ALZEPIL 10MG N28 TB

Alzepil, 5 mg; 10 mg coated tablets

Alzepil composition

Each tablet contains 5 mg (as 5.21 mg donepezil hydrochloride monohydrate) and/or 10 mg (as 10.42 mg donepezil hydrochloride monohydrate) of donepezil hydrochloride. Excipients: microcrystalline cellulose, low-substituted hydroxypropylcellulose (L-HPC B1), magnesium stearate: white Opadry Y-1-7000 (hypromellose, titanium dioxide (E 171), macrogol 400.

Indications

Alzepil is indicated for symptomatic treatment of mild to moderate Alzheimer’s disease.

Contraindications

Alzepil is contraindicated in patients with hypersensitivity to piperidine derivatives or to any component of the product in their medical history.

Use during pregnancy and lactation

There is insufficient information about the use of donepezil in pregnant women. In studies conducted, no teratogenic effects of the product were found; however, signs of peri- and postnatal toxicity were observed. The potential risk of the product is not known. Unless absolutely necessary, Alzepil should not be used. In rats, donepezil is excreted in breast milk. It has not been determined whether donepezil passes into human breast milk; no studies have been conducted with the participation of pregnant women. Therefore, women using donepezil should not feed their infants with breast milk.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

Donepezil has an insignificant or mild effect on the ability to drive and work with machinery. However, it may worsen the ability to drive or work with machinery. Donepezil may cause fatigue, dizziness, and muscle spasms, especially at the beginning of the course or when the dose is increased; the treating physician should regularly assess the patient’s ability to drive vehicles and operate complex machinery.

How to use Alzepil and dosage

For adults and elderly patients, treatment should be started orally once daily with a 5 mg dose. It should be taken before going to sleep in the evening. In order to evaluate the earliest clinical responses and to achieve a steady-state concentration of donepezil, the 5 mg daily dose should be used for a period of not less than 1 month. After clinically evaluating the effect of the 5 mg daily dose over one month, the dose of Alzepil may be increased to 10 mg once daily. The recommended maximum daily dose is 10 mg. In clinical trials, doses higher than 10 mg per day were not studied. If it becomes necessary to prescribe doses other than those indicated, other medicinal products should be used. Treatment should be initiated and carried out under the supervision of a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. It should be confirmed based on generally accepted recommendations, for example, DSM IV, BNO 10 recommendations. Treatment can be started only if there are persons who can provide care to the patient and who can monitor the regular use of the product. Treatment should be continued until the therapeutic effect of the product is observed in the patient. Therefore, the clinical effectiveness of donepezil should be assessed regularly. If the effect is not observed, the possibility of discontinuing the product should be considered. It is not possible to predict an individual response in advance.

After discontinuation of the product, a gradual weakening of the positive effect of Alzepil is observed. If use is stopped suddenly, a “rebound” effect is not observed.

Pharmacological properties

Mechanism of action: Donepezil hydrochloride is a specific, reversible inhibitor of acetylcholinesterase, the main cholinesterase in the brain. In in vitro experiments, the inhibitory effect of donepezil hydrochloride on this enzyme is more than 1000 times stronger than its effect on butyrylcholinesterase, which is located outside the central nervous system.

Special warnings and precautions

The effectiveness of donepezil has not been established in patients with severe Alzheimer’s dementia, other types of dementia, or memory disorders (for example, age-related decline in cognitive functions). It was developed to exclude patients suffering from the disease and to identify patients in whom dementia could be of vascular origin. In the study, the incidence of deaths was 2/198 (1%) in the group receiving donepezil hydrochloride 5 mg, 5/206 (2.4%) in the group receiving donepezil hydrochloride 10 mg, and 7/199 (3.5%) in the group using placebo. In the study, the incidence of deaths was 4/208 (1.9%) in the group receiving donepezil hydrochloride 5 mg, 3/215 (1.4%) in the group receiving donepezil hydrochloride 10 mg, and 1/193 (0.5%) in the group using placebo. In the study, the incidence of deaths was 11/648 (1.7%) in the group receiving donepezil hydrochloride 5 mg and 0/326 (0%) in the group using placebo. In all three studies conducted in the direction of investigation, compared with the placebo group (1.1), the incidence of deaths in all groups using donepezil hydrochloride was quantitatively higher (1.7%), but these differences were not statistically significant. Most deaths in patients using hydrochloride or placebo occurred as a result of various presumed vascular disorders in the indicated population of elderly patients in whom vascular lesions were also noted. In the analysis of all serious vascular disorders that did not cause death and resulted in death, no differences were found in the incidence of their occurrence between the groups using donepezil hydrochloride and placebo. In the generalized materials of Alzheimer’s disease studies (total number of patients 6888), including additional studies of the disease (n=4146) and studies of vascular dementia, it was shown that the death indicators in the placebo group were quantitatively higher than the same indicators noted in the groups using donepezil hydrochloride. There is no requirement.

Any unused amount and residue of the product should be disposed of according to the relevant local requirements.

Interactions with other medicinal products

In the human body, donepezil hydrochloride and/or any of its metabolites have not shown an inhibitory effect on the metabolism of theophylline, warfarin, cimetidine, or digoxin, and when used simultaneously with cimetidine, the metabolism of donepezil does not change. This has been shown in in vitro studies. In in vitro studies investigating interactions with other medicinal products, it has been shown that the cytochrome P450 system isoenzyme 3A4 and, to a lesser extent, isoenzyme 2D6 are involved in the metabolism of donepezil. In in vitro studies, it has been shown that inhibitors of CYP3A4 and 2D6 isoenzymes, respectively, ketoconazole and quinidine inhibit the metabolism of donepezil. Therefore, the indicated medicinal products and inhibitors of the CYP3A4 isoenzyme, for example itraconazole and erythromycin, as well as inhibitors of the CYP2D6 isoenzyme, for example fluoxetine, may inhibit the metabolism of donepezil. In a study conducted with the participation of volunteers, ketoconazole caused an approximately 30% increase in donepezil concentrations. Inducers, for example rifampicin, phenytoin, carbamazepine, and alcohol, may cause a decrease in donepezil levels, although the extent of the non-specificity of inhibitory or inducing effects is not clearly determined. When combinations of the above medicinal products are prescribed, precautions should be followed. In addition to interactions with medicinal products that have anticholinergic activity, interactions may also occur with medicinal products used simultaneously, for example succinylcholine, with other blockers of conduction and with alocada. Effects on laboratory and instrumental study results. Complications of trauma, intoxications and manipulations. Adverse event. A slight increase in concentration and creatine kinase in blood serum. *When examining patients with syncope and/or seizure, the possible occurrence of heart block or prolonged phase in sinus rhythm should be considered.

**In cases where information is provided, the development of hallucinations, abnormal dreams, frightening dreams, impaired alertness, and aggressive behavior stopped after reducing the dose of the product or discontinuing it. ***In cases of undetermined impairment of liver function, the possibility of discontinuing the Alzepil product should be considered. ****It has been reported that rhabdomyolysis may develop within a short period regardless of malignant neuroleptic syndrome and in connection with the initiation of treatment or an increase in the dose of donepezil. Additional information about side effects. Information about the possible

Adverse effects

It is important to provide information about this. This allows continuous monitoring of the benefit/risk ratio of the medicinal product. Employees should report any suspected adverse effects to the address indicated at the end of the package leaflet, as well as through the national system.