Alzancer Special Precautions



Nobel Ilac




Full Prescribing Info
Special Precautions
The treatment should be started and directed by a doctor who is experienced in the diagnosis of Alzheimer's Dementia and in the treatment of the disease. The diagnosis should be done in compliance with the approved directives (eg. DSM IV, ICD 10).
Donepezil treatment should only be started when there is a responsible person (a relative of the patients, caregiver etc.) who can regularly monitor the medicine intake of the patient.
The treatment should be continued as long as the patient has therapeutical benefits from the medicine. Therefore, the clinical advantages of donepezil should be re-evaluated in certain time intervals. When there is no evidence showing the presence of the therapeutic effect left, the medicine should be stopped. The response that individuals will give to donepezil cannot be expected beforehand.
The use of donepezil hydrochloride in patients with other dementia types and other Memory disorders (eg. Amnestic Mild Cognitive Impairment) is still under evaluation.
Anaesthesia: Being a cholinesterase inhibitor, donepezil hydrochloride may increase the succinylcholine type of muscle relaxation during anaesthesia.
Cardiovascular conditions: Vagotonic effects (like bradycardia) may occur on the heartbeat due to the pharmacological effects of the cholinesterase inhibitors. The potential of this effect to be seen may be particularly important for patients with "sick sinus syndrome" and other supraventricular cardiac conduction disorders like sinoatrial or atrioventricular block.
There are reports of syncope and convulsions. Heart block or long sinus remission should be considered while examining these patients.
Gastrointestinal conditions: Cholinomimetics may increase the production of gastric acid. Patients with ulcer history or with high risk of ulcer development such as patients taking concomitant non-steroidal antiinflammatory drug (NSAID) should be closely followed in terms of the symptoms. On the other hand, no increase was observed in the incidence of peptic ulcer or gastrointestinal bleeding in clinical studies comparing donepezil hydrochloride and placebo.
Genito-urinary system: Cholinomimetics may lead to bladder outlet obstruction although this has not been observed in the clinical studies performed with donepezil hydrochloride.
Central nervous system: Attacks: It is believed that cholinomimetics has a potential to cause generalized convulsions. However, the attacks may also be an indicator of Alzheimer's disease. Cholinomimetics have a potential to induce or increase the extrapyramidal symptoms.
Pulmonary system: Cholinesterase inhibitors should be used with care in patients with a history of asthma or obstructive pulmonary disease depending on its cholinomimetic effects.
The concomitant use of donepezil hydrochloride with other acetylcholinesterase (AchE) inhibitors, cholinergic system agonists or antagonists should be avoided.
Effects on ability to drive and use machines: Alzheimer's Dementia may lead to impairment in driving performance and increase the ability to use machines.
Additionally, donepezil may cause tiredness, dizziness and muscle cramps especially at the beginning or during dose increasement. The doctor managing the treatment should regularly evaluate the ability of patients taking donepezil treatment for driving or using complex machines.
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