PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICEPT 5 mg Film Coated Tablets
ARICEPT 10 mg Film Coated Tablets
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 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
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.
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
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 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. This is because these medicines may weaken or strengthen the effects of ARICEPT.
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.
Pregnancy and breast-feeding
ARICEPT 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.
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.
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.
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.
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 known as “Neuroleptic Malignant Syndrome”) (affects less than 1 user in 10,000).
Very common side effects (affects more than 1 user in 10):
- feeling or being sick
Common side effects (affects 1 to 10 users in 100):
- muscle cramp
- difficulty in sleeping (insomnia)
- the common cold
- loss of appetite
- hallucinations (seeing or hearing things that are not really there)
- unusual dreams including nightmares
- aggressive behaviour
- stomach feeling uncomfortable
- passing urine uncontrollably
- accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (affects 1 to 10 users in 1,000):
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below).
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ARICEPT
DO NOT use ARICEPT tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month.
Do not store this medicine above 30°C. 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 tablets contain ?
- The active substance is donepezil hydrochloride. The 5 mg tablet contains 5 mg of donepezil hydrochloride and the 10 mg tablet contains 10 mg of donepezil hydrochloride.
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, macrogol, and titanium dioxide (E171).
- Additionally, the 10 mg tablet contains synthetic yellow iron oxide (E172).
What do ARICEPT tablets look like ?
- 5 mg white tablets marked ‘ARICEPT’ on one side and '5' on the other.
- 10 mg yellow tablets marked ‘ARICEPT’ on one side and '10' on the other.
What is in a pack of Aricept ?
The tablets are supplied in packs of 7, 14, 28, 30, 50, 56, 60, 84, 98,112 or 120 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
ARICEPT tablets are manufactured for Eisai Ltd. by:
Eisai Manufacturing Ltd.
29, route des Industries