Donepezil Hydrochloride 5 Mg Film-Coated Tablets
Package Leaflet: Information for the user
Donepezil hydrochloride, 5 mg, film-coated tablets
Donepezil hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. Y ou 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 is and what it is used for
2. What you need to know before you take Donepezil hydrochloride
3. How to take Donepezil hydrochloride
4. Possible side effects
5. How to store Donepezil hydrochloride
6. Contents of the pack and other information
1. What Donepezil hydrochloride is and what it is used for
Donepezil hydrochloride tablets contain the active substance, donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of dementia (disorder of rational behaviour) in people diagnosed as having mild to moderately severe Alzheimer's disease (a chronic mental disease). It is for use only in adult patients.
2. What you need to know before you take Donepezil hydrochloride Do not take Donepezil hydrochloride:
■ 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 hydrochloride if:
■ you have ever had stomach or duodenal ulcers
■ you have ever had a seizure (fit) or convulsion
■ you have a heart condition (irregular or very slow heart beat)
■ you have asthma (dyspnoea) or other long term lung disease
■ you have ever had any liver problems or hepatitis (inflammation of the liver)
■ you have difficulty passing urine or mild kidney disease
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.
Other medicines and Donepezil hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Donepezil hydrochloride:
■ 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
■ muscle relaxants e.g. diazepam, succinylcholine
■ anti-depressants e.g. fluoxetine
■ anticonvulsants (medicines used in prevention of the occurrence of several types of seizures) e.g. phenytoin, carbamazepine
■ medication for a heart condition e.g. quinidine, beta-blockers (propanolol and atenolol)
■ 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 (narcosis) 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 with food, drink and alcohol
Donepezil hydrochloride should be taken with liquid (a glass of water). Food does not have any effect on this medication. Alcohol consumption should be restricted when taking donepezil, as alcohol may reduce the levels of donepezil.
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 hydrochloride should not be used while breast-feeding.
Driving and using machines
Do not drive because 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.
Do not use any tool or machine because your medicine can cause fatigue, dizziness and muscle cramp and if affected you must not drive or operate machinery.
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Donepezil hydrochloride
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 5 mg every night. After one month, your doctor may tell you to take 10 mg every night. The maximum recommended dose is 10 mg each night.
Take your Donepezil hydrochloride tablet by mouth with a drink of water at night before you go to bed.
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.
You should 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. 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 than you should
Do not take more than one tablet each day. If you do, you may experience nausea, vomiting, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), difficulty in breathing, collapse and convulsion. Call your doctor immediately or contact the local hospital. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.
If you forget to take Donepezil hydrochloride
If you forget to take a tablet, just take one tablet the following day at the usual time. If you forget to take your medicine for more than one week, call your doctor before taking any more medicine. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by your doctor.
If you have any further question on the use of this product, ask your doctor or your pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients taking Donepezil hydrochloride have reported following side effects.
Serious side effects
You must tell your doctor immediately if you notice these serious side effects mentioned. You
may need urgent medical treatment.
Uncommon: may affect up to 1 in 100 people
■ Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel 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.
Rare: may affect up to 1 in 1,000 people
■ 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.
Very rare: may affect up to 1 in 10,000 people
■ 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).
Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride.
Other side effects:
Very common: may affect more than 1 in 10 people
• diarrhoea
• feeling sick (nausea)
• headache
Common: may affect up to 1 in 10 people
accidents
being sick (vomiting) abdominal disturbances
rash
itching
muscle cramp urinary incontinence fatigue pain
• common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there)
• unusual dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• insomnia (difficulty in sleeping)
Uncommon: may affect up to 1 in 100 people
• slow heart beat
• minor increase in serum concentration of muscle creatine kinase
Rare: may affect up to 1 in 1,000 people
• sino-atrial block, atrioventricular block
• 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
Do not store above 30 °C.
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. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Donepezil hydrochloride contains
The active substance is donepezil hydrochloride.
5 mg tablet: each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base.
The other ingredients are:
Tablet core:
Lactose Monohydrate, Maize starch, Hydroxypropyl cellulose, Microcrystalline cellulose,
Magnesium Stearate
Film-coating:
HPMC 2910/Hypromellose 5 cP (E464), Titanium dioxide (E171), Propylene Glycol, Talc
What Donepezil hydrochloride looks like and contents of the pack
5 mg tablet: white, round film-coated tablets with a diameter of 7.5 mm approximately.
Packs: 14, 28, 42, 56, 84, 98, 112 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
PharmaSwiss Ceska republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7, Czech Republic
Manufacturer:
Specifar S.A.
1, 28 Octovriou Street,
123 51 Ag. Varvara Athens,Greece
Valeant sp. z o.o. sp. j.
2 Przemysiowa Street,
35-959 Rzeszow, Poland
This medicinal product is authorised in the member states of the EEA under the following names:
UK:
Donepezil hydrochloride, 5 mg, film-coated tablets PL:
Donectil, 5 mg, tabletki powlekane HU:
Donectil, 5 mg, Filmtabletta
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