DONEPEZIL Aurovitas Spain 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Aurovitas Spain 10 mg Orodispersible 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, consult 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 you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Donepezil Flas Aurovitas Spain and what is it used for

Donepezil Flas Aurovitas Spain belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine) by decreasing 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 include increased memory loss, confusion, and behavioral changes. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.

Donepezil should only be used in adult patients.

2. What you need to know before taking Donepezil Flas Aurovitas Spain

Do not take Donepezil Flas Aurovitas Spain

• If you are allergic to donepezil hydrochloride, piperidine derivatives, 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 Flas Aurovitas Spain if you have or have had:

• Stomach or duodenal ulcers,
• Seizures or convulsions,
• A heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction),
• A heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolongation of the QT interval",
• Low levels of magnesium or potassium in the blood,
• Asthma or other chronic lung disease,
• Liver disease or hepatitis,
• Difficulty urinating or mild kidney disease,
• You have involuntary or abnormal movements of the tongue, face, or body (extrapyramidal symptoms). This medication may induce or exacerbate extrapyramidal symptoms.

In addition, tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Donepezil may be used in patients with mild to moderate kidney or liver disease. Inform your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take this medication. In unexplained cases of altered liver function, your doctor may consider discontinuing treatment with donepezil.

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

Use in Children and Adolescents

Donepezil is not recommended for use in children and adolescents.

Other Medications and Donepezil Flas Aurovitas Spain

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This includes medications that your doctor has not prescribed but that you have purchased at the pharmacy. It also applies to medications that you may take in the future if you continue to take donepezil. This is because these medications can weaken or strengthen the effects of donepezil.

In particular, it is essential that you inform your doctor if you are taking any of the following medications:

• Medications for heart rhythm problems (e.g., amiodarone, sotalol).
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline, fluoxetine).
• Medications for psychosis (e.g., pimozide, sertindole, ziprasidone).
• Medications for bacterial infections (e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin).
• Antifungal medications, e.g., ketoconazole.
• Other medications for Alzheimer's disease, e.g., galantamine.
• Pain relievers or treatments for arthritis, e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• Anticholinergic medications, e.g., tolterodine.
• Muscle relaxants, e.g., diazepam, succinylcholine.
• Anticonvulsants, e.g., phenytoin or carbamazepine.
• Medications for heart disease, e.g., quinidine, beta-blockers (e.g., propranolol and atenolol).
• General anesthetics.
• Medications obtained without a prescription, e.g., herbal remedies.

If you are going to undergo surgery that requires general anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezil. This is because your medication may affect the amount of anesthetic needed.

Taking Donepezil Flas Aurovitas Spain with Food, Drinks, and Alcohol

Food does not affect the effect of donepezil.

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy unless your doctor decides that it is clearly necessary.

Donepezil should not be used in women who are breastfeeding.

Driving and Using Machines

Donepezil and the disease may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so.

The medication may cause fatigue, dizziness, and muscle cramps. If you experience these effects, you should not drive or operate machinery.

Donepezil Flas Aurovitas Spain Contains Sodium, Lactose, and Aspartame

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

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.

This medication contains 124.7 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to Take Donepezil Flas Aurovitas Spain

How much Donepezil Flas Aurovitas Spain should you take? Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the orodispersible tablet as follows:

The tablets are taken orally.

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Figure A).

Fig. A

1. Separate a blister

Each blister pack contains six blisters, which are separated by perforations. Separate a blister by following the perforated lines (Figure 1).

Fig. 1

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow (Figures 2 and 3).

Fig. 2

Fig. 3

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on the tongue (Figure 4).

Fig. 4

It will dissolve quickly and can be swallowed with or without water, according to your preference.

Initially, the recommended dose is 5 mg (one white tablet) each night 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.

After one month of treatment, your doctor may indicate that you take 10 mg (one yellow tablet) each night before bedtime.

The dose of the tablet you take may change depending on the amount of time you have been taking the medication and what your doctor recommends. The maximum recommended dose is 10 mg each night.

Always follow the advice of your doctor or pharmacist on how and when to take the medication. Do not change the dose without consulting your doctor.

How to Take Donepezil Flas Aurovitas Spain

The tablet should be placed on the tongue and allowed to dissolve before swallowing, with or without water, according to your preference.

Use in Children and Adolescents

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

Duration of Treatment with Donepezil Flas Aurovitas Spain

Your doctor or pharmacist will advise you on how long you should continue taking your tablets. You will need to visit your doctor regularly to review your treatment and assess your symptoms.

If You Take More Donepezil Flas Aurovitas Spain Than You Should

In case of overdose or accidental ingestion, go to a Medical Center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the package leaflet of the medication.

The symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure (dizziness or vertigo when standing up), difficulty breathing, loss of consciousness, and epileptic seizures or convulsions.

If You Forget to Take Donepezil Flas Aurovitas Spain

If you forget to take your medication, take the next dose at the usual time.

Do not take a double dose to make up for the missed tablet.

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

If You Stop Taking Donepezil Flas Aurovitas Spain

Do not stop taking donepezil unless your doctor tells you to. If you stop taking donepezil, the benefits of treatment will gradually disappear.

If you have any other 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 gets them.

The following side effects have been reported by people taking donepezil.

Contact your doctor if you have any of these side effects during treatment with donepezil.

Serious Side Effects:

You must inform your doctor immediately if you notice the following serious side effects. You may need urgent medical treatment.

• Liver damage, e.g., hepatitis. The symptoms of hepatitis are nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) that feels between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause the appearance of black-colored stools or visible blood in the rectum (may affect up to 1 in 100 people).
• Seizures (epileptic seizures) (may affect up to 1 in 100 people).
• Fever accompanied by muscle stiffness, sweating, or low level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, particularly if you feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Other Side Effects

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

• Diarrhea.
• Headache.

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

• Fatigue.
• Difficulty sleeping (insomnia).
• Common cold.
• Hallucinations (seeing or hearing things that are not really there), aggressive behavior, unusual dreams including nightmares.
• Restlessness.
• Dizziness, fainting.
• Stomach upset.
• Rash.
• Muscle cramps.
• Urinary incontinence.
• Pain.
• Accidents (patients may be more prone to falls or accidental injuries).

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

• Slow heartbeat.
• Increased saliva production.

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

• Stiffness, tremor, or uncontrolled movements, especially of the face and tongue, but also of the limbs.

Frequency Not Known (cannot be estimated from available data):

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval".
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes.
• 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, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Flas Aurovitas Spain

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

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Store in the original blister pack to protect it from moisture.

This medication does not require any special storage temperature.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donepezil Flas Aurovitas Spain

• The active ingredient is donepezil hydrochloride. Each orodispersible tablet contains 10 mg of donepezil hydrochloride.
• The other components are: potassium polacrylate, microcrystalline cellulose, lactose monohydrate, anhydrous monosodium citrate, aspartame (E951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the Product and Package Contents

The Donepezil Flas Aurovitas Spain 10 mg orodispersible tablets are white to off-white, round, flat, with beveled edges, engraved with a '10' on one of their faces.

Package Sizes:

Package with blisters of 7, 28, 30, 50, 56, 60, 98, and 120 orodispersible tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue

Pallini 15351, Attiki

Greece

This medication is authorized in the Member States of the European Economic Area with the following names:

Germany: Donepezilhydrochlorid PUREN 10 mg Schmelztabletten

Spain: Donepezilo Flas Aurovitas Spain 10 mg orodispersible tablets EFG

Portugal: Donepezilo Aurovitas

Date of the Last Revision of this Package Leaflet:December 2022

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