Donepezil Almus 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Almus 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read the entire leaflet carefully before you start using 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Donepezil Almus 5 mg tablets are and what they are used for
2. What you need to know before taking Donepezil Almus 5 mg tablets
3. How to take Donepezil Almus 5 mg tablets
4. Possible side effects
5. How to store Donepezil Almus 5 mg tablets
6. Contents of the pack and other 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 moderate Alzheimer's disease. It is used only in adult patients.

2. What you need to know before taking DONEPEZIL ALMUS 5 mg FILM-COATED TABLETS

Do not take Donepezil Almus

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

Warnings and precautions

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

Treatment with donepezil should only be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease.

Inform your doctor if:

• you have ever had a stomach 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 heartbeat, heart failure, myocardial infarction, sick sinus syndrome, or any other condition affecting heart rhythm), as donepezil may slow down the heart rate.
• you have a heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if someone in your family has "QT interval prolongation".
• you have low levels of magnesium or potassium in the blood.
• you have asthma or another chronic lung disease.
• you have ever had liver problems.
• you have difficulty urinating.
• you are scheduled for surgery requiring general anesthesia, as it may be necessary to adjust the dose of anesthetic medication.

Taking Donepezil Almus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important to inform your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems, for example amiodarone or sotalol.
• medicines for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine.
• medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone.
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin.
• antifungal medicines, such as ketoconazole.
• other medicines for Alzheimer's disease, for example, galantamine.
• painkillers or arthritis treatments, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac.
• anticholinergic medicines, e.g., tolterodine.
• anticonvulsants, e.g., phenytoin, carbamazepine.
• medications for heart disease, for example quinidine, beta-blockers (propranolol and atenolol).
• muscle relaxants, e.g., diazepam, succinylcholine.
• general anesthetics.
• over-the-counter medicines, for example, herbal remedies.

Taking Donepezil Almus with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Donepezil Almus 5 mg during pregnancy.

Inform your doctor if you are breastfeeding. You must not use Donepezil Almus 5 mg if you are breastfeeding.

Driving and using machines

Donepezil Almus and the disease itself may affect your ability to drive or operate machinery. This medicine may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment, and if this occurs, you should not drive or operate machinery. You should speak with your doctor before engaging in such activities.

Donepezil Almus 5 mg film-coated tablets contain lactose. 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 ALMUS 5 mg TABLETS

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your dose may vary depending on how long you have been taking the medicine and on your doctor's recommendation.

You will usually start by taking one tablet (5 mg of donepezil hydrochloride) each night. After one month, your doctor may instruct 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 formulation, other strengths of this medicine are available.

Take donepezil 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 Almus in the morning.

Dose adjustment is not necessary if you have kidney problems.

For adults with moderate liver disease, your doctor may adjust your dose.

If you have severe liver problems, you should exercise special caution with donepezil (see section 2 "Before taking Donepezil Almus"). In cases of unexplained liver abnormalities during treatment with donepezil, discontinuation of Donepezil Almus should be considered.

Use in children and adolescents

Donepezil is not recommended for use in children or adolescents.

Always follow your doctor's instructions regarding how and when to take your medicine. Do not change the dose unless instructed by your doctor. Do not stop taking the tablets unless your doctor tells you to do so.

Your doctor will advise you on how long to take the treatment. You should visit your doctor regularly to review your treatment and assess your symptoms.

If you take more Donepezil Almus than you should

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

Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, difficulty breathing, muscle weakness, fainting, and seizures.

In case of accidental ingestion, contact the toxicology information service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Donepezil Almus

Do not take a double dose to make up for a missed dose.

If you forget to take a tablet, take one tablet the following day at your usual time. If you have missed taking your medicine for more than one week, consult your doctor before taking any further medicine.

If you stop taking Donepezil Almus

When treatment with Donepezil Almus is stopped, 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 do so.

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

4. Possible adverse effects

Like all medicines, Donepezil Almus may cause adverse effects, although not everyone experiences them.

The frequency of adverse 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

Serious adverse effects:

If you, as a patient, experience fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder known as "neuroleptic malignant syndrome"), you must consult your doctor immediately, as you may require urgent medical treatment.

Seek immediate medical advice if you experience any of these serious adverse effects. You may require urgent medical treatment.

• Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a fever, or have dark-colored 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 adverse effects (may affect more than 1 in 10 people):

• Diarrhea
• Nausea
• Headache

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

• Common cold
• Loss of appetite
• Hallucinations, aggressive behavior, agitation, which may resolve with a dose reduction or discontinuation of treatment
• Dizziness, somnolence, fainting
• Vomiting, abdominal discomfort
• Itching, rash
• Muscle cramps
• Urinary incontinence
• Fatigue, pain
• Accidents

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

• Seizures
• Slow heart rate
• Gastrointestinal bleeding, stomach and duodenal ulcers
• Slight increase in serum concentration of muscle creatine kinase

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

• Muscle stiffness or uncontrollable movements, especially of the face, tongue, and limbs
• Heart disorders
• Liver disorders including hepatitis

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

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation."
• 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 contractions with abnormal sideways bending of the body and head).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if you suspect possible adverse effects 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 ALMUS 5 mg tablets

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use Donepezil Almus after the expiry date stated on the packaging. 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 point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Almus

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

Appearance of the product and contents of the pack

Donepezil Almus 5 mg film-coated tablets are round, biconvex, white tablets, marked with “DZ 5” on one side.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Italy: Donepezil Almus 5 mg film-coated tablets

Date of the most recent revision of this leaflet: 11/2022

Detailed and up-to-date 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/