Donepezil Hydrochloride 10mg Film-Coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Donepezil hydrochloride

Dostupno od:

Wockhardt UK Limited

ATC koda:

N06DA; N06DA02

INN (International ime):

Donepezil hydrochloride

Doziranje:

10 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

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

Područje terapije:

Anticholinesterases; donepezil

Status autorizacije:

Marketed

Datum autorizacije:

2013-05-17

Uputa o lijeku

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
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 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 Donepezil Tablets are and
what they are used for
2. What you need to know before
you take Donepezil Tablets
3. How to take Donepezil Tablets
4. Possible side effects
5. How to store Donepezil Tablets
6. Contents of the pack and other
information
1. WHAT DONEPEZIL TABLETS ARE
AND WHAT THEY ARE USED FOR
Donepezil Tablets contain the active
substance donepezil hydrochloride.
Donepezil Tablets (donepezil
hydrochloride) belong 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.
Donepezil Tablets are for use in
adult patients only.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DONEPEZIL TABLETS
DO NOT TAKE DONEPEZIL TABLETS:
• If you are allergic to donepezil
hydrochloride, 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 TAKIN

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 10mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12
mg of donepezil free base.
Excipient with known effect:
Each tablet contains 165mg lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex, film-coated tablets, debossed with ‘W’ on
one side and ‘3I2’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil hydrochloride 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:
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 donepezil hydrochloride tablets 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 treatment, a gr