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Prometax is a brand name for Rivastigmine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease.
Verbatim from this product's EMA label. Tap a section to expand.
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 should be administered twice a day, with morning and evening meals.
The capsules should be swallowed whole. 5 mg twice a day. 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.
1). Treatment effect has not been studied in placebo-controlled trials beyond 6 months. 5 mg twice daily. Dose titration should then be carried out as described above. 4 Special populations Renal and hepatic impairment No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
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 Prometax. 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 Prometax 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 in patients with dementia associated with Parkinson’s disease treated with Prometax 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 Dystonia Not Known Pleurothotonus (Pisa syndrome) Cardiac disorders Common Bradycardia Uncommon Atrial Fibrillation Uncommon Atrioventricular block Not known Sick sinus syndrome 9 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 Prometax 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 5 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
2). Paediatric population There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer’s disease.
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax in patients with dementia associated with Parkinson’s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
3) 0 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. Healthcare 10 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
2 must be made. 8). Such events appeared to occur particularly after dose increments or high doses of rivastigmine. 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). Rivastigmine may cause increased gastric acid secretions. Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions. Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Cholinomimetics may induce or exacerbate urinary obstruction and seizures. Caution is recommended in treating patients predisposed to such diseases. g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms. 8). g. 7% on rivastigmine vs 0% on placebo). Clinical monitoring is recommended for these adverse reactions. 2). Dosing recommendations to titrate according to individual tolerability must be closely followed.
Patients with severe hepatic impairment have not been studied. However, Prometax may be used in this patient population and close monitoring is necessary. Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
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