ARICEPT EVESS

Posology Adults/Elderly people Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved.

Following a one-month clinical assessment of treatment at 5 mg/day, the dose of ARICEPT EVESS can be increased to 10 mg/day (once-a- day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials.

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient.

Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present.

Individual response to donepezil cannot be predicted. Upon discontinuation of treatment, a gradual abatement of the beneficial effects of ARICEPT EVESS is seen. Paediatric population ARICEPT EVESS is not recommended for use in children and adolescents below 18 years of age.

Patients with renal and hepatic impairment A similar dose schedule can be followed for patients with renal impairment, as clearance of donepezil hydrochloride is not affected by this condition. 2), dose escalation should be performed according to individual tolerability.

There are no data for patients with severe hepatic impairment. Method of administration ARICEPT EVESS should be taken orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference.

8) intake of ARICEPT EVESS in the morning may be considered.

The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea, vomiting and insomnia. Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequencies are defined as: 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) and not known (cannot be estimated from available data).

4). ** Reports of hallucinations, abnormal dreams, nightmares, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment. *** In cases of unexplained liver dysfunction, withdrawal of ARICEPT EVESS should be considered.

**** Rhabdomyolysis has been reported to occur independently of Neuroleptic Malignant syndrome and in close temporal association with donepezil initiation or dose increase. 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 App Store.

, age-related cognitive decline), has not been investigated. Anaesthesia ARICEPT EVESS as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia. g. bradycardia). The potential for this action may be particularly important to patients with “sick sinus syndrome” or other supraventricular cardiac conduction conditions, such as sinoatrial or atrioventricular block.

There have been reports of syncope and seizures. In investigating such patients the possibility of heart block or long sinusal pauses should be considered. 8). g. uncompensated heart failure, recent myocardial infarction, bradyarrhythmias), or electrolyte disturbances (hypokalaemia, hypomagnesaemia).

Clinical monitoring (ECG) may be required. g. those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), should be monitored for symptoms. However, the clinical studies with ARICEPT EVESS showed no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

Genitourinary Although not observed in clinical trials of ARICEPT EVESS, cholinomimetics may cause bladder outflow obstruction.

Neurological Conditions Seizures:

Cholinomimetics are believed to have some potential to cause generalised convulsions. However, seizure activity may also be a manifestation of Alzheimer's disease. Cholinomimetics may have the potential to exacerbate or induce extrapyramidal symptoms.

Neuroleptic Malignant Syndrome (NMS) NMS, a potentially life-threatening condition characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur very rarely in association with donepezil, particularly in patients also receiving concomitant antipsychotics.

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