Donepezil Flas Viatris Pharmaceuticals 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Donepezilo Flas Viatris Pharmaceuticals 5 mg orodispersible tablets EFG

donepezil hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any 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 adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Donepezilo Flas Viatris Pharmaceuticals contains the active substance donepezil hydrochloride.

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases levels in the brain of a substance related to memory (acetylcholine) by slowing down its breakdown.

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

It is used only in adult patients.

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

Do not take Donepezilo Flas Viatris Pharmaceuticals:

• If you are allergic to donepezil hydrochloride, to piperidine derivatives, 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 treatment with Donepezilo Flas Viatris Pharmaceuticals if you have or have had:

• Stomach or duodenal ulcers.

• Epileptic seizures (syncope) or convulsions.

• Heart disease (for example, irregular heartbeat or bradycardia, heart failure, myocardial infarction).

• A heart condition called "long QT syndrome" or a family history of this condition, or a history of any type of heart rhythm disorder, such as torsades de pointes ventricular tachycardia.

• Low levels of magnesium or potassium in the blood.

• Asthma or other long-term lung diseases.

• Liver disorders or hepatitis.

• Difficulty urinating or moderate kidney disease.

You should also inform your doctor if you are pregnant or think you might be pregnant.

Children and adolescents

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

Other medicines and Donepezilo Flas Viatris Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you have purchased over-the-counter without a prescription. It also applies to any medicines you might need to take in the future while continuing treatment with donepezil. This is because these medicines could reduce or intensify the effects of donepezil.

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

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

If you are undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking donepezil. This is because the medicine may affect the amount of anaesthetic required.

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

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

Donepezilo Flas Viatris Pharmaceuticals with food, drinks and alcohol

Food does not affect the action of donepezil; however, it should not be taken with alcohol, as this could alter its effects.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Donepezil should not be used during breastfeeding.

Driving and using machines

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

The medicine may also cause fatigue, dizziness, and muscle cramps. If you experience any of these effects, you should not drive or operate tools or machinery.

Donepezilo Flas Viatris Pharmaceuticals contains sodium

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

3. How to take Donepezil Flas Viatris Pharmaceuticals

How much Donepezil Flas Viatris Pharmaceuticals should you take

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

Initially, the recommended dose is 5 mg (one white tablet) once daily at bedtime. After one month, your doctor may increase the dose to 10 mg (one yellow tablet) once daily at bedtime.

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

The strength of the dose you will take depends on how long you have been taking the medicine and your doctor's recommendation. The maximum recommended dose is 10 mg every night.

Always follow your doctor’s or pharmacist’s instructions regarding how and when to take the medicine.

Do not change the dose on your own without prior recommendation from your doctor.

How to take Donepezil Flas Viatris Pharmaceuticals

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

Use in children and adolescents

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

If you take more Donepezil Flas Viatris Pharmaceuticals than you should

If you take more medicine than you should, contact your doctor immediately or go to the nearest hospital emergency department. Bring this leaflet and any remaining tablets with you, or call the Toxicology Information Service at telephone number 91 562 04 20.

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

If you forget to take Donepezil Flas Viatris Pharmaceuticals

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

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

If you stop taking Donepezil Flas Viatris Pharmaceuticals

Do not stop taking the medicine unless instructed by your doctor. If you discontinue treatment with donepezil, the benefits of treatment will gradually disappear.

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

How long should you take Donepezil Flas Viatris Pharmaceuticals

Your doctor or pharmacist 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.

4. Possible adverse effects

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

The following adverse effects have been reported in people taking donepezil.

Tell your doctor if you experience any of the following while taking donepezil.

Serious adverse effects

You should inform your doctor immediately if you notice any of the following serious adverse effects listed below. You may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause black, tar-like stools or visible blood from the rectum (last part of the intestine) (may affect up to 1 in 100 people).
• Epileptic fits (syncope) or seizures (may affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 100 people).
• Muscle weakness, sensitivity, or pain, particularly if accompanied by feeling unwell, 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) (may affect up to 1 in 10,000 people).
• Fast and irregular heartbeat, fainting, which 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 contractions with abnormal tilting of the body and head to one side).

Other adverse effects:

Very common adverse effects (may affect more than 1 in 10 people):

• Diarrhea.
• Headache.

Common adverse 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 discomfort.
• Skin rash.
• Involuntary loss of urine.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Slowing of the heartbeat.
• Hypersecretion.

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

• Stiffness, tremors, or uncontrollable 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 may be seen on an electrocardiogram (ECG) and are known as "prolongation of the QT interval".

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Flas Viatris Pharmaceuticals

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Donepezilo 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 components are: mannitol (E-421), anhydrous colloidal silica (E-551), hydroxypropylcellulose (E-463), potassium acesulfame (E-950), glycine (E-640), sodium starch glycolate from potato, crospovidone (Type A), microcrystalline cellulose (E-460), and magnesium stearate (E-470b).

Appearance of the medicine and contents of the pack

Your medicine is available as orodispersible tablets.

Round, white, flat orodispersible tablets with beveled edges, marked with “DL5” on one side and “M” on the other.

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

Only certain pack sizes may be commercially available.

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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Austria Donepezil Arcana 5 mg Schemelztabletten
Belgium Donepezil ODIS Mylan 5 mg
Cyprus Donepezil/Generics
Slovakia Donepezil Mylan 5 mg orodispergovatel’né tablety
Slovenia Donepezil Mylan 5 mg orodisperzibilne tablete
Spain Donepezilo Flas Viatris Pharmaceuticals 5 mg comprimidos bucodispersables EFG
France Donepezil Mylan 5 mg comprimé orodispersible
Greece Donepezil/Mylan
Ireland Aripil Orotab 5 mg oro-dispersible tablets
Poland Donegen ODT
Portugal Donepezilo Mylan
United Kingdom Donepezil Hydrochloride 5 mg Orodispersible Tablets
Czech Republic Donepezil Mylan 5 mg tablety dispergovatelné v ústech
Romania Donepezil Mylan 5 mg comprimate orodispersabile
Sweden Donepezil Mylan

Date of the most recent review of this leaflet: November 2022

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