Medicinal Products

DONEPEZIL SANDOZ 5 mg

Generic drug of Aricept
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Donepezil
laboratory: Sandoz

Coated tablet
Box of 28
All forms

Indication

Donepezil is indicated for the symptomatic treatment of Alzheimer's disease in its mild to moderately severe forms.

Dosage DONEPEZIL SANDOZ 5 mg Film-coated tablet Box of 28

Adults - Elderly

DONEPEZIL SANDOZ should be given orally in the evening before bedtime.

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. Depending on the clinical results observed after 1 month of treatment at a dose of 5 mg / day, the dose of DONEPEZIL SANDOZ 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 under 18 years of age.

Against indications

Hypersensitivity to the active substance, piperidine derivatives, soy, peanut or any of the excipients of the product.

Adverse effects Donepezil Sandoz

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 / 1, 000, <1/100), rare (≥1 / 10, 000, <1 / 1, 000), very rare (<1 / 10, 000), and unknown frequency (impossible to estimate with available data) .

System Organ

Very frequent

frequent

Uncommon

few

infections

Cold

Metabolism and nutrition

Anorexia

Psychiatry

hallucinations **

agitation **

Aggressiveness**

The nervous system

Syncope*

seizures *

sYMPTOMS

Dizziness

extrapyramidal

Insomnia

cardiac

bradycardia

Sino-auricular block

Atrioventricular block

ventricular

Gastrointestinal

Diarrhea

vomiting

hemorrhage

Nausea

Abdominal disorders

gastrointestinal

Gastric ulcer

and duodenal

hepatobiliary

Hepatic involvement including hepatitis ***

Skin and dander

rash

itching

Musculoskeletal

Muscle cramps

Urogenital

Urinary incontinence

generals

cephalalgia

Tired

pains

Biological examination

Slight increase in serum creatinine levels

Muscle kinase

Trauma and poisoning

Accident

* 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 cases of hepatitis of unknown etiology, discontinuation of DONEPEZIL SANDOZ should be considered.

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