Eslibon

Patient Information Leaflet Included in the Package

Eslibon, 200 mg, tablets
Eslibon, 400 mg, tablets
Eslibon, 600 mg, tablets
Eslibon, 800 mg, tablets
Eslicarbazepini acetas
Please read this leaflet carefully before 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the Leaflet

1. What Eslibon is and what it is 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 pack and other information

1. What Eslibon is and what it is used for

Eslibon contains the active substance eslicarbazepine acetate.
Eslibon belongs to a group of medicines called antiepileptic drugs, used in the treatment of epilepsy, a condition in which patients experience repeated epileptic seizures (convulsions).
The medicine Eslibon is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• in combination with other antiepileptic medicines (add-on therapy) in adult, adolescent, and pediatric patients aged above 6 years who experience partial-onset seizures (seizures affecting part of the brain). These seizures may, but do not necessarily, progress to generalized seizures (secondary generalization).

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

2. Important information before using Eslibon

When not to use Eslibon

• if the patient is allergic to eslicarbazepine acetate, to other carbamoyl derivatives (e.g. carbamazepine or oxcarbazepine – medicines used in the treatment of 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

A small number of people treated with antiepileptic medicines have had thoughts about self-harm or suicide. If such thoughts occur in the patient while taking Eslibon, contact a doctor immediately.
Before starting treatment with Eslibon, discuss this with a doctor or pharmacist.
Inform the doctor immediately:

• if the patient develops a rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue; these may be symptoms of an allergic reaction;
• if the patient experiences confusion, worsening of seizures, or reduced level of consciousness, which may indicate low blood sodium levels.

Inform the doctor:

• if the patient has kidney function disorders; the doctor may decide to adjust the dose of the medicine; Eslibon is not recommended in patients with severe kidney function disorders;
• if the patient has liver function disorders; Eslibon is not recommended in patients with severe liver function disorders;
• if the patient is taking any medicine that may cause abnormalities in the ECG (electrocardiogram), known as PR interval prolongation; if the patient is unsure whether their medicine may have such an effect, they should ask their doctor;
• if the patient has heart disease, e.g. heart failure or heart attack, or any heart rhythm disorders;
• if the patient has seizures that begin with widespread electrical discharges involving both sides of the brain.

Eslibon may cause dizziness and/or drowsiness, especially at the beginning of treatment. Extreme caution should be exercised when taking Eslibon to avoid accidental injuries, such as those caused by falls.
In patients of Han Chinese or Thai descent, the risk of serious skin reactions associated with carbamazepine or chemically related compounds may be predicted by testing a blood sample. The doctor should advise the patient if a blood test is necessary before starting Eslibon.

Children

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

Eslibon and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, as they may interfere with the action of Eslibon or Eslibon may interfere with their action.
The patient should inform the 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 this may require dose adjustment, and the following adverse effects caused by Eslibon may occur more frequently: double vision, lack of coordination, and dizziness;
• hormonal contraceptives (such as birth control pills), as Eslibon may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as this may require dose adjustment;
• rosuvastatin, a medicine used to lower cholesterol levels;
• warfarin – a medicine that reduces blood clotting;
• tricyclic antidepressants, e.g. amitriptyline;
• Do not take oxcarbazepine (a medicine used to treat epilepsy) together with Eslibon, as it is unknown whether concomitant use of these medicines is safe.

Advice on the use of contraceptives is provided in the section "Pregnancy and breastfeeding".

Pregnancy and breastfeeding

Eslibon is not recommended for use in pregnant women, as the effect of Eslibon on pregnancy and the unborn child is unknown.
If the patient plans to become pregnant, she should talk to her doctor before stopping contraception and before becoming pregnant. The doctor may decide to change the treatment.
Limited data are available on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations and neurological development problems (brain development) in children of mothers taking antiepileptic medicines, especially when more than one antiepileptic medicine is taken simultaneously.
Inform the doctor immediately if the patient is pregnant or suspects she may be pregnant. Do not stop taking the medicine without discussing it with the doctor. Stopping the medicine without consulting a doctor may cause seizures, which could be dangerous for the patient and her 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 action of hormonal contraceptives, such as birth control pills, making 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. Discuss with the doctor the most appropriate type of contraception to use during treatment with Eslibon. After stopping treatment with Eslibon, the patient should continue using effective contraception until the end of the current menstrual cycle.
If the patient takes Eslibon during pregnancy, her baby is also at risk of bleeding problems shortly after birth. The doctor may give the patient and the baby a medicine to prevent this.
Do not breast-feed while taking Eslibon. It is not known whether the medicine passes into human milk.

