Donepezil Hydrochloride 5mg Orodispersible Tablets
Package leaflet: Information for the patient
Donepezil hydrochloride 5mg and 10mg Orodispersible Tablets
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 side effects talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Donepezil hydrochloride 5mg and 10mg Orodispersible Tablets but within the leaflet it will be referred to as Donepezil tablets.
What is in this leaflet:
1 What Donepezil tablets are and what they are used for
2 What you need to know before you take Donepezil tablets
3 How to take Donepezil tablets
4 Possible side effects
5 How to store Donepezil tablets
6 Contents of the pack and other information
1 What Donepezil tablets are and what they are used for
Donepezil tablets belong 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. Donepezil tablets are for use in adult patients only.
2 What you need to know before you take
Do not take Donepezil tablets 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
Treatment with Donepezil tablets should only be started and supervised by a doctor with experience in diagnosing and treating Alzheimer's dementia.
Talk to your doctor or pharmacist before taking Donepezil tablets if you:
• have ever had stomach or duodenal ulcers, or if you are taking non steroidal anti-inflammatory drugs (NSAIDS)
• have ever had a seizure. Donepezil may have the potential to cause fits or seizures. Your doctor will monitor your symptoms
• have a heart condition (especially if you have an irregular heart beat, sick sinus syndrome, or other conditions that affect the rhythm of the heart), as Donepezil tablets may slow down your heart rate
• have asthma or other long term lung disease
• have ever had liver disease
• have difficulty passing urine
• are going to have an operation that requires you to have a general anaesthetic, as the dose of the medication used in anaesthesia may need to be adjusted.
Donepezil tablets 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 Donepezil tablets.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
Children and Adolescents
Donepezil is not recommended for children and adolescents.
Other medicines and Donepezil tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important for
• medicines to treat pain and inflammation e.g. acetylsalicylic acid, non steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or diclofenac sodium
• medicines obtained without a prescription, e.g. herbal remedies
• antibiotics such as erythromycin or rifampicin
• anti-fungal medicine, such as ketoconazole or itraconazole
• muscle relaxants, such as succinylcholine
• anti-depressants such as fluoxetine
• anticonvulsants, such as phenytoin or carbamazepine
• medication for a heart condition, such as quinidine, or high blood pressure, such as beta blockers (e.g. propranolol and atenolol)
• other medicines that act the same way as Donepezil tablets (such as galantamine or rivastigmine), and some medicines for diarrhoea, Parkinson's disease, asthma or urinary incontinence (such as tolterodine).
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 Donepezil tablets. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil tablets with alcohol
You must avoid drinking alcohol while you are being treated with Donepezil tablets, because it could reduce the effect of Donepezil tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Donepezil tablets should not be used while breast-feeding.
Driving and using machines
Donepezil tablets and the disease may impair your ability to drive or operate machinery. The medicine can cause fatigue, dizziness and muscle cramp especially in the beginning of treatment, and if affected you must not drive or operate machinery. You should discuss this with your doctor before performing these activities.
Donepezil tablets contain lactose and aspartame
Donepezil tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Donepezil tablets also contain aspartame (E951), a source of phenylalanine. This may be harmful for people with phenylketonuria.
3 How to take Donepezil tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 will recommend. Usually, you will start by taking one 5mg tablet every night before you go to bed. After one month, your doctor may tell you to take one 10mg tablet every night before you go to bed. The maximum recommended dose is 10mg each night.
No dosage adjustment is required if you have kidney problems.
If you have a mild to moderate liver disease, your doctor may need to adjust your dose.
If you have severe liver problems, you should take extra care with Donepezil tablets (see section 2 "What you need to know before you take"). In cases of unexplained liver dysfunction under treatment with Donepezil tablets, withdrawal of Donepezil tablets should be considered.
You should always follow your doctor'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 Donepezil tablets
Your doctor will advise you on how long you should continue to take your tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.
If you take more Donepezil tablets than you should
Do not take more tablets than the doctor has told you. Contact your doctor or hospital immediately if you take more than you should. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.
Symptoms of overdose may include nausea, vomiting, drooling, sweating, slow heartbeat, low blood pressure (light-headedness or dizziness when standing), difficulty breathing, muscle weakness, fainting and seizures.
If you forget to take Donepezil tablets
Do not take a double dose to make up for a forgotten dose.
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.
If you stop taking Donepezil tablets
When treatment is stopped the beneficial effects of Donepezil tablets will decrease gradually. Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 (which may affect up to 1 in 1,000 users)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (which may affect up to 1 in 100 users)
• bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (which may affect up to 1 in 100 users)
• seizures (fits) or convulsions (which may affect up to 1 in 100 users)
• fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called 'Neuroleptic Malignant Syndrome').
• Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis).
Other side effects:
Very common side effects which may affect more than 1 in 10 users:
• diarrhoea
• nausea (feeling sick)
• headache.
Common side effects which may affect up to 1 in 10 users:
• common cold
• loss of appetite
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• hallucinations (seeing or hearing things that are not really there), aggressive behaviour, unusual dreams including nightmares, agitation, which have resolved on dose-reduction or discontinuation of treatment
• dizziness, sleeplessness, fainting
• vomiting, abdominal disturbance
• itching, rash
• muscle cramp
• urinary incontinence
• fatigue, pain
• accidents (patients may be more prone to falls and accidental injury).
Uncommon side effects which may affect up to 1 in 100 users:
• slow heart beat
• minor increase of the muscle enzyme creatine kinase in blood tests.
Rare side effects which may affect up to 1 in 1,000 users:
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
• cardiac disturbances
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
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Donepezil tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original blister in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Donepezil tablets contain
• The active substance is donezepil hydrochloride. Each orodispersible tablet contains 5mg or 10mg donepezil hydrochloride.
• The other ingredients are polacrilin potassium; microcrystalline cellulose; lactose monohydrate; monosodium citrate anhydrous; aspartame (E951); croscarmellose sodium; silica colloidal anhydrous; magnesium stearate.
What Donepezil tablets look like and contents of the pack Donepezil hydrochloride 5mg Orodispersible tablets are white to off-white round, flat tablets with bevelled edges, embossed with '5' on one side.
Donepezil hydrochloride 10mg Orodispersible tablets are white to off-white round, flat tablets with bevelled edges, embossed with '10' on one side.
Pack sizes;
28 orodispersible tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Manufacturer
Genepharm S.A.
18th km Marathonos Avenue Pallini 15351, Attiki Greece
This leaflet was last revised in September 2015
If you would like a leaflet with larger text, please contact 01271 385257.
Actavis, Barnstaple, EX32 8NS, UK