Eslibon

Leaflet included in the packaging: patient information

Eslibon, 200 mg, tablets

Eslibon, 400 mg, tablets

Eslibon, 600 mg, tablets

Eslibon, 800 mg, tablets

Eslicarbazepine acetate
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you personally; do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Eslibon and what is it used for
• 2. Important information before taking Eslibon
• 3. How to take Eslibon
• 4. Possible side effects
• 5. How to store Eslibon
• 6. Contents of the packaging and other information

1. What is Eslibon and what is it used for

Eslibon contains the active substance eslicarbazepine acetate.
Eslibon belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition where the patient has repeated epileptic seizures (fits).
Eslibon is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• with other antiepileptic medicines (adjunctive therapy) in adult patients, adolescents, and children over 6 years of age who have partial seizures (seizures that affect only part of the brain). These seizures may or may not spread to become generalized seizures (secondary generalization).

The doctor has prescribed Eslibon to reduce the number of seizures.

2. Important information before taking Eslibon

When not to take Eslibon

• if the patient is allergic to eslicarbazepine acetate, to other carbamazepine derivatives (e.g., carbamazepine or oxcarbazepine - medicines used to treat epilepsy), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has certain heart rhythm disorders (second or third degree atrioventricular block).

Warnings and precautions

In a small number of people treated with antiepileptic medicines, thoughts of self-harm or suicide have occurred. If such thoughts occur while taking Eslibon, the patient should immediately contact their doctor.
Before starting to take Eslibon, the patient should discuss this with their doctor or pharmacist.
The patient should immediately inform their doctor:

• if they experience a rash, difficulty swallowing, or breathing, or swelling of the lips, face, throat, or tongue; these may be signs of an allergic reaction;
• if they experience confusion, increased seizures, or reduced consciousness, which may indicate low sodium levels in the blood.

The patient should inform their doctor:

• if they have kidney problems; the doctor may decide to adjust the dose of Eslibon; Eslibon is not recommended for patients with severe kidney problems;
• if they have liver problems; Eslibon is not recommended for patients with severe liver problems;
• if they are taking any medicine that may affect the heart's electrical activity (ECG), known as prolongation of the PR interval; if the patient is unsure whether the medicine they are taking may have this effect, they should ask their doctor;
• if they have heart disease, such as heart failure or heart attack, or any heart rhythm disorders;
• if they have seizures that start with a widespread electrical discharge involving both sides of the brain.

Eslibon may cause dizziness and (or) drowsiness, especially at the beginning of treatment. The patient should be particularly careful when taking Eslibon to avoid accidental injuries, such as falls.
In patients of Han Chinese or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by testing a blood sample from such patients. The doctor should advise the patient whether a blood test is necessary before taking Eslibon.

Children

Eslibon should not be given to children under 6 years of age.

Eslibon and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as they may interfere with the action of Eslibon or Eslibon may interfere with the action of these medicines.
The patient should inform their doctor if they are taking:

• phenytoin (a medicine used to treat epilepsy), as a dose adjustment may be necessary;
• carbamazepine (a medicine used to treat epilepsy), as a dose adjustment may be necessary, and side effects caused by Eslibon, such as double vision, lack of coordination, and dizziness, may occur more frequently;
• hormonal contraceptives (such as birth control pills), as Eslibon may reduce their effectiveness;
• simvastatin (a medicine that lowers cholesterol levels), as a dose adjustment may be necessary;
• rosuvastatin, a medicine used to lower cholesterol levels;
• warfarin, a medicine that reduces blood clotting;
• tricyclic antidepressants, such as amitriptyline;
• Eslibon should not be taken with oxcarbazepine (a medicine used to treat epilepsy), as it is not known whether taking these medicines together is safe.

Information on the use of contraceptives can be found in the section "Pregnancy and breastfeeding".