Driving and operating machinery

Eslibon may cause dizziness, drowsiness, and affect vision, especially at the beginning of treatment. If such symptoms occur, the patient should not drive, use tools, or operate machinery.

Eslibon contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. the medicine is considered "sodium-free".

3. How to take Eslibon

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult your
doctor or pharmacist.

Adults
Initial dose
400 mg once daily for one or two weeks, before increasing to the maintenance dose.
Your doctor will decide whether this dose should be taken for one week or two weeks.
Maintenance dose
The usual maintenance dose is 800 mg once daily.
Depending on the individual patient's response to Eslibon, the dose may be increased to 1200 mg
once daily. If the patient is taking Eslibon as monotherapy, the doctor may consider a dose of 1600 mg
once daily to be beneficial.
Patients with renal impairment
Patients with impaired kidney function usually require a lower dose of Eslibon.
The doctor will determine the appropriate dose for the patient. Eslibon is not recommended in patients
with severe renal impairment.
Elderly patients (over 65 years of age)
If the patient is elderly and is taking Eslibon as monotherapy, the 1600 mg dose is not appropriate.
Children over 6 years of age
Initial dose
The initial dose is 10 mg per kg of body weight once daily for one or two weeks, before increasing to
the maintenance dose.
Maintenance dose
Depending on the response to Eslibon, the dose may be increased by 10 mg per kg of body weight
every one or two weeks, up to a maximum of 30 mg per kg of body weight. The maximum dose is
1200 mg once daily.
Children with body weight ≥ 60 kg
Children with body weight of 60 kg or more should receive the same dose as adults.
Other dosage forms of the medicine, such as oral suspension, may be more suitable for children. Your
doctor or pharmacist can help select the appropriate dosage form.
Method and route of administration
Eslibon is intended for oral administration. The tablets should be swallowed with a glass of water.
Eslibon tablets may be taken with or without food.
Taking more Eslibon than prescribed
If the patient accidentally takes more than the prescribed dose, they may be at risk of experiencing
an increased number of epileptic seizures or may feel irregular or rapid heartbeat. The patient should
immediately contact a doctor or go to a hospital if any of these symptoms occur. The medicine package
should be brought along, as this will help the doctor determine what has been taken.
Missing a dose of Eslibon
If the patient forgets to take a tablet, they should take it as soon as possible and continue with the
recommended dosing schedule. The patient should not take a double dose to make up for a missed dose.
Stopping treatment with Eslibon
Do not stop taking this medicine suddenly. If the patient stops treatment abruptly, there is a risk of
increased frequency of epileptic seizures. The doctor will inform the patient how long Eslibon should be
taken. If the doctor decides to discontinue Eslibon, the dose will usually be gradually reduced. It is
important to complete treatment according to the doctor's instructions; otherwise, symptoms may
worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.

The following adverse reactions may be very serious. If they occur in a patient, treatment with Eslibon must be discontinued immediately and the doctor should be informed without delay or the patient should go immediately to a hospital emergency department, as urgent treatment may be necessary:

• Rash, difficulty in swallowing or breathing, swelling of the lips, face, throat or tongue. These may be symptoms of an allergic reaction.

