Donepezil UR 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Donepezil UR 5 mg prolonged-release film-coated tablets EFG

donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine , because it contains important information for you.

• Keep this leaflet. 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, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1 What Donepezil UR is and what it is used for

2 What you need to know before taking Donepezil UR

3 How to take Donepezil UR

4 Possible side effects

5 How to store Donepezil UR

6 Contents of the pack and other information

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

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

Donepezil increases levels in the brain of a substance involved in memory (acetylcholine), by reducing the rate at which this substance is broken down.

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

Symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, having Alzheimer's disease makes it difficult to carry out daily activities.

Donepezil is used only in adult patients.

2. What you need to know before starting 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

Talk to your doctor or pharmacist before taking 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 "prolongation of the QT interval" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "prolongation of the QT interval";
• low levels of magnesium or potassium in the blood;
• asthma or another chronic lung disease;
• liver problems or hepatitis;
• difficulty urinating or mild kidney disease.

Also inform your doctor if you are pregnant or think you might 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 might need to use any other medicines. This includes medicines your doctor has not prescribed but that you have purchased at the pharmacy. This also applies to medicines you might take in the future while continuing 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;
• painkillers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or sodium diclofenac;
• anticholinergic medicines such as tolterodine;
• anticonvulsants, e.g., phenytoin, carbamazepine;
• medications for heart disease, such as quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, e.g., diazepam, succinylcholine;
• general anesthetics;
• herbal remedies or over-the-counter medicines.

If you are undergoing surgery requiring general anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezil, as this may affect the amount of anesthetic required.

Donepezil can be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not take donepezil.

Inform your doctor or pharmacist of your caregiver's name. Your caregiver will help you take your medicine as prescribed.

Taking donepezil with food, drinks, and alcohol:

Food does not affect the action 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 this medicine.

Donepezil should not be used during breastfeeding.

Driving and using machines

Alzheimer's disease may impair your ability to drive or operate machinery; therefore, you should not perform these activities unless your doctor specifically states it is safe for you to do so. In addition, this medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these side effects, you should not drive or operate machinery.

Donepezil UR contains lactose.

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

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

3. How to take Donepezil UR

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The initial recommended dose is 5 mg taken at night. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg at night.

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

The strength of the tablet you take may change depending on how long 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

The use of donepezil is not recommended in children and adolescents (under 18 years of age).

If you take more donepezil than you should

Contact your doctor or go to 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 unwell, drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

You may also 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

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

If you stop taking donepezil

Do not stop taking the tablets unless instructed by your doctor. If you stop taking donepezil, the benefits of treatment will gradually disappear.

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

How long should you take Donepezil?

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

4. Possible adverse effects

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

The following adverse effects have been reported in people taking Donepezil UR.

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

Serious adverse effects:

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

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (may affect up to 1 in 1,000 patients).
• Stomach or duodenal ulcers. Symptoms of ulcers include 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 may cause black, tarry stools or visible rectal bleeding (may affect up to 1 in 100 patients).
• Epileptic seizures or convulsions (may affect up to 1 in 100 patients).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (these 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 fever, or dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (may affect up to 1 in 10,000 patients).

Very common: may affect more than 1 in 10 patients

• diarrhoea,
• 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 behaviour,
• 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

• slowing of the heart rate,
• increased salivation.

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

• stiffness, tremor, or uncontrollable movements, especially of the face and tongue, but also of the limbs.

Frequency not known:

• 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 contraction leading to abnormal lateral flexion of the body and head)

Reporting of adverse effects

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

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other 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 components are:

Tablet core:

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

Film coating:

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

Appearance of the medicinal product and contents of the pack

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

Pack sizes are as follows:

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

Only certain 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/