DONEPEZIL AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Aurovitas 10 mg film-coated 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 Aurovitas and what is it used for
2. What you need to know before you take Donepezil Aurovitas
3. How to take Donepezil Aurovitas
4. Possible side effects

5 Storage of Donepezil Aurovitas

1. Contents of the pack and further information

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

Donepezil Aurovitas (donepezil hydrochloride) 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 rate of breakdown of this substance.

It is used for the treatment of the symptoms of Alzheimer's disease of mild to moderate severity. The symptoms include increasing memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it more and more difficult to carry out their daily activities.

Donepezil Aurovitas should only be used in adult patients.

2. What you need to know before you take Donepezil Aurovitas

Do not take Donepezil Aurovitas

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor before you start taking Donepezil Aurovitas if you have or have had:

• stomach or duodenal ulcers,
• epileptic seizures or convulsions,
• heart disease (such as irregular heartbeat or very slow heart rate, heart failure, heart attack),
• a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades 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 pulmonary disease,
• liver problems or hepatitis,
• difficulty urinating or mild kidney disease.

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

Children and adolescents

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

Taking Donepezil Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you have bought without a prescription. It also applies to medicines that you might take in the future while you are still taking Donepezil Aurovitas. This is because these medicines may weaken or strengthen the effects of Donepezil Aurovitas.

In particular, 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),
• analgesics or treatments for arthritis (e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or diclofenac sodium),
• anticholinergic medicines (e.g. tolterodine),
• anticonvulsants (e.g. phenytoin or carbamazepine),
• medicines for heart disease (e.g. quinidine or beta-blockers (propranolol and atenolol)),
• muscle relaxants (e.g. diazepam and succinylcholine),
• general anesthesia,
• medicines obtained without a prescription, e.g. herbal remedies.

If you are going to have surgery with general anesthesia, tell your doctor that you are taking Donepezil Aurovitas, as this may affect the amount of anesthetic needed.

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

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

Taking Donepezil Aurovitas with food, drinks, and alcohol

Food does not affect the effect of Donepezil Aurovitas.

Donepezil Aurovitas should not be taken with alcohol, as alcohol may change the effect of this medicine.

Pregnancy, breast-feeding, and fertility

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

Donepezil Aurovitas should not be used in women who are breast-feeding.

Driving and using machines

Your illness 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. Donepezil Aurovitas may cause tiredness, dizziness, somnolence, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Donepezil Aurovitas contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Donepezil Aurovitas

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, ask your doctor or pharmacist again.

How much Donepezil Aurovitas should you take?

Usually, treatment starts with 5 mg (one white tablet) every night. After one month of treatment, your doctor may tell you to increase the dose to 10 mg (one yellow tablet) every night.

The dose of the tablet you take may vary depending on how long you have been taking the medicine and your doctor's recommendation. The maximum recommended dose is 10 mg every night.

Do not change the dose without talking to your doctor.

How to take your medicine

Swallow your Donepezil 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 donepezil in the morning.

Use in children and adolescents

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

If you take more Donepezil Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used. Bring this leaflet and the remaining tablets with you.

Symptoms of overdose may include feeling sick, drooling, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and convulsions.

If you forget to take Donepezil Aurovitas

Take your usual dose the next day at the usual time. Do not take a double dose to make up for forgotten doses.

If you forget to take your medicine for more than one week, contact your doctor before taking the dose again.

If you stop taking Donepezil Aurovitas

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

How long will you need to take Donepezil Aurovitas?

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

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 Aurovitas.

Tell your doctor if you get any of these side effects while taking Donepezil Aurovitas.

Serious side effects:

You should tell your doctor immediately if you notice any of the following serious 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 pain and discomfort in the stomach (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause you to have black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Dizziness (fits) 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, especially if you also feel unwell, have a fever, or have dark-colored urine. This may be due to an abnormal breakdown of muscle that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

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

• Diarrhea.
• Nausea.
• 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 upset.
• Rash.
• Itching.
• Loss of bladder control.
• Pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Slow heart rate.
• Increased saliva production.

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

• Stiffness, tremors, 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 condition called 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Aurovitas

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Donepezil Aurovitas

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
• The other ingredients are:

Core of the tablet:lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

Coating of the tablet:hypromellose, macrogol 6000, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance and packaging of the product

Film-coated tablet.

Yellow, round, biconvex film-coated tablets, engraved with "X" on one side and "12" on the other side.

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

Package sizes:14, 28, 30, 50, 56, and 90 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:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Donepezil Aurovitas 10 mg film-coated tablets EFG

Portugal Donepezil 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/)