Lixben 5 mg film-coated tablets EFG: detailed information

Brand name Lixben 5 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

DONEPEZIL HYDROCHLORIDE · 5 mg

Prescription type Hospital Diagnosis

ATC code

N06D N06DA N06DA02

Registration number 74187

Manufacturer Laboratorios Alter S.A.

Table of Contents

Patient Information Leaflet
Introduction
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 adverse effects
5. Storage of Lixben
6. Contents of the pack and other information

Patient Information Leaflet

Introduction

Patient Information Leaflet

LIXBEN 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read all of 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 and must not be given to other people, even if they have the same symptoms, as 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.

Leaflet contents:

What Lixben is and what it is used for
What you need to know before taking Lixben
How to take Lixben
Possible side effects
How to store Lixben
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 known as acetylcholinesterase inhibitors. Donepezil hydrochloride increases the 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 changes in behaviour.

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 components of this medicine (listed in section 6).

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 heartbeats, heart failure, myocardial infarction)
a heart condition known as "prolongation of the QT interval" or a history of certain abnormal heart rhythms called 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 medicines, 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-blocking medicines 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 anaesthesia

If you are undergoing surgery under general anaesthesia, you must inform your doctor that you are taking Lixben, as this may affect the amount of anaesthetic 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. Lixben must not be taken by patients with severe liver disease.

Taking Lixben with food, drinks and alcohol:

This medicine should be taken with a glass of water.

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

Driving and using machines:

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has told you it is safe to do so. Lixben may cause tiredness, 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

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

3. How to take Lixben

Follow exactly the instructions for administration of this medicine provided 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 some 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/day.

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

You may take Lixben if you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease). 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 Poison 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, slowed 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 missed doses.

If you stop taking Lixben

Do not stop treatment with Lixben unless instructed by your doctor. 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, this medicine can cause adverse effects, although not everyone experiences them. The estimated frequency of occurrence is as follows:

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, and dark-colored urine (affects between 1 and 10 in every 10,000 people).
Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (affects between 1 and 10 in every 1,000 people).
Bleeding in the stomach or intestines. This may cause you to have black, tarry stools or visible rectal bleeding (affects between 1 and 10 in every 1,000 people).
Dizziness (attacks) or seizures (affects between 1 and 10 in every 1,000 people).
Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affects fewer than 1 in every 10,000 patients).
Weakness, tenderness, or muscle pain, particularly if you also feel unwell, have a fever, or have 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 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 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 in every 10,000 patients

Extrapyramidal symptoms (such as tremor or stiffness in 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 flexion of the body and head to one side)
Changes in heart activity that can 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.

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, 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 package. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point (available at pharmacies). If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lixben 5 mg tablets

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

Appearance of the product and contents of the pack

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

They are available in packs of 28 or 56 tablets.