is no relevant use of Voleze 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 No dose adjustment is necessary for patients with hepatic impairment. However, due increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate accordingly to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions.

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.

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 854 patients with Alzheimer’s dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches or a duration of 24-48 weeks and from post-marketing data.

g. g. 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: somnolence, malaise, tremor, 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 a 24-week double-blind, placebo-controlled clinical trial, skin reactions were measured at each visit using a skin irritation rating scale that rated the degree of erythema, oedema, scaling, fissures, pruritus and pain/stinging/burning at the application site.

The most commonly observed symptom was erythema which disappeared within 24 hours in the vast majority of patients. 0%) pruritus. 1%). 5 mg/24 h transdermal patch group. In a 48-week active-controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse reactions.

The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes. 6 mg/24 h. Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.

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 Voleze 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.

1. 4).