DONEPEZIL VIATRIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Donepezil Viatris 5 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

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

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

Contents of the Package Leaflet:

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

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

Donepezil Viatris contains the active substance donepezil hydrochloride, which belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain, involved in memory function, by reducing the breakdown of this substance.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease.

The symptoms of the disease include increased memory loss, increased confusion, and changes in behavior. As a result, people with Alzheimer's disease have more difficulty performing normal daily activities.

2. What you need to know before taking Donepezil Viatris

Do not take Donepezil Viatris

• If you are allergic to donepezil, piperidine derivatives (your doctor or pharmacist can advise you), 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 if you have or have ever had any of the following conditions:

• A heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• A heart rhythm or frequency problem (e.g., sick sinus syndrome or other conditions that affect heart rhythm or frequency). Donepezil may slow down the heart rate.
• A heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval"
• Low magnesium or potassium levels in the blood
• Stomach or duodenal ulcers (intestine).
• Difficulty urinating.
• Fainting or seizures: donepezil may have the potential to cause fainting or seizures. Your doctor will monitor your symptoms.
• Stiffness, tremors, or uncontrolled movements, especially of the face and tongue, but also of the limbs (which may have occurred after taking certain medications and are known as "Parkinson-like" or "extrapyramidal symptoms").
• Asthma or other long-term lung problems.
• Liver problems.

Children and Adolescents

Children and adolescents under 18 years of age should not take this medication.

Other Medications and Donepezil Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking any of the following:

• Other medications for Alzheimer's disease, such as galantamine.
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline, fluoxetine).
• Medications for psychosis (e.g., pimozide, sertindole, or ziprasidone).
• Medications for bacterial infections (e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin)
• Rifampicin (for tuberculosis treatment).
• Antifungal medications (e.g., ketoconazole, itraconazole).
• Carbamazepine or phenytoin (for epilepsy treatment).
• Medications for heart conditions, such as quinidine, beta-blockers (e.g., propranolol, atenolol).
• Medications for heart rhythm problems, such as amiodarone, sotalol, quinidine.
• Pain relievers or treatments for arthritis, such as acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac.
• Anticholinergic medications (which can cause dry mouth, blurred vision, or drowsiness), such as tolterodine (used for bladder problems).

If you are going to undergo surgery, including dental surgery, where you will be administered anesthesia, inform your doctor, dentist, hospital staff, or anesthesiologist that you are taking this medication.

Taking Donepezil Viatris with Food and Alcohol

You should avoid drinking alcohol while being treated with this medication, as it may reduce the effect of donepezil.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take this medication before consulting your doctor for advice. Donepezil should not be used during pregnancy unless clearly necessary.

Donepezil should not be used during breastfeeding.

Driving and Using Machines

Do not drive or operate tools or machines if you feel dizzy, sleepy, and have muscle cramps while taking this medication. Additionally, 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.

Donepezil Viatris contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Donepezil Viatris

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Adults

The recommended starting dose is 5 mg of donepezil once daily for at least one month. Your doctor may increase the dose to 10 mg of donepezil per day. The maximum recommended dose is 10 mg per day. If you experience an increase in side effects while taking the 10 mg per day dose, consult your doctor or pharmacist.

Use in Patients with Hepatic and Renal Impairment

Your doctor may need to adjust the dose in adults with mild to moderate liver disease. No dose adjustment is required if you have kidney problems.

Method of Administration:

Take donepezil orally with a glass of water at night before bedtime.

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

Your doctor 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. You can take this medication with or without food.

If you take more Donepezil Viatris than you should

Do not take more than one tablet per day. Contact your doctor or the nearest hospital emergency department immediately if you take more tablets than you should. Bring the package and any remaining tablets to the hospital so the doctor knows what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20. Bring the package and any remaining tablets with you.

If you take more donepezil than you should, you may experience symptoms such as nausea, vomiting, salivation, sweating, slow heart rate (bradycardia), low blood pressure (dizziness or fainting when standing), respiratory problems, loss of consciousness, seizures (attacks). You may also experience an increase in muscle weakness, which can be life-threatening when respiratory muscles are involved.

