Donepezil Hydrochloride 5mg Orodispersible Tablets
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Donepezil hydrochloride 5 mg orodispersible tablets Donepezil hydrochloride 10 mg orodispersible tablets
Donepezil hydrochloride
Read all of this leaflet carefully before you start taking 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 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.
In this leaflet:
1. What Donepezil hydrochloride is and what 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 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. BEFORE YOU TAKE Donepezil hydrochloride Do not take Donepezil hydrochloride
- if you are allergic (hypersensitive) to donepezil hydrochloride, to piperidine derivates or any of the other ingredients of Donepezil hydrochloride
Take special care with Donepezil hydrochloride Please 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.
- if you have heart rhythm disorder (sick sinus syndrome) or other cardiac conduction disorders (as sinuatrial or atrioventricular block). Donepezil may slow down your heart rate.
- if you take anti-inflammatory medicines
- if you have ever had stomach or duodenal ulcer
- if you have difficulty passing urine or mild kidney disease
- if you have ever had seizures. Donepezil may cause a new seizure.
- if you have asthma or obstructive pulmonary disease
- if you have or had severe liver problems or hepatitis
Taking other medicines
Other medicines may change the effect of Donepezil hydrochloride or Donepezil hydrochloride may change the effect of 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 or herbal remedies.
It is especially important to mention to the doctor if you are using or you have used any of the following medicines:
- ketoconazole or itraconazole (antifungal agents)
- quinidine (heart medicine) and other heart medicines (as beta-blockers)
- pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen or diclofenac sodium
- erythromycin and rifampicin (antibiotics)
- fluoxetine (antidepressant)
- phenytoin and carbamazepine (antiepileptic medicines)
- diazepam and succinylcholine (muscle relaxants)
- inhibitors of acetylcholinesterase (other medicines for Alzheimer's disease) or medicine affecting to cholinergic system
If you are going to surgery or to have an operation that requires you to have an anaesthetic, tell your anaesthetist that you are taking Donepezil hydrochloride because Donepezil hydrochloride may increase the effect of medicines used during the anaesthesia.
Taking Donepezil hydrochloride with food and drink
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.
Ask your doctor or pharmacist 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 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 Donepezil hydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You and your caregivers should be aware of the doctor’s instructions.
The usual 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.
Donepezil hydrochloride is not recommended for use in children (younger than 18 years).
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 symptom.
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 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Donepezil hydrochloride 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)).
Other side effects
Very common (affects more than 1 user in 10):
Headache, diarrhoea, nausea.
Common (affects 1 to 10 users in 100):
Common cold, loss of appetite, hallucinations, agitation, aggressive behaviour, fainting, dizziness, inability to sleep, vomiting, abdominal disturbances, itching, rash, muscle cramps, urinary incontinence, fatigue, pain, accident proneness.
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, uncontrollable movements), 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 out of the reach and sight of children.
Do not use Donepezil hydrochloride 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.
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 protect the environment.
6. FURTHER INFORMATION
What Donepezil hydrochloride contains
- The active substance is donepezil hydrochloride.
Each film-coated 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, 10, 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
Marketing Authorisation Holder: Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Manufacturer: HBM Pharma s.r.o., Sklabinska 30, 036 80 Martin, Slovak Republic
OR*
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany OR*
Teva Pharmaceutical Works Private Ltd.
Pallagi Ut 13
4042 Debrecen Hungary
This leaflet was last revised in April 2015
PL 15773/0785-6
* Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL
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