Package Leaflet: Information for the user

LIXBEN 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Lixbencontains the active ingredient donepezil hydrochloride.

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

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

Do not takeLixben:

• if you are allergic to hydrochloride donepezil, piperidine derivatives, or any of the components of this medication (listed in section 6).

Warnings and precautions

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

• stomach or duodenal ulcers
• heart disease (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
• seizures
• asthma or chronic lung disease
• difficulty urinating or mild kidney disease.

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

Other medications and Lixben

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially if you are taking any of the following medications:

-medications for heart rhythm problems, for example amiodarone or sotalol

-medications for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine

-medications for psychosis, for example pimozide, sertindole, or ziprasidone

-medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin

-antifungal medications, such as ketoconazole

-other medications to treat Alzheimer's disease, for example galantamine

-pain relievers or treatments for arthritis such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.

-quinidine and beta-blockers for treating irregular heartbeats such as propranolol and atenolol

-phenytoin and carbamazepine (for treating epilepsy)

-cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system) such as tolterodine

-succinylcholine, diazepam, and other neuromuscular blockers (to produce muscle relaxation)

-general anesthesia

In the event of surgery with general anesthesia, inform your doctor that you are taking Lixben as this may affect the amount of anesthetic needed.

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

Taking Lixben with food, drinks, and alcohol:

This medication should be taken with a little water.

Lixben 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, consult your doctor or pharmacist before using this medication

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

Driving and operating machinery:

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Lixben may cause fatigue, dizziness, drowsiness, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

This medication contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Lixbenis administered orally.

Treatment withLixbenbegins with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.

If you have 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 liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can take Lixben. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease (a disease that affects the liver) should not take Lixben.

Use in children

Lixben is not recommended for use in children.

If you take moreLixbenthan you should

If you have taken moreLixbenthan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The symptoms of overdose may include nausea (feeling sick), vomiting (being sick), drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing problems, loss of consciousness, and seizures.

If you forgot to takeLixben

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

If you interrupt the treatment with Lixben

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The estimated frequency of their occurrence is as follows:

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

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

Severe side effects:

You must inform your doctor immediately if you notice the following severe side effects mentioned, as you may need urgent medical treatment.

•Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea or vomiting (feeling or being sick), loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark urine (affecting between 1 and 10 in 10,000).

•Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (affecting between 1 and 10 in 1,000).

•Bleeding in the stomach or intestine. This may cause you to have black, tar-like stools or visible blood from the rectum (affecting between 1 and 10 in 1,000).

•Dizziness (attacks) or convulsions (affecting between 1 and 10 in 1,000).

•Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affecting fewer than 1 in 10,000 patients)

•.Muscle weakness, sensitivity, or pain, particularly if you feel unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of side effects is as follows:

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Discomfort
• Headache

Common: may affect between 1 and 100 patients.

• Cold
• 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 of every 1,000 patients:

• Convulsions
• Decreased heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increased levels of a type of enzyme (creatine kinase muscle) in the blood

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

• Extrapyramidal symptoms (such as tremors or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function alteration, including hepatitis

Frequency not known(cannot be estimated from available data

•Increased libido, hypersexuality

•Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

•Changes in heart activity that can be observed on an electrocardiogram (ECG) called "prolongation of the QT interval"

•Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade de pointes.

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.

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

This medication does not require special storage conditions.

Do not useLixbenafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lixben 5 mg tablets

• The active ingredient is donepezilo. Each tablet contains 5 mg of donepezilo hydrochloride.
• The other components are:Core:monohydrate lactose, microcrystalline cellulose,hydroxypropylmethylcellulose, sodium carboxymethyl starch, anhydrous colloidal silica, and magnesium stearate.Covering:Opadry White.

Appearance of the product and contents of the packaging

Lixben 5 mg are film-coated tablets, round, biconvex, and white in color.

They are presented in packs of 28 or 56 tablets.

Other presentations:

Lixben 10 mg film-coated tablets: packs of 28 or 56 tablets.

Holder of the marketing authorization and responsible 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

Last review date of this leaflet:

July 2023

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