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. The preparation contains lactose.

Selective and reversible acetylcholinesterase inhibitor - the main enzyme that breaks down acetylcholine in the brain. Reduction of acetylcholinesterase in red blood cells by donepezil hydrochloride has been shown to correlate with changes in the sensitive ADAS-Cog scale measuring selected elements of cognitive activity. The effect of the drug on neuropathological changes has not been studied, so it can not be attributed to any effect on the development of the disease. In clinical trials, it was confirmed that the drug in a statistically significant and dose-dependent manner increases the percentage of patients included in the treatment group (at least 6-month treatment, improvement of cognitive ability, general functioning and functioning in social and family life or the possibility of independent living ). 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. Pregnancy.

Treatment should be carried out 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 dementia criteria, ICD 10 criteria). Donepezil should only be treated if regular monitoring of the patient's intake is possible. Maintenance treatment should be continued as long as the beneficial effects are maintained. The therapeutic benefits of donepezil should be regularly evaluated. If beneficial effects cease, discontinuation of treatment should be considered. It is not possible to predict individual patient's sensitivity to therapy. The use of the preparation 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 may increase muscle relaxation caused by succinylcholine derivatives during anesthesia. Cholinesterase inhibitors may exert their haemotonic effects on heart rate (e.g. bradycardia), which may be particularly important in patients with sick sinus syndrome or supraventricular conduction disorders, such as sinoatrial or atrioventricular block. There are reports of syncope and convulsions. Patients should be considered for block of the heart or sinus block during the examination. Patients with an increased risk of developing peptic ulcers, eg with a history of peptic ulcer disease or those taking NSAIDs simultaneously, should be monitored for signs of peptic ulcer disease. Cholinomimetics may cause obstruction of the bladder outlet (this was not observed in studies with the preparation). Cholinomimetics may cause generalized convulsions and may exacerbate or induce extrapyramidal symptoms. If a patient develops signs and symptoms indicative of a neuroleptic malignant syndrome (NMS) or a high unexplained fever without other clinical symptoms of hepatitis, donepezil should be discontinued. Caution should be exercised when prescribing cholinesterase inhibitors to patients with a history of asthma or obstructive pulmonary disease. Dope should not be administered concomitantly with acetylcholinesterase inhibitors, agonists or cholinergic antagonists. There are no data on the use of the drug in patients with severe hepatic impairment. The drug contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or with malabsorption of glucose-galactose.

The use of the drug during pregnancy is contraindicated if it is not absolutely necessary. Women taking donepezil should not breastfeed.

Very common: diarrhea, nausea, headache. Common: colds, anorexia, hallucinations, agitation, unusual dreams, nightmares, fainting, dizziness, insomnia, vomiting, stomach upset, rash, pruritus, muscle cramps, urinary incontinence, fatigue, aches, accidents. Uncommon: convulsions, bradycardia, gastrointestinal haemorrhage, peptic ulcer of the stomach and duodenum, slight increase in CK muscle activity in the blood. Rare: extrapyramidal symptoms, sinoatrial block, atrioventricular block, liver dysfunction (including hepatitis). Very rare: a neuroleptic malignant syndrome. Patients being examined for fainting or seizures should consider the possibility of a heart block or sinus arrest. Hallucinations, atypical dreams, nightmares, agitation and aggressive behavior subsided after dose reduction or discontinuation of treatment. In case of unexplained liver dysfunction, discontinuation should be considered.

Orally. Adults (including the elderly): the starting dose is 5 mg once a day. Administration of a 5 mg daily dose should continue for at least 1 month, allowing clinical assessment of treatment efficacy and reaching a steady-state concentration 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. After discontinuation of therapy, a gradual decrease in the beneficial effects of donepezil therapy was observed. There was no rebound effect after abrupt cessation of treatment.Special groups of patients. In patients with renal insufficiency, a similar dosage regimen may be used as in patients with normal renal function. In patients with mild and moderate hepatic impairment, the dose should be increased according to individual patient tolerability. There are no data on the use of the preparation in patients with severe hepatic impairment. The drug is not recommended for use in children.Way of giving. The tablets should be taken in the evening, just before bedtime.