DONEPEZIL Aurovitas Spain 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Aurovitas Spain 5 mg Orodispersible Tablets EFG

Donepezil Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Donepezil Flas Aurovitas Spain belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the speed of 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 you take Donepezil Flas Aurovitas Spain

Do not take Donepezil Flas Aurovitas Spain

• If you are allergic to donepezil hydrochloride, or to piperidine derivatives, or to any of the other ingredients of this medicine (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,
• epileptic 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 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 medicine may induce or exacerbate extrapyramidal symptoms.

In addition, tell your doctor if you are pregnant, or think you may be 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 medicine. 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 medicine as prescribed.

Use in children and adolescents

Donepezil is not recommended for use in children and adolescents.

Other medicines and Donepezil Flas Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that your doctor has not prescribed but that you have bought yourself. It also applies to medicines that you might take in the future if you continue to take donepezil. This is because these medicines may weaken or strengthen the effects of donepezil.

In particular, it is important that you tell your doctor if you are taking any of the following medicines:

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

If you are going to undergo an operation that requires general anesthesia, you must inform your doctor and anesthetist that you are taking donepezil. This is because your medicine 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 medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine 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 use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so.

The medicine may cause fatigue, dizziness, and muscle cramps. If you experience these effects, do not drive or use machines.

Donepezil Flas Aurovitas Spain contains sodium, lactose, and aspartame

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder 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 medicine 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

Carefully remove the foil, 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, as you prefer.

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 how long you have been taking the medicine 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 medicine. Do not change the dose without consulting your doctor.

How to take Donepezil Flas Aurovitas Spain

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

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, telephone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to carry the package and the package leaflet of the medicine.

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 medicine, 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 medicine for more than one week, call your doctor before taking the medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 should tell your doctor immediately if you notice any of 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 black-colored 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 disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This can be due to abnormal muscle destruction that can be life-threatening 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 injury).

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 the 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 life-threatening disorder known as torsade de pointes.
• Increased libido, hypersexuality.
• Syndrome of Pisa (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 side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Flas Aurovitas Spain

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in the original blister pack to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Flas Aurovitas Spain

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 5 mg of donepezil hydrochloride.
• The other ingredients are: potassium polacrylate, microcrystalline cellulose, lactose monohydrate, anhydrous monosodium citrate, aspartame (E951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and pack contents

The Donepezil Flas Aurovitas Spain 5 mg orodispersible tablets are white to off-white, round, flat, with beveled edges, engraved with a '5' on one face.

Pack sizes:

Blister packs of 7, 28, 30, 50, 56, 60, 98, and 120 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 under the following names:

Germany: Donepezilhydrochlorid PUREN 5 mg Schmelztabletten

Spain: Donepezilo Flas Aurovitas Spain 5 mg orodispersible tablets EFG

Portugal: Donepezilo Aurovitas

Date of last revision of this leaflet:December 2022

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