DONEPEZIL UR 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil UR 5 mg film-coated tablets EFG

donepezil hydrochloride

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1 What is Donepezil UR and what is it used for

2 What you need to know before taking Donepezil UR

3 How to take Donepezil UR

4 Possible side effects

5 Storage of Donepezil UR

6 Contents of the pack and further information

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

Donepezil UR contains the active substance donepezil hydrochloride. Donepezil UR (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the breakdown of this substance.

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

The symptoms include increased memory loss, confusion, and changes in behavior. As a result, having Alzheimer's disease makes it difficult to perform daily activities.

Donepezil is used only in adult patients.

2. What you need to know before taking Donepezil UR

Do not take donepezil

• 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

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

• stomach or duodenal ulcers;
• seizures;
• a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung disease;
• liver or hepatitis problems;
• difficulty urinating or mild kidney disease.

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

Children and adolescents

Donepezil is not recommended for children and adolescents (under 18 years of age).

Other medicines and donepezil

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

In particular, it is important to inform your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine);
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine;
• medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone;
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• other medicines for treating 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, e.g., phenytoin, carbamazepine;
• medicines for heart disease, such as quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, e.g., diazepam, succinylcholine;
• general anesthetics;
• over-the-counter medicines, such as herbal remedies.

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

Donepezil can 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 donepezil.

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

Taking donepezil with food, drinks, and alcohol:

Food does not affect the effect of donepezil.

Donepezil should 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 your medicine.

Donepezil should not be used during breastfeeding.

Driving and using machines

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

Donepezil UR contains lactose.

Each 5 mg tablet of donepezil hydrochloride contains approximately 75.35 mg of 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 UR

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Initially, the recommended dose is 5 mg at night. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg at night.

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

The dose of the tablet you take may change depending on the period you have been taking the medicine and your doctor's recommendation.

The maximum recommended dose is 10 mg/day. Do not change the dose without consulting your doctor.

How to take this medicine

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

Use in children and adolescents

Donepezil is not recommended for children and adolescents (under 18 years of age).

If you take more donepezil than you should

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

Symptoms of overdose may include nausea, drooling, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures.

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

If you forget to take donepezil

If you forget to take your medicine, take the next dose the following day at the usual time. Do not take a double dose to make up for forgotten doses. If you forget to take your medicine for more than one week, inform your doctor before taking any medicine.

If you stop taking donepezil

Do not stop taking the tablets unless your doctor tells you to. If you stop taking donepezil, 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?

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Donepezil UR.

Tell your doctor if you have any of these side effects during treatment with Donepezil UR.

Serious side effects:

You should inform your doctor immediately if you notice any of the serious side effects mentioned below. You may need urgent medical treatment.

• Liver damage, such as hepatitis. The symptoms of hepatitis are feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1000 patients).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 patients).
• Bleeding in the stomach or intestines. This can cause black, tarry 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, especially if you also feel unwell, have a fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening 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,
• nausea,
• headache.

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• slow heart rate,
• excessive salivation.

Rare: may affect up to 1 in 1000 patients

• 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 "prolonged QT interval",
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition called 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)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online reporting system: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil UR

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

Do not use this medicine after the expiration date stated on the carton and blister or bottle after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Donepezil UR 5 mg film-coated tablets

The active substance is donepezil hydrochloride.

Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.

The other ingredients are:

Core of the tablet:

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

Coating:

Hypromellose (E464), titanium dioxide (E171), propylene glycol, talc.

Appearance and packaging of the product

White, round, film-coated tablets, approximately 7.5 mm in diameter.

The following pack sizes are available:

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

Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26, 28850 Torrejón de Ardoz, Madrid, Spain.

Manufacturer

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 package leaflet was approved in December 2021

This package leaflet was revised in March 2023

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