ALZANCER EASYTAB 10MG N28 TB

Alzanser İzitab, 5 mg and 10 mg orally dissolving tablets

Composition of Alzanser

Active ingredient: Each tablet contains 5 mg or 10 mg donepezil hydrochloride.

Contraindications

Alzanser İziTab 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 effects were observed, however peri- and postnatal toxicity was noted. The potential risk to humans is unknown.
Unless the use of Alzanser İziTab 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 course of treatment starts with 5 mg per day (once daily). Alzanser® İziTab should be taken orally before going to bed at night. 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. Taking 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 İziTab may be increased up to 10 mg per day (once daily). The maximum recommended daily dose is 10 mg. In clinical studies, doses higher than 10 mg per 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 there is a caregiver who will monitor the patient’s regular 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 effect of Alzanser İziTab is observed.
Renal and hepatic impairment
In renal impairment, the clearance of donepezil hydrochloride is not affected; therefore, treatment can be continued with the dosing regimen used in patients with renal impairment. Dose increases should be carried out according to individual tolerability due to the possible increase in mild or moderate hepatic impairment. There is no information on use in patients with severe hepatic impairment.
Children
Use of Alzanser İziTab in children is not recommended (under 18 years).