Package Leaflet: Information for the User

Zekilep 800 mg EFG Tablets

Eslicarbazepine Acetate

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

This medication contains the active ingredient eslicarbazepine acetate.

This medication belongs to a group of medications called antiepileptics, used to treat epilepsy, a disease where the affected person has seizures or repeated convulsive crises.

This medication is used:

- as a single medication (monotherapy) in adult patients with newly diagnosed epilepsy,

- in combination with other antiepileptic medications (adjunctive therapy) in adult, adolescent, and children over 6 years old who suffer from epileptic seizures (convulsions) affecting a part of the brain (partial seizures). These seizures may be followed or not by a seizure affecting the entire brain (secondary generalization).

Your doctor has prescribed this medication to reduce the number of seizures.

Do not take Zekilep:

- if you are allergic to eslicarbazepine acetate, other carboxamide derivatives (such as carbamazepine or oxcarbazepine, medications used to treat epilepsy), or any of the other components of this medication (listed in section 6),

- if you have a certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

Inform your doctor immediately:

- if you experience blisters or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat, or tongue. These may be signs of an allergic reaction,

- if you experience confusion, worsening seizures, or decreased consciousness, which may be signs of low blood levels of salts.

Inform your doctor:

- if you have kidney problems. Your doctor may need to adjust the dose. This medication is not recommended for patients with severe kidney disease,

- if you have liver problems. This medication is not recommended for patients with severe liver disease,

- if you are taking any medication that can cause an ECG (electrocardiogram) anomaly called prolonged PR interval. If you are unsure whether the medications you are taking can cause this effect, discuss it with your doctor,

- if you have any heart disease, such as heart failure or myocardial infarction, or have any heart rhythm alterations,

- if you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If this occurs while taking this medication, contact your doctor immediately.

This medication may cause dizziness and/or disorientation, particularly at the beginning of treatment. Be extra cautious while taking this medication to avoid accidental injuries, such as falls.

Be extra cautious with Zekilep

During post-marketing experience in patients treated with eslicarbazepine, severe skin reactions and potentially life-threatening reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported.

If you develop a severe rash or other skin symptoms (see section 4), stop taking this medication and consult your doctor or seek immediate medical attention.

In patients of Thai origin and Chinese Han ethnic group, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by blood analysis of these patients. Your doctor will advise on the need for this blood test before taking this medication.

Children

This medication should not be administered to children under 6 years old.

Taking Zekilep with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This recommendation is in case any of them interfere with the way this medication works, or if this medication interferes with the effect of such medications. Inform your doctor if you are taking:

- phenytoin (a medication used to treat epilepsy), as you may need to adjust the dose,

- carbamazepine (a medication used to treat epilepsy), as you may need to adjust the dose, and the following side effects of this medication may occur more frequently: double vision, abnormal coordination, and dizziness,

- hormonal contraceptives (such as the birth control pill) as Zekilep may reduce the effectiveness of these,

- simvastatin (a medication used to reduce cholesterol levels), as you may need to adjust the dose,

- rosuvastatin, a medication used to reduce cholesterol levels,

- the anticoagulant warfarin,

- monoamine oxidase inhibitors (MAOIs),

- do not take oxcarbazepine (a medication used to treat epilepsy) with this medication, as it is unknown whether it is safe to take these two medications together.

See the section “Pregnancy and breastfeeding” for recommendations on contraception.

Pregnancy and breastfeeding

This medication is not recommended for use during pregnancy, as the effects of eslicarbazepine acetate on pregnancy and the fetus are unknown.

If you plan to become pregnant, discuss this with your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There is limited data on the use of eslicarbazepine acetate in pregnant women.

Research has shown an increased risk of congenital defects and neurological development problems (brain development) in children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at a time. If you think you may be pregnant, inform your doctor immediately. Do not stop taking your medication until you have discussed this with your doctor. Stopping your medication without consulting your doctor 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 fertile woman and do not plan to become pregnant, use an effective contraceptive method during treatment with eslicarbazepine acetate. Eslicarbazepine acetate may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective contraceptive methods while taking this medication. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable to use while taking eslicarbazepine acetate. If you stop treatment with eslicarbazepine acetate, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take eslicarbazepine acetate during pregnancy, your baby may be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medication to prevent this.

Do not breastfeed while taking eslicarbazepine acetate. It is unknown whether it passes into breast milk.

Driving and operating machinery

This medication may cause dizziness, disorientation, and affect your vision, particularly at the beginning of treatment. If this occurs, do not drive or operate any tools or machinery.

