RIVASTIGMINE ROSEMONT

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia or dementia associated with Parkinson’s disease. Diagnosis should be made according to current guidelines.

Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient. Posology Rivastigmine oral solution should be administered twice a day, with morning and evening meals.

The prescribed amount of solution should be withdrawn from the container using the oral dosing syringe supplied. Rivastigmine oral solution may be swallowed directly from the syringe. Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.

5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. 5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.

g. g. tremor) in patients with dementia associated with Parkinson’s disease are observed during treatment, these may respond to omitting one or more doses. If adverse reactions persist, the daily dose should be temporarily reduced to the previous well- tolerated dose or the treatment may be discontinued.

Maintenance dose The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg twice a day. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.

Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day. If after 3 months of maintenance dose treatment the patient’s rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.

Discontinuation should also be considered when evidence of a therapeutic effect is no longer present. Individual response to rivastigmine cannot be predicted. However, a greater treatment effect was seen in Parkinson’s disease patients with moderate dementia.

Summary of the safety profile The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.

Tabulated list of adverse reactions Adverse reactions in Table 1 and Table 2 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).

The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’s dementia treated with rivastigmine. g. 4). Hepatobiliary disorders Uncommon Elevated liver function tests Not known Hepatitis Skin and subcutaneous tissue disorders Common Hyperhydrosis Rare Rash Not known Pruritus, allergic dermatitis (disseminated) General disorders and administration site conditions Common Fatigue and asthenia Common Malaise Uncommon Fall Investigations Common Weight loss The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).

Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson’s disease treated with rivastigmine capsules. Table 2 Metabolism and nutrition disorders Common Decreased appetite Common Dehydration Psychiatric disorders Common Insomnia Common Anxiety Common Restlessness Common Hallucination, visual Common Depression Not known Aggression Nervous system disorders Very common Tremor Common Dizziness Common Somnolence Common Headache Common Parkinson’s disease (worsening) Common Bradykinesia Common Dyskinesia Common Hypokinesia Common Cogwheel rigidity Uncommon Unknown Dystonia Pleurothotonus (Pisa syndrome) Cardiac disorders Common Bradycardia Uncommon Atrial Fibrillation Uncommon Atrioventricular block Not known Sick sinus syndrome Vascular disorders Common Hypertension Uncommon Hypotension Gastrointestinal disorders Very common Nausea Very common Vomiting Common Diarrhoea Common Abdominal pain and dyspepsia Common Salivary hypersecretion Hepatobiliary disorders Not known Hepatitis Skin and subcutaneous tissue disorders Common Hyperhydrosis Not known Allergic dermatitis (disseminated) General disorders and administration site conditions Very common Fall Common Fatigue and asthenia Common Gait disturbance Common Parkinson gait The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson’s disease treated with rivastigmine transdermal patches: agitation (common).

The incidence and severity of adverse reactions generally increase with higher doses. g. vomiting). Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity. 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). Patients and caregivers should be instructed accordingly. g. hypertension and hallucinations in patients with Alzheimer’s dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’s disease) have been observed shortly after dose increase.

They may respond to a dose reduction. 8). 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. Patients with Alzheimer’s disease may lose weight. Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients. During therapy patient’s weight should be monitored.

1. 4).