Donepezil Mylan
Package leaflet: Information for the patient
Donepezil Mylan 5 mg Film-coated Tablets
Donepezil Mylan 10 mg Film-coated Tablets
donepezil hydrochloride
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.
What is in this leaflet
1. What Donepezil Mylan is and what it is used for
2. What you need to know before you take Donepezil Mylan
3. How to take Donepezil Mylan
4. Possible side effects
5. How to store Donepezil Mylan
6. Contents of the pack and other information
1. What Donepezil Mylan is and what it is used for
Donepezil Mylan contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of mild to moderately severe dementia of the Alzheimer type.
Dementia of the Alzheimer type is a disease that alters the way the brain works and is common in the elderly. Symptoms include increase in memory loss, increasing confusion and changes in the way you behave, making it more difficult to carry out normal daily activities. It is for use only in adult patients.
2. What you need to know before you take Donepezil Mylan
Do not take Donepezil Mylan:
if you are allergic to donepezil hydrochloride, to piperidine derivatives or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil Mylan if you suffer or have ever suffered from any of the following conditions:
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a disorder of the heart (especially if you have an irregular heart beat, sick sinus syndrome, or other conditions that affect the rhythm of the heart). Donepezil Mylan may slow down your heart rate
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stomach or duodenal ulcers, or if you are taking non-steroidal anti-inflammatory drugs (NSAIDS) (for treatment of pain or arthritis)
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difficulty in passing urine
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fits or seizures: Donepezil Mylan may have the potential to cause fits or seizures. Your doctor will monitor your symptoms
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asthma or other lung disease
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liver disease.
Please inform your doctor if you need to have an operation, as the dose of the medication used in anaesthesia may need to be adjusted.
Children and adolescents
Children and adolescents under the age of 18 years of age should not take this medicine.
Other medicines and Donepezil Mylan
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:
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antidepressants (e.g. fluoxetine)
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quinidine (for heart rhythm disorders)
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erythromycin (an antibiotic)
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rifampicin (for treatment of tuberculosis)
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ketoconazole or itraconazole (antifungal)
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carbamazepine or phenytoin (for the control of epilepsy)
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beta blockers (medication for a heart condition)
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non-steroidal anti-inflammatory drugs such as ibuprofen, or diclofenac sodium (for treatment of pain or arthritis)
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anticholinergic medicines (e.g. tolterodine).
Donepezil Mylan should not be taken with other medicines that act in the same way i.e. increasing the amount of acetylcholine in the brain by blocking its breakdown by the enzyme acetylcholinesterase (e.g. galantamine). Medicines that reduce the amount of acetylcholine may work less well if taken together with Donepezil Mylan. If you are unsure please speak to your doctor.
Tell your doctor if you need to have an operation as Donepezil Mylan may increase the effect of muscle relaxants used in anaesthesia.
Donepezil Mylan with alcohol
Take special care if drinking alcohol whilst taking Donepezil Mylan as alcohol can reduce the effect of Donepezil Mylan.
Pregnancy and breast-feeding
Donepezil Mylan should not be used while breast-feeding.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery if you feel dizzy, sleepy or get muscle cramps while taking Donepezil Mylan. Alzheimer’s disease may also impair your ability to drive or operate machinery. You must not perform these activities unless your doctor tells you that it is safe to do so.
Donepezil Mylan contains 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 Mylan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tell the doctor the name of your caregiver. Your caregiver will help you take your medicine as it is prescribed.
Adults
The recommended starting dose is 5 mg of Donepezil Mylan taken once a day for at least one month. Your doctor may increase this to 10 mg of Donepezil Mylan taken once a day. The maximum recommended daily dose is 10 mg. If you experience an increase in side effects while taking 10 mg each day, tell your doctor or pharmacist.
Use in patients with liver and kidney disease
For adults with mild to moderate liver disease, your doctor may need to adjust your dose. No dosage adjustment is required if you have kidney problems.
Use in children or adolescents
Donepezil Mylan is only recommended for adults.
Method of administration:
Take your Donepezil Mylan by mouth with a drink of water in the evening before you go to sleep.
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 Mylan 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 Mylan 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 Mylan
If you forgot 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, contact your doctor before taking any more medicine.
If you stop taking Donepezil Mylan
When treatment is stopped the beneficial effects of Donepezil Mylan will decrease gradually.
Do not stop taking your tablets without first discussing with your doctor.
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.
You must tell your doctor immediately if you notice these serious side effects mentioned.
