LIXBEN 5 mg FILM-COATED TABLETS

2. What you need to know before taking Lixben

Do not takeLixben:

• 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

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

• history of 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 a family member has "prolongation of the QT interval"
• low levels of magnesium or potassium in the blood
• seizures
• asthma or chronic pulmonary disease
• difficulty urinating or mild kidney disease.

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

Other medicines and Lixben

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine, especially if you are taking any of the following medicines:

-medicines for heart rhythm problems, such as amiodarone or sotalol

-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

-antifungal medicines, such as ketoconazole

-other medicines for treating Alzheimer's disease, such as galantamine

-pain relievers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like 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 medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine

-succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation)

-general anesthesia

In case of surgical intervention with general anesthesia, you should inform your doctor that you are taking Lixben, as this may affect the amount of anesthetic needed.

Lixben can be used in patients with mild to moderate kidney or liver disease. Inform your doctor before starting treatment if you have kidney or liver problems. Patients with severe liver disease should not take Lixben.

Taking Lixben with food, drinks, and alcohol:

This medicine should be taken with a little 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines:

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

This medicine contains lactose

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

3. How to take Lixben

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Lixben is administered orally.

Treatment with Lixben starts with one 5 mg tablet, taken once a day with a little water, at night, immediately before bedtime. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day, 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 taking Lixben in the morning.

If you have mild or moderate liver or kidney disease, you can take Lixben. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should 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, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

The symptoms of overdose may include nausea, vomiting, drooling, sweating, decreased heart rate, low blood pressure, breathing problems, 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 taking Lixben unless your doctor tells you to. If you stop taking Lixben, the benefits of the treatment will gradually disappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The estimated frequency of their occurrence is as follows:

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

Consult your doctor if you have any of these side effects during treatment with Lixben.

Serious side effects:

You should inform your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment.

• Liver damage, such as hepatitis. The symptoms of hepatitis are nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored 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 can cause you to have black, tarry stools or visible blood from the rectum (affecting between 1 and 10 in 1,000).
• Dizziness (fits) or seizures (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 less than 1 in 10,000 patients)
• Weakness, sensitivity, or muscle pain, particularly if you feel unwell, have a fever, or have dark-colored urine. This may be due to an abnormal destruction of muscle that can be life-threatening and cause kidney problems (a disease 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 in 1,000 patients:

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

Rare: may affect between 1 and 10 in 10,000 patients

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
• Alterations in cardiac conduction
• Liver function disorders, 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 cardiac activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as torsades de pointes.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es.

5. Storage of Lixben

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

This medicine does not require special storage conditions.

Do not use Lixben after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point (at the pharmacy). If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lixben 5 mg tablets

• The active substance is donepezil. Each tablet contains 5 mg of donepezil hydrochloride.
• The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium starch glycolate, colloidal anhydrous silica, and magnesium stearate. Coating:Opadry White.

Appearance of the product and pack contents

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

They are available in packs of 28 or 56 tablets.

Other presentations:

Lixben 10 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 last revision of this package leaflet:

July 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/