Rivastigmine Teva

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. 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 the 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.

2Medicinal product no longer authorised 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. 2). 4).

The most commonly reported adverse reactions 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.

The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine. 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).

g. 4). Hepatobiliary disorders Uncommon Elevated liver function tests Not known Hepatitis Skin and subcutaneous tissue disorders Common Hyperhydrosis Rare Rash Not known Pruritus General disorders and administration site conditions Common Fatigue and asthenia Common Malaise Uncommon Fall 6Medicinal product no longer authorised Investigations Common Weight loss Table 2 shows the adverse reactions reported in patients with dementia associated with Parkison’s disease treated with rivastigmine.

Table 2 Metabolism and nutrition disorders Common Anorexia Common Dehydration Psychiatric disorders Common Insomnia Common Anxiety Common Restlessness Not known Aggression Nervous system disorders Very common Tremor Common Dizziness Common Somnolence Common Headache Common Worsening of Parkinson’s disease Common Bradykinesia Common Dyskinesia Uncommon Dystonia Cardiac disorders Common Bradycardia Uncommon Atrial fibrillation Uncommon Atrioventricular block Not known Sick sinus syndrome Gastrointestinal disorders Very common Nausea Very common Vomiting Common Diarrhoea Common Abdominal pain and dyspepsia Common Salivary hypersecretion Hepatobiliary disorders Not known Hepatitis 7Medicinal product no longer authorised Skin and subcutaneous tissue disorders Common Hyperhydrosis Musculoskeletal and connective tissue disorders Common Muscle rigidity General disorders and administration site conditions Common Fatigue and asthenia Common Gait abnormality Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.

The incidence and severity of adverse reactions generally increase with higher doses. g. vomiting). 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. 3Medicinal product no longer authorised 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. 2 must be made. 8). Such events appeared to occur particularly after dose increments or high doses of rivastigmine. 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). Patients with severe hepatic impairment have not been studied. However, Rivastigmine Teva 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.

The use of this medicinal product is contraindicated in patients with - hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients used in the formulation,