You may need urgent medical treatment.
liver problems including hepatitis (inflammation of the liver characterised by dark urine, pale stools, jaundice, feeling sick and fever); this effect is rare (may affect up to 1 in 1,000 people)
severe stomach pain, especially after eating, or blood in your stools, which may be signs of bleeding and stomach or bowel ulcers; this effect is uncommon (may affect up to 1 in 100 people)
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fits; this effect is uncommon (may affect up to 1 in 100 people)
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fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"); this effect is very rare (may affect up to 1 in 10,000 people).
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changes to your heart beat, such as changes to the rhythm or ‘missed’ beats, which may be signs of problems with the electrical signals in your heart; these effects are rare (may affect up to 1 in 1,000 people)
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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); this effect is very rare (may affect up to 1 in 10,000 people).
Other side effects include:
Very common (may affect more than 1 in 10 people):
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diarrhoea
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feeling sick
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headache.
Common (may affect up to 1 in 10 people):
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being sick
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muscle cramps
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feeling tired
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insomnia (difficulty sleeping)
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common cold
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anorexia (loss of appetite)
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hallucinations (seeing or hearing things that are not real)
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unusual dreams including nightmares
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agitation
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aggressive behaviour
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fainting
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feeling dizzy
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abdominal pain or discomfort
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skin rash and itching
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urinary incontinence
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pain
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accidents (patients may be more prone to falls and accidental injury).
Uncommon (may affect up to 1 in 100 people):
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slow heartbeat
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an increase in the levels of a substance called creatine kinase in your blood which is involved in metabolism.
Rare (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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Donepezil Mylan
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/bottle after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special 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 Mylan contains
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The active substance is donepezil hydrochloride.
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Donepezil Mylan 5 mg Film-coated Tablet: Each tablet contains 5 mg donepezil hydrochloride.
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Donepezil Mylan 10 mg Film-coated Tablet: Each tablet contains 10 mg donepezil hydrochloride.
The other ingredients are
Tablet core: lactose monohydrate (see section 2, ‘Donepezil Mylan contains lactose’), maize starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate
Tablet coating: hypromellose, titanium dioxide E171, macrogol
What Donepezil Mylan looks like and contents of the pack
Your medicine is in the form of a film-coated tablet.
Donepezil Mylan 5 mg Film-coated Tablets are white, film-coated, round tablets marked with “DL” over “5” on one side and “G” on the reverse.
Donepezil Mylan 10 mg Film-coated Tablets are white, film-coated, round tablets, marked with “DL” over “10” on one side and “G” on the reverse.
Donepezil Mylan 5 mg Film-coated Tablets are available in blisters containing 7, 10, 28, 30, 56, 60, 84, 98, 100 film-coated tablets, calendar packs of 28 and 98 and blister unit dose of 50 x1.
Donepezil Mylan 5 mg Film-coated Tablets are also available in bottles containing 100 and 250 film-coated tablets.
Donepezil Mylan 10 mg Film-coated Tablets are available in blisters containing 10, 28, 30, 56, 60, 84, 98, 100 film-coatedtablets, calendar packs of 28 and 98 and blister unit dose of 50 x1.
Donepezil Mylan 10 mg Film-coated Tablets are also available in bottles containing 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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Marketing Authorisation Holder: |
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[to be completed nationally] |
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Manufacturers: |
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McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. |
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria “Donepezil HCL“Arcana” 5 mg - Filmtabletten” “Donepezil HCL“Arcana” 10 mg - Filmtabletten”
Belgium “Donepezil Mylan” 5 mg filmomhulde tabletten” “Donepezil Mylan 10 mg filmomhulde tabletten”
Czech Republic “Donepezil Mylan 5 mg” “Donepezil Mylan 10 mg”
Denmark “Donepezil Mylan”
Finland “Donepezil Mylan”
France “DONEPEZIL MYLAN 5 mg, comprimé pelliculé” “DONEPEZIL MYLAN 10 mg, comprimé pelliculé”
Greece “DONEPEZIL/Mylan”
Hungary “Donepezil Mylan 5 mg filmtabletta” “Donepezil Mylan 10 mg filmtabletta”
Ireland Aripil 5mg Film-coated Tablets” “Aripil 10mg Film-coated Tablets”
Italy “DONEPEZIL MYLAN GENERICS”
Poland “Pamigen”
Portugal “Donepezilo Mylan”
Spain “Donepezilo MYLAN 5 mg comprimidos recubiertos con pelìcula EFG” “Donepezilo MYLAN 10 mg comprimidos recubiertos con pelìcula EFG”
Sweden “Donepezil Mylan”
UK “Donepezil Hydrochloride 5mg Film-coated Tablets” “Donepezil Hydrochloride 10mg Film-coated Tablets”