Donepezil Hydrochloride 10mg Film Coated Tablets
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Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated tablets
donepezil hydrochloride
You and your caregiver should read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyour 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 andwhat 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 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 breakdown of acetylcholine.
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 andmore difficultto carry outtheir normal daily activities.
Donepezil hydrochloride is foruse in adult patients only.
2. Before you take Donepezil hydrochloride Do not take Donepezil hydrochloride
• ifyou are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivates or to any ofthe other ingredients ofDonepezil hydrochloride listed in section 6.
Take special care with Donepezil hydrochloride
Tell your doctor or pharmacistbefore starting to take Donepezil Hydrochloride ifyou have orhave had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (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 ifyou are pregnant or think you might be pregnant
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine. 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 some time in the future if you continue to take Donepezil Hydrochloride. This is because these medicines may weaken or strengthen the effects of Donepezil Hydrochloride.
Especially tell your doctor ifyou are taking any ofthe following types ofmedicines:
• otherAlzheimer'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
• antifungal medicines (e.g. ketoconazole and itraconazole)
• anti-depressants e.g. fluoxetine
• anti-convulsants e.g. phenytoin, carbamazepine
• medication foraheart condition e.g. quinidine, beta-blockers (propanolol and atenolol)
• muscle relaxants e.g. diazepam, succinylcholine
• general anaesthetic
• medicines obtainedwithoutaprescription e.g. herbalremedies
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 affectthe amountofanaesthetic needed.
Donepezil Hydrochloride can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first ifyou have kidney or liver disease. Patients with severe liver disease shouldnottake 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.
Taking Donepezil hydrochloride with food and drink
Foodwill not influence the effect ofDonepezil 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.
Donepezil hydrochlorideshouldnotbeusedwhile breast-feeding.
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 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 andmuscle cramps. Ifyou experience any ofthese side effects, you mustnot drive or operate machinery.
Important information about some ofthe ingredients ofDonepezil hydrochloride
Donepezil hydrochloride tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
3. How to take Donepezil hydrochloride
How much Donepezil Hydrochloride should you take?
The usual starting dose is 5 mg donepezil hydrochloride every night. After one month, you doctor may tell you to take 10 mg donepezil hydrochloride every night.
Swallow your Donepezil Hydrochloride tablet with a drink ofwater before you go to bed at night.
The tablet strength you 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 is10 mg each night.
Always take Donepezil hydrochloride exactly as your doctor has told you. You should checkwith your doctor or pharmacist ifyou are not sure.
Do not alter the dose yourselfwithoutyour 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 yoursymptoms.
Ifyou stop taking Donepezil hydrochloride
Do not stop taking your tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride, the benefits ofyour treatmentwill gradually fade away.
Ifyou take more Donepezil hydrochloride than you should
Do not exceed the dose that your doctor has told you to take. 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 overdose include feeling and being sick, drooling, sweating, slow heartbeat, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions, as well as increasing muscles weakness, a possible life threatening condition.
Ifyou 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. Ifyou forget to take your medicine for more than a week, call your doctor before taking any more medicine.
Ifyou have any further questions on the use ofthis product, askyour doctor or pharmacist.
4. Possiblesideeffects
Like all medicines, donepezil hydrochloride can cause side effects, although not everybody gets them.
The following side effects have been reportedby 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 ofhepatitis are feeling or being sick, loss ofappetite, feeling generally unwell, fever, itching, yellowing ofthe skin andeyes, anddarkcolouredurine(affects 1 to 10usersin 10,000)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (affects 1 to 10 usersin 1,000)
• bleeding in the stomach or intestines. This may cause you to pass black tar like stoolsorvisiblebloodfromtherectum(affects 1to 10usersin 1,000)
• seizures (fits) or convulsions (affects 1 to 10users in 1,000)
• Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (affects fewer than 1 user in 10,000).
Very common side effects (affects more than 1 user in10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users in 100):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the common cold
• loss ofappetite
• hallucinations (seeing or hearing things that are not really there)
• unusual dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach feeling uncomfortable
• rash
• itching
• passing urine uncontrollably
• pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (affects 1to 10usersin 1,000):
• slow heart beat
Rare side effects (affects 1 to 10users in 10,000):
• stiffness, shaking or uncontrollable movement especially ofthe face andtongue but also ofthe limbs
If any ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Donepezil hydrochloride
Keep out ofthe reach and sight ofchildren.
Do not use Donepezil hydrochloride after the expiry date which is stated on the blister and the outer carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day ofthatmonth.
This medicinal product 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 protectthe environment.
6. Further information
What Donepezil hydrochloride contains
• The active substance is donepezil hydrochloride.
Donepezilhydrochloride 5 mg, film-coated tablets
Eachtabletcontains 5 mg donepezil hydrochloride, equivalentto 4.56mg ofdonepezil. Donepezilhydrochloride10mg, film-coated tablets
Each tablet contains 10 mg donepezil hydrochloride, equivalent to9.12 mg ofdonepezil.
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose (E460), maize starch, hydroxypropyl cellulose (E463), magnesium stearate (E572).
The ingredients in the tablet coating are hypromellose (E464), macrogols, talc, titanium dioxide (E171) and purified water.
What Donepezil hydrochloride looks like and contents ofthe pack Donepezilhydrochloride 5 mg, film-coated tablets
Donepezil hydrochloride 5 mg, film-coated tablets are white to off-white, round film-coatedtablets, debossedwith J on one side and 5 on the other side.
Donepezilhydrochloride10mg, film-coated tablets
Donepezil hydrochloride 10 mg, film-coated tablets are white to off-white, round film-coatedtablets, debossedwith J on one side and 10on the other side.
The film-coatedtablets are available in blisters of28,50,56,98,100 film-coatedtablets.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
MarketingAuthorisationHolder:
Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C B-9820 Merelbeke Belgium
Manufacturers:
PSI supplynv Axxes Business Park Guldensporenpark 22 - Block C B-9820 Merelbeke Belgium
Distributedby:
Sovereign Medical Sovereign House Miles Gray Road Basildon EssexSS143FR United Kingdom
This leafletwas last revised in December 2012.