Donepezil Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Aurovitas 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Donepezilo Aurovitas (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil increases the levels in the brain of a substance involved in memory (acetylcholine), by reducing the rate at which this substance is broken down.

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

Donepezilo Aurovitas should only be used in adult patients.

2. What you need to know before taking 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

Talk to your doctor before starting to take Donepezil Aurovitas if you have or have had:

• stomach or duodenal ulcers,
• epileptic seizures or convulsions,
• heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction),
• a heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "QT interval prolongation",
• 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 are planning to become pregnant, consult your doctor before using this medicine.

Children and adolescents

The use of donepezil is not recommended 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 need to take any other medicines. This includes medicines not prescribed by your doctor but which you have purchased from a pharmacy. It also applies to medicines you might take at any time in the future while continuing to take Donepezil Aurovitas. This is because these medicines may reduce or intensify the effects of Donepezil Aurovitas.

In particular, 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 treating Alzheimer's disease, e.g., galantamine,
• painkillers or treatments for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac,
• 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 anaesthesia,
• over-the-counter medicines, e.g., herbal remedies.

If you are undergoing surgery with general anaesthesia, you must inform your doctor that you are taking Donepezil Aurovitas, as this may affect the amount of anaesthetic required.

Donepezil Aurovitas may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment must not take Donepezil Aurovitas.

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

Taking Donepezil Aurovitas with food, drinks and alcohol

Food does not affect the action of Donepezil Aurovitas.

Donepezil Aurovitas must not be taken with alcohol, as alcohol may alter the effect 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.

Donepezil Aurovitas must not be used in women who are breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not carry out these activities unless your doctor tells you it is safe to do so. Donepezil Aurovitas may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Donepezil Aurovitas contains lactose monohydrate

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

3. How to take Donepezil Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much Donepezil Aurovitas should you take?

Usually, treatment starts with a dose of 5 mg (one white tablet) each night. After one month of treatment, your doctor may decide to increase your dose to 10 mg (one yellow tablet) each night.

The tablet strength 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 each night.

Do not change the dose without consulting 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 experience 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 at telephone number: 91 562 04 20, stating the medicine and the amount taken. Bring this leaflet and any remaining tablets with you.

Symptoms of overdose may include feeling unwell, drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Donepezil Aurovitas

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

If you have missed taking your medicine for more than one week, call your doctor before resuming treatment.

If you stop taking Donepezil Aurovitas

Do not stop treatment with Donepezil Aurovitas unless instructed by your doctor. If you stop taking Donepezil Aurovitas, the benefits of treatment will gradually disappear.

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

How long should you take Donepezil Aurovitas?

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

4. Possible adverse effects

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

The following adverse effects have been reported in people taking Donepezil Aurovitas.

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

Serious adverse effects:

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

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling sick, 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 (dyspepsia) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Dizziness (syncope) or seizures (may affect up to 1 in 10,000 people).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a condition known as “Neuroleptic Malignant Syndrome”) (may affect up to 1 in 10,000 people).
• Weakness, tenderness, or muscle pain, particularly if you also feel unwell, have fever, or 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).

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

• Diarrhoea.
• Nausea.
• Headache.

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

• Muscle cramps.
• Fatigue.
• Difficulty sleeping (insomnia).
• Common cold.
• Loss of appetite.
• Hallucinations (seeing or hearing things that are not real).
• Unusual dreams, including nightmares.
• Agitation.
• Aggressive behaviour.
• Fainting.
• Dizziness.
• Stomach discomfort.
• Rash.
• Itching.
• Involuntary urination.
• 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):

• Stiffness, tremors, or uncontrollable 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 contraction with abnormal sideways bending of the body and head).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Aurovitas

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and on the carton following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. 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 Aurovitas

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

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

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

Appearance of the product and contents of the pack

Film-coated tablet.

White, round, biconvex film-coated tablets, engraved with "X" on one side and "11" on the other.

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

Pack sizes: 14, 28, 30, 50, 56 and 90 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 under the following names:

Spain Donepezilo Aurovitas 5 mg film-coated tablets EFG

Portugal Donepezilo Aurovitas

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

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