Donepezil Hydrochloride 5 Mg Film-Coated Tablets
Package leaflet: Information for the user 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 because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, 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 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. Howto take Donepezil Tablets
4. Possible side-effects
5. Howto store Donepezil Tablets
6. Contents of the pack and other information
The active ingredient in your medicine is donepezil hydrochloride which 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 to 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 Tablets is for use in adult patients only.
Do not take Donepezil Tablets if you:
• are allergic to donepezil hydrochloride, or to piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil Tablets if you:
• have ever had stomach or duodenal ulcers
• have ever had a seizure
• have a heart condition (irregular or very slow heart beat)
• have asthma or other long term lung disease
• have ever had any severe liver problems. No studies have been done and therefore no information is available on the safe use of Donepezil tablets in patients with severe liver problems.
• have difficulty passing urine or bladder problems
• are pregnant, or think you might be pregnant
• have kidney disease Children and adolescents
Children and adolescents under the age of 18 years of age should not take this medicine.
Other medicines and Donepezil Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular if you are taking any of the following:
Pagel
• other Alzheimer’s disease medicines, e.g. galantamine
3. How to take Donepezil tablets
• non-steroidal anti-inflammatory drugs such as ibuprofen, or diclofenac sodium (for treatment of pain or arthritis)
• anticholinergic medicines, e.g. tolterodine
• antibiotics e.g. erythromycin
• rifampicin (for treatment of tuberculosis)
• 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
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.
This medicine 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.
Donepezil Tablets with food and drink
Food will not influence the effect of this medicine.
Donepezil tablets should not be taken with alcohol because alcohol may change its effects.
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 in pregnancy unless clearly necessary.
Donepezil Tablets should not be used while breast-feeding.
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.
Donepezil Tablet contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: recommended, 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.
If you experience an increase in side effects while taking 10 mg each day, tell your doctor or pharmacist.
Use in children or adolescents: Donepezil Tablets are not recommended for children under 18 years of age.
Method of administration
Take your Donepezil Tablets by mouth with a drink of water at night before you go to sleep. <o
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. °
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Use in patients with liver and kidney disease
If you have mild to moderate liver problems, your dose needs to be gradually and carefully adjusted to your needs by your doctor. If you have severe liver problem, you should take extra care with Donepezil tablets (see section 2, before you take Donepezil tablets). If you have an unexplained liver disease, your doctor may decide to stop your treatment with Donepezil tablet completely No dosage adjustment is required if you have kidney problems. Paae2
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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 than one tablet each day. Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.
If you take more Donepezil Tablets than you should, you might have symptoms such as severe nausea, vomiting, salivation, sweating, slow heartbeat (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse) and involuntary contractions of the muscles (convulsions). You could also suffer from an increased muscles weakness which may be a life threatening condition if respiratory muscles are involved.
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. 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 Tablets:
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking this medicine, the benefits of your treatment will gradually fade away.
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 have 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.
• 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).
• 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 naval 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 Other side effects include:
Very common side effects may affect more than 1 in 10 people
• diarrhoea; feeling or being sick; headaches Common side effects may affect up to 1 in 10 people
• muscle cramps
• tiredness; difficulty in sleeping (insomnia)
• 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 Page 3
Uncommon side effects may affect up to 1 in 100 people
• slow heart beat
• an increase in the levels of a substance called creatine kinase in your blood which is involved in metabolism Rare side effects may affect up to 1 in 1,000 people
• Extrapyramidal symptoms (EPS) which include involuntary movements, tremors and rigidity, body restlessness, muscle contractions and changes in breathing and heart rate
• changes in heart rhythm 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the label after EXP. 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 protect the environment.
What Donepezil Tablets contain:
The active substance is donepezil hydrochloride.
Donepezil 5 mg film-coated tablet: Each film-coated tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil.
Donepezil 10 mg film-coated tablet: Each film-coated tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.The other ingredients are:
Tablet core:
Lactose monohydrate, 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, iron oxide yellow (E172) and titanium dioxide (E171).
What Donepezil Tablets looks like and contents of the pack:
Donepezil Hydrochloride 5mg Tablets are white, circular, biconvex, film coated tablets with ‘5’ on one side and ‘DPZ’ on the other side.
Donepezil Hydrochloride 10mg 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:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London, W1K6TL, United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
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Cipla
Date : 10-11-15