Leaflet: information for the user

Eslicarbazepine Zentiva 800 mg tablets EFG

eslicarbazepine acetate

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Eslicarbazepine Zentiva and what is it used for

2.What you need to know before you start taking Eslicarbazepine Zentiva

3.How to take Eslicarbazepine Zentiva

4.Possible side effects

5.Storage of Eslicarbazepine Zentiva

6.Contents of the pack and additional information

This medicationcontains the active ingredient eslicarbazepine acetate.

Eslicarbazepinebelongs 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:

• 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 seizures (convulsions) that affect a part of the brain (partial seizures). These seizures may be followed or not by a seizure that affects the entire brain (secondary generalization).

Your doctor has prescribedthis medicationto reduce the number of seizures.

Do not takeEslicarbazepina Zentiva:

•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 to take this medication.

Inform your doctor immediately:

•if you experience 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 may be signs of an allergic reaction;

•if you experience confusion, worsening 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 your 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 may cause an abnormality in the electrocardiogram (ECG) called 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 myocardial infarction, or have any heart rhythm disorder;

•if you have seizures that begin with a generalized seizure that affects 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 careful while taking this medication to avoid accidental injuries, such as falls.

Be especially careful withEslicarbazepina Zentiva

In post-marketing experience, 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 in patients treated with this medication.

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 may advise you 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 Eslicarbazepina Zentiva 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 because some medications may interact with the way Eslicarbazepina Zentiva works, or Eslicarbazepina Zentiva may interfere with the effect of these medications. Inform your doctor if you are taking:

•phenytoin (a medication used to treat epilepsy), as your doctor may need to adjust your dose;

•carbamazepine (a medication used to treat epilepsy), as your doctor may need to adjust your 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 this medication may reduce the effectiveness of these medications;

•simvastatin (a medication used to reduce cholesterol levels), as your doctor may need to adjust your dose;

•rosuvastatin, a medication used to reduce cholesterol levels;

•the anticoagulant warfarin;

•monoamine oxidase inhibitors (MAOIs), 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 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 Eslicarbazepina Zentiva 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.

Studies have 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 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 are not planning to become pregnant, you should use an effective contraceptive method during treatment with Eslicarbazepina Zentiva. Eslicarbazepina Zentiva 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 forms of safe and effective contraception while taking Eslicarbazepina Zentiva. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable for you to use while taking Eslicarbazepina Zentiva. If you stop treatment with Eslicarbazepina Zentiva, you should continue using an effective contraceptive method until the end of the current menstrual cycle.

If you take Eslicarbazepina Zentiva during pregnancy, your baby may also 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 this medication. It is unknown whether the medication 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 use any tools or machinery.

Eslicarbazepina Zentiva contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this 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.

Depending on how you respond to this medication, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine 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. This medication 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 in 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

Depending on your response to this medication, 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 may be taken with or without food.

The tablet can be divided into equal doses.

If you take more Eslicarbazepine Zentiva than you should

If you accidentally take more eslicarbazepine than you should, you are at potential 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.

If you forgot to take Eslicarbazepine Zentiva

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.

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

If you interrupt treatment with Eslicarbazepine Zentiva

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 treating you with this medication, the dose will usually be gradually reduced. It is essential that you complete the treatment as instructed by your doctor; 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 taking this medicine and inform your 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 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 vision or blurred vision

•difficulty concentrating

•feeling tired or decreased energy

•shaking

•skin rash

•blood tests showing low sodium levels

•decreased appetite

•difficulty sleeping

•difficulty coordinating movements (ataxia).

•weight gain.

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

•clumsiness of movements

•allergy

•constipation

•convulsions

•underactive thyroid gland. 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

•blood tests showing low levels of salts (including chloride), or a reduction in the number of red blood cells

•dehydration

•changes in eye movements, hazy vision or red eyes

•experiencing falls

•burning sensation

•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 discomfort or dry mouth

•black stools

•inflammation of the gums or pain in the teeth

•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

•slow or irregular heartbeats

•extreme drowsiness

•sedation

•neuromuscular disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps

•drug toxicity

•anxiety.

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

•reduction of platelets that increases the risk of bleeding or hematomas.

•intense pain in the back or stomach (caused by inflammation of the pancreas).

•reduction of white blood cells that makes 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 that 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 (eosinophilic reaction 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).

• lethargy, 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 ofthis medicineis associated with an ECG anomaly called increased PR interval. Side effects associated with this ECG anomaly (such as fainting and slowed heartbeats) may occur.

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 treatment with antiepileptics, have a history of osteoporosis, or take steroids.

Reporting of 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 Spanish System of Pharmacovigilance of Medicines for Human Use: https://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 notrequire special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of EslicarbazepineZentiva

•Each tablet contains 800 mg of eslicarbazepine acetate.

•The other components are povidone K29/32, sodium croscarmellose, and magnesium stearate.

Appearance of the product and content of the container

The Eslicarbazepine Zentiva tablets are white to off-white, oval, and biconvex, 19 mm in length with an IC engraved on one face and a breaking notch on the other face. The tablet can be divided into equal doses.

The tablets are packaged in transparent blisters in carton boxes of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zentiva, k.s.,

U kabelovny 130,

Dolni Mecholupy,

102 37 Prague 10,

Czech Republic

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

Last review date of this leaflet: May 2022

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