Donepezil 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N06DA02

INN (International Name):

DONEPEZIL HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DONEPEZIL HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2012-02-17

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL 5 MG FILM-COATED TABLETS
DONEPEZIL 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 is and what it is used for
2.
What you need to know before you take Donepezil
3.
How to take Donepezil
4.
Possible side effects
5.
How to store Donepezil
6.
Contents of the pack and other information
1. WHAT DONEPEZIL IS AND WHAT IT IS USED FOR
Donepezil belongs to a group of medicines called acetylcholinesterase
inhibitors.
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 is for use only in adult patients.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL
DO NOT TAKE DONEPEZIL
•
if you are allergic to donepezil hydrochloride, or piperidine
derivatives, or to any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Donepezil . In
particular, tell your doctor:
•
if you have or have had stomach or duodenal ulcers
•
if you have or have had seizures (fits) or convulsions
•
if you have or have had a heart condition (irregular or very slow
heart beat)
•
if you have or have had asthma or other long term lung dise

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Donepezil 5 mg Film-coated tablets
Donepezil 10 mg Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For 5 mg:
Each film-coated tablet contains: Donepezil hydrochloride monohydrate
equivalent to
donepezil hydrochloride 5 mg
Excipient with known effect: Lactose monohydrate 98.00 mg
For 10 mg:
Each film-coated tablet contains: Donepezil hydrochloride monohydrate
equivalent to
donepezil hydrochloride 10 mg
Excipient with known effect: Lactose monohydrate 196.00 mg
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
5 mg: White to off-white, round,
approximately 7.14 mm in diameter,
bevelled edge,
biconvex, film coated tablets with inscription "5" on one side and
plain on other side.
10 mg: Yellow, round, approximately 8.73 mm in diameter, biconvex,
film coated
tablets with inscription "10" on one side and plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil are indicated for the symptomatic treatment of mild to
moderately severe
Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult and elderly patients
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil
should be taken
orally, in the evening, just prior to retiring. 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