ARICEPT 10 mg FILM-COATED TABLETS

2. What you need to know before taking Aricept

Do not take Aricept:

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

Warnings and Precautions

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

• a history of stomach or duodenal ulcers

• heart disease (such as irregular or slow heartbeats, heart failure, myocardial infarction)
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged 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 agonists or antagonists of the cholinergic system.

Other Medications and Aricept

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

• medications for heart rhythm problems, such as amiodarone or sotalol
• medications for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, such as pimozide, sertindole, or ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for treating Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like 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 on the central nervous system) such as tolterodine.
• succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation)
• general anesthesia

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

Aricept can be used in patients with mild to moderate kidney or liver disease. Inform your doctor before starting treatment if you have kidney or liver problems. Patients with severe liver disease should not take Aricept.

Taking 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 alter the effect of this medication.

Pregnancy, Breastfeeding, and Fertility

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

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

Driving and Using Machines

Your illness may affect your ability to drive or use 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, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or use machinery.

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

3. How to Take Aricept

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Aricept is administered orally.

Treatment with Aricept starts with a 5 mg tablet, taken once a day with a little water, at night immediately before bedtime. After a month of treatment, your doctor may recommend increasing the dose to 10 mg, once a day, 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 to moderate liver or kidney impairment, you can take Aricept. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver impairment should not take Aricept.

Use in Children

Aricept is not recommended for use in children.

If You Take More Aricept Than You Should

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

Symptoms of overdose may include nausea, vomiting, drooling, sweating, decreased heart rate, low blood pressure, breathing problems, loss of consciousness, and seizures.

If You Forget to Take Aricept

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

If You Stop Taking 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 using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Aricept can 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.

Serious Side Effects:

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

• Liver damage, such as hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (affecting 1 to 10 in 10,000 people).
• Ulcers in the stomach or duodenum. Symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (affecting 1 to 10 in 1,000 people).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (affecting 1 to 10 in 1,000 people).
• Dizziness (fits) or seizures (affecting 1 to 10 in 1,000 people).
• Fever with muscle stiffness, sweating, decreased consciousness (which can be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affecting less than 1 in 10,000 patients).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark urine. This can be due to abnormal muscle destruction, which 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 1 to 10 in 100 Patients

• 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 1 to 10 in 1,000 Patients

• Seizures
• Decreased 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) in the Blood

Rare: May Affect 1 to 10 in 10,000 Patients

• Extrapyramidal Symptoms (such as tremor or rigidity of the hands or feet)
• Conduction Disorders
• Liver Function Disorders, 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 Observed in an Electrocardiogram (ECG) Called "Prolonged QT Interval"
• Rapid and Irregular Heartbeat, Fainting that Can Be Symptoms of a Potentially Fatal Disorder Known as Torsades de Pointes

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, Website: www.notificaRAM.es

5. Storage of Aricept

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

Store below 30°C.

Do not use Aricept after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aricept 10 mg Film-Coated Tablets

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

Appearance of the Product and Package Contents

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

Aricept 10 mg film-coated tablets are available in a pack size with a unit dose blister formed by PVC with an aluminum foil on the back, containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

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

Eisai Farmacéutica, S.A.

Parque Empresarial Cristalia.

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

4th floor

28033 Madrid

Phone: + (34) 91 455 94 55

Date of the last revision of this package leaflet: December 2022

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"