Generic drug of Aricept
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Donepezil
laboratory: Sanofi-Aventis France
Divisible coated tablet
Box of 28
DONEPEZIL ZENTIVA is indicated for the symptomatic treatment of Alzheimer's disease in its mild to moderately severe forms.
Dosage DONEPEZIL ZENTIVA 10 mg scored film tablet Box of 28
Adults - Elderly
Treatment should be started at a dose of 5 mg daily (single dose). The dosage of 5 mg / day, will be maintained for at least 1 month, the time required to evaluate the first clinical responses to treatment and achievement of steady state plasma concentrations. Based on the clinical results observed after 1 month of treatment at a dose of 5 mg / day, the dose of DONEPEZIL ZENTIVA may be increased to 10 mg / day (once daily). The maximum recommended daily dosage is 10 mg. Dosages above 10 mg / day have not been studied in clinical studies.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of patients with Alzheimer's disease. The diagnosis will be made in accordance with the criteria in force (eg DSM IV, ICD 10). Donepezil treatment should only be initiated in the presence of a family member who can regularly check that the patient is taking the medicine. Maintenance treatment can be continued as long as the benefit exists for the patient. As a result, the clinical benefit must be reevaluated on a regular basis. The individual response to treatment is not predictable.
Upon discontinuation of treatment, a gradual reduction of the beneficial effects produced by donepezil was observed.
Renal and hepatic insufficiency
In patients with renal insufficiency, the donepezil hydrochloride clearance is not changed, so dose adjustment is not required.
In mild to moderate hepatic impairment, due to a possible increase in donepezil exposure (see section 5.2 ), the dose increase should be adjusted according to the individual tolerance of the product. There are no data in patients with severe hepatic impairment.
Child and teenagers
Donepezil is not recommended for use in children and adolescents.
DONEPEZIL ZENTIVA should be given orally in the evening before bedtime.
· Hypersensitivity to donepezil hydrochloride, piperidine derivatives or any of the excipients of the product.
Side effects Donepezil Zentiva
The most commonly observed side effects were diarrhea, muscle cramps, fatigue, nausea, vomiting and insomnia.
Adverse reactions that have been reported more than once are categorized below by organ system and frequency as defined below: very common (≥ 1/10), common (≥ 1/100, <1/10) ), infrequent (≥ 1/1000, <1/100), rare (≥1 / 10, 000, <1/1000), very rare (<1 / 10, 000), and unknown frequency (impossible to estimate with available data).
Metabolism and nutrition
The nervous system
Gastric and duodenal ulcer.
Hepatic involvement including hepatitis ***.
Skin and dander
Slight increase in serum creatinine muscle kinase levels.
Trauma, poisoning and procedural complications
* When examining patients who have experienced syncope or convulsion, the possibility of heart block or prolonged sinus pause should be considered (see Warnings and Precautions ).
** Reported cases of hallucinations, agitation and aggression decreased with dose reduction or discontinuation.
*** In case of hepatitis of unknown etiology, discontinuation of DONEPEZIL ZENTIVA should be considered.