Prospect: information for the user

Donepezilo Aurovitas 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read this prospect carefully before starting to take this medicine, as 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 medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

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

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

3.How to take Donepezilo Aurovitas

4.Possible adverse effects

5Storage of Donepezilo Aurovitas

6.Contents of the pack and additional information

Donepezilo Aurovitas (hydrochloride of donepezil) belongs to the group of medications called acetylcholinesterase inhibitors.

Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by means of the decrease in the speed of decomposition of this substance.

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

Donepezilo Aurovitas should only be used in adult patients.

Do not take Donepezilo Aurovitas

• 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 before starting Donepezilo Aurovitas if you have or have had:

• stomach or duodenal ulcers,
• epileptic seizures or convulsions,
• heart disease (such as irregular or very slow heart rhythm, 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 chronic lung disease,
• liver problems or hepatitis,
• difficulty urinating or mild kidney disease.

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.

Children and Adolescents

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

Taking Donepezilo Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication. This includes medications not prescribed by your doctor but purchased at the pharmacy. It also applies to medications you may take in the future if you continue taking Donepezilo Aurovitas. This is because these medications may decrease or intensify the effects of Donepezilo Aurovitas.

Especially inform your doctor if you are taking:

• 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 treatments for arthritis (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium),
• anticholinergic medications (e.g., tolterodine),
• anticonvulsants (e.g., phenytoin or carbamazepine),
• medications for heart disease (e.g., quinidine, or beta-blockers (propranolol and atenolol)),
• muscle relaxants (e.g., diazepam and succinylcholine),
• general anesthesia,
• over-the-counter medications (e.g., herbal remedies).

Inform your doctor that you are taking Donepezilo Aurovitas before undergoing surgery with general anesthesia, as this may affect the amount of anesthetic needed.

Donepezilo Aurovitas may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take Donepezilo Aurovitas.

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

Taking Donepezilo Aurovitas with food, drinks, and alcohol

Foods do not affect the effect of Donepezilo Aurovitas.

Donepezilo Aurovitas should not be taken with alcohol, as alcohol may modify 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.

Donepezilo Aurovitas should not be used in women who are breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery, and you should not do so unless your doctor tells you it is safe to do so. Donepezilo Aurovitas may cause fatigue, dizziness, drowsiness, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Donepezilo Aurovitas contains lactose monohydrate

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much Donepezilo Aurovitas should I take?

Generally, treatment begins by taking 5 mg (one white tablet) at night. After a month of treatment, your doctor may indicate an increase in the dose to 10 mg (one yellow tablet) at night.

The dose of the tablet you will take may vary depending on the period you have been taking the medication and the recommendation of your doctor. The maximum recommended dose is 10 mg per night.

Do not change the dose without consulting your doctor.

How to take my medication?

Swallow your Donepezilo Aurovitas tablet with a glass of water, at night before going to bed.

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

Use in children and adolescents

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

If I take more Donepezilo Aurovitas than I should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Bring this leaflet and the remaining tablets with you.

The symptoms of overdose may include feeling sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing problems, loss of consciousness, and seizures.

If I forgot to take Donepezilo Aurovitas

Take your usual dose the next day at the usual time. Do not take a double dose to compensate for the missed doses.

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

If I interrupt the treatment with Donepezilo Aurovitas

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

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

For how long should I take Donepezilo Aurovitas?

Your doctor or pharmacist will indicate how long you should continue taking your tablets. You will need to visit your doctor periodically to review your treatment and evaluate your symptoms.

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

The following side effects have been reported by people taking Donepezilo Aurovitas.

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

Severe side effects:

Inform your doctor immediately if you notice any of the following severe side effects, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This may cause you to have black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Dizziness (attacks) or convulsions (may affect up to 1 in 10,000 people).
• Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, particularly if you are feeling unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).

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

• Diarrhea.
• Discomfort.
• Headache.

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

• Muscle cramps.
• Tiredness.
• Difficulty sleeping (insomnia).
• Common cold.
• Loss of appetite.
• Hallucinations (seeing or hearing things that are not real).
• Unusual dreams, including nightmares.
• Agitation.
• Aggressive behavior.
• Fainting.
• Dizziness.
• Stomach discomfort.
• Rash.
• Itching.
• Incontinence.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Slow heart rate.
• Excessive salivation.

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

• Rigidity, tremors, or uncontrollable 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 may be symptoms 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 or pharmacist, 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 Pharmacovigilance 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.

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

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Donepezilo Aurovitas

• The active ingredient is donepezilo hydrochloride. Each film-coated tablet contains 5 mg of donepezilo hydrochloride, equivalent to 4.56 mg of donepezilo.
• The other components are:

Tablet core:monohydrate lactose, pregelatinized cornstarch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

Film coating:hypromellose, macrogol 6000, talc, and titanium dioxide (E171).

Appearance of the product and content of the container

Film-coated tablet.

White, round, biconvex, film-coated tablets, engraved with “X” on one face and “11” on the other face.

Donepezilo Aurovitas film-coated tablets are available in PVC/PE/PVdC-aluminum blister packs.

Pack sizes:14, 28, 30, 50, 56, and 90 film-coated tablets.

Only some 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:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

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

SpainDonepezilo Aurovitas 5mg film-coated tablets EFG

PortugalDonepezilo Aurovitas

Last review date of this leaflet:December 2022

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