Lixben 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

LIXBEN 10 mg 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, 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are serious adverse effects not listed in this leaflet.

Leaflet contents:

1. What Lixben is and what it is used for
2. What you need to know before taking Lixben
3. How to take Lixben
4. Possible side effects
5. How to store Lixben
6. Contents of the pack and other information

1. What Lixben is and what it is used for

Lixben contains the active substance donepezil hydrochloride.

Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases levels in the brain of a substance related to memory (acetylcholine), by slowing down the breakdown of this substance.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and behavioural changes.

2. What you need to know before taking Lixben

Do not take Lixben:

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

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Warnings and precautions

Talk to your doctor before starting to take Lixben if you have or have had:

? a history of stomach or duodenal ulcer

? heart disease (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

? seizures

? asthma or chronic lung disease

? difficulty urinating or mild kidney disease.

You should avoid taking Lixben together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Other medicines and Lixben:

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, especially if you are taking any of the following:

• medicines for heart rhythm problems, for example amiodarone or sotalol
• medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, e.g. pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines for treating Alzheimer's disease, for example, galantamine
• painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• quinidine and beta-blockers for treating irregular heartbeats such as propranolol and atenolol
• phenytoin and carbamazepine (for treating epilepsy)
• cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine, succinylcholine, diazepam, and
• other neuromuscular blockers (to produce muscle relaxation)
• general anesthetics

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

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

Taking Lixben with food, drinks and alcohol:

This medicine should be taken with a glass of water.

Lixben 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Lixben if you are breastfeeding your child.

Driving and using machines:

Your medical condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has advised you that it is safe to do so. Lixben may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

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

3. How to take Lixben

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Lixben is administered orally.

Treatment with Lixben starts with one 5 mg tablet taken once daily with a little water, at night immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg per day.

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

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take Lixben. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take Lixben.

Use in children

The use of Lixben is not recommended in children.

If you take more Lixben than you should

If you have taken more Lixben than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), salivation, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Lixben

Do not take a double dose to make up for forgotten doses.

If you stop taking Lixben

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

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

4. Possible adverse effects

Like all medicines, Lixben may produce adverse effects, although not everyone experiences them.

The following adverse effects have been reported by people taking Lixben.

Contact your doctor if you experience any of these effects during treatment with Lixben.

Serious adverse effects:

You must inform your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment.

? Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (occurs in 1 to 10 out of 10,000 people).

? Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (occurs in 1 to 10 out of 1,000 people).

? Bleeding in the stomach or intestines. This may cause black, tarry stools or visible rectal bleeding (occurs in 1 to 10 out of 1,000 people).

? Dizziness (attacks) or seizures (occurs in 1 to 10 out of 1,000 people).

? Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a condition known as "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 patients).

• Muscle weakness, sensitivity, or pain, particularly if accompanied by feeling unwell, 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 called rhabdomyolysis).

The estimated frequency of occurrence of adverse effects is as follows:

Very common: may affect more than 1 in 10 patients:

• Diarrhea
• Malaise
• Headache

Common: may affect between 1 and 10 out of 100 patients:

• Cold (upper respiratory tract infection)

• Loss of appetite

• Hallucinations

• Agitation

• Aggressive behavior

• Abnormal dreams and nightmares

• Fainting

• Dizziness

• Difficulty sleeping

• Vomiting

• Abdominal discomfort

• Urinary incontinence

• Rash

• Itching

• Muscle cramps

• Fatigue

• Pain

• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect between 1 and 10 out of 1,000 patients:

• Seizures
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

Rare: may affect between 1 and 10 out of 10,000 patients:

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Cardiac conduction disturbances
• Impaired liver function, including hepatitis

Frequency not known (cannot be estimated from available data):

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal bending of the body and head to one side)
• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at website www.notificaRAM.es.

5. Storage of Lixben

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

This medicine does not require any special storage conditions.

Do not use Lixben after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lixben 10 mg tablets

• The active substance is donepezil. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: Core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate from potato, colloidal silicon dioxide, and magnesium stearate. Coating: Opadry White.

Appearance of the product and contents of the pack

Lixben 10 mg are film-coated, round, white tablets.

They are available in packs containing 28 or 56 tablets.

Other pack sizes:

Lixben 5 mg film-coated tablets: packs of 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Date of the most recent revision of this leaflet:

July 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.es/