ARICEPT FLAS 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Aricept Flas 5 mg Orodispersible Tablets

Donepezil, Hydrochloride

Read this entire 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What is Aricept Flas and what is it used for
2. What you need to know before taking Aricept Flas
3. How to take Aricept Flas
4. Possible side effects
5. Storage of Aricept Flas
6. Package Contents and Additional Information

1. What is Aricept Flas and what is it used for

Aricept Flas 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 reducing the speed of breakdown of this substance.

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

2. What you need to know before taking Aricept Flas

Do not take Aricept Flas:

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

Warnings and Precautions

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

• history of 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 torsades de pointes, or if a family member has "prolongation of the QT interval"

• low levels of magnesium or potassium in the blood
• seizures
• asthma or chronic pulmonary disease
• difficulty urinating or mild kidney disease.

You should avoid taking Aricept Flas with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

Using Aricept Flas with other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, and especially if you are taking any of the following medicines:

• medicines for heart rhythm problems, such as amiodarone or sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines 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 medicines 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 Flas, as this may affect the amount of anesthetic needed.

Aricept Flas 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 Flas.

Taking Aricept Flas with Food, Drinks, and Alcohol

Place the tablet on the tongue and let it dissolve. Swallow with or without water.

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

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 medicine.

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

Driving and Using Machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Aricept Flas may cause fatigue, dizziness, somnolence, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

3. How to Take Aricept Flas

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

Aricept Flas is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water.

Treatment with Aricept Flas starts with a 5 mg tablet, taken once daily, at night, immediately before bedtime. 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 have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Aricept Flas in the morning.

If you have mild or moderate liver or kidney impairment, you can take Aricept Flas. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver impairment should not take Aricept Flas.

Use in Children

Aricept Flas is not recommended for use in children.

If you Take More Aricept Flas than you Should

If you have taken more Aricept Flas than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 Flas

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

If you Stop Taking Aricept Flas

Do not stop taking Aricept Flas unless your doctor tells you to. If you stop taking Aricept Flas, 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 Flas can cause side effects, although not everybody gets them.

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

Contact your doctor if you have 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, for example, hepatitis. The symptoms of hepatitis are nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine.
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum.
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum.
• Dizziness (fits) or seizures.
• Fever with muscle stiffness, sweating, decreased consciousness (can be symptoms of a condition called "Neuroleptic Malignant Syndrome").
• 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 disease called rhabdomyolysis).

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

Very Common: may affect more than 1 in 10 patients

• Diarrhea
• Nausea
• Headache

Common: may affect between 1 and 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 between 1 and 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 between 1 and 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 seen on an electrocardiogram (ECG) called "prolongation of the 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 of these side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use, Website: www.notificaRAM.es

5. Storage of Aricept Flas

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

This medicine does not require special storage conditions.

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

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

6. Package Contents and Additional Information

Composition of Aricept Flas 5 mg Orodispersible Tablets

• The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other ingredients are: mannitol, colloidal anhydrous silica, carrageenan, polyvinyl alcohol.

Appearance of the Product and Package Contents

• Aricept Flas 5 mg is presented in orodispersible tablets, which dissolve in the mouth. The tablets are round, white, and engraved with "5" on one side and "ARICEPT" on the other.

Aricept Flas 5 mg orodispersible tablets are available in a pack size with a unit dose blister formed by PVC/PVdC/PE/PVdC/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 medicine 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 leaflet: December 2022

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