ESLIBON 400 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Eslibon, 200 mg, tablets
3. Eslibon, 400 mg, tablets
4. Eslibon, 600 mg, tablets
5. Eslibon, 800 mg, tablets
   1. Table of contents of the leaflet
6. What is Eslibon and what is it used for
7. Important information before taking Eslibon
   1. When not to take Eslibon
   2. Warnings and precautions
   3. Children
   4. Eslibon and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Eslibon contains sodium
8. How to take Eslibon
   1. Taking a higher dose of Eslibon than recommended
   2. Missing a dose of Eslibon
   3. Stopping Eslibon
9. Possible side effects
   1. Reporting side effects
10. How to store Eslibon
11. Contents of the packaging and other information
    1. What Eslibon contains
    2. What Eslibon looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. For more information, please contact the marketing authorization holder:
    6. Date of last revision of the leaflet: 28.07.2022

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 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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 (add-on 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).

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

2. Important information before taking Eslibon

When not to take Eslibon

• if you are 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 you have 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 you experience such thoughts while taking Eslibon, you should contact your doctor immediately.
Before starting to take Eslibon, you should discuss this with your doctor or pharmacist.
You should immediately inform your doctor:

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

You should inform your doctor:

• if you have kidney problems; your doctor may decide to adjust the dose of Eslibon; it is not recommended to take Eslibon if you have severe kidney problems;
• if you have liver problems; it is not recommended to take Eslibon if you have severe liver problems;
• if you are taking any medicine that may affect the heart's electrical activity (ECG), known as PR interval prolongation; if you are unsure whether the medicine you are taking may have this effect, you should ask your doctor;
• if you have heart disease, such as heart failure or heart attack, or any heart rhythm disorders;
• if you 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. You should be particularly careful when taking Eslibon to avoid accidental injuries, such as falls.
In patients of Han Chinese or Thai origin, it is possible to predict the risk of serious skin reactions associated with the use of carbamazepine or chemically related compounds by testing a blood sample from such patients. Your doctor should advise you 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

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

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

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

Pregnancy and breastfeeding

Eslibon should not be used in pregnant women, as the effect of Eslibon on pregnancy and the unborn child is not known.
If you plan to become pregnant, you should discuss this with your doctor before stopping contraception and before becoming pregnant. Your doctor may decide to change your treatment.
There are limited data 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.
You should immediately inform your doctor if you are pregnant or think you may be pregnant. You should not stop taking Eslibon without discussing it with your doctor. Stopping Eslibon suddenly may cause seizures, which can be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing age and do not plan to become pregnant, you 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 you use another safe and effective method of contraception. You should discuss with your doctor the most suitable type of contraception to use while taking Eslibon. After stopping Eslibon, you should continue to use effective contraception until the end of the current menstrual cycle.
If you take Eslibon during pregnancy, your child is also at risk of bleeding problems shortly after birth. Your doctor may give you and your child a medicine to prevent this.
You should not breastfeed while taking Eslibon. 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 you experience such symptoms, you should not drive, use machines, or operate equipment.

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 your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Adults
Initial dose
400 mg once a day for one or two weeks, before increasing to a maintenance dose.
Your doctor will decide whether this dose should be taken for one or two weeks.
Maintenance dose
The usual maintenance dose is 800 mg once a day.
Depending on the individual patient's response to Eslibon, the dose may be increased to 1200 mg once a day. If you are taking Eslibon as the only medicine, your doctor may consider it beneficial for you to take a dose of 1600 mg once a day.
Patient with kidney problems
Patient with kidney problems usually receive a lower dose of Eslibon.
Your doctor will choose a dose suitable for you. It is not recommended to take Eslibon if you have severe kidney problems.
Patient over 65 years of age
If you are elderly and taking Eslibon as the only medicine, a dose of 1600 mg is not suitable for you.
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 weighing 60 kg or more
Children weighing 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. Your doctor or pharmacist can help you choose the right form of the medicine.
Method and route of administration
Eslibon is intended for oral use. 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 you accidentally take a higher dose of Eslibon than recommended, you are at risk of experiencing more seizures or irregular or faster heartbeat. You should immediately contact your doctor or go to the hospital if you experience any of these symptoms. You should take the packaging of the medicine with you. This will allow the doctor to assess what you have taken.

Missing a dose of Eslibon

If you forget to take a tablet, you should do so as soon as possible and continue with the recommended dose. You should not take a double dose to make up for the missed dose.

Stopping Eslibon

You should not stop taking Eslibon suddenly. If you suddenly stop taking Eslibon, there is a risk of increasing the number of seizures. Your doctor will inform you how long you should take Eslibon. If your doctor decides to stop Eslibon, the dose of the medicine will usually be gradually reduced. It is important to complete the treatment as recommended by your doctor, otherwise, your symptoms may worsen.
If you have any further questions about taking this medicine, you should ask your 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 you experience them, you should stop taking Eslibon and immediately inform your doctor or go to the hospital, as you may need urgent treatment:

• rash, difficulty swallowing or breathing, 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 imbalance, spinning, or floating
• nausea or vomiting
• headache
• diarrhea
• double or blurred vision
• difficulty concentrating
• feeling of lack of energy or fatigue
• dizziness
• 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, weight gain, 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 decrease 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
• inability to speak or write or understand speech or writing
• agitation
• hyperkinetic disorder with attention deficit
• irritability
• mood swings or hallucinations
• speech disorders
• nosebleeds
• chest pain
• tingling or numbness of any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• disorders of smell
• tinnitus
• hearing problems
• swelling of the feet or hands
• heartburn, stomach upset, abdominal pain, bloating, or 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, 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 effects 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 abdominal 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)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this 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. You should ask your 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:

G.L. PHARMA POLAND Sp. z o.o.
Jana Pawła II Avenue 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