Index of drugs

Symptomatic treatment of mild to moderately severe dementia in Alzheimer's disease.

1 tabl powl. contains 5 mg or 10 mg donepezil hydrochloride (and respectively 91 mg or 182 mg lactose).

Selective and reversible acetylcholinesterase inhibitor - the main enzyme that breaks down acetylcholine in the brain. In clinical trials, it was confirmed that the drug in a statistically significant and dose-dependent manner increases the percentage of patients who have improved cognitive skills, general functioning and functioning in social and family life or the ability to function independently (therapy at least 6 months). The effect of the drug on neuropathological changes has not been studied, so it can not be attributed to any effects on the progression of the disease. The maximum concentration of the drug in plasma occurs 3-4 h after administration. Final T_0,5 It is about 70 hours. Steady state is achieved within 3 weeks after starting treatment. The food does not affect absorption. The drug binds to plasma proteins in 95%. It is excreted unchanged in the urine as well as in the form of metabolites (metabolism involving the cytochrome P450 system).

Hypersensitivity to the active substance, piperidine derivatives or to any of the excipients.

Caution should be used in patients with sick sinus syndrome or supraventricular conduction disorders (eg sinoatrial or atrioventricular block) - in patients with syncope or seizures, the possibility of a heart block or sinus arrest should be considered. Use with caution in patients with an increased risk of peptic ulcer disease (history of peptic ulcer disease or NSAID therapy) and in patients with a history of asthma or obstructive pulmonary disease. Donepezil should not be used concomitantly with acetylcholinesterase inhibitors, agonists or cholinergic antagonists. Cholinomimetics may exacerbate or induce extrapyramidal symptoms, and may also cause obstruction of the bladder outlet. The drug may increase muscle relaxation caused by succinylcholine derivatives during anesthesia. The use of the drug in patients with severe dementia in Alzheimer's disease, other types of dementia or other types of memory impairment (eg age-related cognitive impairment) has not been studied. The drug contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The drug should not be used during pregnancy unless it is absolutely necessary. Women receiving donepezil hydrochloride should not breast-feed.

Very common: diarrhea, nausea, headache. Common: colds, anorexia, hallucinations, agitation, unusual dreams and nightmares, fainting, dizziness, insomnia, vomiting, abdominal disorder, rash, pruritus, muscle spasms, incontinence, fatigue, pain, accidents. Uncommon: convulsions, bradycardia, gastrointestinal haemorrhage, gastric and duodenal ulcers, slight increase in CK muscular activity. Rarely: extrapyramidal symptoms, sinoatrial block, atrio-ventricular block, liver disorders (including hepatitis). If patients are examined for fainting or convulsions, the possibility of a block of the heart or long pauses caused by sinus arrest should be considered. There have been reports of hallucinations, unusual dreams, nightmares, agitation and aggressive behavior receding after dose reduction or discontinuation of the drug. In case of unexplained liver dysfunction, discontinuation should be considered.

Orally. Adults (including elderly): treatment starts with a 5 mg dose once a day, in the evening, just before bedtime. Administration of a 5 mg daily dose should continue for at least 1 month, allowing a clinical assessment of the effectiveness of the treatment and achieving a steady state of donepezil hydrochloride. After a clinical review of the treatment for one month at a dose of 5 mg per day, the dose may be increased to 10 mg once a day.The maximum recommended daily dose is 10 mg.Special groups of patients. In patients with renal insufficiency, a similar dosing regimen may be used. In patients with mild to moderate hepatic insufficiency, the dose should be increased according to individual patient tolerability. There are no data on the use of the drug in patients with severe hepatic impairment. The drug is not recommended for use in children and adolescents.Way of giving. Treatment with the product should be started and supervised by a doctor who has experience in the diagnosis and treatment of dementia in Alzheimer's disease. The diagnosis should be made in accordance with the approved guidelines (eg DSM IV, ICD 10). Treatment with donepezil hydrochloride can only be started if the patient can be monitored continuously. Maintenance treatment should be continued for as long as the beneficial effects of the medicine remain. The assessment of the therapeutic benefits of donepezil hydrochloride should be done regularly. You should consider discontinuing the medicine when there is no longer any curative effect. The individual response of the patient to donepezil hydrochloride can not be predicted. After discontinuation of treatment, a gradual decrease in the beneficial effects of treatment with the preparation was observed.