Pregnancy and breastfeeding

Eslibon should not be taken by women who are pregnant, as the effect of Eslibon on pregnancy and the unborn child is not known.
If the patient plans to become pregnant, they should discuss this with their doctor before stopping contraception and before becoming pregnant. The doctor may decide to change the treatment.
There is limited information on the use of eslicarbazepine acetate in pregnant women.
Studies have shown an increased risk of birth defects and neurodevelopmental problems (brain development) in children of mothers taking antiepileptic medicines, especially when taking more than one antiepileptic medicine at the same time.
The patient should immediately inform their doctor if they are pregnant or think they may be pregnant. The patient should not stop taking Eslibon before discussing it with their doctor. Stopping Eslibon suddenly may cause seizures, which can be dangerous for the patient and their unborn child. The doctor may decide to change the treatment.
If the patient is a woman of childbearing age and does not plan to become pregnant, she should use effective contraception during treatment with Eslibon. Eslibon may affect the effectiveness of hormonal contraceptives, such as birth control pills, and make them less effective in preventing pregnancy. Therefore, during treatment with Eslibon, it is recommended that the patient use another safe and effective method of contraception. The patient should discuss with their doctor the most suitable type of contraception to use while taking Eslibon. After stopping treatment with Eslibon, the patient should continue to use effective contraception until the end of the current menstrual cycle.
If the patient takes Eslibon during pregnancy, their child is also at risk of bleeding problems shortly after birth. The doctor may give the patient and child a medicine to prevent this.
The patient should not breastfeed while taking Eslibon, as it is not known whether the medicine passes into human milk.

Driving and using machines

Eslibon may cause dizziness, drowsiness, and affect vision, especially at the beginning of treatment. If the patient experiences these symptoms, they should not drive, use machines, or perform any activities that require attention.

Eslibon contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means it is essentially "sodium-free".

3. How to take Eslibon

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should ask their doctor or pharmacist.
Adults
Initial dose
400 mg once a day for one or two weeks, before increasing to a maintenance dose.
The doctor will decide whether this dose will be taken for one or two weeks.
Maintenance dose
The usual maintenance dose is 800 mg once a day.
Depending on the patient's individual response to Eslibon, the dose may be increased to 1200 mg once a day. If the patient is taking Eslibon as the only medicine, the doctor may consider a dose of 1600 mg once a day to be beneficial for the patient.
Patient with kidney problems
Patient with kidney problems usually receive a lower dose of Eslibon.
The doctor will choose a dose suitable for the patient. Eslibon is not recommended for patients with severe kidney problems.
Patient over 65 years of age
If the patient is elderly and taking Eslibon as the only medicine, a dose of 1600 mg is not suitable for the patient.
Children over 6 years of age
Initial dose
The initial dose of Eslibon is 10 mg per kilogram of body weight taken once a day for one or two weeks, before increasing to a maintenance dose.
Maintenance dose
Depending on the response to Eslibon, the dose may be increased by 10 mg per kilogram of body weight every one or two weeks, up to a maximum of 30 mg per kilogram of body weight. The maximum dose is 1200 mg once a day.
Children with a body weight of 60 kg or more
Children with a body weight of 60 kg or more should take the same dose as adults.
For children, other forms of the medicine, such as an oral suspension, may be suitable. The doctor or pharmacist can help choose the right form of the medicine.
Method and route of administration
Eslibon is intended for oral administration. The tablets should be swallowed with a glass of water.
Eslibon tablets can be taken with or without food.

Taking a higher dose of Eslibon than recommended

If the patient accidentally takes a higher dose of Eslibon than recommended, they are at risk of experiencing more seizures or irregular or faster heartbeat. The patient should immediately contact their doctor or go to the hospital if they experience any of these symptoms. The patient should take the packaging of the medicine with them, so the doctor can assess what the patient has taken.

Missing a dose of Eslibon

If the patient forgets to take a tablet, they should do so as soon as possible and continue with the recommended dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Eslibon

The patient should not stop taking Eslibon suddenly. If the patient stops taking Eslibon suddenly, there is a risk of increasing the number of seizures. The doctor will inform the patient how long to take Eslibon. If the doctor decides to stop treatment with Eslibon, the dose of the medicine will usually be gradually reduced. It is essential to complete the treatment as recommended by the doctor; otherwise, the symptoms may worsen.
If the patient has any further doubts about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eslibon can cause side effects, although not everybody gets them.
The following side effects may be very serious. If the patient experiences them, they should stop taking Eslibon and immediately inform their doctor or go to the hospital, as urgent treatment may be necessary:

• rash, difficulty swallowing, or breathing, or swelling of the lips, face, throat, or tongue. These may be signs of an allergic reaction;

Very commonside effects (may affect more than 1 in 10 people):

• dizziness or drowsiness

Commonside effects (may affect up to 1 in 10 people):

• feeling of lack of balance, spinning, or floating
• nausea or vomiting
• headache
• diarrhea
• double or blurred vision
• difficulty concentrating
• feeling of lack of energy or fatigue
• agitation
• skin rash
• blood tests showing low sodium levels in the blood
• decreased appetite
• sleep disturbances
• difficulty with coordination (ataxia)
• weight gain.

