Patient Information Leaflet
ARICEPT® 5 mg tablets
ARICEPT® 10 mg tablets
(Donepezil Hydrochloride)
Please read this leaflet
You and your caregiver should read this leaflet carefully before you start to use your medicine. It contains a summary of the information available on your medicine. If after reading this you do not understand or have any questions, ask your doctor or pharmacist (chemist).
Keep this leaflet. You may want to read it again.
1. What is in your tablets?
The active ingredient in Aricept is donepezil hydrochloride. Aricept tablets are available in two strengths:
5 mg white tablets marked ‘ARICEPT’ on one side and '5' on the other, containing 5 mg of donepezil hydrochloride.
10 mg yellow tablets marked ‘ARICEPT’ on one side and '10' on the other, containing 10 mg of donepezil hydrochloride.
The tablets are supplied in packs of 28.
Other ingredients include lactose, maize starch, microcrystalline cellulose, hyprolose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide (E171). Additionally, the 10 mg tablet contains synthetic yellow iron oxide (E172).
2. Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Eisai Ltd.
Hammersmith International Centre
3 Shortlands
London
W6 8EE
UK
ARICEPT tablets are manufactured for Eisai Ltd. by:
Pfizer PGM
29, Route des Industries
37530 Pocé-sur-Cisse
France
3. What is ARICEPT and what is it for?
ARICEPT (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s Disease. It is for use only in adult patients.
4. Before using ARICEPT tablets
You must not take ARICEPT if:
- you are allergic to donepezil hydrochloride, or to piperidine derivatives, or to any of the ingredients used in the formulation as listed above
- you are breast feeding
Tell your doctor or pharmacist if:
- you have ever had stomach or duodenal ulcers
- you have ever had a seizure
- you have a heart condition
- you have asthma or other long term lung disease
- you have ever had any liver problems or hepatitis
- you have difficulty passing urine
- you are pregnant, think you might be pregnant
Tell your doctor or pharmacist if you are taking any other medicines especially:
pain killers or treatment for arthritis, antibiotics or anti-fungal medicine, muscle relaxants, anti-depressants, anticonvulsants or medication for a heart condition.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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.
If you are in doubt, consult your doctor or pharmacist before using ARICEPT tablets.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
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 fatigue, dizziness and muscle cramp and if affected you must not drive or operate machinery.
5. How to use ARICEPT tablets
How much ARICEPT should you take?
Take your Aricept tablet by mouth with a drink of water at night before you go to bed.
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 will recommend. 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. The maximum recommended dose is 10 mg each night.
You should 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. Do not stop taking the tablets unless told to do so by your doctor.
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.
What if you take too many tablets?
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.
What if you miss taking your tablets?
If you forget to take a tablet, just take one tablet the following day at the usual time. If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
6. After using ARICEPT tablets
What side effects could ARICEPT cause?
Like all medicines, ARICEPT can have side effects.
The most commonly reported side effects of ARICEPT are diarrhoea, nausea, vomiting, muscle cramp, fatigue, and insomnia (difficulty in sleeping). Dizziness, headaches, pain, accidents and the common cold have also been reported. In most cases these go away without having to stop treatment. Tell your doctor if you have any of these effects and if they are too uncomfortable for you.
Patients taking ARICEPT have also reported loss of appetite; hallucinations, agitation, aggressive behaviour; fainting, seizures; shaking, stiffness or uncontrollable movement especially of the face and tongue but also of the limbs; slow heart beat; abdominal disturbances including bleeding, stomach and duodenal ulcers; liver disorders including hepatitis; itching, rash and urinary incontinence.
You should tell your doctor if you have any of these or any other adverse effects while you are taking ARICEPT.
7. How to look after your medicine (ARICEPT tablets)
Do not store this medicine above 30°C. As with all medicines, the tablets should be kept in a safe place where children cannot see or reach them.
DO NOT use ARICEPT tablets after the expiry date that is printed on the label.
If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist.
This medicine is for you. Do not share it with anyone else even if they have the same symptoms as you.
8. More information
If you want to know more about your medicine, ask your doctor or pharmacist who can give you more information.
