Zekilep 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zekilep 800 mg tablets EFG

eslicarbazepine acetate

Read the entire leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Zekilep is and what it is used for
2. What you need to know before taking Zekilep
3. How to take Zekilep
4. Possible side effects
5. How to store Zekilep
6. Contents of the pack and other information

1. What Zekilep is and what it is used for

This medicine contains the active substance eslicarbazepine acetate.

This medicine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsions.

This medicine is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy,
• together with other antiepileptic medicines (adjunctive therapy) in adult, adolescent and pediatric patients over 6 years of age who experience epileptic seizures (convulsions) originating in one part of the brain (partial seizures). These seizures may or may not be followed by a seizure affecting the entire brain (secondary generalization).

Your doctor has prescribed this medicine 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 (for example 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 a certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Tell your doctor immediately:

• if you develop blisters or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, or 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 level of consciousness, which could be signs of low blood levels of salts.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust your dose. This medicine is not recommended for patients with severe renal impairment,
• if you have liver problems. This medicine is not recommended for patients with severe hepatic impairment,
• if you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) known as PR interval prolongation. If you are unsure whether your medicines may cause this effect, discuss it with your doctor,
• if you have any heart condition such as heart failure or heart attack, or have any heart rhythm disorders,
• if you have seizures that begin with a widespread electrical discharge affecting both sides of the brain.

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

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

Take special care 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, and drug reaction with eosinophilia and systemic symptoms (DRESS).

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

In patients of Thai origin and Han Chinese ethnic group, 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 whether such a blood test is necessary before starting this medicine.

Children

This medicine must not be given to children aged 6 years or younger.

Taking Zekilep with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because some medicines may interfere with how this medicine works, or this medicine may interfere with the effect of other medicines. Inform your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as your dose may need to be adjusted,
• carbamazepine (a medicine used to treat epilepsy), as your dose may need to be adjusted, and the following side effects of this medicine may occur more frequently: double vision, abnormal coordination, and dizziness,
• hormonal contraceptives (such as the contraceptive pill), as Zekilep may reduce their effectiveness,
• simvastatin (a medicine used to lower cholesterol levels), as your dose may need to be adjusted,
• rosuvastatin, a medicine used to lower cholesterol levels,
• the anticoagulant warfarin,
• monoamine oxidase inhibitor (MAOI) antidepressants,
• do not take oxcarbazepine (a medicine used to treat epilepsy) together with this medicine, as it is unknown whether it is safe to take these two medicines together.

See section “Pregnancy and breastfeeding” for recommendations regarding contraception.

Pregnancy and breastfeeding

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

If you are planning to become pregnant, speak with your doctor before stopping contraception 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.

Studies have shown an increased risk of congenital malformations and neurological development problems (brain development) in children of women taking antiepileptic medicines, particularly when more than one antiepileptic medicine is taken at the same time. If you are or think you might be pregnant, inform your doctor immediately. You must not stop taking your medicine without first discussing it with your doctor. Stopping your medication without medical advice 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 potential and not planning to become pregnant, you should use an effective method of contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate may affect the effectiveness of hormonal contraceptives, such as the contraceptive pill, making them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective forms of contraception while taking this medicine. Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking eslicarbazepine acetate. If treatment with eslicarbazepine acetate is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle. If you take eslicarbazepine acetate during pregnancy, your baby may also be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medicine to prevent this.

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

Driving and using machines

This medicine may cause dizziness, drowsiness, 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 medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Zekilep

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

Starting dose

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

Maintenance dose

The usual maintenance dose is 800 mg once daily.

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

Patients with renal problems

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

Elderly patients (over 65 years of age)

If you are elderly and are taking this medicine as monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years of age

Starting dose

The starting 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 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 daily.

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 medicine, may be more suitable for administration in children. Consult your doctor or pharmacist.

Method and route of administration

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

This medicine may be taken with or without food.

The tablet may be divided into equal doses.

If you take more Zekilep than you should

If you accidentally take more Zekilep than you should, you may be 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 medicine packaging with you so that 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 then 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 may be at risk of having more seizures. Your doctor will decide for how long you should take this medicine. If your doctor decides to stop your treatment with this medicine, your 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects may be very serious. If any of these occur, stop taking this medicine immediately and contact a doctor or go to a hospital straight away, as you may require urgent medical treatment:

• blistering 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.

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

• dizziness or drowsiness

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

• feeling unsteady, spinning, or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling tired or lack of energy
• tremor
• skin rash
• blood tests showing low sodium levels
• loss of appetite
• difficulty sleeping
• problems with movement coordination (ataxia)
• weight gain

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

• clumsiness of movements
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or marked increase in blood pressure
• low blood pressure, or reduced blood pressure upon standing
• blood tests showing low levels of salts (including chloride), or reduced number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• falls
• thermal burns
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotions
• inability to speak, write, or understand spoken or written language
• agitation
• attention deficit/hyperactivity
• irritability
• mood changes or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• changes in smell
• ringing in the ears
• hearing difficulty
• swelling of arms and legs
• heartburn, stomach discomfort, abdominal pain, bloating, abdominal discomfort, or dry mouth
• black stools
• swollen gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. skin redness)
• hair loss
• urinary tract infection
• general malaise, weakness, or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing, cold extremities
• slower or irregular heartbeat
• extreme drowsiness
• sedation
• motor neurological disorder involving muscle contractions causing twisting movements, repetitive movements, or abnormal postures. Symptoms may include tremors, pain, and cramps
• drug toxicity
• anxiety

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Reduction in platelet count, increasing the risk of bleeding or bruising.
• Severe back or stomach pain (caused by inflammation of the pancreas).
• Reduction in white blood cells, making infections more likely.
• Red spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, red and inflamed eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis).
• Initially flu-like symptoms, facial rash, generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic symptoms (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs.
• Hives (itchy skin rash).
• lethargy, confusion, muscle spasms, or a marked worsening of seizures (possible symptoms of low blood sodium levels due to inappropriate antidiuretic hormone (ADH) secretion).

Use of this medicine is associated with an ECG (electrocardiogram) abnormality called PR interval prolongation. Adverse effects related to this ECG abnormality may occur (e.g. fainting and slowed heart rate).

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine. Speak with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and outer carton after the letters "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zekilep

• The active substance 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 pack

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

The tablets are packed in blisters, in cardboard boxes containing 30 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 most recent revision of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.