Uncommonside effects (may affect up to 1 in 100 people):

• clumsiness
• allergy
• constipation
• seizures
• hypothyroidism; symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, swelling of the thyroid gland, thinning or brittle hair or nails, and low body temperature
• liver disorders (such as increased liver enzyme activity)
• high blood pressure or significant increase in blood pressure
• low blood pressure or drop in blood pressure when standing up
• blood tests showing low levels of salts (including chlorides) in the blood or decreased blood cell count
• dehydration
• eye movement disorders, blurred vision, or eye redness
• falls
• heat stroke
• memory disorders or forgetfulness
• crying, feeling depressed, nervous, or confused, lack of interest or emotions
• difficulty speaking or writing or understanding speech or writing
• excitement
• hyperkinetic disorder with attention deficit
• irritability
• mood swings or hallucinations
• speech disorders
• nosebleeds
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• disorders of smell
• tinnitus
• hearing problems
• swelling of the legs or arms
• heartburn, stomach upset, stomach pain, bloating, and discomfort or dry mouth
• dark stools
• gum inflammation or toothache
• sweating or dry skin
• flushing
• skin changes (e.g., skin redness)
• hair loss
• urinary tract infections
• general weakness, malaise, or chills
• weight loss
• muscle pain, joint pain, muscle weakness
• bone metabolism disorders
• increased bone protein levels
• sudden flushing of the face, cold extremities
• slower or irregular heartbeat
• feeling of uncontrolled drowsiness
• sedation
• neurological movement disorders, characterized by muscle spasms causing twisting movements or repetitive movements, or abnormal posture; symptoms include tremors, pain, spasms
• toxic effect of the medicine
• cancer.

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

• decreased platelet count, increasing the risk of bleeding or bruising
• severe back and stomach pain (caused by pancreatitis)
• decreased white blood cell count, making it easier to get infections
• drug reaction with eosinophilia and systemic symptoms (DRESS): symptoms may include skin rash, fever, fatigue, swelling of lymph nodes, increased eosinophil count (a type of white blood cell), and liver, kidney, or lung disorders; DRESS may develop several weeks after starting treatment.
• lethargy, confusion, muscle seizures, or significant increase in seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion)

Taking Eslibon is associated with abnormal ECG (electrocardiogram) readings, known as prolongation of the PR interval. Side effects associated with this abnormal ECG reading may occur (e.g., fainting or slower heart rate).
There have been reports of bone tissue disorders, including osteopenia and osteoporosis (decreased bone mass) and fractures, associated with long-term use of similar antiepileptic medicines, such as carbamazepine and oxcarbazepine. If the patient is taking antiepileptic medicines for a long time, has a history of osteoporosis, or is taking steroid medicines, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Eslibon

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eslibon contains

• The active substance is eslicarbazepine acetate. Eslibon 200 mg: each tablet contains 200 mg of eslicarbazepine acetate. Eslibon 400 mg: each tablet contains 400 mg of eslicarbazepine acetate. Eslibon 600 mg: each tablet contains 600 mg of eslicarbazepine acetate. Eslibon 800 mg: each tablet contains 800 mg of eslicarbazepine acetate.
• Other ingredients are: sodium croscarmellose, povidone K 30, magnesium stearate.

What Eslibon looks like and contents of the pack

Eslibon, 200 mg, tablets
White or almost white, oblong, and biconvex tablets with a score line on both sides, approximately 11.8 mm long and 3.9 mm thick. The tablet can be divided into equal doses.
Eslibon, 400 mg, tablets
White or almost white, oblong, and biconvex tablets with a score line on both sides, approximately 15.0 mm long and 4.9 mm thick. The tablet can be divided into equal doses.
Eslibon, 600 mg, tablets
White or almost white, oblong, and biconvex tablets with a score line on both sides, approximately 17.0 mm long and 5.7 mm thick. The tablet can be divided into equal doses.
Eslibon, 800 mg, tablets
White or almost white, oblong, and biconvex tablets with a score line on both sides, approximately 18.9 mm long and 6.1 mm thick. The tablet can be divided into equal doses.
The tablets are packaged in a transparent or opaque PVC/PVDC/Aluminum blister pack in a cardboard box containing 30 tablets.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
{marketing authorization holder logo}

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Delorbis Pharmaceuticals Ltd,
Industrial Area, Athinon 17 V
Ergates, Nicosia 2643
Cyprus

For more information, please contact the marketing authorization holder's representative:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 28.07.2022