ARICEPT F.C. 5MG

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

DONEPEZIL HCL

Beszerezhető a:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (nemzetközi neve):

DONEPEZIL HCL

db csomag:

28 Tablet Tablets

Gyártó:

Bora Pharmaceuticals Co.,Ltd.

Betegtájékoztató

ARICEPT TABLET
®
Donepezil Hydrochloride (5mg,10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_ARICEPT® _
is used for
2.
How
_ARICEPT® _
works
3.
Before you use
_ARICEPT®_
4.
How to use
_ARICEPT®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ARICEPT® _
_8. _
Product Description
9. Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT _ARICEPT® _IS USED FOR
_ARICEPT® _
is a prescription medicine to
treat dementia Alzheimer’s disease. The
symptoms include increasing memory
loss, confusion and behavioural changes.
HOW _ARICEPT® _WORKS
_ARICEPT® _
can help with mental
function and with doing daily tasks.
_ARICEPT® _
does not work the same in all
people. This medicine belongs to a group
of medicines called acetylcholinesterase
inhibitors. They are thought to work by
increasing the level of a chemical called
acetylcholine in the brain.
_ARICEPT® _
does not cure Alzheimer’s
disease but helps to control your
condition.
BEFORE YOU USE _ARICEPT®_
-
_ When you must not use it _
_ARICEPT®_
should be taken in the
evening prior to retiring
You should not take
_ARICEPT®_
-if you are allergic to Donepezil or any
of the ingredients in
_ARICEPT® _
or to
similar medicines that contain
piperidines.
-if you are not sure. See the end of this
leaflet for a list of ingredients in
_ARICEPT®_
.
_Children _
Aricept is not recommended for use in
children.
_Pregnancy and lactation_
Do not take
_ARICEPT® _
if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take
_ARICEPT® _
if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_ Before you start to use it _
Tell the doctor about all your
present or past health problems.
Include:
• Any heart problems including problems
with irregular or slow heartbeats
• Asthma or lung problems
• Stomach ulcers
• Difficulty passing urine or kidney
problems
• Liver problems
• Trouble swallowing tablets
-
_ Taking other med

Termékjellemzők

1. TRADE NAME OF THE MEDICINAL PRODUCT
Aricept 5 mg Film-Coated tablet
Aricept 10 mg Film-Coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg donepezil hydrochloride tablets each containing 4.56 mg donepezil f\
ree base
10 mg donepezil hydrochloride tablets each containing 9.12 mg donepezil \
free base
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Aricept 5mg film coated tablets are white, round, biconvex and debossed.
Aricept 10mg film coated tablets are yellow, round, biconvex and debossed.
4. CLINICAL PARTICULARS
4.1 Therapeutic indication
Aricept tablets are indicated for the treatment of mild, moderate, and severe dementia in
Alzheimer's Disease.
4.2 Posology and method of administration Adults/Elderly:
Mild to Moderate Alzheimer's Disease
Treatment is initiated at 5mg/day (once-a-day dosing). Aricept should be taken orally, in
the evening, just prior to retiring. The tablet should be swallowed whole with water. The
5mg/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 5mg/day, the dose of Aricept can be increased to 10mg/day (once-a-day
dosing). The maximum recommended daily dose is 10mg. Doses greater than 10mg/day
have not been studied in clinical trials.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Aricept
is seen.
Severe Alzheimer's Disease
Aricept has been shown to be effective in controlled clinical trials at a dose of 10mg
administered once daily.
Evidence from the controlled trials in mild, moderate Alzheimer's Disease indicates that
the 10mg dose, with one week titration, is likely to be associated with a higher incidence
of cholinergic adverse events than the 5mg dose. In open label trials using a 6 week
titration, the frequency of these same adverse events was similar between the 5mg and
10mg dose groups. Therefore, because ste