Eslicarbazepine Normon 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eslicarbazepine Normon 800 mg tablets EFG

Eslicarbazepine acetate

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Eslicarbazepina Normon is and what it is used for

Eslicarbazepina Normon contains the active substance eslicarbazepine acetate.

Eslicarbazepine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsions.

Eslicarbazepina Normon is used:

• As a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• In combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and pediatric patients over 6 years of age who experience epileptic seizures (convulsions) originating in one part of the brain (partial seizures). These seizures may or may not be followed by a seizure affecting the entire brain (secondary generalization).

Your doctor has prescribed eslicarbazepine to reduce the number of your seizures.

2. What you need to know before starting to take Eslicarbazepine Normon

Do not take Eslicarbazepine Normon

• If you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (for example carbamazepine or oxcarbazepine, medicines used to treat epilepsy), or to any of the other ingredients of this medicine (listed in section 6);
• If you suffer from 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 eslicarbazepine.

Inform your doctor immediately:

• If you develop blisters or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, or swelling of the lips, face, eyelids, throat, or tongue. These could be signs of an allergic reaction;
• If you experience confusion, worsening of seizures, or decreased level of consciousness, which could 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 in patients with severe renal impairment;
• If you have liver problems. Eslicarbazepine is not recommended in patients with severe hepatic impairment;
• If you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) known as PR interval prolongation. If you are unsure whether your current medications may cause this effect, discuss it with your doctor;
• If you have any heart condition such as heart failure or heart attack, or any heart rhythm disturbances;
• If you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medicines have had thoughts of self-harm or suicide. If this happens to you while taking eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may make you feel dizzy and/or drowsy, especially at the beginning of treatment. Take special care while taking eslicarbazepine to avoid accidental injuries such as falls.

Take special care with this medicine

In post-marketing experience, serious and potentially life-threatening skin reactions have been reported in patients treated with eslicarbazepine, including Stevens-Johnson Syndrome / toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

If you develop a severe rash or other skin symptoms (see section 4), stop taking this medicine and consult your doctor or seek immediate medical attention.

In patients of Thai origin and the Han Chinese ethnic group, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by a blood test. Your doctor may advise you about the need for such a blood test before starting eslicarbazepine.

Children

Eslicarbazepine must not be given to children aged 6 years or younger.

Taking Eslicarbazepine Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This recommendation is because some medicines may interfere with how eslicarbazepine works, or eslicarbazepine may interfere with the effect of other medicines. Inform your doctor if you are taking:

• Phenytoin (a medicine used to treat epilepsy), as dose adjustment may be necessary;
• Carbamazepine (a medicine used to treat epilepsy), as dose adjustment may be required, and the following adverse effects of eslicarbazepine may occur more frequently: double vision, abnormal coordination, and dizziness;
• Hormonal contraceptives (such as the oral contraceptive pill), as eslicarbazepine may reduce their effectiveness;
• Simvastatin (a medicine used to lower cholesterol levels), as dose adjustment may be required;
• Rosuvastatin, a medicine used to lower cholesterol levels;
• The anticoagulant warfarin;
• Monoamine oxidase inhibitor (MAOI) antidepressants;
• Do not take oxcarbazepine (a medicine used to treat epilepsy) together with eslicarbazepine, as it is unknown whether it is safe to take these two medicines together.

See the section “Pregnancy and breastfeeding” for recommendations regarding contraception.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of eslicarbazepine acetate is not recommended during pregnancy, as the effects of eslicarbazepine acetate on pregnancy and the unborn child are unknown.

If you plan to become pregnant, talk to your doctor before stopping contraception 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 malformations and neurological development problems (brain development) in children of women taking antiepileptic medicines, particularly when more than one antiepileptic medicine is taken at the same time.

If you are or think you may be pregnant, inform your doctor immediately. Do not stop taking your medicine until you have discussed it with your doctor. Stopping your medication without consulting your doctor may cause seizures, which could be dangerous for you and your unborn child. Your doctor may decide to change your treatment.

