ARICEPT 10 mg film coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Donepezil hydrochloride

Dostupné z:

Pfizer Healthcare Ireland

ATC kód:

N06DA; N06DA02

INN (Medzinárodný Name):

Donepezil hydrochloride

Dávkovanie:

10 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

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

Terapeutické oblasti:

Anticholinesterases; donepezil

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1997-02-25

Príbalový leták

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Pfleet 2022-0079599
Pfleet 2021-0074518
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:
�

Súhrn charakteristických

Health Products Regulatory Authority
04 January 2023
CRN00D7FM
Page 1 of 8
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:174.33 mg lactose per film-coated tablet
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 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 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 r