ZEKILEP 600 mg TABLETS

Introduction

Package Leaflet: Information for the User

Zekilep 600 mg EFG Tablets

eslicarbazepine acetate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Zekilep and what is it used for
2. What you need to know before taking Zekilep
3. How to take Zekilep
4. Possible side effects
5. Storage of Zekilep
6. Package Contents and Additional Information

1. What is Zekilep and what is it used for

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 repeated seizures or convulsions.

This medication is used:

• as the only medication (monotherapy) in adult patients with newly diagnosed epilepsy,
• in combination with other antiepileptic medications (adjunctive therapy) in adult, adolescent, and child patients over 6 years of age who suffer from epileptic seizures (convulsions) that affect a part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the entire brain (secondary generalization).

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

2. What you need to know before taking Zekilep

Do not take Zekilep:

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g., carbamazepine or oxcarbazepine, medications used to treat epilepsy), or to 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 to take this medication.

Inform your doctor immediately:

• if you experience blisters or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of the lips, face, eyelids, throat, or tongue. These could be signs of an allergic reaction,
• if you experience confusion, worsening of seizures, or decreased consciousness, which could be signs of low blood salt levels.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. This medication is not recommended in patients with severe kidney disease,
• if you have liver problems. This medication is not recommended in patients with severe liver problems,
• if you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) called a prolonged PR interval. If you are unsure whether the medications you are taking may cause this effect, discuss it with your doctor,
• if you have any heart disease, such as heart failure or heart attack, or have any heart rhythm disorder,
• if you experience seizures that start with an extended electrical discharge that affects both sides of the brain.

A small number of people taking antiepileptics have had thoughts of self-harm or suicide. If this happens to you while taking this medication, contact your doctor immediately.

This medication may make you feel dizzy and/or drowsy, particularly at the start of treatment. Be careful while taking this medication to avoid accidental injuries, such as falls.

Be careful with Zekilep

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

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

In patients of Thai and Chinese Han ethnic origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by a blood test. Your doctor may advise you on the need for such a blood test before taking this medication.

Children

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

Taking Zekilep with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This is to ensure that none of them interfere with the way this medication works or that this medication interferes with their effect. Inform your doctor if you are taking:

• phenytoin (a medication used to treat epilepsy), as your doctor may need to adjust the dose,
• carbamazepine (a medication used to treat epilepsy), as your doctor 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 their effectiveness,
• simvastatin (a medication used to lower cholesterol levels), as your doctor may need to adjust the dose,
• rosuvastatin, a medication used to lower cholesterol levels,
• the anticoagulant warfarin,
• monoamine oxidase inhibitor (MAOI) antidepressants
• 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

The use of eslicarbazepine acetate is not recommended if you are pregnant, as its effects on pregnancy and the unborn child are unknown.

If you plan to become pregnant, consult your doctor before stopping your contraceptive method 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 congenital defects and problems with neurological development (brain development) in children of women who take antiepileptic medications, particularly when taking more than one antiepileptic medication at a time. If you are pregnant or think you may be pregnant, inform your doctor immediately. Do not stop taking your medication until you have discussed it with your doctor. Stopping your medication without consulting your doctor may cause seizures, which could 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 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, you are advised to use other safe and effective contraceptive methods while taking this medication. Discuss with your doctor the type of contraceptive most suitable for you to use while taking eslicarbazepine acetate. If you stop treatment with eslicarbazepine acetate, you should continue to use an effective contraceptive method until the end of your current menstrual cycle.

If you take eslicarbazepine acetate during pregnancy, your baby is also 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 Using Machines

This medication may cause dizziness, drowsiness, and affect your vision, particularly at the start of treatment. If this happens to you, do not drive or use any tools or machines.

Zekilep contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Zekilep

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

Initial dose

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether to administer this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once a day.

Depending on how you respond to this medication, the dose may be increased to 1,200 mg once a day. If you are taking this medication only (monotherapy), your doctor may consider increasing the dose to 1,600 mg once a day.

Patient 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 disease.

Elderly patients (over 65 years of age)

If you are an elderly patient and are taking this medication in monotherapy, the dose of 1,600 mg is not suitable for you.

Children over 6 years of age

Initial 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

Depending on the response to Zekilep, 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 heartbeat is irregular or faster.

Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Take the medication packaging with you, so the doctor knows what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

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 forgotten doses.

If you stop taking Zekilep

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects may be very serious. If they appear, stop administering this medicine and inform a doctor or go to a hospital immediately, as you may need urgent medical treatment:

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

The very commonadverse effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness

The commonadverse effects (may affect up to 1 in 10 people) are:

• feeling of instability, or spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double vision or blurred vision
• difficulty concentrating
• feeling of fatigue or decreased energy
• tremors
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• difficulty with movement coordination (ataxia)
• weight gain

The uncommonadverse effects (may affect up to 1 in 100 people) are:

• clumsiness
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails and 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, blurred vision, or red eyes
• suffering from falls
• thermal burn
• poor memory or forgetfulness
• crying, feeling of depression, nervousness, or confusion, lack of interest or emotions
• inability to speak, write, or understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• mood changes or hallucinations
• difficulty speaking
• nasal bleeding
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• olfactory disorders
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• acidity, stomach discomfort, abdominal pain, bloating, and abdominal discomfort or dry mouth
• black stools
• gum inflammation or tooth pain
• sweating or dry skin
• itching

• skin changes (e.g., redness of the skin)
• hair loss
• urinary tract infection
• general malaise, weakness, or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing (hot flush), coldness in the extremities
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• motor neurological disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps
• drug toxicity
• anxiety.

The adverse effects of unknown frequency(cannot be estimated from the available data) are:

• reduction of platelets that increases the risk of bleeding or bruising.
• severe back or stomach pain (caused by pancreas inflammation).
• reduction of white blood cells that makes infections more likely.
• red patches or circular spots often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes that may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• initially flu-like symptoms, 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, 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).
• lethargy, confusion, muscle spasms, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of antidiuretic hormone (ADH)).

The use of this medicine is associated with an ECG (electrocardiogram) anomaly called an increase in the PR interval. Adverse effects associated with this ECG anomaly (e.g., fainting and slowing of heartbeats) may occur.

Bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures, have been reported with structurally related antiepileptic medications 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 are taking steroids.

Reporting of Adverse Effects

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

5. Storage of Zekilep

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Zekilep Composition

• The active ingredient is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine acetate.

• The other ingredients are povidone K30, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Package Contents

Zekilep 600 mg tablets are white, oblong, biconvex, with a score line on each face, and a length of 17.0 mm. The tablet can be divided into equal doses.

The tablets are packaged in blister packs, in cardboard boxes of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

G.L. Pharma GmbH

Schlossplatz 1,

A-8502 Lannach Austria

or

Delorbis Pharmaceuticals Ltd.

17 Athinon street, Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

Date of the Last Revision of this Leaflet: April 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.