Leaflet: information for the user

EslicarbazepineNormon 200 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 doubts, 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 Eslicarbazepine Normon is and what it is used for

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

3. How to take Eslicarbazepine Normon

4. Possible side effects

5. Storage of Eslicarbazepine Normon

6. Contents of the pack and additional information

Eslicarbazepina Normon contains the active ingredient eslicarbazepine acetate.

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

Eslicarbazepine is used:

• As a single medication (monotherapy) in adult patients with newly diagnosed epilepsy.
• Together 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 prescribed eslicarbazepine to reduce the number of seizures.

Do not take Eslicarbazepina Normon:

• If you are allergic to eslicarbazepine acetate, other carboxamide derivatives (such as carbamazepine or oxcarbazepine, medications used for the treatment of 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 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 electrolytes.

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 any 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 eslicarbazepine

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 eslicarbazepine and consult your doctor or seek medical attention immediately.

In patients of Thai and Chinese Han ethnic origin, 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.

Other medications and Eslicarbazepina Normon

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 eslicarbazepine side effects may occur more frequently: double vision, abnormal coordination, and dizziness.
• Oral contraceptives (such as the birth control pill) as eslicarbazepine may reduce the effectiveness of these.
• 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

Eslicarbazepine is not recommended for use during pregnancy, as the effects of eslicarbazepine 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 may 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. Eslicarbazepine 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 that you 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 for 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 problems 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; 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.

Depending on how you respond toeslicarbazepine, 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 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 eslicarbazepine 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 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 is administered orally. Swallow the tablet with a glass of water.

Eslicarbazepine can be taken with or without food.

If you have difficulty swallowing the entire tablet, 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 moreeslicarbazepinethan 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.

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 Eslicarbazepine Normon

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 compensate 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 takeeslicarbazepine. If your doctor decides to stop your treatment with eslicarbazepine, they will usually reduce your dose gradually. 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.
• Trembling.
• Rash.
• Blood tests showing low sodium levels.
• Loss of appetite.
• Difficulty sleeping.
• Difficulty with coordination of movements (ataxia).
• Weight gain.

The side effectsuncommon(can 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, 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 blood pressure decreased 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 falls.
• Thermal 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.
• Burning sensation.
• Abnormal sensation to touch.
• Alterations in sense of 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.
• 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 feeling of illness, weakness, or chills.
• Weight loss.
• Muscle pain, pain in extremities, muscle weakness.
• Bone metabolism disorder.
• Increased bone proteins.
• Redness (flushing), coldness in extremities.
• Slower or irregular heartbeats.
• Extreme drowsiness.
• Sedation.
• Neuromuscular alteration where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps.
• Medication toxicity.
• Anxiety.

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

• Reduction of platelets, increasing the risk of bleeding or hematomas.
• Intense pain in the back or stomach (caused by pancreatitis inflammation).
• Reduction of white blood cells, making infections more likely.
• Red spots or circular patches often with central blisters on the trunk, skin peeling, 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 eslicarbazepine is associated with an ECG anomaly called increased PR interval. Side effects associated with this ECG anomaly may occur (e.g., fainting and slowed heartbeats).

Bone disorders, including osteopenia and osteoporosis (bone thinning), and fractures have been reported 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 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: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 after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicationsshould not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofEslicarbazepina Normon

• The active ingredient is eslicarbazepine acetate. Each tablet contains 200 mg of eslicarbazepine acetate.
• The other components are povidone, anhydrous colloidal silica, sodium croscarmellose and magnesium stearate.

Appearance of the product and contents of the packaging

Eslicarbazepina Normon 200 mg tablets are white, oblong and biconvex, engraved with "E200" and scored on one side and smooth on the other side, with a diameter of 11.1 mm x 5.8 mm ±10%. The tablet can be divided into equal doses.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet: September 2023

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