Lizidra

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lizidra 5 mg film-coated tablets, 10 mg film-coated tablets

Donepezil hydrochloride
Generic medicine
You and those caring for you should read this leaflet carefully before taking this medicine, as it contains important information for you:

• • Keep this leaflet. You may need to read it again.
• • If you have any questions, ask your doctor or pharmacist.
• • This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful. If you experience any of the side effects worsening, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet (see section 4).
• Contents of this leaflet:
  1. What Lizidra is and what it is used for
  2. What you need to know before taking Lizidra
  3. How to take Lizidra
  4. Possible side effects
  5. How to store Lizidra
  6. Contents of the pack and other information

1. WHAT LIZIDRA IS AND WHAT IT IS USED FOR

Lizidra (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 functions, thereby slowing the decline of acetylcholine.
It is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, people affected by Alzheimer's disease find it increasingly difficult to manage everyday activities.
Lizidra should only be used in adult patients.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LIZIDRA

Do not take Lizidra

• If you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the excipients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before taking Lizidra if you have or have had any of the
following conditions:

• Stomach or duodenal ulcers
  • Epileptic seizures or convulsions
  • Heart disease (irregular or very slow heartbeat)
  • Asthma or other long-term lung diseases
  • Liver problems or hepatitis
  • Difficulty urinating or mild kidney disease

Also inform your doctor if you are pregnant or think you might be pregnant.
Other medicines and Lizidra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
This includes medicines not prescribed by your doctor but purchased by you from a pharmacist. The same applies to medicines you might take in the future while continuing to take Lizidra. This is because these medicines may weaken or strengthen the effects of Lizidra.
In particular, inform your doctor or pharmacist if you are taking any of the following types of
medicines:

• Other medicines for Alzheimer's disease, for example galantamine
• Painkillers or treatments for arthritis, for example aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or sodium diclofenac
• Anticholinergic medicines, for example tolterodine
• Antibiotics, for example erythromycin, rifampicin
• Antifungal medicines, for example ketoconazole
• Antidepressants, for example fluoxetine
• Antiepileptic medicines, for example phenytoin, carbamazepine
• Medicines for heart conditions, for example quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, for example diazepam, succinylcholine
• General anaesthetics

If you are about to undergo surgery requiring a general anaesthetic, you must inform your doctor and anaesthetist that you are taking Lizidra. This is because the medicine may affect the amount of anaesthetic required.
Lizidra can be used in patients with renal disease or with mild to moderate hepatic impairment. Inform your doctor if you have kidney or liver disease. Lizidra must not be taken by patients with severe liver disease.
Lizidra with food and drink
Food does not affect the effects of Lizidra.
Lizidra must not be taken with alcohol because alcohol may alter its effect.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Lizidra must not be used during breastfeeding.
Driving and using machines
Your medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these effects, you must not drive or operate machinery.
Alzheimer's disease may impair your ability to drive or use machinery, and you should not engage in these activities unless your doctor has told you that it is safe for you to do so.
Lizidra contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE LIZIDRA

Always take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist. Never change the dose on your own initiative without
advice from your doctor.
Tell your doctor the name of the person who assists you. That person will help you take the
medicine as prescribed.
Normally, treatment starts with 5 mg every evening.
After one month, your doctor may increase the dose to 10 mg every evening.
Take Lizidra tablets with a glass of water before going to bed.
The dose of tablets you will take may change depending on how long ago you started taking the medicine and according to your doctor's recommendations.
The maximum recommended dose is 10 mg per evening.
For how long you should take Lizidra
Your doctor or pharmacist will tell you how long you should continue taking the tablets. You should see your doctor regularly to review your treatment and assess your symptoms.
If you take more Lizidra than you should
Do not take more than one tablet per day. Contact your doctor immediately if you have taken more tablets than prescribed.
If you cannot contact your doctor, contact the Emergency Department of the nearest hospital. Always bring the pack and any remaining tablets
to the hospital so the doctor knows what you have taken.
Symptoms of overdose include feeling and being sick, salivation, sweating, slowing of the heartbeat, low blood pressure (dizziness or vertigo upon standing), breathing difficulties, loss of consciousness, and epileptic seizures or convulsions.
If you forget to take Lizidra
If you have forgotten to take a tablet, take one tablet the next day at the usual time. Do not take a double dose to make up for the forgotten tablet.
If you have forgotten to take your tablets for more than one week, contact your doctor before taking them again.
If you stop taking Lizidra
Do not stop taking the tablets unless your doctor has told you to do so. If you stop taking Lizidra, the beneficial effects of treatment will gradually fade away.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported in people treated with Lizidra.

Serious side effects:
You must immediately inform your doctor if you experience any of the serious side effects listed below.
Urgent medical treatment may be required.

• Liver damage, for example hepatitis. Symptoms of hepatitis include feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-coloured urine (may affect up to 1 in 1,000 people).
• Duodenal or gastric ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) felt between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause passage of black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Seizures or convulsions (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "neuroleptic malignant syndrome") (may affect up to 1 in 10,000 people).

Muscle weakness, low muscle tone, or muscle pain, particularly if you also feel unwell, have high fever, and dark urine. These symptoms could be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Other possible side effects:
Very common side effects (may affect more than 1 in 10 people)

• diarrhoea
• feeling or being sick
• headache

Common side effects (may affect up to 1 in 10 people)

• muscle cramps
• fatigue
• insomnia
• cold symptoms
• loss of appetite
• hallucinations (seeing or hearing things that are not real)
• unusual dreams including nightmares
• restlessness
• aggressive behaviour
• feeling faint
• dizziness
• stomach discomfort
• skin rashes
• itching
• difficulty controlling urination
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may affect up to 1 in 100 people)

• slowing of the heartbeat

Rare side effects (may affect up to 1 in 1,000 people)

• Stiffness, tremor, or uncontrollable movements, especially of the face and tongue, but also of the limbs.

Reporting of side effects:
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet.
You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you help provide more information on the safety of this medicine.

5. HOW TO STORE LIZIDRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after the "Exp." mark. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Lizidra contains

• • The active substance is donepezil hydrochloride

Lizidra 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of donepezil hydrochloride
Lizidra 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of donepezil hydrochloride

• • The other components (excipients) are:

Tablet core:
monohydrate lactose, microcrystalline cellulose (E460), maize starch, hydroxypropylcellulose (E463), magnesium stearate (E470b)
Tablet coating:
hypromellose (E464), macrogol, talc, titanium dioxide (E171)

Description of the appearance of Lizidra and pack contents
Lizidra 5 mg, film-coated tablets: white, opaque white, round, film-coated tablets, with the letter "J" engraved on one side and "5" on the other. The tablet size is 7.7 x 3.4 mm.
Lizidra 10 mg, film-coated tablets: white, opaque white, round, film-coated tablets, with the letter "J" engraved on one side and "10" on the other.
The medicine is available in blisters containing 28, 50, 56, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
FB Health S.p.A.
Via dei Sabini 28
63100 Ascoli Piceno
Italy

Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – block C
B-9820 Merelbeke
Belgium

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Sweden: Donepezil Jubilant 5 mg film-coated tablets
Donepezil Jubilant 10 mg film-coated tablets
Denmark: Donepezil Jubilant 5 mg film-coated tablets
Donepezil Jubilant 10 mg film-coated tablets
Italy: Lizidra 5 mg film-coated tablets
Lizidra 10 mg film-coated tablets
Cyprus: Donepezil Jubilant 5 mg film-coated tablets
Donepezil Jubilant 10 mg film-coated tablets

This Patient Information Leaflet was last approved on