Prospect: information for the user

Donepezilo UR 5 mg film-coated tablets EFG

donepezilo hydrochloride

Read this prospect carefully before starting to take the medicine,because it contains important information for you

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist even if they do not appear in this prospect. See section 4.

1What is Donepezilo UR and for what it is used

2What you need to know before starting to take Donepezilo UR

3How to take Donepezilo UR

4Possible adverse effects

5Storage of Donepezilo UR

6Contents of the package and additional information

Donepezilo UR contains the active ingredient hydrochloride of donepezilo. Donepezilo UR (hydrochloride of donepezilo) belongs to the group of medications called cholinesterase 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 donepezil

• If you are allergic to donepezil 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 donepezil if you have or have had:

• stomach or duodenal ulcers;
• convulsions;
• 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 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

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

Other medications and donepezil

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 that you may take in the future if you continue to take Donepezil. This is because these medications may reduce or enhance the effects of Donepezil.

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, sertindole, 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 anesthetics;
• 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 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.

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

Donepezil intake with food, drinks, and alcohol:

Foods do not affect the effect of donepezil.

Donepezil 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, or intend to become pregnant, consult your doctor or pharmacist before using your medication.

Donepezil 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. Also, the medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these adverse effects, do not drive or operate machinery.

Donepezil UR contains lactose.

Each 5 mg donepezil hydrochloride tablet contains approximately 75.35 mg of lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. 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.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking 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 old).

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 this leaflet and any remaining tablets with you.

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

You can also contact 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 it the next day at the usual time. Do not take a double dose to compensate for the missed doses. 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 any further 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 take the tablets. You will need to see your doctor to review your treatment and evaluate your symptoms.

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

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

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

Severe side effects:

You must inform your doctor immediately if you notice any of the serious side effects mentioned below. 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 may 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 dark urine. 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,
• uncomfortable feeling,
• 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

• 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 symptoms 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 Vigilance 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 and in the blister or bottle after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the 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 ofDonepezilo UR 5 mg coated tablets

The active ingredient is hydrochloride of donepezilo

Each tablet contains 5 mg of hydrochloride of donepezilo equivalent to 4.56 mg of donepezilo.

The other components are:

Tablet core:

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

Coating:

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

Appearance of the product and contents of the packaging

White, round, coated tablets with a diameter of approximately 7.5 mm

The formats are as follows:

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

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 2628850,

Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara,

123 51 Athens

Greece

O

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 reviewed in March 2023

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