Donepezil hydrochloride 10mg film-coated Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

DONEPEZIL HYDROCHLORIDE

Inapatikana kutoka:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC kanuni:

N06DA02

INN (Jina la Kimataifa):

DONEPEZIL HYDROCHLORIDE 10 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

DONEPEZIL HYDROCHLORIDE 10 mg

Dawa ya aina:

POM

Eneo la matibabu:

PSYCHOANALEPTICS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-05-29

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL HYDROCHLORIDE
5 MG FILM-COATED TABLETS
DONEPEZIL HYDROCHLORIDE
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 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 hydrochloride is and what it is used for
2.
What you need to know before you take Donepezil hydrochloride
3.
How to take Donepezil hydrochloride
4.
Possible side effects
5.
How to store Donepezil hydrochloride
6.
Contents of the pack and other information
1.
WHAT DONEPEZIL HYDROCHLORIDE
IS AND WHAT IT IS USED FOR
Donepezil hydrochloride (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.
Donepezil hydrochloride is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
DO NOT TAKE DONEPEZIL HYDROCHLORIDE:
•
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
Tell your doctor or pharmacist before st

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Donepezil hydrochloride 5 mg film-coated tablets
Donepezil hydrochloride 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg donepezil hydrochloride,
equivalent to 4.56 mg of donepezil.
Each film-coated tablet contains 10 mg donepezil hydrochloride,
equivalent to 9.12 mg of donepezil.
Excipients:
<5 mg>
Each film-coated tablet contains 80 mg lactose.
<10 mg>
Each film-coated tablet contains 160 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Donepezil hydrochloride 5 mg film coated tablets _
White to off-white, circular, biconvex film-coated tablets debossed
with ‘X’ on one side and ‘11’ on
the other side
_Donepezil hydrochloride_
_10 mg film coated tablets _
Yellow colored, circular, biconvex film-coated tablets debossed with
‘X’ on one side and ‘12’ on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil tablets are indicated for the symptomatic treatment of mild
to moderately severe
Alzheimer's dementia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/Older 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 Donepezil
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
regu