Patient Information Leaflet: Product Characteristics

Donepezilo Flas Viatris Pharmaceuticals 5 mg buccal film-coated tablets EFG

donepezil hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Donepezilo Flas Viatris Pharmaceuticals and what it is used for

2.What you need to know before you start taking Donepezilo Flas Viatris Pharmaceuticals

3.How to take Donepezilo Flas Viatris Pharmaceuticals

4.Possible side effects

5.Storage of Donepezilo Flas Viatris Pharmaceuticals

6. Contents of the pack and additional information

Donepezilo Flas Viatris Pharmaceuticals contains the active substance donepezil hydrochloride.

Donepezilo belongsto the group of medicines known as cholinesterase 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 symptoms of dementia in patients with a diagnosis of Alzheimer's disease, mild to moderately severe.The symptoms of the disease include an increase in memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease have more difficulty performing their daily routine activities.

It is used only in adult patients.

Do not take Donepezilo Flas Viatris Pharmaceuticals:

• 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 or pharmacist before starting to take Donepezilo Flas Viatris Pharmaceuticals,if you suffer or have suffered:

• Stomach or duodenal ulcers.
• Seizures or convulsions.
• A heart disease(for example, irregular heartbeats or bradycardia, heart failure, myocardial infarction).
• A heart condition called “prolonged QT interval syndrome” or a family history of the same, or a history of any type of heart rhythm alteration, such as ventricular tachycardia.
• Low levels of magnesium or potassium in the blood.

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• Chronic lung diseases, such as asthma.
• Liver damage or hepatitis.
• Difficulty urinating or moderate kidney disease.

Also inform your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Donepezilo is not recommended for children and adolescents (under 18 years).

Other medications and Donepezilo Flas Viatris Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications you have purchased over the counter at the pharmacy without a doctor's prescription.This also applies to medications you may need to take in the future if you continue to take donepezilo. This is because these medications may decrease or intensify the effects of donepezilo.

Especially,it is essential to inform your doctor or pharmacistif you are taking any of the following types of medications:

• Medications for heart rhythm problems (for example, amiodarone, sotalol).
• Antidepressants (for example, citalopram, escitalopram, amitriptyline, fluoxetine).
• Medications for psychosis (for example, pimozide, sertindole, ziprasidone).
• Medications for bacterial infections (for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin).
• Antifungal medications, for example, ketoconazole
• Other medications for treating Alzheimer's disease, for example, galantamine.
• Pain relievers or medications for arthritis, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• Anticholinergics (for example, tolterodine, used for bladder problems).
• Carbamazepine or phenytoin (for the treatment of epilepsy).
• Medications for heart disease, for example, quinidine, beta-blockers (for example, propranolol and atenolol).
• Muscle relaxants, for example, diazepam, succinylcholine.
• General anesthetics.
• Over-the-counter medications, for example, herbal remedies.

If you are to undergo asurgical procedure,in which general anesthesia is required, you must inform your doctorandthe anesthesiologistthat you are takingdonepezilo.This is because the medication may affect the amount of anesthesia needed.

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

Inform your doctor or pharmacist of the name of your caregiver. Your caregiver will help you take the medication as prescribed.

Donepezilo Flas Viatris Pharmaceuticals with food, drinks, and alcohol

Food does not affect the effect of donepezilo, however, it should not be taken with alcohol because it may alter its effects.

Pregnancy, lactation, and fertility

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

Donepezilo should not be used during lactation.

Driving and operating machinery

Alzheimer's disease may affect your ability to drive or operate machinery, so you should not do so unless your doctor tells you that you can.

The medication may also cause fatigue, dizziness, and muscle cramps. If you experience any of these effects, you should not drive or operate tools or machinery.

Donepezilo Flas Viatris Pharmaceuticals contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

How Much Donepezilo Flas Viatris Pharmaceuticals Should I Take

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

Initially, the recommended dose is 5 mg (one white tablet) per day before bedtime. After a month, your doctor may increase the dose to 10 mg (one yellow tablet) per day before bedtime.

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

The intensity of the dose you will take will change depending on the amount of time you have been taking the medication or your doctor's recommendation. The maximum recommended dose is 10 mg per night.

Always follow the recommendations of your doctor or pharmacist on how and when to take the medication.

Do not change the dose on your own without your doctor's prior recommendation.

How to Take Donepezilo Flas Viatris Pharmaceuticals

The tablet should be placed on the tongue and allowed to disintegrate before swallowing, with or without water, as preferred.