Very common adverse reactions (may affect more than 1 in 10 people):

• Dizziness or somnolence

Common adverse reactions (may affect up to 1 in 10 people):

• Sensation of imbalance, spinning or fluid motion
• Nausea or vomiting
• Headache
• Diarrhoea
• Double or blurred vision
• Difficulty concentrating
• Feeling of lack of energy or fatigue
• Tremor
• Skin rash
• Blood tests showing low sodium levels in the blood
• Decreased appetite
• Sleep disturbances
• Problems with movement coordination (ataxia)
• Weight gain

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Clumsiness
• Allergy
• Constipation
• Seizure attacks
• Hypothyroidism; symptoms include reduced thyroid hormone levels (detected in blood tests), cold intolerance, enlarged tongue, brittle or thin nails or hair, and low body temperature
• Liver disorders (such as increased liver enzyme activity)
• High blood pressure or severe increase in blood pressure
• Low blood pressure or drop in blood pressure upon standing
• Blood tests indicating low levels of salts (including chlorides) in the blood or reduced number of blood cells
• Dehydration
• Eye movement disorders, blurred vision or redness of the eyes
• Falls
• Thermal burn
• Memory disturbances or forgetfulness
• Crying, feeling depressed, nervousness or confusion, lack of interest or emotions
• Inability to speak or write or to understand speech or writing
• Agitation
• Attention deficit hyperactivity disorder (ADHD)
• Irritability
• Mood changes or hallucinations
• Speech disorders
• Nosebleeds
• Chest pain
• Tingling and (or) numbness in any part of the body
• Migraine
• Burning sensation
• Abnormal sensitivity to touch
• Smell disturbances
• Tinnitus
• Hearing problems
• Swelling of hands or feet
• Heartburn, indigestion, abdominal pain, bloating and discomfort or dryness in the mouth
• Dark stools
• Gum inflammation or toothache
• Sweating or dry skin
• Itching
• Skin changes (e.g. skin redness)
• Hair loss
• Urinary tract infection
• General weakness, malaise or chills
• Weight loss
• Muscle pain, limb pain, muscle weakness
• Bone metabolism disorders
• Increased levels of bone protein
• Sudden facial flushing, cold extremities
• Slower or irregular heartbeat
• Feeling of uncontrollable sleepiness
• Sedation
• Neurological movement disorders, manifesting as muscle contractions causing twisting movements, repetitive movements or abnormal posture; symptoms include tremor, pain, spasms
• Drug toxicity
• Anxiety

Frequency unknown (frequency cannot be estimated from available data):

• Decreased platelet count, increasing the risk of bleeding or easy bruising
• Severe back and stomach pain (caused by pancreatitis)
• Decreased white blood cell count, predisposing to infections
• Drug reaction with eosinophilia and systemic symptoms (DRESS): symptoms may include skin rash, fever, fatigue, lymph node swelling, increased eosinophil count (a type of white blood cell), and abnormalities in liver, kidney or lung function; DRESS may develop several weeks after starting treatment
• Lethargy, confusion, muscle twitching or marked worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion)

Treatment with Eslibon is associated with abnormal ECG (electrocardiogram) findings, known as PR interval prolongation. Adverse reactions related to such abnormal ECG findings may occur (e.g. fainting or slower heart rate).

Cases of bone tissue disorders, including osteopenia and osteoporosis (reduced bone mass) and fractures, have been reported with the use of similar antiepileptic medicines such as carbamazepine and oxcarbazepine. If a patient is taking antiepileptic medicines long-term, has a history of osteoporosis, or is taking steroid medicines, they should consult their doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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

Adverse reactions may also be reported directly to the marketing authorisation holder.

By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Eslibon

Keep this medicine 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 stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack 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, elongated, biconvex tablets with a score line on both sides,
approximately 11.8 mm in length and 3.9 mm in thickness. The tablet can be divided into equal doses.
Eslibon 400 mg, tablets
White or almost white, elongated, biconvex tablets with a score line on both sides,
approximately 15.0 mm in length and 4.9 mm in thickness. The tablet can be divided into equal doses.
Eslibon 600 mg, tablets
White or almost white, elongated, biconvex tablets with a score line on both sides,
approximately 17.0 mm in length and 5.7 mm in thickness. The tablet can be divided into equal doses.
Eslibon 800 mg, tablets
White or almost white, elongated, biconvex tablets with a score line on both sides,
approximately 18.9 mm in length and 6.1 mm in thickness. The tablet can be divided into equal doses.
The tablets are packed in transparent or opaque PVC/PVDC/Aluminium blisters,
contained in a cardboard box with 30 tablets.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
{logo of the marketing authorisation holder}

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

For further information, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75
00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
Email: [email protected]