ARICEPT 10 Milligram Film Coated Tablet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

DONEPEZIL HYDROCHLORIDE

Saatavilla:

Clear Pharmacy

ATC-koodi:

N06DA02

INN (Kansainvälinen yleisnimi):

DONEPEZIL HYDROCHLORIDE

Annos:

10 Milligram

Lääkemuoto:

Film Coated Tablet

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Anticholinesterases

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-06-23

Pakkausseloste

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 side possible 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 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. 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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aricept 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg donepezil hydrochloride tablets each containing 9.12 mg of
donepezil free base.
Excipient: lactose monohydrate 174.33 mg per tablet.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from the Czech Republic:_
Yellow round, biconvex tablets embossed ‘ARICEPT’ on one side and
‘10’ on the other side.
4 CLINICAL PARTICULARS
As per PA0822/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Hyprolose
Magnesium stearate
_film coating_
Talc
Macrogol 8000
Hypromellose
Titanium dioxide (E171)
Yellow iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer packaging of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters in cardboard cartons of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT