DONEPEZIL VIATRIS PHARMACEUTICALS 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Donepezil Flas Viatris Pharmaceuticals 5 mg Orodispersible Tablets EFG

Donepezil hydrochloride

Read the entire patient information leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

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

Donepezil Flas Viatris Pharmaceuticals contains the active substance donepezil hydrochloride.

Donepezil belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance related to memory (acetylcholine) in the brain by reducing the breakdown of this substance.

It is used to treat the symptoms of dementia in patients with a diagnosis of Alzheimer's disease, from mild to moderately severe. The symptoms of the disease include increased memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease have more difficulty performing their daily activities.

It is used only in adult patients.

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

Do not take Donepezil 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 Donepezil Flas Viatris Pharmaceuticals,if you have or have had:

• Stomach or duodenal ulcers.
• Seizures or convulsions.
• A heart condition (e.g., irregular heartbeat or bradycardia, heart failure, myocardial infarction).
• A heart condition known as "prolonged QT interval syndrome" or a family history of it, or a history of any type of heart rhythm disorder, such as ventricular tachycardia in torsades.
• Low magnesium or potassium levels in the blood.

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• Asthma or other long-term lung diseases.
• Liver disorders 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

Donepezil is not recommended for children and adolescents (under 18 years of age).

Other Medications and Donepezil Flas Viatris Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes medications you have purchased without a prescription from a pharmacy. It also applies to medications you may need to take in the future if you continue to take donepezil. This is because these medications may reduce or enhance the effects of donepezil.

In particular, it is essential to inform your doctor or pharmacist if you are taking any of the following types of medications:

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

If you are going to undergo surgery that requires general anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezil. This is because the medication may affect the amount of anesthesia needed.

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

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

Donepezil Flas Viatris Pharmaceuticals with Food, Drinks, and Alcohol

Food does not affect the effect of donepezil; however, you should not take it with alcohol, as it may alter its effects.

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.

Donepezil should not be used during breastfeeding.

Driving and Using Machines

Alzheimer's disease may affect your ability to drive or operate machines, so you should not perform these activities unless your doctor tells you it is safe to do so.

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 machines.

Donepezil Flas Viatris Pharmaceuticals Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Donepezil Flas Viatris Pharmaceuticals

How Much Donepezil Flas Viatris Pharmaceuticals to Take

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

Initially, the recommended dose is 5 mg (one white tablet) once daily before bedtime. After one month, your doctor may increase the dose to 10 mg (one yellow tablet) once daily 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 take will change depending on how long you have been taking the medication or your doctor's recommendation. The maximum recommended dose is 10 mg once daily.

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

Do not change the dose on your own without consulting your doctor first.

How to Take Donepezil Flas Viatris Pharmaceuticals

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

Use in Children and Adolescents

Donepezil is not recommended for children and adolescents (under 18 years of age).

If You Take More Donepezil Flas Viatris Pharmaceuticals Than You Should

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

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

If You Forget to Take Donepezil Flas Viatris Pharmaceuticals

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

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

If You Stop Taking Donepezil Flas Viatris Pharmaceuticals

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

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

How Long to Take Donepezil 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 assess your symptoms.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Tell Your Doctor If You Have Any of the Following Side Effects While Taking Donepezil.

Serious Side Effects

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

• Liver damage, such as hepatitis. Symptoms of hepatitis are nausea, vomiting, loss of appetite, general malaise, 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. Symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This can cause black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Seizures or convulsions (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 100 people).
• Weakness, sensitivity, or muscle pain, especially if you also feel unwell, have a fever, or dark urine. 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 heartbeat, fainting that could be symptoms of a potentially life-threatening condition 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:

Very Common 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.
• Hallucinations (seeing or hearing things that are not real).
• Abnormal dreams, including nightmares.
• Agitation.
• Aggressive behavior.
• Fainting.
• Dizziness.
• Stomach upset.
• Rash.
• Involuntary loss of urine.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

Uncommon Side Effects (may affect up to 1 in 100 people):

• Decreased heart rate.
• Hypersecretion.

Rare Side Effects (may affect up to 1 in 1,000 people):

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

Frequency Not Known (cannot be estimated from available data):

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Flas Viatris Pharmaceuticals

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging and blister pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Return the packaging and any unused medication to a pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donepezil Flas Viatris Pharmaceuticals

• The active substance is donepezil hydrochloride.

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

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

Appearance of the Product and Package Contents

Your medication comes in the form of orodispersible tablets.

Orodispersible tablets are round, white, flat, with a beveled edge, marked with "DL5" on one face and "M" on the other face.

Donepezil Flas Viatris Pharmaceuticals is available in blister packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 98, 100, 120, and 180 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 medication from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria Donepezil Arcana 5 mg Orodispersible Tablets

Belgium Donepezil ODIS Mylan 5 mg

Cyprus Donepezil/Generics

Slovakia Donepezil Mylan 5 mg Orodispersible Tablets

Slovenia Donepezil Mylan 5 mg Orodispersible Tablets

Spain Donepezil Flas Viatris Pharmaceuticals 5 mg Orodispersible Tablets EFG

France Donepezil Mylan 5 mg Orodispersible Tablets

Greece Donepezil/Mylan

Ireland Aripil Orotab 5 mg Orodispersible Tablets

Poland Donegen ODT

Portugal Donepezil Mylan

United Kingdom Donepezil Hydrochloride 5 mg Orodispersible Tablets

Czech Republic Donepezil Mylan 5 mg Orodispersible Tablets

Romania Donepezil Mylan 5 mg Orodispersible Tablets

Sweden Donepezil Mylan

Date of Last Revision of this Leaflet:November 2022

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