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
You and your caregiver should 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 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 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.
Donepezil hydrochloride 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 hydrochloride is for use in adult patients only.
2. What you need to know before you take Donepezil hydrochloride
Do not take Donepezil hydrochloride
- if you are allergic (hypersensitive) to donepezil hydrochloride, to piperidine derivatives or 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 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
• difficulties passing urine or mild kidney disease
Also tell your doctor if
• you are going to have an operation or if you need to have an anaesthetic before surgery. Donepezil may exaggerate muscle relaxation during anaesthesia.
• you take anti-inflammatory medicines
• you are pregnant or think you might be pregnant
Other medicines and Donepezil hydrochloride
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use 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 Donepezil 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 medicine e.g. ketoconazole or itraconazole
• 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.
Donepezil hydrochloride with food and alcohol
Food has no influence on the absorption 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 during pregnancy or 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.
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 cramp. If you experience any of these effects you must not drive or operate machinery.
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. You and your caregivers should be aware of the doctor’s instructions.
The recommended starting dose is 5 mg once daily. When Donepezil hydrochloride treatment of 5 mg/day has continued for one month, the dose can be increased by your doctor to 10 mg per day. The maximum recommended dose is 10 mg per day.
Kidney problems: No dosage adjustment needed.
Liver problems:
• mild to moderate: Your dose is adjusted by your doctor.
• severe: No data available, therefore Donepezil hydrochloride should not be used.
You should take Donepezil hydrochloride just before going to sleep. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to your preference.
Use in children and adolescents
Donepezil hydrochloride is not recommended for use in children and adolescents.
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 than you should
Overdosage with donepezil hydrochloride can result in cholinergic crisis (acetylcholine affects too much) characterized by severe nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
If you have taken too many tablets, or another adult or a child has accidentally swallowed Donepezil hydrochloride, immediately contact a doctor, hospital or the Poison Information Centre. 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
Do not take a double dose to make up for a forgotten tablet. Take your customary dose on 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.
If you stop taking Donepezil hydrochloride
When Donepezil hydrochloride treatment is discontinued, the beneficial effects of the treatment gradually disappear.
Do not stop taking Donepezil hydrochloride without first discussing it with your doctor.
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.
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 (affects 1 to 10 users in 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 users in 1,000).
• bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (affects 1 to 10 users in 1,000).
• seizures (fits) or convulsions (affects 1 to 10 users in 1,000).
• fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”) (very rare (affects less than 1 user in 10,000)).
• 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) (affects less than 1 user in 10,000).
Other side effects
Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride
Very common (affects more than 1 user in 10)
• diarrhoea
• feeling or beeing sick
• headache
Common (affects 1 to 10 users in 100)
• 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
• vomiting
• stomach feeling uncomfortable
• rash
• itching
• passing urine uncontrollably
• Pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon (affects 1 to 10 users in 1,000)
• slow heart beat,
• minor increase in serum concentration of muscle creatine kinase
Rare (affects 1 to 10 users in 10,000)
• extrapyramidal symptoms (e.g. muscle stiffness, shaking or uncontrollable movements especially of
the face and tongue but also of the limbs),
• cardiac disorders (sinuatrial block or atrioventricular block)
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 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 after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and 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 hydrochloride contains
- The active substance is donepezil hydrochloride.
Each orodispersible tablet contains 5 mg or 10 mg donepezil hydrochloride
- The other ingredients are
Mannitol (E 421), micocrystalline cellulose, disodium phosphate dihydrate, sodium stearyl fumarate, flavour peppermint (containing menthol, thymol, methyl-tert-butylether, maltodextrin and modified starch), flavour menthol (containing menthol and gum arabic) and saccharin sodium.
Only in 10 mg tablets pigment blend yellow containing iron oxide (E 172) and microcrystalline cellulose.
What Donepezil hydrochloride looks like and contents of the pack
5 mg: White, round, biconvex tablet, embossed with ‘D’ on one side.
10 mg: Yellow, round, biconvex tablet, embossed with ‘D’ on one side.
Packs with 7, 14, 28, 30, 3x30, 50, 56, 60, 98, 100 and 120 orodispersible tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ratiopharm GmbH
Graf-Arco-Strasse 3, D-89079 Ulm, Germany Or*
HBM PHARMA SRO SKLABINSKA 30, MARTIN, SK-036 80,
SLOVAKIA
Or*
Teva Pharmaceutical Works Private Ltd.
Pallagi Ut 13 4042 Debrecen Hungary