Aricept Evess 10mg orodispersible tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Donepezil hydrochloride

Fáanlegur frá:

Waymade Healthcare Plc

ATC númer:

N06DA02

INN (Alþjóðlegt nafn):

Donepezil hydrochloride

Skammtar:

10mg

Lyfjaform:

Orodispersible tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04110000

Upplýsingar fylgiseðill

READ
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 of the 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 ARICEPT EVESS is and what it is
used for
2.
What you need to know before you take
ARICEPT EVESS
3.
How to take ARICEPT EVESS
4.
Possible side effects
5.
How to store ARICEPT EVESS
6.
Contents of the pack and other
information
1. WHAT ARICEPT EVESS IS AND WHAT IT IS
USED FOR
ARICEPT EVESS contains the active
substance donepezil hydrochloride.
ARICEPT EVESS (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.
ARICEPT EVESS is for use in adult patients
only.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ARICEPT EVESS
DO NOT TAKE ARICEPT EVESS
• 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
Talk to your doctor or pharmacist before
taking ARICEPT EVESS if you have or have
had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow
heart beat)
• a

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aricept Evess 10 mg orodispersible tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg donepezil hydrochloride,
equivalent to 9.12
mg of donepezil free base.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Orodispersible tablet
ARICEPT EVESS 10 mg orodispersible tablets are yellow, round tablets
debossed ‘ARICEPT’ on one side and ‘10’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aricept Evess 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 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
ARICEPT
EVESS 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.
Upon discontinuation of treatment, a gradual abatement of the
beneficial
effects of A