ALZANCER EASYTAB 5MG N28 TB

Alzanser izitab, 5 mg and 10 mg mouth-dissolving tablets

Alzanser izitab composition

Active substance: Each tablet contains 5 mg and/or 10 mg donepezil hydrochloride.

Contraindications 

Alzanser IziTab is contraindicated in patients with hypersensitivity to donepezil hydrochloride, piperidine derivatives, or any of the excipients of the medicinal product.

Use during pregnancy and lactation 

Pregnancy 
There is no information on the use of donepezil in pregnant women. 
In animal studies, no teratogenic effect was observed, however, peri- and postnatal toxicity was noted. The potential risk to humans is unknown. 
Unless the use of Alzanser IziTab is essential, it is not recommended during pregnancy. 
Lactation 
Donepezil is excreted in milk in rats. It is not known whether donepezil hydrochloride passes into human breast milk and no studies have been conducted with women who are breastfeeding. Therefore, women taking donepezil should not breastfeed their children.

Dosage and method of administration 

Dosage 
Adults/Elderly 
The treatment course starts at 5 mg once daily. Alzanser IziTab should be taken orally before going to bed. The tablet should be placed on the tongue and, depending on the patient’s preference, allowed to disintegrate before swallowing with water or without water. The intake of the 5 mg daily dose should be continued for at least one month so that an early clinical response to treatment can be assessed and stable concentrations of donepezil hydrochloride can be achieved. After evaluating a one-month clinical treatment course at a dose of 5 mg/day, the dose of Alzanser IziTab may be increased up to 10 mg once daily. The maximum recommended daily dose is 10 mg. In clinical studies, doses higher than 10 mg/day have not been investigated. 
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. The diagnosis should be confirmed according to accepted recommendations (e.g., DSM IV, ICD 10). Treatment with donepezil should be started only if a caregiver is available who can ensure regular monitoring of the patient’s intake of the medicine. Supportive treatment may be continued for as long as it provides therapeutic benefit to the patient. Therefore, the clinical benefit of donepezil should be reviewed regularly. Discontinuation of treatment should be considered when there is no longer evidence of therapeutic effect. Individual response to donepezil cannot be predicted. 
After discontinuation of treatment, a gradual decrease in the beneficial effects of Alzanser IziTab is observed. 
Renal and hepatic impairment 
In renal impairment, since the clearance of donepezil hydrochloride is not affected, treatment can be continued with the dosing regimen used in patients with renal impairment. Due to the possible increase in mild to moderate hepatic impairment, dose escalation should be carried out according to individual tolerability. There is no information on use in patients with severe hepatic 
impairment. 
Children 
Use of Alzanser IziTab in children is not recommended (under 18 years).