Aricept 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aricept 10 mg film-coated tablets

Donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Aricept is and what it is used for
2. What you need to know before taking Aricept
3. How to take Aricept
4. Possible side effects
5. How to store Aricept
6. Contents of the pack and other information

1. What Aricept is and what it is used for

Aricept belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine), by slowing down the breakdown of this substance.

It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour.

2. What you need to know before taking Aricept

Do not take Aricept:

• if you are allergic to donepezil hydrochloride, to piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting Aricept if you have or have had:

• a history of stomach or duodenal ulcer

• heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction)

• a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "prolongation of the QT interval"

• low levels of magnesium or potassium in the blood

• seizures

• asthma or chronic lung disease

• difficulty urinating or mild kidney disease.

You should avoid taking Aricept together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Other medicines and Aricept

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• medicines for heart rhythm problems, for example amiodarone or sotalol
• medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines for treating Alzheimer's disease, for example galantamine
• painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• quinidine and beta-blockers used to treat irregular heartbeats, such as propranolol and atenolol
• phenytoin and carbamazepine (used to treat epilepsy)
• cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine
• succinylcholine, diazepam and other neuromuscular blockers (used to produce muscle relaxation)
• general anaesthesia

If you are undergoing surgery under general anaesthesia, you must inform your doctor that you are taking Aricept, as this may affect the amount of anaesthetic required.

Aricept may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take Aricept.

Taking Aricept with food, drinks and alcohol

This medicine should be taken with a glass of water.

Aricept should not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Aricept if you are breastfeeding your child.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Aricept may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Aricept

Follow exactly the dosing instructions for this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Aricept is administered orally.

Treatment with Aricept starts with one 5 mg tablet taken once daily with a glass of water, at night immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg per day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Aricept in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take Aricept. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take Aricept.

Use in children

The use of Aricept in children is not recommended.

If you take more Aricept than you should

If you have taken more Aricept than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Aricept

Do not take a double dose to make up for missed doses.

If you stop taking Aricept

Do not stop treatment with Aricept unless your doctor tells you to. If you stop taking Aricept, the benefits of treatment will gradually disappear.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aricept can cause side effects, although not everyone gets them.

The following side effects have been reported by people taking Aricept.

Contact your doctor if you experience any of these effects during treatment with Aricept.

Serious side effects:

You must inform your doctor immediately if you notice the following serious side effects, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (affects between 1 and 10 out of 10,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (affects between 1 and 10 out of 1,000 people).
• Bleeding in the stomach or intestine. This may cause you to have black, tarry stools or visible rectal bleeding (affects between 1 and 10 out of 1,000 people).
• Dizziness (fainting) or seizures (affects between 1 and 10 out of 1,000 people).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affects fewer than 1 out of 10,000 patients).
• Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a fever, or have dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

The estimated frequency of occurrence of side effects is as follows:

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Malaise
• Headache

Common: may affect between 1 and 10 out of 100 patients

• Cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behaviour
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect between 1 and 10 out of 1,000 patients

• Seizures
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

Rare: may affect between 1 and 10 out of 10,000 patients

• Extrapyramidal symptoms (such as tremor or stiffness of hands or legs)
• Cardiac conduction disturbances
• Liver function abnormalities, including hepatitis

Frequency not known (cannot be estimated from available data)

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side)
• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Fast and irregular heartbeat, fainting which may be symptoms of a potentially life-threatening disorder known as torsade de pointes

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

5. Storage of Aricept

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use Aricept after the expiry date shown on the carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aricept 10 mg film-coated tablets

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: monohydrate lactose, gluten-free corn starch, microcrystalline cellulose, hypromellose, magnesium stearate, talc, polyethylene glycol, hypromellose, yellow iron oxide (E172) and titanium dioxide (E171).

Appearance of the product and contents of the pack

• Aricept 10 mg is presented as film-coated tablets. The tablets are round, biconvex, yellow in colour and marked with "10" on one side and "ARICEPT" on the other.

Aricept 10 mg film-coated tablets are available in one pack size: a unit-dose blister made of PVC with an aluminium backing foil, containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Manufacturer:

Fareva Amboise

Zone Industrielle

29 route des Industries

37530 Pocé-sur-Cisse

France

or

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Eisai Farmacéutica, S.A.

Parque Empresarial Cristalia

Calle Via de los Poblados 3, Edificio 7/8

4th floor

28033 Madrid

Tel: + (34) 91 455 94 55

Date of the most recent revision of this leaflet: December 2022

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"