Name of the medicinal product: DEZIAL

Content: Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4,56 mg of donepezil, or 10mg of donepezil hydrochloride, equivalent to 9,12 mg of donepezil

Pharmaceutical Form: Film-coated tablets.

Pharmacotherapeutic group: Anti-dementia medicines, Acetylcholinesterase inhibitors

Packaging Description: Cardboard box containing 3 aluminum / polyethylene sheet blisters with 10 tablet each.

DEZIAL tablets belong to the group of drugs against dementia.
These drugs act as acetylcholinesterase inhibitors. Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, which is the overriding cholinesterase in the brain.
Induced, from donepezil hydrochloride, inhibition of acetylcholinesterase (AChE) in red blood cells has been shown that is associated with changes in the ADAS-cog, a sensitive scale which selectively examines some aspects of cognition.
Symptomatic treatment of mild to moderately severe, Alzheimer's dementia.
DEZIAL is contraindicated in patients with known hypersensitivity to hydrochloride donepezil, to piperidine derivatives or to any of the excipients contained in composition.

Adults and elderly:

The treatment begins by administering 5 mg (once daily).

DEZIAL must be taken orally in the evening, just before bedtime. The daily dose of 5 mg must be maintained for at least one month to evaluate the initial clinical response to treatment with DEZIAL and stabilize the concentration levels of donepezil hydrochloride. After assessing clinical response to one month therapy with 5 mg DEZIAL per day, the "once daily" dose of DEZIAL can be increased to 10 mg. The maximum recommended daily dose is 10 mg. There have been no clinical studies with doses greater than 10 mg per day.

The initiation and monitoring of therapy should be held by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. The diagnosis should be made according to accepted criteria (eg DSM IV, ICD 10). The treatment with donepezil should be started only if there is a person who takes care of the patient and will regularly monitor the intake of the drug. Maintenance treatment can be continued for as long as there is a therapeutic benefit for the patient. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. The discontinuation of therapy should be considered when no longer observed therapeutic effect. Individual response to donepezil can not be fixed in advance.

In case of withdrawal, there is a gradual reduction of the beneficial results of DEZIAL.

Paediatric population:

DEZIAL is not recommended for use in children