Donepezil Hydrochloride 10mg Film-Coated Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

DONEPEZIL HYDROCHLORIDE

Disponibil de la:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

Codul ATC:

N06DA02

INN (nume internaţional):

DONEPEZIL HYDROCHLORIDE 10 mg

Forma farmaceutică:

FILM-COATED TABLET

Compoziție:

DONEPEZIL HYDROCHLORIDE 10 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOANALEPTICS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2013-03-01

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL HYDROCHLORIDE 5MG FILM-COATED TABLETS
DONEPEZIL HYDROCHLORIDE 10MG FILM-COATED TABLETS
(Referred to as Donepezil Tablets in the remainder of the leaflet)
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 _
B
_B_
efore 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 contains the active substance donepezil
hydrochloride. Donepezil Tablets
(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.
_ _
_DONEPEZIL TABLETS ARE FOR USE IN ADULT PATIENTS ONLY. _
2. _WHAT YOU NEED TO KNOW B_EFORE YOU TAKE DONEPEZIL TABLETS
_DO _NOT TAKE DONEPEZIL
TABLETS:

If you are allergic to donepezil hydrochloride, piperidine derivatives
or any of the othe

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 10 mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12
mg of donepezil free
base.
Excipients 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.
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