DONEPEZIL ALMUS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Almus5 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 Almus5 mg tabletsand what is it used for
2. What you need to know before you takeDonepezil Almus5 mg tablets
3. How to takeDonepezil Almus5 mg tablets
4. Possible side effects
5. Storage ofDonepezil Almus5 mg tablets
6. Contents of the pack and further information

1. What is DONEPEZIL ALMUS 5 mg TABLETS and what is it used for

Donepezil Almus belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. It is only used in adult patients.

2. What you need to know before you take DONEPEZIL ALMUS 5 mg TABLETS

Do not take Donepezil Almus

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezil Almus.

Treatment with donepezil should only be started and supervised by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

Tell your doctor if:

• you have ever had a stomach ulcer or intestinal ulcer, or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs).
• you have ever had seizures. Donepezil may cause seizures and convulsions. Your doctor will monitor your symptoms.
• you have or have had a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction, sick sinus syndrome, or any other condition that affects heart rhythm), as donepezil may slow down your heart rate.
• 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.
• you have asthma or other chronic lung disease.
• you have ever had liver problems.
• you have difficulty urinating.
• if you are going to have an operation that requires general anesthesia, as it may be necessary to adjust the dose of the medication used in the anesthesia.

Using Donepezil Almus with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, it is important to tell your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems, such as amiodarone or sotalol.
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine.
• medicines for psychosis, such as pimozide, sertindole, or ziprasidone.
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin.
• antifungal medicines, such as ketoconazole.
• other medicines for Alzheimer's disease, such as galantamine.
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.
• anticholinergic medicines, such as tolterodine.
• anticonvulsants, such as phenytoin, carbamazepine.
• medicines for heart disease, such as quinidine, beta-blockers (propranolol and atenolol).
• muscle relaxants, such as diazepam, succinylcholine.
• general anesthetics.
• medicines obtained without a prescription, such as herbal remedies.

Taking Donepezil Almus with food and drinks

You should avoid drinking alcohol while being treated with donepezil, as it may reduce the effect of donepezil.

Pregnancy and Breastfeeding

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.

You should not use Donepezil Almus 5 mg during pregnancy.

Tell your doctor if you are breastfeeding. You should not use Donepezil Almus 5 mg if you are breastfeeding.

Driving and using machines

Donepezil Almus and the disease may affect your ability to drive or use machines. This medicine may cause fatigue, dizziness, and muscle cramps, especially at the start of treatment, and if this happens, you should not drive or use machines. You should talk to your doctor before performing these activities.

Donepezil Almus 5 mg film-coated tablets contain lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take DONEPEZIL ALMUS 5 mg TABLETS

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose you take may vary depending on how long you have been taking the medicine and what your doctor recommends.

Usually, you will start by taking one tablet (5 mg of donepezil hydrochloride) each night. After a month, your doctor may tell you to take two tablets (10 mg of donepezil hydrochloride) each night. The maximum recommended dose is 10 mg each night.

For doses that cannot be administered with this presentation, other doses of this medicine are available.

Take donepezil with a little 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 Almus in the morning.

No dose adjustment is necessary if you have kidney problems.

For adults with moderate liver disease, your doctor may perform a dose adjustment.

If you have severe liver problems, you should be cautious with donepezil (see section 2 "Before taking Donepezil Almus"). In cases of unexplained liver alteration with donepezil treatment, withdrawal of Donepezil Almus will be considered.

Use in children and adolescents

Donepezil is not recommended for children or adolescents.

Always follow the instructions of your doctor on how and when to take your medicine. Do not change the dose unless your doctor tells you to. Do not stop taking the tablets unless your doctor tells you to.

Your doctor will tell you the duration of the treatment. You should go to the doctor regularly to review your treatment and evaluate your symptoms.

If you take more Donepezil Almus than you should

Do not take more tablets than your doctor has told you. Contact your doctor immediately or go to the emergency department of the nearest hospital if you have taken more than you should. Always take the tablets and the packaging to the hospital so that the doctor knows what you have taken.

The symptoms of an overdose may be nausea, vomiting, salivation, sweating, slow heartbeat, difficulty breathing, muscle weakness, fainting, and convulsions.

In case of accidental ingestion, consult the toxicological information service, telephone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to take Donepezil Almus

Do not take a double dose to make up for forgotten doses.

If you forget to take a tablet, take a tablet the next day at the usual time. If you forget to take your medicine for more than a week, consult your doctor before taking more medicine.

If you stop taking Donepezil Almus

When you stop taking Donepezil Almus, the beneficial effects of donepezil will gradually decrease. Do not stop taking your tablets, even if you feel well, unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, Donepezil Almus can cause side effects, although not everybody gets them.

The frequency of side effects is classified as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

Very rare: may affect up to 1 in 10,000 people

Severe side effects:

If as a patient you suffer from fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"), you should consult your doctor immediately as you may need urgent medical treatment.

Consult your doctor immediately if you suffer from these severe side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, especially if you also feel unwell, have a fever, or dark-colored urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

Very common side effects that may affect more than 1 in 10 people:

• diarrhea
• nausea
• headache

Common side effects that may affect up to 1 in 10 people:

• common cold
• loss of appetite
• hallucinations, aggressive behavior, agitation, which may resolve with a reduction in dose or with treatment interruption.
• dizziness, somnolence, fainting
• vomiting, abdominal discomfort
• itching, rash
• muscle cramps
• urinary incontinence
• fatigue, pain
• accidents

Uncommon side effects that may affect up to 1 in 100 people:

• seizures
• slow heart rate
• gastrointestinal bleeding, stomach and duodenal ulcers
• small increase in serum concentration of muscle creatine kinase

Rare side effects that may affect up to 1 in 1,000 people:

• rigidity or uncontrolled movements, especially of the face and tongue as well as the limbs
• heart disorders
• liver disorders, including hepatitis

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".
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as 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).

If you experience side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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 ALMUS 5 mg TABLETS

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

This medicine does not require special storage conditions.

Do not use Donepezil Almus after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Donepezil Almus

• The active substance is donepezil hydrochloride. Each tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg of donepezil hydrochloride.
• The other ingredients are: tablet core: lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, tablet coating: polyvinyl alcohol, macrogol 3350, talc, and titanium dioxide E171.

Appearance of the product and packaging contents

Donepezil Almus 5 mg film-coated tablets are round and biconvex, white, engraved with "DZ 5" on one side.

Pack sizes:

Blister: 14, 20, 28, 50, 56, and 60 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

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

Italy Donepezil Almus 5 mg film-coated tablets

Date of last revision of this leaflet: 11/2022

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