Medicinal Products

DONEPEZIL TEVA 5 mg

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

Orodispersible tablet
Box of 28
All forms

Indication

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

Dosage DONEPEZIL TEVA 5 mg Orodispersible Tablet Box of 28

Oral way.

For doses that are not feasible / feasible with this specialty, other dosages or other dosage forms are available.

Adults - Elderly:

Treatment should be started at a dose of 5 mg daily (single dose).

The orodispersible tablet should be administered orally in the evening before bedtime. The tablet should be placed on the tongue to allow disintegration before swallowing, with or without water, depending on the patient's preference.

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 to the 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 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. Discontinuation of therapy should be considered when the therapeutic effect is no longer demonstrated. 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.

Children and adolescents:

The use of DONEPEZIL TEVA in children and adolescents is not recommended.

Against indications

Hypersensitivity to donepezil hydrochloride, piperidine derivatives or any of the excipients (see Warnings and Precautions ) section.

Adverse effects Donepezil Teva

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 on the available data base).

System Organ

Very frequent

frequent

Uncommon

few

infections

Cold

Metabolism and nutrition

Anorexia

Psychiatry

hallucinations **

agitation **

Aggressiveness**

The nervous system

Syncope*

Dizziness

Insomnia

seizures *

Extra-pyramidal symptoms

cardiac

bradycardia

Sino-auricular block

Atrioventricular block

Gastrointestinal

Diarrhea,

Nausea,

vomiting,

Abdominal disorders

Gastrointestinal bleeding

Gastric and duodenal ulcer

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 muscle kinase levels

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 TEVA should be considered.

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