Aricept 10mg 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:

10mg

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICEPT
® 10MG TABLETS
(donepezil hydrochloride)
YOU AND YOUR CAREGIVER SHOULD READ ALL OF
THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
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. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
The name of your medicine is Aricept 10mg
Tablets but will be referred to as Aricept
throughout this leaflet. Please note that the
leaflet also contains information about other
strength Aricept 5mg Tablets.
IN THIS LEAFLET:
1.
WHAT ARICEPT IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE ARICEPT
3.
HOW TO TAKE ARICEPT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ARICEPT
6.
FURTHER INFORMATION
1.
WHAT ARICEPT IS AND WHAT IT IS
USED FOR
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 break
down 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.
BEFORE YOU TAKE ARICEPT
DO NOT TAKE ARICEPT
if you are allergic (hypersensitive) to
donepezil hydrochloride, or to piperidine
derivatives, or any of the other ingredients
of Aricept listed in section 6.
TAKE SPECIAL CARE WITH ARICEPT
Tell your doctor or pharmacist before starting
to take Aricept if you have or have had:
stomach or duodenal ulcers
seizures (fits) or convulsions
a heart condit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ARICEPT 10 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg donepezil hydrochloride,
equivalent to
9.12 mg of donepezil free base.
Excipients with known effect: Each 10 mg tablet contains 174.33 mg of
lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
ARICEPT 10 mg film coated tablets are yellow, round, biconvex tablets
debossed ‘ARICEPT’ on one side and ‘10’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARICEPT 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