Medicinal Products

DONEPEZIL MYLAN 5 mg

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

Orodispersible tablet
Box of 28
All forms

Indication

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

Dosage DONEPEZIL MYLAN 5 mg Orodispersible Tablet Box of 28

Adults - Elderly

Treatment should be started at a dose of 5 mg daily (single dose). DONEPEZIL MYLAN should be given 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 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 MYLAN 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. Stopping treatment should be considered when the therapeutic effects have disappeared. 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

The use of DONEPEZIL MYLAN in children is not recommended.

Against indications

· Hypersensitivity to donepezil hydrochloride, piperidine derivatives or any of the excipients of the product.

Adverse effects Donepezil Mylan

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 from available data) ).

System Organ

Very frequent

frequent

Uncommon

few

infections

Cold

Metabolism and nutrition

Anorexia

Psychiatry

hallucinations **
agitation **
Aggressiveness**

Unusual dreams, nightmares **

The nervous system

Syncope*

seizures *

Extra-pyramidal symptoms

Dizziness

Insomnia

cardiac

bradycardia

Sino-auricular block

Atrioventricular block

Gastrointestinal

Diarrhea,
Nausea

vomiting

Gastrointestinal bleeding

Abdominal disorders

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 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, unusual dreams, nightmares, and aggression decreased with dose reduction or discontinuation.

*** In case of hepatitis of unknown etiology, discontinuation of DONEPEZIL MYLAN should be considered.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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