Medicinal Products

DONEPEZIL ZENTIVA 5 mg

Generic drug of Aricept
Therapeutic Class: Neurology-Psychiatry
Active ingredients: Donepezil
laboratory: Sanofi-Aventis France

Coated tablet
Box of 28
All forms

Indication

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

Dosage DONEPEZIL ZENTIVA 5 mg Film-coated 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.

Administration mode

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

Against indications

· 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).

System Organ

Very frequent

frequent

Uncommon

few

infections

Cold.

Metabolism and nutrition

Anorexia.

Psychiatry

Hallucinations **.

** agitation.

Aggressiveness**.

The nervous system

Syncope*.

* Seizures.

Extra-pyramidal symptoms.

Dizziness.

Insomnia.

cardiac

Bradycardia.

Sino-auricular block

Atrioventricular block

Gastrointestinal

Diarrhea.

Vomiting.

Gastrointestinal bleeding.

Nausea.

Abdominal disorders.

Gastric and duodenal ulcer.

Hepatobiliary

Hepatic involvement including hepatitis ***.

Skin and dander

Rash.

Pruritus.

Musculoskeletal

Muscle cramps.

Urogenital

Urinary incontinence.

generals

cephalalgia

Tired.

Pain.

Biological examination

Slight increase in serum creatinine muscle kinase levels.

Trauma, poisoning and procedural complications

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 case of hepatitis of unknown etiology, discontinuation of DONEPEZIL ZENTIVA should be considered.

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