Donepezil Hydrochloride 5 Mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET DONEPEZIL HYDROCHLORIDE 5 & 10 mg FILM-COATED TABLETS
(donepezil hydrochloride)
The name of this medicine is Donepezil Hydrochloride 5 & 10 mg Film-coated Tablets which will be referred to as Donepezil Tablets throughout this leaflet.
• 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 further questions, please ask your doctor or your 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.
What isin 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. Howto store Donepezil Tablets
6. Contents of the pack and other information
1. WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your medicine is donepezil hydrochloride which 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL TABLETS
Do not take Donepezil Tablets if you:
• are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or to any of the other ingredients used in the tablets (these are listed in Section 6, Further Information)
• are breast-feeding
• have severe liver disease
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil tablets if you have had had any of the following conditions:
• experience any movement difficulties such as muscle stiffness or uncontrolled movements
• are going to have an anaesthetic at the hospital or dentist
• have ever had stomach or duodenal ulcers
• have ever had a seizure (fits) or convulsions
• have a heart condition (irregular or very slow heart beat)
• have asthma or other long term lung disease
• have ever had any liver problems or hepatitis
• have difficulty passing urine or bladder problems
• are pregnant, or think you might be pregnant
• have kidney disease
• have mild to moderate liver disease.
Taking other medicines
Please tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines even those not prescribed.
Tell your doctor or pharmacist if you are taking any of the following medicines:
• other Alzheimer’s disease medicines, e.g. galantamine
• pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medicines, e.g. tolterodine
• antibiotics e.g. erythromycin, rifampicin
• anti-fungal medicine e.g. ketoconazole, itraconazole
• 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 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 Donepezil Tablets. This is because your medicine may affect the amount of anaesthetic needed.
If you are in doubt, consult your doctor or pharmacist before taking 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.
It may still be alright for you to take Donepezil Tablets and your doctor will be able to decide what is suitable for you.
Taking your Donepezil tablets with food and drink
Do not drink alcohol whilst you are taking Donepezil Tablets. .
Pregnancy, breast-feeding and fertility
Do not take Donepezil Tablets if you are pregnant or think that you might be pregnant, unless you doctor has specifically advised you to do so. You should not breast-feed whist you are taking Donepezil Tablets. Ask your doctor or pharmacist 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 fatigue, dizziness and muscle cramps and if affected you must not drive or operate machinery.
Important information about some of the ingredients of Donepezil Tablets
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 medicine.
3. HOW TO TAKE DONEPEZIL TABLETS
Always take Donepezil Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is:
Adults: 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.
Children: Donepezil Tablets are not recommended for children.
Take your Donepezil Tablets by mouth with a drink of water at night before you go to bed. Food will not influence the effect of Donepezil tablets.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.
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 your tablets unless told to do so by your doctor.
How long should you take Donepezil Tablets for
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 take more Donepezil Tablets 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 an overdose include severe nausea (feeling sick), vomiting (being sick), salivation (drooling), sweating, a slower heart beat, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take Donepezil 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.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Donepezil Tablets
The beneficial effects of Donepezil Tablets will gradually diminish if you stop taking Donepezil Tablets. You should not stop taking Donepezil Tablets unless your doctor has told you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Donepezil Tablets can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately:
• Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat
• Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome").
The following serious side effects have been reported:
• 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 the whites of the eyes, and dark coloured urine
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone
• bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum
• seizures (fits) or convulsions
• heart block, a disease in the electrical system of the heart.
Very common side effects
• diarrhoea; feeling or being sick; headaches
Common side effects
• muscle cramps
• tiredness; difficulty in sleeping (insomnia)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there)
• agitation; aggressive behavior
• fainting; dizziness
• stomach feeling uncomfortable
• rash; Itching
• passing urine uncontrollably
• pain
• accidents (patients may be more prone to falls and accidental injury)
• unusual dreams including nightmares
Uncommon side effects
• slow heart beat
Rare side effects
• stiffness, shaking or uncontrollable movements 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, talktoyour doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).
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 Donepezil Tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Store in the original package.
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 to protect the environment.
Do not use this medicine if you notice any visible signs of deterioration or damage
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Donepezil Tablets contain:
Donepezil Tablets contains 5 mg or 10 mg of the active substance donepezil hydrochloride. The other ingredients are:
Tablet core:
Lactose, maize starch, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, & magnesium stearate.
Film-Coating:
Opadry white which consists of hypromellose, polyethylene glycol and titanium dioxide (E171).
Opadry yellow which consists of hypromellose, polyethylene glycol, yellow iron oxide (E172) and titanium dioxide (E171).
What Donepezil Tablets look like and contents of the pack:
Donepezil Hydrochloride 5 mg Tablets are white, circular, biconvex, film coated tablets with ‘5’ on one side and ‘DPZ’ on the other side.
Donepezil Hydrochloride 10 mg Tablets are yellow, circular, biconvex film coated tablets with ‘10’ on one side and ‘DPZ’ on the other side.
This medicine is available in blister packs containing 28 tablets.
Marketing Authorisation Holder:
Galewll Limited, 26 Upper Pembroke Street, Dublin 2, Ireland Manufacturer responsible for Batch Release
neolab
Fannin (UK) Limited, 42-46, Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT This leaflet was last revised in June 2014