Donepezil Hydrochloride 5 Mg Film-Coated Tablets
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Package leaflet: Information for the user Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated tablets
Donepezil Hydrochloride
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.
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 (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 break down 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 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 to donepezil hydrochloride or to piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor or pharmacist before starting to take 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
• 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 hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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
• 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 will not influence the effect of Donepezil hydrochloride. Donepezil hydrochloride should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding and fertility
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 breastfeeding. 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.
Donepezil hydrochloride contains lactose
Donepezil hydrochloride film-coated tablets contains lactose monohydrate. 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 hydrochloride
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Donepezil hydrochloride should you take?
Usually, you will start by taking 5 mg (one white tablet) every night. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night.
Swallow your Donepezil hydrochloride tablet with a drink of water before you go to bed at night.
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 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 stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride, the benefits of your treatment will gradually fade away.
If you take more Donepezil hydrochloride 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 hydrochloride
If you forget to take a tablet, just take one tablet the following day at
Black
the usual time. Do not take a double dose to make up for a forgotten dose.
If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
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.
The following side effects have been reported by people taking Donepezil hydrochloride.
Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride.
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”) (affects less than 1 user in 10,000)
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):
- 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 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, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
HDPE bottle: Keep the HDPE bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. 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 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.
5 mg: Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil.
10 mg: Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.
- The other ingredients are.
Tablet core: Lactose monohydrate, pregelatinized starch (maize starch), microcrystalline cellulose, low - substituted hydroxypropyl cellulose and magnesium stearate Film coating: Hypromellose, macrogol 6000, talc, titanium dioxide (E171), iron oxide yellow (E172) (for only 10 mg)
What Donepezil hydrochloride looks like and contents of the pack
Film-coated tablet
Donepezil hydrochloride 5 mg film coated tablets
White to off-white, circular, biconvex film-coated tablets debossed
with ‘X’ on one side and ‘11’ on the other side
Donepezil hydrochloride 10 mg film coated tablets
Yellow colored, circular, biconvex film-coated tablets debossed with
‘X’ on one side and ‘12’ on the other side.
Donepezil hydrochloride tablets are available in PVC/PE/PVdC-Aluminium blister packs and HDPE bottle pack with polypropylene closure containing silica gel desiccant.
Pack sizes:
Blister pack: 14, 28, 50, 56 and 98 tablets HDPE bottle pack: 30, 250 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
UK _ Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
MT_ Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This leaflet was last revised in 07/2013.
5. How to store Donepezil hydrochloride
Keep this medicine out of the sight and reach of children.
OS I'd
Blister: Store in the original package in order to protect from moisture.
