ZEKILEP 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Zekilep 800 mg EFG Tablets

eslicarbazepine acetate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Zekilep and what is it 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 where the person has repeated seizures or fits.

This medicine is used:

• as the only medicine (monotherapy) in adult patients with newly diagnosed epilepsy,
• in combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and child patients above 6 years of age who have partial seizures (seizures that affect only a part of the brain). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalisation).

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

2. What you need to know before you take Zekilep

Do not take Zekilep:

• if you are allergic to eslicarbazepine acetate, to other carbamazepine-related compounds (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 a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Tell your doctor immediately:

• if you develop blisters or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, 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 levels of salts.

Tell your doctor:

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

A small number of people taking antiepileptics have had thoughts of harming themselves or suicidal thoughts. If at any time you have these thoughts, contact your doctor immediately.

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

Be extra careful with Zekilep

In post-marketing experience, serious and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome/toxic epidermal necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with eslicarbazepine.

If you develop a severe rash or other sign of an allergic reaction (see section 4), stop taking this medicine and contact your doctor or seek medical attention immediately.

In patients of Thai and Chinese Han ethnicity, the risk of serious skin reactions associated with carbamazepine or chemically-related compounds can be predicted by testing these patients. Your doctor will be able to advise you on the need for such a blood test before taking this medicine.

Children

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

Taking Zekilep with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way Zekilep works, or Zekilep may affect the way other medicines work. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as your doctor may need to adjust the dose,
• carbamazepine (a medicine used to treat epilepsy), as your doctor may need to adjust the dose, and the following side effects of this medicine may occur more frequently: double vision, abnormal coordination, and dizziness,
• hormonal contraceptives (such as the pill) as Zekilep may reduce their effectiveness,
• simvastatin (a medicine used to lower cholesterol levels), as your doctor may need to adjust the dose,
• rosuvastatin, a medicine used to lower cholesterol levels,
• the anticoagulant warfarin,

-monoamine oxidase inhibitors (MAOIs),

• do not take oxcarbazepine (a medicine used to treat epilepsy) with this medicine, as it is not known if it is safe to take these two medicines together.

See the section “Pregnancy and breast-feeding” for recommendations on contraception.

Pregnancy and breast-feeding

Zekilep should not be used during pregnancy unless clearly necessary. The use of Zekilep during pregnancy has been associated with an increased risk of congenital malformations and developmental delay.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited experience with the use of eslicarbazepine in pregnant women.

Studies have shown an increased risk of congenital malformations and developmental delay in children born to women with epilepsy who took antiepileptic drugs during pregnancy, particularly when taking more than one antiepileptic drug. If you are a woman of childbearing age and are taking this medicine, you should use an effective method of contraception while taking this medicine. You should discuss with your doctor the best method of contraception to use while taking this medicine.

Do not stop taking this medicine until you have discussed this with your doctor.

Do not breast-feed while taking Zekilep. It is not known if this medicine passes into breast milk.

Driving and using machines

This medicine 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 medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially ‘sodium-free’.

3. How to take Zekilep

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Starting dose

400 mg once a day 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 a day.

Depending on how you respond to this medicine, the dose may be increased to 1,200 mg once a day. If you are taking this medicine alone (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 medicine. Your doctor will determine the correct dose for you. Zekilep is not recommended if you have severe kidney disease.

Elderly patients (above 65 years of age)

If you are an elderly patient and are taking this medicine alone (monotherapy), the dose of 1,600 mg is not suitable for you.

Children above 6 years of age

Starting dose

The starting 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 form of this medicine, may be more suitable for administration in children. Ask your doctor or pharmacist.

Method and route of administration

This medicine is taken by mouth. Swallow the tablet with a glass of water.

This medicine 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. Take the medicine package 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 then continue as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Zekilep

Do not stop taking this medicine suddenly. If you do, you may have more seizures. Your doctor will decide how long you should take this medicine. If your doctor decides to stop your treatment with this medicine, they will usually reduce the dose gradually. It is important that you complete the treatment as instructed by your doctor; otherwise, your symptoms may get worse.

If you have any further questions on the use of this product, 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 frequentadverse effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness

The frequentadverse 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
• tremor
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• difficulty with movement coordination (ataxia).
• weight gain

The infrequentadverse 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
• alterations in smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• heartburn, stomach discomfort, abdominal pain, bloating, and abdominal discomfort or dry mouth
• black stools
• gum inflammation or tooth pain
• sweating or dry skin
• itching
• changes in skin (e.g., redness of the skin)
• hair loss
• urinary tract infection
• general discomfort, weakness, or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing (blushing), 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.
• Reddish 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.
• Hives (itchy skin rash).
• 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 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 prospectus. You can also report them directly through the national notification 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 on the 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Zekilep Composition

• The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other ingredients are povidone K30, sodium croscarmellose, and magnesium stearate.

Product Appearance and Package Contents

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 come in blister packs, in cardboard boxes of 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 Last Revision of this Prospectus: 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.