Aricept 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Donepezil hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

N06DA02

INN (International Name):

Donepezil hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICEPT 5 MG FILM COATED TABLETS
ARICEPT 10 MG FILM COATED 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 is and what it is used for
2.
What you need to know before you take ARICEPT
3.
How to take ARICEPT
4.
Possible side effects
5.
How to store ARICEPT
6.
Contents of the pack and other information
1.
WHAT ARICEPT IS AND WHAT IT IS USED FOR
ARICEPT contains the active substance donepezil hydrochloride. ARICEPT
(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 is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARICEPT
DO NOT TAKE ARICEPT

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 ARICEPT if you have or
have had:

stomach or duodenal ulcers

seizures (fi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aricept Evess 5 mg orodispersible tablet
2
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
3
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.
4
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