Product Information for the Patient

Donepezilo Viatris 5 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 product information. See section 4.

Donepezilo Viatris contains the active substance donepezil hydrochloride, whichbelongs to a group of medicines called cholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain, involved in memory function, by reducing the rate of breakdown of that 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, increase in confusion, and changes in behavior. As a result, Alzheimer's patients have more difficulty performing their normal daily activities.

Do not take Donepezilo Viatris

• If you are allergic to donepezilo, to piperidina-derived medications (your doctor or pharmacist may advise you), or to 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 if you suffer or have ever suffered from 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 (for example, sick sinus syndrome or other conditions that affect the heart rhythm or frequency). Donepezilo may slow the heart rate.
• 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
• Stomach or duodenal ulcers (intestine).
• Difficulty urinating.
• Syncope or convulsions: donepezilo may have the potential to cause syncope or convulsions. Your doctor will monitor your symptoms.
• Rigidity, 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 cholinergic-like effects or extrapyramidal symptoms).
• Asthma or other long-term respiratory problems.
• Liver problems.

Children and adolescents

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

Other medications and Donepezilo Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. Especially, inform your doctor or pharmacist if you are taking some of the following:

• Other medications for Alzheimer's disease, for example, galantamine.
• Depression medications (for example, citalopram, escitalopram, amitriptyline, fluoxetine).
• Psychosis medications (for example, pimozide, sertindole, or ziprasidone).
• Bacterial infection medications (for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin)
• Rifampicin (for tuberculosis treatment).
• Antifungal medications, for example, ketoconazole, itraconazole.
• Carbamazepine or phenytoin (for epilepsy treatment).
• Heart medications, for example, quinidine, beta-blockers (for example, propranolol, atenolol).
• Medications for heart rhythm problems, for example, amiodarone, sotalol, quinidine.
• Pain relievers or treatments for arthritis, for example, acetylsalicylic acid (aspirin), nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac.
• Anticholinergic medications (medications that normally cause dry mouth, blurred vision, or drowsiness), for example, tolterodine (used for bladder problems).

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

Taking Donepezilo Viatris with food, alcohol

You should avoid drinking alcohol while taking this medication, as it may reduce the effect of donepezilo.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant, do not take this medication before speaking with your doctor to request advice..Donepezilo should not be used during pregnancy except in clearly necessary cases.

Donepezilo should not be used during breastfeeding.

Driving and operating machinery

Do not drive or operate tools or machines if you feel dizzy, drowsy, and 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 that you can.

Donepezilo 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 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 adverse 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 some liver disease, from mild to moderate. No dose adjustment is required if you have kidney problems.

Administration form:

Take donepezil orally with a glass of water at night before going to bed.

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 evaluate your symptoms. You can take this medication with or without food.

If you take more Donepezilo Viatristhan you should

Do not take more than one tablet a day. Contact your doctor or the nearest hospital emergency service immediately if you take more tablets than you should. Bring the box and the 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 Toxicological Information Service, phone: 91 562 04 20. Bring the packaging and the remaining tablets with you.

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

If you forget to take DonepeziloViatris

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 compensate for the missed doses.

If you forget to take the medication for more than a week, consult your doctor before resuming the medication.

If you interrupt treatment with DonepeziloViatris

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

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

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

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

Inform your doctor or go to the nearest hospital emergency service 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 resemble coffee grounds in the vomit; and in the stool, you may observe that they have 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 observe dark urine, pale stools, yellow discoloration of the skin and sclera (jaundice), feel unwell, and have a fever.
• Changes in heart rhythm, such as changes in rhythm or "lost" beats, which may be signs of problems with the heart's electrical signals

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

• Fever with muscle rigidity, sweating, or a decrease in level of consciousness (a condition called "Neuroleptic Malignant Syndrome").
• Weakness, sensitivity, or muscle 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 fatal and cause kidney problems (a disease called rhabdomyolysis).

Frequency not known(cannot be estimated from available data)

• Fast and irregular heart rate, fainting spells that may be symptoms of a potentially fatal condition known as torsade 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.
• Incontinence.
• 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 may 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, tremor, 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 may be observed in an electrocardiogram (ECG) called "prolongation of the QT interval"
• Increased libido.
• Hypersexuality.

Torticollis (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo Viatris

• 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: lactose monohydrate, (see section 2, “Donepezilo Viatris contains lactose”), cornstarch,hydroxypropylcellulose, microcrystalline cellulose and magnesium stearate (E-470b).

Coating of the tablet: hypromellose, titanium dioxide (E-171) and macrogol 400.

Appearance of the product and packaging size

Your medicine is presented in the form offilm-coated tablets, round, white, marked with “DL” over a “5”on one side and “G” on the reverse.

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

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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) with the following names:

SpainDonepezilo Viatris 5 mg film-coated tablets EFG

FranceDONEPEZIL MYLAN 5 mg, coated tablet

GreeceDONEPEZIL/MYLAN

IrelandAripil 5 mg Film-coated Tablets

ItalyDONEPEZIL MYLAN GENERICS

PolandPamigen

PortugalDonepezilo Mylan

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

Czech RepublicDonepezil Mylan 5 mg

SwedenDonepezil Mylan

Last review date of this leaflet: April 2023

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