Leaflet: information for the user

Eslicarbazepine Normon 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.

Eslicarbazepina Normon contains the active ingredient eslicarbazepine acetate.

Eslicarbazepine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a disease where the affected person has seizures or repeated convulsive crises.

Eslicarbazepina Normon is used:

• As a single medication (monotherapy) in adult patients with newly diagnosed epilepsy;

• Along with other antiepileptic medications (adjunctive therapy) in adult, adolescent, and children over 6 years old who suffer from epileptic 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 prescribed eslicarbazepine to reduce the number of seizures.

Do not take Eslicarbazepina Normon

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine.

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 blood levels of salts.

Inform your doctor:

• If you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepine is not recommended for patients with severe kidney disease;
• If you have liver problems. Eslicarbazepine is not recommended for patients with severe liver disease;
• If you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) 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 heart disease such as heart failure or myocardial infarction, or have any alteration of 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 eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may cause dizziness and/or drowsiness, particularly at the start of treatment. Be extra careful while taking eslicarbazepine to avoid accidental injuries, such as falls.

Be extra careful with this medication

In the 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 eslicarbazepine.

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 Chinese Han ethnic group, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by blood analysis of these patients. Your doctor will advise you on the need for this blood test before taking eslicarbazepine.

Children

Eslicarbazepine should not be administered to children under 6 years of age.

Taking Eslicarbazepina Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This recommendation is in case any of them may interfere with the way eslicarbazepine works, or if eslicarbazepine may interfere with the effect of such medications. Inform your doctor if you are taking:

• Fenitoin (a medication used for the treatment of epilepsy), as you may need to adjust the dose.
• Carbamazepine (a medication used for the treatment of epilepsy), as you may need to adjust the dose, and the following adverse effects of eslicarbazepine may occur more frequently: double vision, abnormal coordination, and dizziness.
• Oral contraceptives (such as the birth control pill) as eslicarbazepine may reduce their effectiveness.
• Simvastatin (a medication used to reduce cholesterol levels), as you may need to adjust the dose.
• Rosuvastatin, a medication used to reduce cholesterol levels.
• The anticoagulant warfarin.
• Monamine oxidase inhibitors (MAOIs).
• Do not take oxcarbazepine (a medication used for the treatment of epilepsy) with eslicarbazepine, 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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Eslicarbazepine is not recommended for use during pregnancy, as its effects on pregnancy and the fetus are unknown.

If you intend to become pregnant, discuss it 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 in pregnant women.

Research has shown an increased risk of congenital defects and neurological development problems (brain development) in 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 it with your doctor. Stopping your medication without consulting your doctor may cause seizures, which may be hazardous to you and your unborn child. Your doctor may decide to change your treatment.

If you are a fertile woman and do not intend to become pregnant, you should use an effective contraceptive method during treatment with eslicarbazepine. Eslicarbazepine may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective for preventing pregnancy. Therefore, you are recommended to use other safe and effective forms of contraception while taking eslicarbazepine,

Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable to use while taking eslicarbazepine. If you stop treatment with eslicarbazepine, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take eslicarbazepine during pregnancy, your baby may also be at risk of bleeding immediately after birth. Your doctor may give you and your baby a medication to prevent this.

Do not breastfeed while taking eslicarbazepine. It is unknown whether it passes into breast milk.

Driving and operating machinery

Eslicarbazepine may cause dizziness, drowsiness, and affect your vision, particularly at the start of treatment. If this occurs, do not drive or operate any tools or machinery.

Eslicarbazepina Normon 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 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 eslicarbazepine, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine alone (monotherapy), your doctor may consider increasing the 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 eslicarbazepine. Your doctor will determine the correct dose for you. Eslicarbazepine 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 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 your response to eslicarbazepine, 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 the medication, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

Eslicarbazepine Normon is administered orally. Swallow the tablet with a glass of water.

Eslicarbazepine Normon can be taken with or without food.

If you have difficulty swallowing the tablet whole, you can crush it and add it to a small amount of water or apple sauce to take it immediately.

