Donepezil Viatris 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Donepezil Viatris 5 mg film-coated tablets EFG

donepezil hydrochloride

Read the entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Donepezil Viatris is and what it is used for
2. What you need to know before taking Donepezil Viatris
3. How to take Donepezil Viatris
4. Possible side effects
5. How to store Donepezil Viatris
6. Contents of the pack and other information

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

Donepezilo Viatris contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases levels of a substance (acetylcholine) in the brain involved in memory function, by slowing down 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 increasing memory loss, increasing confusion, and changes in behaviour. As a result, people with Alzheimer's disease have increasing difficulty performing everyday activities.

2. What you need to know before taking Donepezil Viatris

Do not take Donepezil Viatris

• If you are allergic to donepezil, to piperidine-derived medicines (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 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 problem with heart rhythm or heart rate (for example, sick sinus syndrome or other conditions affecting heart rhythm or rate). Donepezil may slow the heart rate.
• A heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "QT interval prolongation"
• Low levels of magnesium or potassium in the blood
• Stomach or duodenal (intestinal) ulcers
• Difficulty urinating
• Fainting or seizures: donepezil may potentially 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 must not take this medicine.

Other medicines and Donepezil Viatris

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

• Other medicines for Alzheimer's disease, for example, galantamine
• Medicines for depression, (for example, citalopram, escitalopram, amitriptyline, fluoxetine)
• Medicines for psychosis, (for example, pimozide, sertindole, or ziprasidone)
• Medicines for bacterial infections (for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin)
• Rifampicin (for the treatment of tuberculosis)
• Antifungal medicines, for example, ketoconazole, itraconazole
• Carbamazepine or phenytoin (for the treatment of epilepsy)
• Medicines for heart conditions, for example, quinidine, beta-blockers (for example, propranolol, atenolol)
• Medicines for heart rhythm problems, for example, amiodarone, sotalol, quinidine
• Painkillers or treatments for arthritis, for example, acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac
• Anticholinergics (medicines that typically cause dry mouth, blurred vision, or drowsiness), for example, tolterodine (used for bladder problems)

If you are going to undergo surgery, including dental surgery, and require anesthesia, inform 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 alcohol 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 speaking with your doctor for advice. Donepezil must not be used during pregnancy except if clearly necessary.

Donepezil must not be used during breastfeeding.

Driving and using machines

Do not drive or operate tools or machinery if you experience dizziness, drowsiness, or muscle cramps while taking this medicine. In addition, Alzheimer's disease may affect your ability to drive or operate machinery, so you should not perform such activities unless your doctor tells you it is safe to do so.

Donepezil Viatris contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Donepezil Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Inform the doctor of your caregiver's name. Your caregiver will help you take the medicine as prescribed.

Adults

The recommended starting dose is 5 mg of donepezil once daily for at least one month. Your doctor may increase your 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 daily dose, consult your doctor or pharmacist.

Use in patients with hepatic and renal 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 at night before going to bed.

If you experience 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 you should continue taking the tablets. You will need to visit your doctor regularly to review your treatment and assess your symptoms. You may 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 with you to the hospital so the doctor knows what has been taken.

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

If you take more donepezil than you should, symptoms may include feeling unwell (nausea), vomiting, salivation, sweating, slow heart rate (bradycardia), low blood pressure (dizziness or vertigo when standing), breathing difficulties, loss of consciousness, seizures (fits). There may also be an increase in muscle weakness, which could be life-threatening if respiratory muscles are involved.

If you forget to take Donepezil Viatris

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

If you have missed taking the medicine for more than one week, consult your doctor before resuming treatment.

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 first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Uncommon (may affect up to 1 in 100 people)

• Bleeding in the stomach or intestines, or stomach or duodenal (intestinal) ulcers. If you vomit, you may see red blood particles that look like coffee grounds; and in your stools, you may notice black, tarry stools 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 whites of the eyes (jaundice), feeling unwell and fever.
• Changes in heart rhythm, such as changes in rhythm or "missed" 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 decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome").
• Muscle weakness, tenderness or pain, particularly if you also feel unwell, have fever, or dark-colored urine. This may be due to abnormal muscle breakdown which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

Frequency not known (cannot be estimated from available data)

• Fast and irregular heartbeat, fainting which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.

Other adverse 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.
• Restlessness.
• Aggressive behaviour.
• Fainting.
• Dizziness.
• Abdominal pain or discomfort.
• Skin rash or itching.
• Involuntary urination.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Slowing of the heartbeat.
• Increase in blood levels of the substance creatine kinase, involved in metabolism, which can be seen in blood tests.
• Increased salivation in the mouth.

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

• Extrapyramidal symptoms including involuntary movements, tremor and rigidity, body restlessness, 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 seen on an electrocardiogram (ECG), known as "QT interval prolongation".
• Increased libido.
• Hypersexuality.

Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other 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: monohydrate lactose (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 sizes

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

Available pack sizes: 7, 10, 28, 30, 56, 60, 84, 98, and 100 film-coated tablets; calendar packs of 28 and 98; and single-dose perforated blisters of 50 x 1.

Available in bottles containing 100 and 250 film-coated tablets.

Only certain 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

For further information about this medicine, please contact 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 European Economic Area countries 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, comprimé pelliculé
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 most recent review of this leaflet: April 2023

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