Donepezil Hydrochloride 5 Mg Film-Coated Tablets
Package leaflet: Information for the user
Donepezil Hydrochloride 5 mg and 10 mg Film-coated Tablets
Donepezil hydrochloride (as monohydrate)
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 Hydrochloride Film-coated Tablets are and what they are used for
2. What you need to know before you take Donepezil Hydrochloride Film-coated Tablets
3. How to take Donepezil Hydrochloride Film-coated Tablets
4. Possible side effects
5. How to store Donepezil Hydrochloride Film-coated Tablets
6. Contents of the pack and other information
1. What Donepezil hydrochloride is and what it is used for
Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride 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. It is for use only in adult patients.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
Do not take Donepezil Hydrochloride Film-coated Tablets if you are
- allergic (hypersensitive) to donepezil hydrochloride,or to piperidine derivatives,or any of the other ingredients of Donepezil Hydrochloride Film-coated Tablets listed in section 6
- Tell your doctor if any of these applies to you.
Warnings and precautions
Treatment with Donepezil Hydrochloride Film-coated Tablets should only be started and supervised by a doctor with experience in diagnosing and treating Alzheimer’s dementia.
Tell your doctor or pharmacist before taking Donepezil hydrochloride if you have or have had:
- stomach or duodenal ulcers
- seizure (fits) or convulsions
- a heart condition (especially if you have an 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.
Other medicines and Donepezil Hydrochloride Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 Donepazil 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
- 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 medicines 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.
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.
If you are in doubt, consult your doctor or pharmacist before using Donepezil Hydrochloride Film-coated Tablets.
Donepezil Hydrochloride Film-coated Tablets with food, drink and alcohol
Donepezil Hydrochloride Film-coated Tablets should be taken with a drink of water. 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. Do not drive or use any tools or machines 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.
Donepezil hydrochloride film-coated tablets contain lactose monohydrate
Donepezil Hydrochloride Film-coated Tablets contain lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in children and adolescents
Donepezil hydrochloride tablets are not recommended for children and adolescents below the age of 18 years.
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 Film-coated Tablets 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 Film-coated 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 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 medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
- 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 (may affect up to 1 in 1000 people).
- stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people).
- bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people).
- seizures (fits) or convulsions (may affect up to 1 in 100 people)
- fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
- 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).
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)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there),
• unusual dreams and nightmares,
• agitation,
• aggressive behaviour
• fainting,
• dizziness,
• difficulty in sleeping (insomnia)
• stomach feeling uncomfortable
• rash,
• itching
• muscle cramps
• passing urine uncontrollably
• (tiredness),
• pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (may affect up to 1 in 100 people)
• slow heart beat
Rare side effects (may affect up to 1 in 1000 people)
shaking, stiffness or uncontrollable movement especially of the face and tongue but also of the limbs
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 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.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE FILM-COATED TABLETS
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 or blister 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 Hydrochloride Film-coated Tablets contain
- The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg or 10 mg of donepezil hydrochloride (as monohydrate).
- The other ingredients of the tablet core are maize starch, lactose monohydrate, cellulose, microcrystalline, sodium starch glycolate, type A, silica, colloidal anhydrous, magnesium stearate.
The film-coating contains:
5 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171)
and macrogol 4000
10 mg film-coated tablets: lactose monohydrate, hypromellose 15 cp, titanium dioxide (E171)
and macrogol 4000 and yellow iron oxide (E172)
What Donepezil Hydrochloride Film-coated Tablets look like and contents of the pack Donepezil Hydrochloride 5 mg Film-coated Tablets are white to off-white, round, biconvex film-coated tablets debossed “DN 5” on one side.
Donepezil Hydrochloride 10 mg Film-coated Tablets are yellow, round, biconvex film-coated tablets debossed “DN 10” on one side.
The film-coated tablets are supplied in blister packs of 7, 28, 30, 50, 56, 60, 84, 90, 98 or 120 film-coated tablets.
The film-coated tablets are supplied in blister calendar packs of 7, 28, 56, 84 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder PLIVA Pharma Limited
Ridings Point, Whistler Drive Castleford, West Yorkshire, WF10 5HA, United Kingdom Manufacturer
Teva Operations Poland Sp. z.o.o ul. Mogilska 80. 31-456, Krakow, Poland OR*
Pliva Ljubljana d.o.o., Pot k sejmiscu 35, Ljubljana 1000, Slovenia OR*
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
OR*
PLIVA Hrvatska d.o.o. (Pliva Croatia Ltd), Prilaza baruna Filipovica 25, 10000 Zagreb, Croatia
OR*
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany.
This leaflet was last revised in April 2016
PL 10622/0345 & 0346
Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL