Package Leaflet: Information for the User

Donepezilo Almus5 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Donepezilo Almus belongs to a group of medicines called cholinesterase inhibitors. Itis 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.

Do not take Donepezilo Almus

Warnings and precautions

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

Donepezilo treatment should only be initiated and monitored by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

Inform your doctor if:

Use of Donepezilo Almus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication. In particular, it is essential to inform your doctor if you are taking any of the following types of medications:

Taking Donepezilo Almus with food and drinks

You should avoid drinking alcohol while taking donepezilo, as it may reduce the effect of donepezilo.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Donepezilo Almus 5 mg during pregnancy.

Inform your doctor if you are breastfeeding. You should not use Donepezilo Almus 5 mg if you are breastfeeding.

Driving and operating machinery

Donepezilo Almus and the disease may affect your ability to drive or operate machinery. This medication may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment, and if this happens, you should not drive or operate machinery. You should talk to your doctor before performing these activities.

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

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

The dose you take may vary depending on the time you have been taking the medication and what your doctor recommends.

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

For doses that cannot be administered with this presentation, other doses of this medication 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 adjust the dose.

If you have severe liver problems, you must exercise special caution with donepezil (see section 2 “Before taking Donepezil Almus”). In cases of unexplained liver alteration with donepezil treatment, the withdrawal of Donepezil Almus will be considered.

Use in children and adolescents

Donepezil is not recommended for children or adolescents.

Always follow your doctor's instructions on how and when to take your medication. Do not change the dose without your doctor's indication. Do not stop taking the tablets unless your doctor tells you to.

Your doctor will indicate the duration of treatment. You should visit your 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 indicated by your doctor. Contact your doctor immediately or go to the nearest hospital emergency room if you have taken more than you should. Always bring the tablets and the packaging to the hospital so that the doctor knows what has been taken.

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

In case of accidental ingestion, consult the toxicology information service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forgot to take Donepezil Almus

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Donepezil Almus

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

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

Like all medicines, Donepezilo Almus may cause side effects, although not everyone will experience them.

The frequency of side effects is classified in the following way:

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 experience fever with muscle stiffness, sweating or a decrease in level of consciousness (a condition called "neuroleptic malignant syndrome"), you should immediately consult your doctor as you may need urgent medical treatment.

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

• Weakness, sensitivity or muscle pain, particularly if you are feeling unwell, have a fever or your urine is dark in color. 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 discontinuation of treatment.
• dizziness, drowsiness, 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 creatine kinase muscle concentration

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

• stiffness or uncontrollable movements, especially of the face and tongue as well as the limbs
• cardiac disorders
• liver disorders, including hepatitis

Frequency not known (cannot be estimated from available data):

• changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval".
• rapid and irregular heart rate, fainting that may be symptoms of a potentially fatal condition known as 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).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear 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 possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System of 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 conditions for conservation.

Do not use Donepezilo Almus after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. By doing so, you will help protect the environment.

Composition of Donepezilo Almus

Appearance of the product and contents of the packaging

Donepezilo Almus 5 mg film-coated tablets are round and biconvex, white in color, and engraved with “DZ5”on one side.

Packaging sizes:

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

Only some packaging sizes may be commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

ItalyDonepezil Almus 5 mg film-coated tablets

Last review date of this leaflet: 11/2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/