Donepezil Hydrochloride 5 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil Hydrochloride 5 mg Film-coated tablets
Donepezil Hydrochloride 10 mg Film-coated tablets
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 during pregnancy unless clearly necessary.
Donepezil Hydrochloride should not be used while breastfeeding.
Donepezil Hydrochloride
Ask your doctor or pharmacist for advice before taking any medicine.
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. How to store Donepezil Hydrochloride
6. Further information
1. WHAT DONEPEZIL
HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
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 is for use only in adult patients.
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 the other ingredients of Donepezil
Hydrochloride.
Take special care with Donepezil
Hydrochloride
Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:
• if you have or have had stomach or duodenal ulcers
• if you have or have had seizures (fits) or convulsions
• if you have or have had a heart condition (irregular or very slow heart beat)
• if you have or have had asthma or other long term lung disease
• if you have or have had liver problems or hepatitis
• if you have or have had difficulty passing urine or mild kidney disease
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Tell your doctor 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 (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 Donepezil Hydrochloride. This is because your medicine may affect the amount of anaesthetic needed.
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
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 Donepezil Hydrochloride.
3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE
Always take donepezil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 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.
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 (probably affecting fewer than 1 in 1,000)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (probably affecting fewer than 1 in 100)
L
• bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (probably affecting fewer than 1 in 100)
• seizures (fits) or convulsions (probably affecting fewer than 1 in 100)
Very common side effects (more than 1 of 10 patients treated):
• diarrhoea
• feeling sick
• headaches
Common side effects (1 to 10 out of 100 patients treated):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there)
• unusual dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach feeling uncomfortable
• vomiting
• rash
• itching
• passing urine uncontrollably
• pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (1 to 10 out of 1,000 patients treated):
• slow heart beat
• minor increase in serum concentration of muscle creatine kinase
• gastrointestinal bleeding
• seizures (fits)
Rare side effects (1 to 10 out of 10,000 patients treated):
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
• disturbance in heart rhythm
• liver dysfunction including hepatitis (inflammation of liver)
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.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
or
Cemelog-BRS Ltd.,
H-2040 Budaors,
Vasut u. 13,
Hungary
This leaflet was approved in: 2012-03-01.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE
• Keep out of the reach and sight of children.
• Do not use Donepezil Hydrochloride 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.
• This medicinal does not require any special storage conditions.
• 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 Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 5 mg / 10 mg
The other ingredients are:
Core:
Lactose monohydrate, maize starch, cellulose microcrystalline, low-substituted hydroxypropyl cellulose, magnesium stearate
Coating:
For 5 mg: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b)
For 10 mg: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b), iron oxide yellow (E172)
What Donepezil Hydrochloride looks like and contents of the pack
Donepezil Hydrochloride is presented as 5 mg, and 10 mg tablets. The tablets are described below.
5 mg:
White to off-white, round, bevelled edge, biconvex, film coated tablets with inscription "5" on one side and plain on other side.
10 mg:
Yellow, round, biconvex, film coated tablets with inscription "10" on one side and plain on other side.
Donepezil 5 mg / 10 mg Tablets is available in the following pack sizes:
PVC/Alu Blister in outer carton: 7, 28, 30, 50, 56, 60, 84, 98 & 120 tablets HDPE Bottle: 100 tablets
Not all pack sizes may be marketed.