Prospect: information for the user

Donepezilo Flas Aurovitas Spain 5 mg buccal dispersible tablets EFG

Donepezil hydrochloride

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist, evenifthey do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Donepezilo Flas Aurovitas Spain

3.How to take Donepezilo Flas Aurovitas Spain

4.Possible adverse effects

5.Storage of Donepezilo Flas Aurovitas Spain

6.Contents of the package and additional information

Donepezilo Flas Aurovitas Spainbelongs to a group of medicines called cholinesterase inhibitors. Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by decreasing the speed of its breakdown.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include an increase in memory loss, confusion, and changes in behavior.As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.

Donepezilo should only be used in adult patients.

Do not take Donepezilo Flas Aurovitas Spain

• If you are allergic to hydrochloride of donepezilo, or to derivatives of piperidina, or to any of the other components of this medication (including in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeDonepezilo Flas Aurovitas Spainif you have or have had:

• stomach or duodenal ulcers,
• epileptic attacks 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 torsade de pointes or if someone in your family 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.

Also, tell your doctor if you are pregnant, or think you may be pregnant.

Donepezilo 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 cases of unexplained liver function alteration, your doctor may consider interrupting treatment with donepezilo.

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

Use in children and adolescents

Donepezilo is not recommendedfor use in children and adolescents.

Other medications and Donepezilo Flas Aurovitas Spain

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

In particular, it is essential to 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.
• Analgesics or treatment for arthritis, e.g., nonsteroidal 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.
• Over-the-counter medications, e.g., herbal remedies.

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

Taking Donepezilo Flas Aurovitas Spain with food, drinks, and alcohol

Foods do not affect the effect of donepezilo.

You should avoid taking alcohol while takingdonepezilo, as it may reduce the effect ofthis medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before using this medication.

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

Donepeziloshould not be used in women who are breastfeeding.

Driving and operating machinery

Donepezilo and the disease may affect your ability to drive or operate machineryand you should not perform these activities unless your doctor tells you 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.

Donepezilo Flas Aurovitas Spaincontains sodium, lactose, and aspartame

This medication contains less than 23 mg of sodium (1 mmol) per buccal dispersible tablet; this is, essentially "sodium-free".

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

This medication contains 124.7 mg of aspartame in each buccal dispersible tablet.

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

How much Donepezilo Flas Aurovitas Spain should be taken? Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Take the buccal dispersible tablet in the following way:

The tablets are taken orally.

1. Do not crush the buccal dispersible tablet

To prevent the buccal dispersible tablet from being crushed, do not press the alveolus(Figure A).

Fig. A

1. Separate an alveolus

Each blister contains six alveoli, which are separated by perforations. Separate an alveolus following the perforated lines (Figure 1).

Fig. 1

1. Remove the sheet

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

Fig. 2

Fig. 3

1. Remove the buccal dispersible tablet

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

Fig. 4

It will disintegrate quickly and can be swallowed with or without water, as desired.

The initial recommended dose is 5 mg(one white tablet)each night before bedtime.

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

After a 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 will take may change depending on the length 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 Donepezilo Flas Aurovitas Spain

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

Use in children and adolescents

Donepezilo is not recommended for use in children and adolescents (under 18 years old).

Duration of treatment with Donepezilo 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 evaluate your symptoms.

If you take moreDonepezilo Flas Aurovitas Spainthan 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 packaging and the medication leaflet.

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

If you forgot to takeDonepezilo 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 compensate 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 interrupt the treatment withDonepezilo Flas Aurovitas Spain

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

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

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

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

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

Severe side effects:

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

• Liver damage, e.g. hepatitis. The symptoms of hepatitis arenauseaor vomiting, loss of appetite, general feeling of illness, 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) felt between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause the appearance of black stools or visible blood in the rectum (may affect up to 1 in 100 people).
• Seizures (epileptic fits) (may affect up to 1 in 100 people).
• Fever accompanied by muscle stiffness, sweating, or low level of consciousness (a condition called "neuroleptic malignant syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, particularly if you are also feeling unwell, have a fever, or your urine is dark-colored. This can 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

Frequent side effects (may affect more than 1 in 10people):

• Diarrhea.
• Headache.

Common side effects (may affect up to 1 in 10people):

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

Rare side effects (may affect up to 1 in 100people):

• Slow heart rate.
• Increased saliva production.

Very rare side effects (may affect up to 1 in 1,000people):

• Rigidity, 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 heart rate, fainting that may be a symptom of a potentially fatal condition called torsade 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout 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.

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

This medication does not require any special storage temperature.

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

Composition of Donepezilo Flas Aurovitas Spain

• The active ingredient is donepezilo hydrochloride. Each buccal dispersible tablet contains 5 mg of donepezilo hydrochloride.
• The other components are: potassium polacrilex,microcrystalline cellulose, lactose monohydrate, anhydrous sodium citrate,aspartame (E951),sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

Donepezilo Flas Aurovitas Spain 5 mg buccal dispersible tablets are white to off-white, round, flat, beveled-edge tablets, engraved with a ‘5’ on one of their faces.

Packaging sizes:

Packaging with blisters of 7, 28, 30, 50, 56, 60, 98 and 120 buccal dispersible tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Genepharm S.A.

18th km Marathonos Avenue

Pallini 15351, Attiki

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Donepezilhydrochlorid PUREN 5 mg Schmelztabletten

Spain:Donepezilo Flas Aurovitas Spain 5 mg buccal dispersible tablets EFG

Portugal:Donepezilo Aurovitas

Last review date of this leaflet:December 2022

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