Donepezil Hydrochloride 5mg Orodispersible Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil hydrochloride 5 mg orodispersible tablets Donepezil hydrochloride 10 mg orodispersible tablets
Read all of this leaflet carefully before you start using 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.
In this leaflet:
1. What Donepezil hydrochloride orodispersible tablets are and what are used for
2. Before you take Donepezil hydrochloride orodispersible tablets
3. How to take Donepezil hydrochloride orodispersible tablets
4. Possible side effects
5. How to store Donepezil hydrochloride orodispersible tablets
6. Further information
1. WHAT DONEPEZIL HYDROCHLORIDE ORODISPERSIBLE TABLETS ARE AND WHAT ARE USED FOR
Donepezil hydrochloride orodispersible tablets belong 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. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE ORODISPERSIBLE
TABLETS
Do not take Donepezil hydrochloride orodispersible tablets if:
• you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any other ingredients of Donepezil hydrochloride orodispersible tablets listed in section 6.
Take special care with Donepezil hydrochloride orodispersible tablets
Tell your doctor or pharmacist 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
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 orodispersible tablets:
• 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 orodispersible tablets .This is because your medicine may affect the amount of anaesthetic needed.
Donepezil hydrochloride orodispersible tablets 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 orodispersible tablets.
Taking Donepezil hydrochloride orodispersible tablets with food and drink
Donepezil hydrochloride orodispersible tablets may be taken with a glass of water once the tablet has dissolved on the tongue. Food does not have any effect on this medication. Alcohol consumption should be restricted when taking Donepezil hydrochloride orodispersible tablets, as alcohol may reduce the levels of donepezil.
Pregnancy and breast-feeding
You should not use donepezil hydrochloride if you are pregnant or are breast feeding.
Ask your doctor or your pharmacist for advice before taking any medicine.
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 tools or machines because your medicine can cause fatigue, dizziness and muscle cramp and if affected you must not drive or operate machinery.
Important information about some of the ingredients of Donepezil hydrochloride orodispersible tablets
Contains source of phenylalanine. May be harmful for people with phenylketonuria.
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 ORODISPERSIBLE TABLETS
Always take Donepezil hydrochloride orodispersible tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
The usual 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 orodispersible tablets by mouth at night before you go to bed. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water according to your preference.
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 orodispersible tablets 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 orodispersible tablets
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 orodispersible tablets
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, Donepezil hydrochloride orodispersible tablets can have side effects, although not everybody gets them.
In most cases these go away without having to stop treatment. Tell your doctor if you have any of these effects and if they are too uncomfortable for you.
Patients taking Donepezil hydrochloride orodispersible tablets have reported the following side effects. Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride orodispersible tablets.
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 (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 (affects more than 1 user in 10)
• diarrhoea
• feeling or being sick
• headaches
Common side effects (affects 1 to 10 users in 100)
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common cold | ||
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loss of appetite |
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abdominal disturbances |
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hallucinations (seeing or hearing things |
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rash |
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that |
are not really there | ||
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agitation |
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itching |
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aggressive behaviour |
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muscle cramp |
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fainting |
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urinary incontinence |
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dizziness |
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fatigue |
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insomnia (difficulty in sleeping) |
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pain |
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accidents |
Uncommon side effects (affects 1 to 10 users in 1,000)
• slow heart beat
Rare side effects (affects 1 to 10 users in 10,000)
• stiffness or uncontrollable movement especially of the face and tongue but also of the limbs
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 your pharmacist.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE ORODISPERSIBLE TABLETS
Keep out of the reach and sight of children.
Do not use Donepezil hydrochloride orodispersible tablets after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask yor pharmacist how to dispose of medicines no longer required. These measures will help to protect the enviroment.
6. FURTHER INFORMATION
What Donepezil hydrochloride orodispersible tablets contain
The active substance in Donepezil hydrochloride orodispersible tablets is donepezil hydrochloride.
5mg: Each tablet contains 5 mg of donepezil hydrochloride.
10mg: Each tablet contains 10 mg of donepezil hydrochloride.
The other ingredients are: polacrilin potassium, microcrystalline cellulose, lactose monohydrate (spray dried), monosodium citrate anhydrous, aspartame (E951), croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hydrochloric acid for pH adjustment.
What Donepezil hydrochloride orodispersible tablets look like and contents of the pack
5 mg: white to off-white, round, flat tablets with bevelled edges, containing 5 mg of Donepezil HCl, embossed with ‘5’ on one side and plain on the other
10 mg: White to off-white round, flat tablets, with bevelled edges, containing 10 mg of Donepezil HCl, embossed with ‘10’ on one side and plain on the other.
Packs:
PVC /Aclar/Aluminium and Aluminium/Aluminium blisters of 14 tablets Pack sizes:
28 orodispersible tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Adamed Sp. z o.o.,
Pienkow 149,
05-152 Czosnow/Warsaw,
Poland
Manufacturer: Genepharm S.A, 18th Km Marathonos Avenue, 153 51 Pallini Attikis, Greece
This medicinal product is authorised in the member states of the EEA under the following names:
Poland:
Spain:
United Kingdom:
Ricordo 5, 10 mg
Donepezilo Flas Combix 5, 10 mg comprimidos bucodispersables EFG Donepezil hydrochloride 5, 10 mg Orodispersible Tablets