Package Insert: Information for the User

Donepezilo Flas Kern Pharma 5 mg Buccodispersible Tablets EFG

Donepezilo hydrochloride

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

-Keep this package insert, 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 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 not listed in this package insert.

Donepezilo Flas is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

Do not take Donepezilo Flas Kern Pharma

• If you are allergic to hydrochloride donepezilo or any of the components of Donepezilo Flas Kern Pharma.
• If you are pregnant or breastfeeding.

Warnings and precautions

• Before starting treatment with Donepezilo Flas Kern Pharma, you must inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic lung disease, or difficulty urinating.
• In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking Donepezilo Flas.
• Donepezilo Flas is not recommended for use in children.
• You should avoid taking Donepezilo Flas with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.
• If you have vascular dementia (loss of brain function due to a series of small strokes).
• A heart condition (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

Use of Donepezilo Flas Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription, and especially if you are taking any of the following medications:

• Ketoconazole and itraconazole (to treat fungal infections).
• Quinidine and beta-blockers (to treat irregular heartbeats).
• Erythromycin (to treat bacterial infections).
• Fluoxetine (to treat depression).
• Rifampicin (to treat bacterial infections and tuberculosis).
• Phenytoin and carbamazepine (to treat epilepsy).
• Cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system level).
• Succinylcholine and other neuromuscular blockers (to produce muscle relaxation).
• Medications for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine).
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline), medications for psychosis (e.g., pimozide, sertindol, ziprasidone), medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

Use of Donepezilo Flas Kern Pharma with food, drink, and alcohol

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

The consumption of Donepezilo with alcohol may reduce the absorption of this medication.

Pregnancy, breastfeeding, and fertility

Do not take Donepezilo Flas if you are pregnant.

Do not take Donepezilo 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 engage in these activities unless your doctor tells you it is safe to do so. Donepezilo may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo Flas Kern Pharma contains aspartame.This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions for Donepezilo Flas Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Treatment with Donepezilo Flas Kern Pharma begins 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, taken once a day and at night. The maximum recommended dose is 10 mg/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo Flas Kern Pharma 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 kidney), you can follow a similar dosing schedule as previously indicated.

If you take more Donepezilo Flas Kern Pharma than you should

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

If you forgot to take Donepezilo Flas Kern Pharma

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

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

Like all medications, Donepezilo Flas Kern Pharma may cause side effects, although not everyone will experience them. The estimated frequency of their occurrence is as follows:

The most frequent side effects that may affect at least 1 in 10 patients are:

• Diarrhea
• Nausea
• Headache

The frequent side effects that may affect more than 1 person in 100 but less than 1 in 10 are:

• Common cold
• Loss of appetite
• Hallucinations, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

The infrequent side effects that may affect more than 1 person in 1,000 but less than 1 in 100 are:

• Seizures
• Decreased heart rate
• 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

The rare side effects that may affect less than 1 person in 1,000 are:

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

The side effects with unknown frequency:

• Changes in cardiac activity that can be observed on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially life-threatening condition known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves an involuntary muscle contraction with an abnormal flexion of the body and head to one side)

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Severe side effects:

Consult your doctor immediately if you experience these severe side effects. You may need urgent medical treatment.

•Weakness, muscle sensitivity or pain, particularly if you also feel unwell, have a fever or your urine is dark. This may be due to abnormal muscle destruction that can be life-threatening and cause kidney problems (a condition known as rhabdomyolysis).

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Donepezilo Flas Kern Pharma

• The active ingredient is donepezilo. Each tablet contains 5 mg of donepezilo hydrochloride (equivalent to 4.56 mg of donepezilo).

• The other components are: mannitol (E-421), microcrystalline cellulose (E-460i), guar gum, crospovidone, aspartame (E-951), and magnesium stearate.

Appearance of the product and content of the packaging

Round tablets, white in color with a notch on one face and the anagram K on the other. The notch serves to break and facilitate swallowing but not to divide into equal doses.

The tablets are presented in blister packs in boxes of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: November 2022.

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