DONEPEZIL VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Donepezil Viatris 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 you take Donepezil Viatris
3. How to take Donepezil Viatris
4. Possible side effects
5. Storage of Donepezil Viatris
6. Contents of the pack and further 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 medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain, involved in memory function, by reducing the rate of 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 an increase in memory loss, increased confusion, and changes in behavior. As a result, people with Alzheimer's disease have more difficulty carrying out their normal daily activities.

2. What you need to know before you take Donepezil Viatris

Do not take Donepezil Viatris

• If you are allergic to donepezil, to medicines derived from piperidine (your doctor or pharmacist can advise you) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before starting to take donepezil if you have or have ever had any of the following:

• 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 the 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 someone in your family has "prolonged QT interval"
• Low levels of magnesium or potassium 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 problem.

Children and Adolescents

Children and adolescents under 18 years should not take this medicine.

Other Medicines and Donepezil Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following:

• Other medicines for Alzheimer's disease, such as galantamine.
• Medicines for depression (e.g., citalopram, escitalopram, amitriptyline, fluoxetine).
• Medicines for psychosis (e.g., pimozide, sertindole, or ziprasidone).
• Medicines for bacterial infections (e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin
• Rifampicin (for the treatment of tuberculosis).
• Antifungal medicines (e.g., ketoconazole, itraconazole).
• Carbamazepine or phenytoin (for the treatment of epilepsy).
• Medicines for heart conditions, such as quinidine, beta-blockers (e.g., propranolol, atenolol).
• Medicines 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 medicines (medicines that normally cause dry mouth, blurred vision, or drowsiness), such as tolterodine (used for bladder problems).

If you are going to have an operation, including dental surgery, in which you will be given anesthesia, tell your doctor, dentist, hospital staff, or anesthesiologist that you are taking this medicine.

Taking Donepezil Viatris with Food and Alcohol

You should avoid drinking alcohol while being treated with this medicine, 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 medicine before talking to 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 use tools or machines if you feel dizzy, sleepy, and have muscle cramps while taking this medicine. Additionally, Alzheimer's disease may affect your ability to drive or use machines, so you should not perform these activities unless your doctor tells you that you can.

Donepezil Viatris contains Lactose

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

3. How to take Donepezil Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Adults

The recommended starting dose is 5 mg of donepezil once a day 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 Liver and Kidney Disease

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 in the evening before bedtime.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take 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 medicine 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. Take the pack and any remaining tablets to the hospital so that the doctor knows what has been taken.

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

If you take more donepezil than you should, you may experience symptoms such as feeling unwell (nausea), vomiting, salivation, sweating, slow heart rate (bradycardia), low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, seizures (fits). You may also experience an increase in muscle weakness that can be life-threatening when the 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 medicine for more than one week, consult your doctor before taking the medicine again.

If you stop taking Donepezil Viatris

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

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell 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 (fits).

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), that you feel unwell and have 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, especially if you also feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be life-threatening and cause kidney problems (a disease called rhabdomyolysis).

Frequency Not Known(cannot be estimated from the 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.
• Skin 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 that can be observed in blood tests.
• Increased salivation in the mouth.

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

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

Frequency Not Known(cannot be estimated from the 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 of Side Effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Viatris

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

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Take the pack and any remaining tablets to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the pack and any remaining tablets. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Donepezil Viatris

• The active substance is donepezil hydrochloride.
• Each tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil).
• The other ingredients are: lactose monohydrate (see section 2, "Donepezil Viatris contains lactose"), corn starch, hydroxypropylcellulose, microcrystalline cellulose, and magnesium stearate (E-470b).

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

Appearance of the Product and Pack Size

Your medicine comes in the form of film-coated tablets, round, white, marked with "DL" over a "10" on one side and "G" on the reverse. It is available in pack sizes of: 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 or 250 film-coated 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.

Mylan utca 1

H-2900 Komárom

Hungary

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

Spain Donepezil Viatris 10 mg film-coated tablets EFG

France DONEPEZIL MYLAN 10 mg, film-coated tablet

Greece DONEPEZIL/MYLAN

Ireland Aripil 10 mg Film-coated Tablets

Italy DONEPEZIL MYLAN GENERICS

Poland Pamigen

Portugal Donepezil Mylan

United Kingdom Donepezil Hydrochloride 10mg Film-coated Tablets

Czech Republic Donepezil Mylan 10 mg

Sweden Donepezil Mylan

Date of Last Revision of this Package Leaflet:April 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/