Donepezil Tablet, film coated 10mg

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

DONEPEZIL HYDROCHLORIDE

থেকে পাওয়া:

Accord Healthcare Limited

এটিসি কোড:

N06DA02

INN (আন্তর্জাতিক নাম):

DONEPEZIL HYDROCHLORIDE

ফার্মাসিউটিকাল ফর্ম:

FILM-COATED TABLET

রচনা:

DONEPEZIL HYDROCHLORIDE 10 mg

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

PSYCHOANALEPTICS

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2012-02-17

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

Page 1 of 10
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 Tablet 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
Tablet 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 Tablet 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