Aricept 10mg 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:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5013457010121

Patient Information leaflet

1
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 (fits) or convulsions

Summary of Product characteristics

OBJECT 1
ARICEPT TABLETS
Summary of Product Characteristics Updated 24-May-2018 | Eisai Ltd
1. Name of the medicinal product
ARICEPT 5 mg film coated tablets
ARICEPT 10 mg film coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg donepezil hydrochloride,
equivalent to 4.56 mg of donepezil free
base.
Excipients with known effect: Each 5 mg tablet contains 87.17 mg of
lactose.
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 5 mg film coated tablets are white, round, biconvex tablets
debossed 'ARICEPT' on one side
and '5' on the other side.
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 film coated 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 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 mo