Prospecto: information for the user

Zekilep 200 mg EFG tablets

eslicarbazepine acetate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. 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 medicationis used:

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

Do not take Zekilep:

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 of seizures, or decreased consciousness, which may be signs of low sodium levels in the blood.

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 abnormality in the ECG (electrocardiogram) 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 abnormal heart rhythm,
• 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 start of treatment. Be extra cautious while taking this medication to avoid accidental injuries, such as falls.

Be extra cautious with Zekilep

In the 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 medical attention immediately.

In patients of Thai origin and the Han Chinese ethnic group, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by a blood test. 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 of age.

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 is to ensure that none of them interfere with the way this medication works, or that this medication interferes with the effect of such medications. Inform your doctor if you are taking:

• phenytoin (a medication used for the treatment of epilepsy), as the dose may need to be adjusted,
• carbamazepine (a medication used for the treatment of epilepsy), as the dose may need to be adjusted, 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 reduce cholesterol levels), as the dose may need to be adjusted,
• rosuvastatin, a medication used to reduce cholesterol levels,
• the anticoagulant warfarin, antidepressants that inhibit monoamine oxidase (IMAOs) do not take oxcarbazepine (a medication used for the treatment of 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 intend 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 the children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at a time. If you are or 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 hazardous to you and your unborn child.

Your doctor may decide to change your treatment.

If you are a fertile woman and are not planning 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, it is recommended to use other safe and effective forms of contraception while taking this medication. Discuss this with your doctor, who will advise on the most suitable contraceptive method for you 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 start 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 1,600 mg dose 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 heartbeat is irregular 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 the missed doses.

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, the dose will usually be gradually reduced. It is essential that you complete the treatment as instructed by your doctor, as otherwise, your symptoms may worsen.

If you have any other doubts 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 administering this medicine and inform a doctor or go to the hospital immediately, as you may need 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.

The side effectsvery frequent(can affect more than 1 in 10 people) are:

• dizziness or drowsiness

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

• feeling unsteady, or feeling like you are spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double vision or blurred vision
• difficulty concentrating
• feeling tired or decreased energy
• shaking
• rash
• blood tests showing low sodium levels
• loss of appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain

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

• clumsiness of movements
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased thyroid hormone levels (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 salt levels (including chloride), or a decrease in the number of red blood cells

• dehydration
• changes in eye movements, blurred vision, or red eyes
• experiencing falls
• thermal burns
• bad memory or forgetfulness
• crying, feeling depressed, nervous, or confused, lack of interest or emotions
• difficulty speaking, writing, or understanding spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nasal bleeding
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning
• abnormal sensation to the touch
• alterations in smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• heartburn, stomach discomfort, abdominal pain, swelling, and abdominal discomfort or dry mouth
• black stools
• inflammation of the gums or tooth pain
• sweating or dry skin
• itching

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

The side effects ofunknown frequency(cannot be estimated from available data) are:

• reduction of platelets, increasing the risk of bleeding or bruising.
• intense back or stomach pain (caused by pancreatitis inflammation).
• reduction of white blood cells, making infections more likely.
• macules, red spots, or circular patches often with central blisters on the trunk, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes, red and inflamed eyes, and may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome / toxic epidermal necrolysis).
• initially flu-like symptoms, facial rash, 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 causing 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 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 (for example, fainting and slowed heartbeats).

There have been reports of bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures with structurally related antiepileptic drugs such as carbamazepine and oxcarbazepine. Talk to your doctor or pharmacist if you are on long-term antiepileptic treatment, 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 prospectus. You can also report them directly through the national notification system included in the Spanish System for 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 the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers 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 200 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 200 mg tablets are white, oblong, biconvex, with a groove on each face and a length of 11.8 mm. The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes of 60 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.