Label: information for the user

Aricept 10 mg film-coated tablets

Donepezil hydrochloride

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label.

Aricept belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the rate of breakdown of this substance.

It is used for the treatment of mild to moderately severe symptoms of Alzheimer's disease. Symptoms include increased memory loss, confusion, and changes in behavior.

Do not take Aricept:

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

Warnings and precautions

Consult your doctor before starting to takeAriceptif you have or have had:

• stomach or duodenal ulcers

• 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 called torsade de pointes or if someone 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 with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Other medications and Aricept

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication and especially if you are taking any of the following medications:

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

In the event of surgery with general anesthesia, you should inform your doctor that you are taking Aricept as this may affect the amount of anesthetic needed.

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

Aricept with food, drinks, and alcohol

This medication should be taken with a little water.

Aricept should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant,consult your doctor or pharmacist before using this medication.

You should not take Ariceptif you are breastfeeding your child.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Aricept may cause fatigue, dizziness, drowsiness, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

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

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt,consult your doctor or pharmacist again.

Ariceptis administered orally.

Aricept treatmentbegins with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed.After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and at night.The maximum recommended dose is 10 mg per day.

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

If you have mild or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidneys), you can take Aricept.Inform your doctor before starting treatment if you have liver or kidney problems.Patients with severe liver disease should not take Aricept.

Use in children

Aricept is not recommended for use in children.

If you take more Ariceptthan you should

If you have taken more Ariceptthan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20,indicating the medication and the amount used.

The symptoms of overdose may include nausea(feeling sick), vomiting(being sick), drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing problems, loss of consciousness, and seizures.

If you forget to take Aricept

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

If you interrupt treatment with Aricept

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

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

Like all medications, Aricept may cause side effects, although not everyone will experience them.

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

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

Severe side effects:

You should inform your doctor immediately if you notice any of the following severe side effects, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis arenausea or vomiting (feeling or being sick), loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affecting between 1 and 10 out of 10,000).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (affecting between 1 and 10 out of 1,000).
• Bleeding in the stomach or intestine. This may cause you to have black, tar-like stools or visible blood from the rectum (affecting between 1 and 10 out of 1,000).
• Dizziness (attacks) or convulsions (affecting between 1 and 10 out of 1,000).
• Fever with muscle stiffness, sweating, decreased level of consciousness (which may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affecting fewer than 1 out of 10,000 patients).
• Weakness, sensitivity, or muscle pain, particularly if you are also feeling unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of side effects is as follows:

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Discomfort
• Headache

Common: may affect between 1 and 10 in 100 patients

• Common cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• 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 in 1,000 patients

• Convulsions
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatine kinase muscle) in the blood

Rare: may affect between 1 and 10 in 10,000 patients

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function alteration, including hepatitis

Frequency not known (cannot be estimated from available data)

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)
• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heart rate, fainting that may be symptoms of a potentially fatal condition called torsade de pointes

Reporting side effects

If you experience any type of sideseffects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Store below30°C.

Do not use Ariceptafter the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aricept 10 mg film-coated tablets

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

Appearance of the product and contents of the packaging

• Aricept 10 mg is presented in film-coated tablets. The tablets are round, biconvex, yellow in color, and are engraved with “10” on one face and “ARICEPT” on the other.

Aricept 10 mg film-coated tablets are available in a blister pack of 28 tablets, made of PVC with an aluminum foil backing.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Responsible 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

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Eisai Pharmaceutical, S.A.

Parque Empresarial Cristalia.

Calle Via de los Poblados 3, Edf. 7/8

4th floor

28033 Madrid

Phone: + (34) 91 455 94 55

Last review date of this leaflet: December 2022

“Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”