Donepezil Hydrochloride 5mg Orodispersible Tablets
Package leaflet: Information for the user
Donepezil hydrochloride 5 mg Orodispersible tablets Donepezil hydrochloride 10 mg Orodispersible tablets
Donepezil Hydrochloride
The name of your medicine is Donepezil hydrochloride orodispersible tablets. It will be referred to as Donepezil tablets throughout the reminder of the leaflet.
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Donepezil tablets is and what it is used for
2. What you need to know before you take Donepezil tablets
3. How to take Donepezil tablets
4. Possible side effects
5. How to store Donepezil tablets
6. Contents of the pack and other information
1. What Donepezil tablets is and what it is used for
Donepezil tablets (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil 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 and more difficult to carry out their normal daily activities.
Donepezil tablets is for use in adult patients only.
2. What you need to know before you take Donepezil tablets DO NOT take Donepezil tablets
• if you are allergic to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Donepezil tablets especially if you have or have 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 if you are pregnant or think you might be pregnant.
Other medicines and Donepezil tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because these medicines may weaken or strengthen the effects of Donepezil tablets
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. acetylsalicylic acid, non-steroidal antiinflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium
• anticholinergics medicines, e.g. tolterodine
• antibiotics e.g. erythromycin, rifampicin
• anti-fungal medicine e.g. ketoconazole
• 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 (propranolol 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 tablets This is because your medicine may affect the amount of anaesthetic needed.
Donepezil 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 tablets.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
Donepezil tablets with food, drink and alcohol
Food will not influence the effect of Donepezil tablets. Donepezil tablets should not be taken with alcohol, because alcohol may change its effect.
Pregnancy and breast-feeding
Donepezil tablets should not be used while breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this 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 and muscle cramps. If you experience any of these effects you must not drive or operate machinery.
Donepezil tablets contains aspartame (E951)
Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Donepezil tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Donepezil tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Donepezil tablets should you take?
Usually, you will start by taking 5 mg every night before you go to bed. After one month, your doctor may tell you to take 10 mg every night before you go to bed.
The tablet should be placed on your tongue and allowed to disintegrate 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 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 tablets?
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 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 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 tablets
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil tablets, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 tablets.
Tell your doctor if you have any of these effects while you are taking Donepezil 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 (rare: may affect up to 1 in 1,000 people).
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (uncommon: 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 (uncommon: may affect up to 1 in 100 people).
• seizures (fits) or convulsions (uncommon: 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") (very rare: 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) (may affect up to 1 in 10,000 people).
Very common (may affect more than 1 in 10 people):
• diarrhoea
• feeling or being sick
• headaches
Common (may affect up to 1 in 10 people):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia
• the common cold
• loss of appetite
• 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 (may affect up to 1 in 100 people):
• slow heart beat
Rare (may affect up to 1 in 1,000 people):
• stiffness, shaking 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 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 blister and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions.
Store in the original blister in order to protect from moisture.
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 tablets contains:
• The active substance in Donepezil tablets is donepezil hydrochloride.
Each tablet contains 5 mg of donepezil hydrochloride.
Each tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are:
Polacrilin potassium, cellulose, microcrystalline, lactose monohydrate (spray dried) monosodium citrate anhydrous, aspartame (E951), croscarmellose sodium, silica colloidal anhydrous, magnesium stearate.
What Donepezil tablets looks like and contents of the pack
White to off-white, round, flat tablets with bevelled edges, embossed with ‘5’ on one side and plain on the other
White to off-white, round, flat tablets with bevelled edges, embossed with ‘10’ on one side and plain on the other
Packs:
Blisters of 7, 10, 14 tablets Pack sizes:
10, 14, 28, 30, 56, 98, 126, 154 and 196 orodispersible tablets 10, 14, 28, 30, 56, 98, 126, 154 and 196 orodispersible tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Stada Arzneimittel AG.
Stadastr. 2-18 D-61118 Bad Vilbel Germany
Manufacturer(s):
Clonmel Healthcare LTD, Waterford Road, Clonmel, Co. Tipperary, Ireland Eurogenerics N.V, Eigenlostraat 5-9100 Sint-Niklaas, Belgium Genepharm S.A, 18th Km Marathonos Avenue, 153 51 Pallini Attikis, Greece STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany STADA Arzneimittel GmbH, Muthgasse 36, 1190 Wien, Austria
This medicinal product is authorised in the member states of the EEA under the following names:
AT: Donepezil STADA 5/ 10 mg Schmelztabletten
BE: Donepezil Instant EG 5/ 10mg orodispergeerbare tabletten
LU: Donepezil Instant EG 5/ 10mg comprimes orodispersibles
CZ: Adonep OROTAB 10 mg tablety dispergovatelne v ustech
DE: Donepezilhydrochlorid AL 5/ 10 mg Schmelztabletten
ES: Donepezilo Flas STADA 5/ 10mg comprimidos bucodispersables EFG
PT: DonepeziloCiclum 5/ 10 mg
RO: Donepezil STADA Hemofarm 5/ 10 mg comprimate orodispersabile UK: Donepezil hydrochloride 5/ 10 mg orodispersible tablets
This leaflet was last revised in May 2016.
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