Package Leaflet: Information for the User

Donepezilo UR 10 mg Film-Coated TabletsEFG Donepezilo 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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before taking Donepezilo UR

3. How to take Donepezilo UR

4. Possible side effects

5. Storage of Donepezilo UR

6. Contents of the pack and additional information

Donepezilo UR contains the active ingredient hydrochloride of donepezilo. Donepezilo (hydrochloride of donepezilo) belongs to the group of medicines called acetylcholinesterase inhibitors.

Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by means of the decrease in the speed of decomposition of this substance.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

The symptoms include an increase in memory loss, confusion, and changes in behavior. As a result, suffering from Alzheimer's disease makes it difficult to develop daily life activities.

Donepezilo is used only in adult patients.

Do not take Donepezilo UR:

?If you are allergic to donepezilo hydrochloride, or derivatives of piperidina or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take donepezilo if you have or have had:

?Stomach or duodenal ulcers;

?Convulsions;

?Cardiac disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction);

?Cardiac disease called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsade 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 other chronic lung disease;

?Liver problems or hepatitis;

?Difficulty urinating or mild kidney disease.

Also inform your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Donepezilo is not recommended for children and adolescents (under 18 years).

Other medications and donepezilo

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication. This includes medications that your doctor has not prescribed but you have bought at the pharmacy. This also applies to medications you may take in the future if you continue to take donepezilo. This is because these medications may decrease or enhance the effects of donepezilo.

Especially, it is essential to inform your doctor if you are taking any of the following types of medications:

?Medications for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine);

?Medications for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine;

• Medications for psychosis, e.g. pimozide, sertindol or ziprasidone;
• Medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;

?Other medications to treat Alzheimer's disease, for example galantamine;

?Analgesics or treatments for arthritis, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;

?Anticholinergic medications, such as 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 anesthetic;

?Over-the-counter medications, for example, herbal remedies.

If you are to undergo surgery that requires general anesthesia, inform your doctor and anesthesiologist that you are taking donepezilo as this may affect the amount of anesthetic needed.

Donepezilo may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not take donepezilo.

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

Taking donepezilo with food, drinks, and alcohol:

Foods do not affect the effect of donepezilo.

Donepezilo should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, breastfeeding, and fertility

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

Donepezilo should not be used during breastfeeding.

Driving and operating machinery

Alzheimer's disease may affect the ability to drive or operate machinery; therefore, do not perform these activities unless your doctor specifies that it is safe to do so. Additionally, the medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these adverse effects, do not drive or operate machinery.

Donepezilo UR contains lactose.

Each coated donepezilo hydrochloride 10 mg tablet contains approximately 150.71 mg of lactose.

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. The initial recommended dose is 5 mg at night. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg at night. In case of doubt, consult your doctor or pharmacist again.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezilo UR in the morning

The dose of the tablet you will take may change depending on the period you have taken the medication and the doctor's recommendation. The maximum recommended dose is 10 mg/day. Do not modify the dose without consulting your doctor.

How to Take This Medication

Swallow the donepezilo tablet with water before going to bed at night.

Use in Children and Adolescents

Donepezilo is not recommended for use in children and adolescents (under 18 years)

If You Take More Donepezilo Than You Should

Contact your doctor or the nearest emergency hospital if you take more medication than you should. Bring with you this leaflet and any remaining tablets.

The symptoms of overdose may include feeling sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness when standing up), breathing problems, loss of consciousness, and seizures.

You can also consult the toxicology information service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Donepezilo

If you forget to take the medication, take the next one the following day at the usual time. Do not take a double dose if you forgot to take a tablet. If you forget to take your medication for more than a week, inform your doctor before taking any medication.

If You Stop Taking Donepezilo

Do not stop taking the tablets unless your doctor tells you to. If you stop taking donepezilo, the benefits of treatment will gradually disappear.

If you have more questions about the use of this medication, consult your doctor or pharmacist.

How Long Should You Take Donepezilo?

Your doctor or pharmacist should advise you on how long you should be taking your tablets. You will need to see your doctor to review your treatment and evaluate your symptoms.

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

The following side effects have been reported by people taking donepezil.

Tell your doctor if you experience any of these side effects during treatment with donepezil.

Severe side effects:

You must inform your doctor immediately if you notice any of the severe side effects listed. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling unwell, loss of appetite, general feeling of illness, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 patients).

• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 patients).

• Bleeding in the stomach or intestines. This can cause black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 patients).

• Seizures or convulsions (may affect up to 1 in 100 patients).

• 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 patients).

• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 patients).

Very common: may affect more than 1 in 10 patients

?diarrhea,

?feeling unwell,

?headache.

Common: may affect up to 1 in 10 patients

• muscle cramps,
• fatigue,
• difficulty sleeping (insomnia),
• common cold,
• loss of appetite,
• hallucinations (seeing or hearing things that are not real),
• abnormal dreams and nightmares,
• agitation,
• aggressive behavior,
• syncope,
• dizziness,
• abdominal discomfort,
• eruption,
• itching,
• urinary incontinence,
• pain,
• accidents (patients may be more prone to falls and accidental injuries).

Uncommon: may affect up to 1 in 100 patients

• decreased heart rate,
• excessive salivation.

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

• tremor,
• stiffness, tremor, or uncontrolled movement, especially of the face and tongue, but also of the limbs.

Frequency not known:

• changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval",
• rapid and irregular heartbeat, fainting that may be a symptom of a potentially fatal condition called torsade de pointes.
• Increased libido, hypersexuality
• Torticollis (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

Do not use this medication after the expiration date that appears on the packaging, in the blister pack or bottle after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Donepezilo UR 10 mg film-coated tablets

The active ingredient is donepezil hydrochloride.

Each tablet contains 10 mg of donepezil hydrochloride equivalent to 9.12 mg of donepezil.

The other components are:

Core tablet:

Lactose monohydrate, cornstarch, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate.

Film coating:

Hydroxypropyl methylcellulose (E464), titanium dioxide (E171), propylene glycol, talc.

Appearance of the product and content of the container

White, round, film-coated tablets with a diameter of approximately 9.3 mm and a dividing line on one face.

The tablet can be divided into two equal halves.

The formats are as follows:

14, 28, 42, 56, 84, 98, 112 tablets

Only some container sizes may be commercially available.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara,

123 51 Athens

Greece

Or

Laboratorios Medicamentos Internacionales S.A. (MEDINSA)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This leaflet was approved in December 2021

This leaflet was revised in March 2023

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