Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Donepezil
Box of 50
Donepezil is indicated for the symptomatic treatment of Alzheimer's disease in its mild to moderately severe forms.
Dosage ARICEPT 10 mg Film-coated tablet Box of 50
- Adults - Elderly:
. Treatment should be started at a dose of 5 mg daily (single dose). ARICEPT should be given orally in the evening before bedtime. 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 ARICEPT 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 case of 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.
The use of donepezil in children is not recommended.
Donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride, piperidine derivatives or any of the excipients of the product.
- This medicine contains lactose . Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
- Breast-feeding: Donepezil is excreted in breast milk in rats. The transition from donepezil to breast milk is not documented and there are no studies in lactating women. As a result, women receiving donepezil should not breastfeed.
NOT RECOMMENDED :
Pregnancy: There are no data on the use of donepezil in pregnant women. Studies in animals have shown no teratogenic effect but have shown peri and post-natal toxicity. The potiential risk to humans is unknown. ARICEPT should not be prescribed during pregnancy unless clearly needed.
- Child: The use of donepezil in children is not recommended.
- Concomitant administration of donepezil with other acetylcholinesterase inhibitors, agonists or antagonists of the cholinergic system should be avoided.
Aricept side effects
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).
Metabolism and nutrition
Hallucinations **. ** agitation. Aggressiveness**. Abnormal dreams and nightmares **.
The nervous system
Neuroleptic malignant syndrome.
Vomiting. Abdominal disorders.
Gastrointestinal bleeding. Gastric and duodenal ulcer.
Hepatic involvement including hepatitis ***.
Skin and dander
Slight increase in serum creatinine muscle kinase levels.
Trauma and poisoning
* 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, abnormal dreams, nightmares, agitation, and aggression decreased with dose reduction or discontinuation.
*** In cases of hepatitis of unknown etiology, discontinuation of ARICEPT 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 report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.