Use in Children and Adolescents

Donepezilo is not recommended for use in children and adolescents (under 18 years)

What to Do If I Take More Donepezilo Flas Viatris Pharmaceuticals Than I Should

If you take more medication than you should, consult your doctor immediately or go to the nearest hospital emergency room, bringing this leaflet and any remaining tablets, or call the Toxicology Information Service, phone 91 562 04 20.

The symptoms of overdose include nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), difficulty breathing, loss of consciousness, seizures, and muscle weakness.

What to Do If I Forget to Take Donepezilo Flas Viatris Pharmaceuticals

If you forget to take the medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you forget to take your medication for more than a week, before taking the medication again, call your doctor.

What to Do If I Stop Taking Donepezilo Flas Viatris Pharmaceuticals

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

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

How Long Should I Take Donepezilo Flas Viatris Pharmaceuticals

Your doctor or pharmacist will advise you on how long to continue taking the tablets. You will need to visit your doctor regularly to review your treatment and evaluate your symptoms.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Inform your doctor if you experience any of the following side effectswhile taking donepezil.

Severe side effects

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

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1,000 people).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This may cause black stools like tar or visible blood from the rectum (last part of the intestine) (may affect up to 1 in 100 people).
• Seizures (fits) or convulsions (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or a decrease in level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 100 people).
• Weakness, sensitivity, or muscle pain, particularly if you are unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction, which can be fatal and cause kidney problems (a disease called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Fast and irregular heart rhythm, fainting that may be a symptom of a potentially fatal disease known as Torsade de Pointes (frequency cannot be estimated from available data).
• Increased libido.
• Hypersexuality.
• Pisa syndrome (involuntary muscle contraction with abnormal tilting of the body and head to one side).

Other side effects:

Frequent side effects (may affect more than 1 in 10 people):

• Diarrhea.

• Headache.

Common side effects (may affect up to 1 in 10 people):

• Muscle cramps.
• Fatigue.
• Difficulty sleeping (insomnia)
• Cold.
• Illusions (seeing or hearing things that are not real).
• Abnormal dreams including nightmares.
• Agitation.
• Aggressive behavior.
• Fainting.
• Dizziness.
• Stomach discomfort.
• Rash.
• Involuntary loss of urine.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

Less common side effects (may affect up to 1 in 100 people):

• Decreased heart rate.
• Excessive secretion.

Rare side effects (may affect up to 1 in 1,000 people):

• Rigidity, tremors, or uncontrolled movements, especially of the face and tongue and also of the limbs.

Unknown frequency (cannot be estimated from available data):

• Changes in heart activity that can be seen in an electrocardiogram (ECG) and are called "prolongation of the QT interval".

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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

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

Composition of Donepezilo Flas Viatris Pharmaceuticals

• The active ingredient is donepezil hydrochloride.

Each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil).

• The other components are: mannitol (E-421), colloidal anhydrous silica (E-551),hydroxypropyl cellulose (E-463), potassium acesulfame (E-950), glycine (E-640), potato starch sodium glycolate, crospovidone (Type A), microcrystalline cellulose (E-460) and magnesium stearate (E-470b).

Appearance of the product and contents of the package

Your medicine is presented in the form of buccal dispersible tablets.

Buccal dispersible tablets, round, white, flat, with a bisected edge, marked with “DL5” on one side and “M” on the other side.

Donepezilo Flas Viatris Pharmaceuticals is presented in blister packs of7, 10, 14, 28, 30, 50, 56, 60, 84, 98, 100, 120 and 180buccal dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

or

Mylan UK Healthcare Limited

Building 20, Station Close

Potters Bar, EN6 1TL

United Kingdom

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaDonepezil Arcana 5 mg Schemelztabletten

BelgiumDonepezil ODIS Mylan 5 mg

CyprusDonepezil/Generics

SlovakiaDonepezil Mylan 5 mg orodispergovatel’né tablety

SloveniaDonepezil Mylan 5 mg orodisperzibilne tablete

SpainDonepezilo Flas Viatris Pharmaceuticals 5 mg buccal dispersible tablets EFG

FranceDonepezil Mylan 5 mg comprimé orodispersible

GreeceDonepezil/Mylan

IrelandAripil Orotab 5 mg oro-dispersible tablets

PolandDonegen ODT

PortugalDonepezilo Mylan

United KingdomDonepezil Hydrochloride 5 mg Orodispersible Tablets

Czech RepublicDonepezil Mylan 5 mg tablety dispergovatelné v ústech

RomaniaDonepezil Mylan 5 mg comprimate orodispersabile

SwedenDonepezil Mylan

Last review date of this leaflet:November 2022

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/