Donepezil Hydrochloride 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
the other ingredients of Donepezil hydrochloride listed in section 6
CONSILIENT HEALTH u„
Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated tablets
Donepezil hydrochloride
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Donepezil hydrochloride is and what it is used for
2. Before you take Donepezil hydrochloride
3. How to take Donepezil hydrochloride
4. Possible side effects
5. Howto store Donepezil hydrochloride
6. Further information
Donepezil hydrochloride (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.
Donepezil hydrochloride is for use in adult patients only.
2. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
Do not take Donepezil hydrochloride
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of
Take special care with Donepezil hydrochloride
Tell your doctor or pharmacist before starting to take Donepezil hydrochloride 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.
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 hydrochloride. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil hydrochloride 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 hydrochloride.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
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 Donepezil hydrochloride. This is because these medicines may weaken or strengthen the effects of Donepezil hydrochloride.
Especially tell your doctor if you are taking any of the following types of medicines:
• other Alzheimer’s disease medicines, e.g. galantamine or rivastigmine,
• 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 or 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 a prescription e.g. herbal remedies
Taking Donepezil hydrochloride with food and drink
Food will not influence the effect of Donepezil hydrochloride.
Donepezil hydrochloride should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Donepezil hydrochloride 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 Donepezil hydrochloride
Donepezil hydrochloride 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.
3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE
Always take Donepezil hydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much Donepezil hydrochloride 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 Donepezil hydrochloride 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 Donepezil hydrochloride?
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 hydrochloride 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 Donepezil hydrochloride
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.
If you stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Donepezil hydrochloride can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil hydrochloride.
Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride.
Serious side effects:
You must tell your doctor immediately if you notice
these serious side effects mentioned. You may need
urgent medical treatment.
• 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).
• 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).
Very common side effects (affects more than 1 user
in 10):
• diarrhoea
• feeling or being sick
• headaches
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)
• 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 heart beat
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.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Donepezil hydrochloride after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 Donepezil hydrochloride contains
• The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg donepezil hydrochloride (as monohydrate) equivalent to 4.56 mg donepezil.
Each film-coated tablet contains 10 mg donepezil hydrochloride (as monohydrate) equivalent to 9.12 mg donepezil.
• The other ingredients are: the core: lactose monohydrate, cellulose microcrystalline, maize starch, hydroxypropylcellulose, magnesium stearate; the film-coating: titanium dioxide (E171), hypromellose 5cp, macrogol 400, yellow ferric oxide (E172) - only in 10 mg tablets.
What Donepezil hydrochloride looks like and contents of the pack
Tablets 5 mg are white to nearly white, rounded, biconvex, film-coated tablets.
Tablets 10 mg are yellowish-brown, rounded, biconvex, film-coated tablets.
Tablets are packed in blisters with 7,10,14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets of 5 mg and 7,10,14, 20, 28, 30, 50, 56, 60, 84,
90, 98 or 100 film-coated tablets of 10 mg.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road, London, W4 5RG.
This leaflet was last revised in January 2013
P0181