Aricept Evess 5mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Donepezil hydrochloride

Available from:

Eisai Ltd

ATC code:

N06DA02

INN (International Name):

Donepezil hydrochloride

Dosage:

5mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5036519000205

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICEPT EVESS 5 MG ORODISPERSIBLE TABLETS
ARICEPT EVESS 10 MG ORODISPERSIBLE TABLETS
Donepezil Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any of the side effects talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ARICEPT EVESS is and what it is used for
2.
What you need to know before you take ARICEPT EVESS
3.
How to take ARICEPT EVESS
4.
Possible side effects
5.
How to store ARICEPT EVESS
6.
Contents of the pack and other information
1.
WHAT ARICEPT EVESS IS AND WHAT IT IS USED FOR
ARICEPT EVESS contains the active substance donepezil hydrochloride.
ARICEPT EVESS
(donepezil hydrochloride) belongs to a group of medicines called
acetylcholinesterase
inhibitors. Donepezil increases the levels of a substance
(acetylcholine) in the brain involved
in memory function by slowing down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed as
having mild and
moderately severe Alzheimer’s disease. The symptoms include
increasing memory loss,
confusion and behavioural changes. As a result, sufferers of
Alzheimer’s disease find it more
and more difficult to carry out their normal daily activities.
ARICEPT EVESS is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARICEPT EVESS
DO NOT TAKE ARICEPT EVESS

if you are allergic to donepezil hydrochloride, or to piperidine
derivatives, or any of
the other ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking AR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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NAME OF THE MEDICINAL PRODUCT
Aricept Evess 5 mg orodispersible tablet
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 5 mg donepezil hydrochloride,
equivalent to 4.56
mg of donepezil free base.
For the full list of excipients, see section 6.1
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PHARMACEUTICAL FORM
Orodispersible tablet
ARICEPT
EVESS
5
mg
orodispersible
tablets
are
white,
round
tablets
debossed ‘ARICEPT’ on one side and ‘5’ on the other side.
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CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aricept Evess tablets are indicated for the symptomatic treatment of:
- mild to moderately severe Alzheimer’s dementia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults/Elderly people_
Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day
dose should be
maintained for at least one month in order to allow the earliest
clinical responses to
treatment to be assessed and to allow steady-state concentrations of
donepezil
hydrochloride to be achieved. Following a one-month clinical
assessment of treatment
at 5 mg/day, the dose of ARICEPT EVESS can be increased to 10 mg/day
(once-a-
day dosing). The maximum recommended daily dose is 10 mg. Doses
greater than
10 mg/day have not been studied in clinical trials.
Treatment should be initiated and supervised by a physician
experienced in the
diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be
made
according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with
donepezil
should only be started if a caregiver is available who will regularly
monitor drug
intake for the patient. Maintenance treatment can be continued for as
long as a
therapeutic benefit for the patient exists. Therefore, the clinical
benefit of donepezil
should be reassessed on a regular basis. Discontinuation should be
considered when
evidence of a therapeutic effect is no longer present. Individual
response to donepezil
cannot be predicted.
Upon discontinuation of treatment, a gradual abatement of the
beneficial effects of
ARIC