DONEPEZIL UR 10 mg FILM-COATED TABLETS

2. What you need to know before you take Donepezil UR

Do not take Donepezil UR:

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking donepezil if you have or have had:

? stomach or duodenal ulcers;

? seizures;

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

? 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;

? asthma or other chronic lung disease;

? liver or hepatitis problems;

? difficulty urinating or mild kidney disease.

Also, tell 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).

Other medicines and donepezil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that your doctor has not prescribed for you but you have bought yourself. This also applies to medicines that you might take in the future if you continue to take donepezil. This is because these medicines may reduce or increase the effects of donepezil.

In particular, it is important that you tell 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, e.g., citalopram, escitalopram, amitriptyline, fluoxetine;

• medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone;
• medicines for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;

? other medicines for treating Alzheimer's disease, e.g., galantamine;

? painkillers or treatments for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;

? anticholinergic medicines, such as tolterodine;

? anticonvulsants, e.g., phenytoin, carbamazepine;

? medication for heart disease, e.g., quinidine, beta-blockers (propranolol and atenolol);

? muscle relaxants, e.g., diazepam, succinylcholine;

? general anesthetic;

? medicines obtained without a prescription, e.g., herbal remedies.

If you are going to have surgery that requires general anesthesia, you should tell your doctor and anesthetist 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. Tell 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 change the effect of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Donepezil should not be used during breastfeeding.

Driving and using machines

Alzheimer's disease may affect your ability to drive or use 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, you should not drive or use machines.

Donepezil UR contains lactose.

Each 10 mg donepezil hydrochloride film-coated tablet contains approximately 150.71 mg of lactose.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Donepezil UR

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Initially, the recommended dose is 5 mg at night. After one month of treatment, your doctor may tell you to increase the dose to 10 mg at night. If in 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 Donepezil UR in the morning.

The dose of the tablet you will take may change depending on the period you have been taking the medicine and the 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).

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 leaflet and any remaining tablets with you.

Symptoms of overdose may include feeling sick, 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, stating the medicine and the amount taken.

If you forget to take Donepezil

If you forget to take your medicine, take it the next day at the usual time. Do not take a double dose if you forget to take a tablet. If you forget to take your medicine for more than one week, tell 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 on the use of this product, ask your doctor or pharmacist.

How long will you need to take donepezil?

Your doctor or pharmacist should advise you on how long you will need to 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.

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

Serious side effects:

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

• liver damage, e.g., 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).
• stomach or duodenal ulcers. 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, particularly if you also feel unwell, have a fever, or dark urine. This could be due to an abnormal breakdown of muscle that 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,

? discomfort,

? 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,
• increased salivation.

Rare: may affect up to 1 in 1000 patients

• tremor,
• rigidity, 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",
• fast 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Information 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 expiry date which is stated on the carton, blister, or bottle after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any 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 required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil UR 10 mg film-coated tablets

The active substance is donepezil hydrochloride.

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

The other ingredients are:

Core of the tablet:

Lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate.

Film coating:

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

Appearance of the product and contents of the pack

White, round, film-coated tablets, approximately 9.3 mm in diameter, with a score line on one side.

The tablet can be divided into two equal halves.

The pack sizes are:

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 leaflet was approved in December 2021

This 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/