Label: information for the user

Aricept Flas 10 mg buccal tablets

Donepezil hydrochloride

Read this label carefully before starting to take this medication, as it contains important information for you

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 not listed in this label.

Aricept Flas 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 Flas:

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

Warnings and precautions

Consult your doctor before starting to take Aricept Flas if 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 Flas with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Use of Aricept Flas with other medications

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, for example 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 (for muscle relaxation)
• general anesthesia

In case of surgical intervention with general anesthesia, 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 if you have any kidney or liver disease. 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 modify the effect of this medication.

Pregnancy, breastfeeding and fertility

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

You should not take Aricept Flas if 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 Flas 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 it with or without water.

Treatment with Aricept Flas begins with a 5 mg tablet, taken once a day, at night, immediately before bedtime. After a month of treatment, your doctor may recommend an increase in dosage to 10 mg, taken once a day and 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 taking Aricept Flas 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 Flas. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease 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 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 lightheadedness when standing up), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Aricept Flas

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Aricept Flasmay 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 mentioned, as you may need urgent medical treatment.

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

The estimated frequency of side effects is as follows:

Very common: can affect more than 1 in 10 patients

• Diarrhea
• Discomfort
• Headache

Common: can affect between 1 and 10 of every 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: can affect between 1 and 10 of every 1,000 patients

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

Rare: can affect between 1 and 10 of every 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 unknown (cannot be estimated from available data)

• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves 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 heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade de pointes

Reporting side effects

If you experience any type ofsideeffects, 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.

This medication does not require special storage conditions.

Do not use Aricept Flasafter 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 Flas 10 mg buccal tablets

• The active ingredient is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: mannitol, anhydrous colloidal silica, carrageenan K, polyvinyl alcohol, and yellow iron oxide (E172).

Appearance of the product and content of the container

• Aricept Flas 10 mg is presented in buccal tablets, which dissolve in the mouth. The tablets are round, yellow in color, and are engraved with “10” on one face and “ARICEPT” on the other.

Aricept Flas 10 mg buccal tablets are available in a blister pack with a single dose size formed by PVC/PVdC/PE/PVdC/PVC with an aluminum foil on the back, containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Responsible for manufacturing:

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/”