If you forget to take Donepezil Viatris

If you forget to take a dose, take only one dose the next day at the usual time. Do not take a double dose to make up for forgotten doses.

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

If you stop taking Donepezil Viatris

When treatment is stopped, the beneficial effects of donepezil will gradually decrease.

Do not stop taking the medication without consulting your doctor first.

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

4. Possible Side Effects

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

Inform your doctor or go to the nearest hospital emergency department immediately if you experience any of the following side effects:

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

• Bleeding in the stomach or intestines, or stomach or duodenal ulcers (intestine). If you vomit, you may see red blood particles that look like coffee grounds in the vomit; and in the stool, you may observe that it has a tar-like appearance or red blood from the rectum.
• Seizures (attacks).

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

• Liver disorders, including hepatitis (inflammation of the liver). You may notice dark urine, pale stools, yellowing of the skin and sclera (jaundice), feeling unwell, and having a fever.
• Changes in heart rhythm, such as changes in rhythm or "missed" beats, which can be signs of problems with the heart's electrical signals

Very Rare(may affect up to 1 in 10,000 people):

• Fever with muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder called "Neuroleptic Malignant Syndrome").
• 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, which can be life-threatening and cause kidney problems (a disease called rhabdomyolysis).

Frequency Not Known(cannot be estimated from available data)

• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as torsades de pointes

Other Side Effects Include:

Very Common(may affect more than 1 in 10 people):

• Diarrhea.
• Dizziness and nausea.
• Headache.

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

• Vomiting.
• Muscle cramps.
• Fatigue.
• Insomnia (difficulty sleeping).
• Cold.
• Anorexia (loss of appetite).
• Hallucinations (seeing or hearing things that are not real).
• Abnormal dreams, including nightmares.
• Agitation.
• Aggressive behavior.
• Fainting.
• Dizziness.
• Abdominal pain or discomfort.
• Rash or itching.
• Uncontrolled urination.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Decreased heart rate.
• An increase in blood levels of the substance creatine kinase involved in metabolism, which can be observed in blood tests.
• Increased salivation in the mouth.

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

• Extrapyramidal symptoms, including involuntary movements, tremors, and rigidity, body agitation, muscle contractions, and changes in breathing and heart rate.

Frequency Not Known(cannot be estimated from available data)

• Changes in heart activity that can be observed in an electrocardiogram (ECG) called "prolonged QT interval"
• Increased libido.
• Hypersexuality.

Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side).

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Viatris

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donepezil Viatris

• The active substance is donepezil hydrochloride
• Each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil).
• The other components are: lactose monohydrate (see section 2, "Donepezil Viatris contains lactose"), cornstarch, hydroxypropylcellulose, microcrystalline cellulose, and magnesium stearate (E-470b).

Tablet coating: hypromellose, titanium dioxide (E-171), and macrogol 400.

Appearance of the Product and Package Size

Your medication is presented in the form of film-coated tablets, round, white, marked with "DL" over a "5" on one side and "G" on the reverse.

It is available in package sizes of: 7, 10, 28, 30, 56, 60, 84, 98, 100 film-coated tablets, calendar packs of 28 and 98, and unit-dose blister packs of 50 x 1.

It is also available in bottles containing 100 and 250 film-coated tablets.

Not all package 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.

Mylan utca 1

H-2900 Komárom

Hungary

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 and in the United Kingdom (Northern Ireland) under the following names:

Spain Donepezil Viatris 5 mg film-coated tablets EFG

France DONEPEZIL MYLAN 5 mg, film-coated tablet

Greece DONEPEZIL/MYLAN

Ireland Aripil 5 mg Film-coated Tablets

Italy DONEPEZIL MYLAN GENERICS

Poland Pamigen

Portugal Donepezil Mylan

United Kingdom (NI) Donepezil Hydrochloride 5 mg Film-coated Tablets

Czech Republic Donepezil Mylan 5 mg

Sweden Donepezil Mylan

Date of the last revision of this package leaflet:April 2023

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