Donepezil Niche 5mg Film Coated Tablets
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Donepezil Niche 5mg and 10mg 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.
ne is Donepezil lm-coated Tablets. l Niche for ease
The name of your medic Niche 5 mg and 10 mg F It will be called Donepez from here on.
In this leaflet:
1. What Donepezil Niche is and what it is used for
2. Before you take Donepezil Niche
3. How to take Donepezil Niche
4. Possible side effects
5. How to store Donepezil Niche
6. Further information
1. What Donepezil Niche is and what it is used for
The active ingredient in your tablets is donepezil hydrochloride. It works by increasing the amount of a substance called acetylcholine in the brain.
It is used to treat the symptoms of dementia (changes in the way the brain works) in people with mild to moderately severe Alzheimer's disease. These symptoms include increasing memory loss, confusion and changes in the way you behave, making it more difficult to carry out normal daily activities.
Donepezil Niche is only for use in adult patients.
2. Before you take Donepezil Niche
Do NOT take Donepezil Niche if you:
■ know that you are allergic (hypersensitive) to Donepezil hydrochloride (which is a piperidine derivative), or to other piperidine derivatives, or any of the other ingredients of Donepezil Niche listed in section 6
Take special care with Donepezil Niche
Please tell your doctor or pharmacist before you take Donepezil Niche if you have or have had:
■ stomach or duodenal ulcers
■ seizures (fits) or convulsions (uncontrollable shaking movements)
■ problems with your heart such as irregular or very slow heart beat
■ asthma or other long term lung disease
■ liver problems including hepatitis (where your skin and whites ofthe eyes go yellow)
■ difficulty passing urine or mild kidney disease
Donepezil Niche is not recommended for use in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines which you have bought yourself from a chemist/pnarmacist. These medicines may alter the effects of Donepezil Niche if they are taken together.
In particular, tell your doctor if you are taking any of the following types of medicines:
■ other Alzheimer's disease medicines, such as galantamine
■ anticholinergics medicines, such as tolterodine
■ antibiotics, such as erythromycin, rifampicin
■ medicines used to treat fungal infections, such as ketoconazole, itraconazole
■ anti-depressants, such as fluoxetine
■ medicines to control fits or convulsions, such as phenytoin, carbamazepine
■ medication for a heart condition, such as quinidine, beta-blocker (propanolol and atenolol)
■ muscle relaxants, such as diazepam, succinylcholine
■ medicines obtained without a prescription, such as 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 Niche. This is because your medicine may affect the amount of anaesthetic needed.
Taking Donepezil Niche with food and drink
Donepezil Niche can be taken with or without food.
You should avoid drinking alcohol while you are taking Donepezil Niche because the alcohol may change the effect of Donepezil Niche.
Pregnancy and breast-feeding
■ If you are pregnant, or think you might be pregnant, ask your doctor for advice before taking any medicine.
■ Donepezil Niche should not be taken if you are pregnant, planning to become or think you could be pregnant unless your doctor decides that it is clearly necessary.
■ Donepezil Niche must not be used while breastfeeding.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery and you must
aerform these activities unless your or tells you that it is safe to do so. Also, your medicine can cause tiredness, dizziness and muscle cramp. If affected you must not drive or operate machinery.
Important information about some of the ingredients of Donepezil Niche
This medicine contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking Donepezil Niche.
3. How to take Donepezil Niche
Always take Donepezil Niche exactly as your doctor has told you to. Please check with your doctor or pharmacist if you are unsure. Tell your doctor the name of your caregivers. Your caregivers will help you take your medicine as it has been prescribed.
■ 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.
■ 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.
Swallow your Donepezil Niche tablet with a drink of water before you go to bed at night.
DO NOT alter the dose yourself without your doctor's advice.
Patients with kidney problems
You can take the usual dose as described above. No dose adjustment is needed.
Patients with liver problems
Your doctor will monitor you before increasing the dose if you have mild or moderate liver problems. If you have severe liver problems, your doctor will decide if Donepezil Niche is suitable for you.
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 Niche than you should
DO NOT take more than one tablet each day. Contact your doctor or nearest hospital casualty department immediately if you take more than you should. Take any remaining tablets, the carton and/or leaflet with you to the hospital so that the doctor knows what has been taken.
If you do take more than you should, you might get symptoms such as feeling and being sick, drooling, sweating, slow heart rate,1ow blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take Donepezil Niche
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 Niche
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil Niche, the benefits of your treatment will gradually fade away.
4. Possible side effects
Like all medicines, Donepezil Niche can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil Niche.
Tell your doctor or pharmacist if you have any of these effects while you are taking Donepezil Niche.
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)
■ bleeding in the stomach or intestines.
This may cause you to pass black tar like stools or visible blood from the rectum (back passage) (probably affecting fewer than 1 in 100)
■ seizures (fits) or convulsions (probably affecting fewer than 1 in 100)
■ fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome")
Very common side effects (affecting more than 1 in 10 people):
■ diarrhoea
■ feeling sick
■ headaches
Common side effects (affecting up to 1 in 10 people)
■ muscle cramp
■ being sick
■ 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
■ inability to control passing water (incontinence)
■ general pain occurring over the body
■ accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (affecting fewer than 1 in 100 people)
■ slow heart beat
■ minor increases in blood levels of muscle enzyme (creatine kinase), as shown by blood tests
Rare side effects (affecting fewer than 1 in 1,000 people)
■ stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
■ irregular heartbeat, e.g. feeling your heart beat faster or slower
If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet while you are taking Donepezil Niche, please tell your doctor or pharmacist.
5. How to store Donepezil Niche
Keep out of the reach and sight of children.
Do not store this medicine above 30°C.
DO NOT use Donepezil Niche tablets after the expiry date (EXP:) that is printed on the blister and carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist. 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 protect the environment.
6. Further information
What do Donepezil Niche Film-coated tablets contain
■ The active substance is Donepezil hydrochloride. The 5 mg tablet contains 5 mg of Donepezil hydrochloride and the
10 mg tablet contains 10 mg of Donepezil hydrochloride.
■ The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, talc, macrogol, polyvinyl alcohol, titanium dioxide (E171).
■ Additionally, the 10 mg tablet contains synthetic iron oxide yellow (E172).
What Donepezil Niche Film-coated tablets look like and contents of the pack
■ 5 mg white tablets marked ‘D5' on one side and plain on the other.
■ 10 mg yellow tablets marked ‘D10' on one side and plain on the other.
The tablets are supplied in packs of 7, 14,
28, 30, 50, 56, 60, 84, 98, 112 or 120 tablets.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Niche Generics Ltd
1 The Cam Centre
Wilbury Way
Hitchin
Herts
SG4 0TW
United Kingdom
The Manufacturer is:
Niche Generics Ltd Unit 5
151 Baldoyle Industrial Estate
Dublin 13
Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Donepezil Niche 5mg/10mg Film-Coated Tablets
Ireland: Donepezil Niche 5mg/10mg Film-Coated Tablets
This leaflet was last approved in
November 2013