Donepezil Flas Aurovitas Spain 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Flas Aurovitas Spain 5 mg orodispersible 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Donepezil Flas Aurovitas Spain is and what it is 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. How to store Donepezil Flas Aurovitas Spain
6. Contents of the pack and other information

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

Donepezilo Flas Aurovitas Spain belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases levels in the brain of a substance related to memory (acetylcholine), by reducing the rate at which this substance breaks down.

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

Donepezil should only be used in adult patients.

2. What you need to know before starting to 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 "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation",
• low levels of magnesium or potassium in the blood,
• asthma or another chronic lung disease,
• liver disease or hepatitis,
• difficulty urinating or mild kidney disease,
• involuntary or abnormal movements of the tongue, face, or body (extrapyramidal symptoms). This medicine may induce or worsen extrapyramidal symptoms.

Also, 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 cases of unexplained liver function abnormalities, your doctor may consider discontinuing donepezil treatment.

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

Use in children and adolescents

The use of donepezil is not recommended in children and adolescents.

Other medicines and Donepezil Flas Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines not prescribed by your doctor but purchased over-the-counter at a pharmacy. This also applies to medicines you might take in the future while continuing donepezil treatment. This is because these medicines may weaken or strengthen the effects of donepezil.

In particular, it is important to inform 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.
• Painkillers or treatment for arthritis, e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac.
• 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 undergoing surgery requiring 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 required.

Taking Donepezil Flas Aurovitas Spain with food, drinks and alcohol

Food does not affect the effect of donepezil.

You should avoid drinking alcohol while taking donepezil, as it could reduce the effectiveness of this medicine.

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 medicine.

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

Donepezil should not be used in women who are breastfeeding.

Driving and using machines

Donepezil and the disease itself may affect your ability to drive or operate machinery, and you should not perform 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, you should not drive or operate machinery.

Donepezil Flas Aurovitas Spain contains sodium, lactose and aspartame

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

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

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

Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Donepezil Flas Aurovitas Spain

How much Donepezil Flas Aurovitas Spain should you take?
Always follow exactly the instructions for administration of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the orodispersible tablet as follows:

The tablets are taken by mouth.

1. Do not crush the orodispersible tablet

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

Fig. A

2. Separate one blister

Each blister strip contains six blisters separated by perforations. Separate one blister along the perforated lines (Fig. 1).

Fig. 1

3. Remove the foil

Carefully peel off the foil, starting at the corner marked with an arrow (Figs. 2 and 3).

Fig. 2

Fig. 3

4. Remove the orodispersible tablet

With dry hands, take out the orodispersible tablet and place it on your tongue (Fig. 4).

Fig. 4

The tablet will rapidly disintegrate and can be swallowed with or without water, according to your preference.

Initially, the recommended dose is 5 mg (one white 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.

After one month of treatment, your doctor may instruct you to take 10 mg (one yellow tablet) once daily at bedtime.

The tablet dose you take may change depending on how long you have been taking the medicine and your doctor's recommendation. The maximum recommended dose is 10 mg once daily.

Always follow your doctor’s or pharmacist’s advice 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 the tongue and allowed to disintegrate 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 the 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 immediately to a medical center or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet.

Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure (dizziness or lightheadedness upon standing), difficulty breathing, loss of consciousness, and epileptic seizures or convulsions.

If you forget to take Donepezil Flas Aurovitas Spain

If you miss a dose, take the next dose at your 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, contact your doctor before taking the medicine again.

If you stop taking Donepezil Flas Aurovitas Spain

Do not stop treatment with donepezil unless instructed by your doctor. If you stop taking 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.

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.

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

Serious adverse effects:

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

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) felt between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause black stools or visible blood from 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 rigidity, sweating, or decreased level of consciousness (a disorder known as "neuroleptic malignant syndrome") (may affect up to 1 in 10,000 people).
• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or have dark-coloured 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).

Other adverse effects

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

• Diarrhoea.
• Headache.

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

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

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

• Slow heartbeat.
• Increased saliva production.

Rare adverse 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 may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval".
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways flexion of the body and head).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

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

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezilo Flas Aurovitas Spain

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

Nature of the product and pack contents

Donepezilo Flas Aurovitas Spain 5 mg orodispersible tablets are white to off-white, round, flat tablets with bevelled edges, marked with a '5' on one side.

Pack sizes:

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

Only certain 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 medicinal product 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 comprimidos bucodispersables EFG

Portugal: Donepezilo Aurovitas

Date of the most recent revision of this leaflet: December 2022

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