ARICEPT

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

DONEPEZIL HYDROCHLORIDE

Mevcut itibaren:

PCO Manufacturing

ATC kodu:

N06DA02

INN (International Adı):

DONEPEZIL HYDROCHLORIDE

Doz:

5 Milligram

Farmasötik formu:

Film Coated Tablet

Reçete türü:

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

Terapötik alanı:

donepezil

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2017-01-20

Bilgilendirme broşürü

_ _
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
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 KNOE 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 (f

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARICEPT 5 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56
mg of donepezil free base.
Excipient with known effect: contains lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from the UK:_
White, round, biconvex tablets embossed “ARICEPT” on one side and
‘5’ on the other side.
4 CLINICAL PARTICULARS
As per PA0822/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Hydroxypropyl cellulose
Magnesium Stearate
Talc
Macrogol
Hypromellose
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package 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 of 28 tablets contained in a carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No spec