DONEPEZIL HYDROCHLORIDE 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated 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.

• 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 hydrochloride 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 hydrochloride is for use in adult patients only.

2. what you need to know before you take donepezil hydrochloridedo not take donepezil hydrochloride if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivates or to 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
• difficulty passing urine or mild kidney disease

Also tell your doctor if you are pregnant or think you might be pregnant.

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.

Othermedicines andDonepezil 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 some time 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:

• otherAlzheimer'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
• antifungalmedi­cines(e.g. ketoconazole and itraconazole)
• anti-depressants e.g. fluoxetine
• anti-convulsants 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
• medicinesobta­inedwithoutapres­criptione.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 with food and drink

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

If you are pregnant or breast-feeding, think you might 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 during pregnancy.

Donepezil hydrochloride should not be used while breast-feeding.

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 side effects, you must not drive or operate machinery.

Donepezil hydrochloride tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. how to take donepezil hydrochloridehow much donepezil hydrochloride should you take?always take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

Do not alter the dose yourself without your doctor's advice.

The usual starting dose is 5 mg donepezil hydrochloride every night. After one month, your doctor may tell you to take 10 mg donepezil hydrochloride every night.

Swallow your Donepezil hydrochloride tablet with a drink of water before you go to bed at night.

The tablet strength you 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.

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

Do not exceed the dose that your doctor has told you to take. 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 overdose include feeling and being sick, drooling, sweating, slow heartbeat, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions, as well as increasing muscles weakness, a possible life threatening condition.

If you forget to take Donepezil hydrochloride

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 a week, call your doctor before taking any more medicine.

If you stop taking Donepezil hydrochloride

Do not stop taking your 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 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 10users in 10,000)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breastbone (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 fewerthan 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).

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: ). 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 Donepezil hydrochloride after the expiry date which is stated on the blister and the outer carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6. contents of the pack and other information

What Donepezil hydrochloride contains

• The active substance is donepezil hydrochloride.

Donepezil hydrochloride 5 mg film-coated tablets

Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil.

Donepezil hydrochloride 10 mg film-coated tablets

Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil.

• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose (E460), maize starch, hydroxypropyl cellulose (E463), magnesium stearate (E572).

What Donepezil hydrochloride looks like and contents of the pack

Donepezil hydrochloride 5 mgfilm-coated tablets

Donepezil hydrochloride 5 mg film-coated tablets are white to off-white, round film-coated tablets, debossed with J on one side and 5 on the other side.

Donepezil hydrochloride 10 mgfilm-coated tablets

Donepezil hydrochloride 10 mg film-coated tablets are white to off-white, round film-coated tablets, debossed with J on one side and 10 on the other side.

The film-coated tablets are available in blisters of28,50,56,98­,100 film-coated tablets.

Not all pack sizes may be marketed.

MarketingAutho­risation Holder and Manufacturer

MarketingAutho­risation Holder	Manufacturers
JubilantPharma­ceuticals nv	PharmaS d.o.o.
Axxes Business Park	Industrijska cesta 5
Guldensporenpark 22 -Block C	Potok
9820Merelbeke	Popovaca, 44317
Belgium	Croatia

Distributed by:

Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex SS143FR

United Kingdom

This leaflet was last revised in April 2019.