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ARICEPT 10MG TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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This product is known as the above names but will be referred to as Aricept throughout this leaflet.

1. What Aricept is and what it is used for
Aricept (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 break down 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 is for use in adult patients only.

DATE:

WARNING!

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. This is because these medicines may weaken or strengthen the effects of Aricept.

DATE:

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. This is because your medicine may affect the
amount of anaesthetic needed.
Aricept 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.
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 with food and drink
Food will not influence the effect of Aricept.
Aricept should not be taken with alcohol because alcohol may change its effect.
UK PIL GRANTED JANUARY 2013
REPORTING OF SIDE EFFECTS

CODE:

6464/2210 2211D

TVT CHECKED

06/02/14

DT
ARTWORKER:
Aricept 5mg 10mg tabs
PRODUCT:

Take special care with Aricept
Tell your doctor or pharmacist before starting to take Aricept if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heartbeat)
• 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.

DATE OF PROOF:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:
CUSTOMER: Waymade

2. Before you take Aricept
Do NOT take Aricept
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of
the other ingredients of Aricept listed in section 6

Pregnancy and breast-feeding
Aricept should not be used while breast-feeding.
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.
Important information about some of the ingredients of Aricept
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some
sugars, you should contact your doctor before taking Aricept.
3. How to take Aricept
How much Aricept should you take?
Usually, you will start by taking 5 mg (one white tablet) every night. After one month, your doctor may tell
you to take 10 mg (one yellow tablet) every night.
Swallow your Aricept tablet with a drink of water before you go to bed at night.
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.
For how long should you take Aricept?
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
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Aricept, the benefits of
your treatment will gradually fade away.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

In this leaflet:
1. What Aricept is and what it is used for
2. Before you take Aricept
3. How to take Aricept
4. Possible side effects
5. How to store Aricept
6. Further information

PROOF HISTORY:
v.2 - waymade - 06/02/14

Leaflet Flat Size = 148 x 400

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ARICEPT® 5mg TABLETS
ARICEPT® 10mg TABLETS
(donepezil hydrochloride)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you take more Aricept 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 (light-headedness or dizziness when standing), breathing problems, losing consciousness and
seizures (fits) or convulsions.
If you forget to take Aricept
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.

WARNING!

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 heartbeat

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.





UK PIL GRANTED JANUARY 2013
REPORTING OF SIDE EFFECTS

6464/2210 2211D

TVT CHECKED

By reporting side effects you can help provide more information on the safety of this medicine.

CODE:

DATE:
06/02/14

DT
ARTWORKER:
Aricept 5mg 10mg tabs
PRODUCT:

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

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




5. How to store Aricept
Aricept Tablets should not be stored above 30°C.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last date of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist who will advise you what to do.
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 Aricept tablets contain:
Your medicine is called Aricept Tablets. The active substance in Aricept tablets is donepezil hydrochloride in
two strengths 5mg (equivalent to 4.56mg of donepezil free base) and 10mg (equivalent to 9.12mg of
donepezil free base).
Aricept Tablets also contain the following:
Lactose monohydrate, maize starch, hydroxypropylcellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, talc, macrogol and titanium dioxide (E171).
The 10mg tablets also contain yellow iron oxide (E172).
What Aricept tablets look like and contents of the pack:
The 5mg tablets are white, round and unmarked.
The 10mg tablets are yellow, round and unmarked.
Aricept Tablets, each strength, are available as blister packs of 28 tablets.
POM

PL No: 6464/2210 5mg
PL No: 6464/2211 10mg

These products are manufactured by Pfizer PGM, Zone Industrielle, 29, Route des Industries, 37530
Pocé-sur-Cisse, France and/or Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way,
Hatfield-Herts, United Kingdom and are procured from within the EU and repackaged by the Product Licence
holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 06.02.2014
MEMAC is a registered trademark in Italy for ARICEPT
ARICEPT is a registered trademark of Eisai Co. Ltd.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Very common side effects (affects more than 1 user in 10):
• diarrhoea
• feeling or being sick
• headaches

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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).

PROOF HISTORY:
v.2 - waymade - 06/02/14

Leaflet Flat Size = 148 x 400

4. Possible side effects
Like all medicines, Aricept can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Aricept.
Tell your doctor if you have any of these effects while you are taking Aricept.

Expand view ⇕

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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