The tablet can be divided into equal doses.

If you take more Eslicarbazepine Normon than you should

If you accidentally take more eslicarbazepine than you should, you are at risk of having more seizures; or you may feel that your heartbeat is irregular or faster. Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging of the medication with you, so that the doctor knows what you have taken.

If you forget to take Eslicarbazepine Normon

SIf 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 Eslicarbazepine Normon

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 eslicarbazepine. If your doctor decides to stop your treatment with eslicarbazepine, they will usually gradually reduce the dose. 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 administering eslicarbazepine and inform your doctor or go to the hospital immediately, as you may need urgent medical treatment:

• 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 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 like you are spinning or floating.
• Nausea or vomiting.
• Headache.
• Diarrhea.
• Double or blurred vision.
• Difficulty concentrating.
• Feeling tired or decreased energy.
• Tremor.
• Rash.
• Blood tests showing low sodium levels.
• Decreased 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.
• Subclinical hypothyroidism. 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 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.
• Falling.
• Burns.
• Poor memory or forgetfulness.
• Crying, feeling depressed, nervous, or confused, lack of interest or emotions.
• Inability to speak, write, or understand spoken or written language.
• Agitation.
• Attention deficit/hyperactivity disorder.
• Irritability.
• Changes in mood or hallucinations.
• Difficulty speaking.
• Nasal bleeding.
• Chest pain.
• Numbness or tingling sensation in any part of the body.
• Migraine.
• Heat.
• Abnormal sensation to the touch.
• Alterations in smell.
• Tinnitus (ringing in the ears).
• Difficulty hearing.
• Swelling of legs and arms.
• Acid reflux, stomach discomfort, abdominal pain, swelling, and abdominal discomfort or dry mouth.
• Black stools.
• Swollen gums or tooth pain.
• Sweating or dry skin.
• Itching.
• Changes in the 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.
• Redness (flushing), cold extremities.
• Slower or irregular heartbeats.
• Extreme drowsiness.
• Sedation.
• Alteration in neuromuscular function where muscles contract, causing spasms 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:

• Letargo, confusión, espasmos musculares o un empeoramiento significativo de las convulsiones (posibles síntomas de niveles bajos de sodio en sangre debido a una secreción inadecuada de la hormona antidiurética (ADH)).
• Reducción de las plaquetas que aumenta el riesgo de sangrado o hematomas.
• Dolor intenso en la espalda o estómago (causado por la inflamación del páncreas).
• Reducción de los glóbulos blancos que hace más probable las infecciones.
• Máculas rojizas o manchas circulares a menudo con ampollas centrales en el tronco, descamación de la piel, úlceras en la boca, garganta, nariz, genitales y ojos, ojos enrojecidos e inflamados y que pueden estar precedidos de fiebre y/o síntomas similares a la gripe (Síndrome de Stevens-Johnson / necrólisis epidérmica tóxica).
• Inicialmente síntomas parecidos a la gripe, erupción en la cara, erupción generalizada, temperatura corporal elevada, elevaciones de las enzimas hepáticas, anomalías sanguíneas (eosinofilia), ganglios linfáticos agrandados y otras afecciones del cuerpo (reacción al medicamento con eosinofilia y síntomas sistémicos que también se conoce como DRESS o síndrome de hipersensibilidad a los medicamentos).
• Reacción alérgica grave que causa hinchazón de la cara, la garganta, las manos, los pies, los tobillos o la parte inferior de las piernas.
• Urticaria (erupción cutánea con picor).

The use of eslicarbazepine is associated with an ECG (electrocardiogram) anomaly called increased PR interval. Side effects associated with this ECG anomaly may occur (e.g., fainting and slowed heartbeats).

There have been reports of bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures with antiepileptic drugs structurally related to eslicarbazepine, 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 for 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, bottle, and box after the letters CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit 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 Eslicarbazepina Normon

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

Appearance of the product and content of the packaging

Eslicarbazepina Normon 800 mg tablets are white, oblong, biconvex, scored on one face and embossed on the other. The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:September 2024

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/