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ARICEPT EVESS 5MG ORODISPERSIBLE TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARICEPT® Evess 5 mg
Orodispersible Tablets
ARICEPT® Evess 10 mg
Orodispersible Tablets
(Donepezil Hydrochloride)
You and your caregiver should read all
of this leaflet carefully before you start
taking this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What ARICEPT Evess is and what it is
used for
2. Before you take ARICEPT Evess
3. How to take ARICEPT Evess
4. Possible side effects
5. How to store ARICEPT Evess
6. Further information
1. WHAT ARICEPT EVESS IS AND WHAT
IT IS USED FOR
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. BEFORE YOU TAKE ARICEPT EVESS
Do NOT take ARICEPT EVESS
• if you are allergic (hypersensitive)
to donepezil hydrochloride, or to
piperidine derivatives, or any of the other
ingredients of ARICEPT Evess listed in
section 6.
Take special care with ARICEPT EVESS
Tell your doctor or pharmacist before
starting to take 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)
• asthma or other long term lung disease
• liver problems or hepatitis
• difficulty passing urine or mild kidney
disease
Also tell your doctor if you are pregnant or
think you might be pregnant.
Taking other medicines
Please tell your doctor or pharmacist if
you are taking, or have recently taken, any
other medicine. This includes medicines
that your doctor has not prescribed for
you but which you have bought yourself
from a chemist/pharmacist. It also applies
to medicines you may take sometime in
the future if you continue to take ARICEPT
Evess. This is because these medicines
may weaken or strengthen the effects of
ARICEPT Evess.
Especially tell your doctor if you are taking
any of the following types of medicines:
• other Alzheimer’s disease medicines,
e.g. galantamine

• pain killers or treatment for arthritis e.g.
aspirin, non-steroidal anti-inflammatory
(NSAID) drugs such as ibuprofen, or
diclofenac sodium
• anticholinergics medicines, e.g.
tolterodine
• antibiotics e.g. erythromycin, rifampicin
• anti-fungal medicine e.g. ketoconazole
• anti-depressants e.g. fluoxetine
• anticonvulsants e.g. phenytoin,
carbamazepine
• medication for a heart condition e.g.
quinidine, beta-blockers (propanolol and
atenolol)
• muscle relaxants e.g. diazepam,
succinylcholine
• general anaesthetic
• medicines obtained without a
prescription e.g. herbal remedies
If you are going to have an operation that
requires you to have a general anaesthetic,
you should tell your doctor and the
anaesthetist that you are taking ARICEPT
Evess. This is because your medicine may
affect the amount of anaesthetic needed.
ARICEPT Evess can be used in patients
with kidney disease or mild to moderate
liver disease. Tell your doctor first if you
have kidney or liver disease. Patients
with severe liver disease should not take
ARICEPT Evess.
Tell your doctor or pharmacist the name of
your caregiver. Your caregiver will help you
to take your medicine as it is prescribed.
Taking ARICEPT EVESS with food and
drink
Food will not influence the effect of
ARICEPT Evess.
ARICEPT Evess should not be taken with
alcohol because alcohol may change its
effect.
Pregnancy and breast-feeding
ARICEPT Evess should not be used while
breastfeeding.
If you are pregnant, or think you might
be pregnant, ask your doctor for advice
before taking any medicine.
Driving and using machines
Alzheimer’s disease may impair your ability
to drive or operate machinery and you
must not perform these activities unless
your doctor tells you that it is safe to do so.
Also, your medicine can cause tiredness,
dizziness and muscle cramp. If you
experience any of these effects you must
not drive or operate machinery.
3. HOW TO TAKE ARICEPT EVESS
How much ARICEPT EVESS should you
take?
Usually, you will start by taking 5 mg (one
white tablet) every night before you go to
bed. After one month, your doctor may tell
you to take 10 mg (one yellow tablet) every
night before you go to bed.
The tablet should be placed on your
tongue and allowed to disintegrate
before swallowing, with or without water,
according to your preference.
The tablet strength you will take may
change depending on the length of time
you have been taking the medicine and
on what your doctor recommends. The
maximum recommended dose is 10 mg
each night.
Always follow your doctor’s, or
pharmacist’s advice about how and when
to take your medicine.
Do not alter the dose yourself without your
doctor’s advice.