Zekilep contains sodium
This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Initial treatment dose

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide if you should take this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once a day.

The dose may be increased to 1,200 mg once a day based on your response to this medication. If you are taking this medication alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once a day.

Patients with kidney problems

If you have kidney problems, you will usually be given a lower dose of this medication. Your doctor will determine the correct dose for you. Zekilep is not recommended if you have severe kidney problems.

Older adults (65 years and older)

If you are an older adult and taking this medication as monotherapy, the dose of 1,600 mg is not suitable for you.

Children over 6 years old

Initial treatment dose

The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

The dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is 1,200 mg once a day.

Children ≥ 60 kg

Children with a body weight of 60 kg or more should take the same dose as adults.

The oral suspension, another pharmaceutical form of the medication, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

This medication is administered orally. Swallow the tablet with a glass of water.

This medication can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Zekilep than you should

If you accidentally take more Zekilep than you should, you are at risk of having more seizures; or you may feel that your heart is beating irregularly or faster. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Bring the medication packaging with you, so the doctor knows what you have taken.

If you forget to take Zekilep

If you forget to take a tablet, take it as soon as you remember and continue as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Zekilep

Do not suddenly stop taking the tablets. If you do, you are at risk of having more seizures. Your doctor will decide for how long you should take this medication. If your doctor decides to stop your treatment with this medication, you will usually be gradually reduced the dose. It is essential that you complete the treatment as instructed by your doctor, otherwise, your symptoms may worsen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects can be very serious. If they occur, stop taking this medicine and inform your doctor or go to the hospital immediately, as you may need urgent medical treatment:

- Blisters or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat, or tongue. These could be signs of an allergic reaction.

The very common side effects (can affect more than 1 in 10 people) are:

- Dizziness or drowsiness

The common side effects (can affect up to 1 in 10 people) are:

- Feeling unsteady, or like you are spinning or floating

- Nausea or vomiting

- Headache

- Diarrhea

- Double or blurred vision

- Difficulty concentrating

- Feeling tired or decreased energy

- Trembling

- Skin rash

- Blood tests showing low sodium levels

- Decreased appetite

- Difficulty sleeping

- Difficulty with movement coordination (ataxia).

- Weight gain

The uncommon side effects (can affect up to 1 in 100 people) are:

- Clumsiness of movements

- Allergy

- Constipation

- Seizures

- Hypothyroidism. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, increased size of the tongue, nails, or hair, and low body temperature

- Liver problems (such as increased liver enzymes);

- High blood pressure or intense increase in blood pressure

- Low blood pressure, or decreased blood pressure when standing up

- Blood tests showing low levels of salts (including chloride), or a decrease in the number of red blood cells

- Dehydration

- Changes in eye movements, hazy vision, or red eyes

- Experiencing falls

- Burns

- Extreme drowsiness

- Sedation

- Neuromuscular alteration where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps

- Medication toxicity

- Anxiety.

The frequency of side effects is unknown (cannot be estimated from available data) are:

- Reduction of platelets that increases the risk of bleeding or bruising.

- Intense pain in the back or stomach (caused by inflammation of the pancreas).

- Reduction of white blood cells that makes infections more likely.

- Red spots or circular patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes, and may be preceded by fever and/or symptoms similar to the flu (Stevens-Johnson syndrome / toxic epidermal necrolysis).

- Initially symptoms similar to the flu, rash on the face, generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other body conditions (drug reaction with eosinophilia and systemic symptoms that is also known as DRESS or drug hypersensitivity syndrome).

- Severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles, or lower legs.

- Urticaria (skin rash with itching).

-Letargo, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)).

The use of this medicine is associated with an ECG anomaly called increased PR interval. Side effects associated with this ECG anomaly may occur (e.g., fainting and slowing of heart rate).

Bone disorders including osteopenia and osteoporosis (bone thinning) and fractures have been reported with antiepileptic drugs structurally related to this medicine, such as carbamazepine and oxcarbazepine. Talk to your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or take steroids.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after the letters CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zekilep

- The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.

- The other components are povidone K30, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the packaging

Zekilep 800 mg tablets are white, oblong, biconvex, with a groove on each face and a length of 18.9 mm. The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

G.L. Pharma GmbH

Schlossplatz 1,

A-8502 Lannach

Austria

or

Delorbis Pharmaceuticals Ltd.

17 Athinon street, Ergates Industrial Area,

2643 Ergates, Lefkosia

Cyprus

Last review date of this leaflet: April 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.