More information can be found on
the back of the leaflet

For how long should you take ARICEPT
EVESS?
Your doctor or pharmacist will advise you
on how long you should continue to take
your tablets. You will need to see your
doctor from time to time to review your
treatment and assess your symptoms.
If you stop taking ARICEPT EVESS
Do not stop taking the tablets unless
told to do so by your doctor. If you stop
taking ARICEPT Evess, the benefits of your
treatment will gradually fade away.
If you take more ARICEPT EVESS than
you should
DO NOT take more than one tablet each
day. Call your doctor immediately if
you take more than you should. If you
cannot contact your doctor, contact the
local hospital Accident and Emergency
department at once. Always take the
tablets and the carton with you to the
hospital so that the doctor knows what has
been taken.
Symptoms of overdosing include feeling
and being sick, drooling, sweating, slow
heart rate, low blood pressure (lightheadedness or dizziness when standing),
breathing problems, losing consciousness
and seizures (fits) or convulsions.
If you forget to take ARICEPT EVESS
If you forget to take a tablet, just take one
tablet the following day at the usual time.
Do not take a double dose to make up for a
forgotten tablet.
If you forget to take your medicine for more
than one week, call your doctor before
taking any more medicine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ARICEPT Evess can
cause side effects, although not everybody
gets them.
The following side effects have been
reported by people taking ARICEPT Evess.
Tell your doctor if you have any of these
effects while you are taking ARICEPT
Evess.
Serious side effects:
You must tell your doctor immediately
if you notice these serious side effects
mentioned. You may need urgent medical
treatment.
• liver damage e.g. hepatitis. The
symptoms of hepatitis are feeling or
being sick, loss of appetite, feeling
generally unwell, fever, itching, yellowing
of the skin and eyes, and dark coloured
urine (affects 1 to 10 users in 10,000)
• stomach or duodenal ulcers. The
symptoms of ulcers are stomach
pain and discomfort (indigestion) felt
between the navel and the breast bone
(affects 1 to 10 users in 1,000).
• bleeding in the stomach or intestines.
This may cause you to pass black tar like
stools or visible blood from the rectum
(affects 1 to 10 users in 1,000).
• seizures (fits) or convulsions (affects 1 to
10 users in 1,000).
• fever with muscle stiffness, sweating
or a lowered level of consciousness (a
disorder called “Neuroleptic Malignant
Syndrome”) (affects less than 1 user in
10,000).
Very common side effects (affects more
than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users
in 100):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things
that are not really there)
• unusual dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach feeling uncomfortable
• rash
• itching
• passing urine uncontrollably
• pain
• accidents (patients may be more prone
to falls and accidental injury)

Uncommon side effects (affects 1 to 10
users in 1,000):
• slow heart beat
Rare side effects (affects 1 to 10 users in
10,000):
• stiffness, shaking or uncontrollable
movement especially of the face and
tongue but also of the limbs
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE ARICEPT EVESS
DO NOT use ARICEPT Evess after the
expiry date that is printed on the label. The
expiry date refers to the last day of that
month.
This medicine does not require any special
storage conditions. Keep out of the reach
and sight of children.
If your doctor tells you to stop taking your
medicine, you should return any you have
not used to your pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What do ARICEPT EVESS orodispersible
tablets contain ?
• The active substance is donepezil
hydrochloride. The 5 mg orodispersible
tablet contains 5 mg of donepezil
hydrochloride and the 10 mg
orodispersible tablet contains 10 mg of
donepezil hydrochloride.
• The other ingredients are mannitol,
colloidal anhydrous silica,
k-carrageenan, and polyvinyl alcohol.
• Additionally, the 10 mg orodispersible
tablet contains synthetic yellow iron
oxide (E172).
What do ARICEPT EVESS orodispersible
tablets look like ?
• 5 mg white orodispersible tablets
marked ‘ARICEPT’ on one side and ‘5’
on the other.
• 10 mg yellow orodispersible tablets
marked ‘ARICEPT’ on one side and ‘10’
on the other.
What is in a pack of ARICEPT EVESS?
The orodispersible tablets are supplied in
packs of 7, 14, 28, 30, 50, 56, 60, 98 or 120.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Eisai Ltd.,
Mosquito Way
Hatfield
Herts.,
AL 10 9SN
UK.
ARICEPT Evess is manufactured for
Eisai Ltd. by:
Eisai Manuafcturing Ltd.,
Mosquito Way
Hatfield
Herts.,
AL 10 9SN
UK.
This leaflet was last approved in Jan 2013

© Copyright Eisai Limited

2001433
Ref: ARF728

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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