If you are a woman of childbearing potential and do not plan to become pregnant, you must use an effective method of contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate may affect the function of hormonal contraceptives, such as the oral contraceptive pill, and make them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective forms of contraception while taking eslicarbazepine.

Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking eslicarbazepine acetate. If treatment with eslicarbazepine acetate is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle. If you take eslicarbazepine acetate during pregnancy, your baby may also be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medicine to prevent this.

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

Driving and using machines

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

Eslicarbazepine Normon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Eslicarbazepine Normon

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

Starting dose

400 mg once daily 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 daily.

Depending on your response to eslicarbazepine, the dose may be increased to 1,200 mg once daily. If you are taking eslicarbazepine alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once daily.

Patients with renal problems

If you have kidney problems, you are generally 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.

Elderly patients (over 65 years of age)

If you are elderly and taking this medicine as monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years of age

Starting dose

The starting dose is 10 mg per kg of body weight once daily for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

Depending on the 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 a maximum of 30 mg per kg of body weight. The maximum dose is 1,200 mg once daily.

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 medicine, may be more suitable for administration in children. Please consult your doctor or pharmacist.

Method and route of administration

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

Eslicarbazepine Normon may be taken with or without food.

If you have difficulty swallowing the whole tablet, you may crush it and mix it with a small amount of water or apple sauce and take it immediately.

The tablet may be divided into equal doses.

If you take more Eslicarbazepine Normon than you should

If you accidentally take more eslicarbazepine than you should, you may be at risk of having more seizures, or you may feel that your heartbeat is irregular or faster. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Take the medicine packaging with you so the doctor knows what you have taken.

If you forget to take Eslicarbazepine Normon

If you forget to take a tablet, take it as soon as you remember and then continue as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eslicarbazepine Normon

Do not suddenly stop taking the tablets. If you do, you may be at risk of having more seizures. Your doctor will decide for how long you should take eslicarbazepine. If your doctor decides to discontinue your treatment with eslicarbazepine, your dose will usually be gradually reduced. It is important that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects may be very serious. If they occur, stop taking eslicarbazepine and contact a doctor or go to a hospital immediately, as you may require 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 very common adverse effects (may affect more than 1 in 10 people) are:

• Dizziness or drowsiness.

The common adverse effects (may affect up to 1 in 10 people) are:

• Feeling unsteady, spinning, or floating.
• Nausea or vomiting.
• Headache.
• Diarrhea.
• Double or blurred vision.
• Difficulty concentrating.
• Feeling tired or lacking energy.
• Tremor.
• Skin rash.
• Blood tests showing low sodium levels.
• Decreased appetite.
• Difficulty sleeping.
• Difficulty coordinating movements (ataxia).
• Weight gain.

The uncommon adverse effects (may affect up to 1 in 100 people) are:

• Clumsiness of movements.
• Allergic reaction.
• Constipation.
• Seizures.
• Underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), cold intolerance, enlarged tongue, brittle nails or hair, and low body temperature.
• Liver problems (such as increased liver enzymes).
• High blood pressure or a marked increase in blood pressure.
• Low blood pressure, or decreased blood pressure upon standing.
• Blood tests showing low levels of salts (including chloride), or reduced number of red blood cells.
• Dehydration.
• Changes in eye movements, blurred vision, or red eyes.
• Falls.
• Thermal burns.
• Poor memory or forgetfulness.
• Crying, feelings of depression, nervousness, or confusion, lack of interest or emotions.
• Inability to speak, write, or understand spoken or written language.
• Restlessness.
• Attention deficit/hyperactivity.
• Irritability.
• Mood changes or hallucinations.
• Difficulty speaking.
• Nosebleeds.
• Chest pain.
• Tingling or numbness in any part of the body.
• Migraine.
• Burning sensation.
• Abnormal sensation to touch.
• Changes in sense of smell.
• Ringing in the ears.
• Hearing difficulty.
• Swelling of arms and legs.
• Heartburn, stomach discomfort, abdominal pain, bloating, abdominal discomfort, or dry mouth.
• Black stools.
• Gum inflammation or toothache.
• Sweating or dry skin.
• Itching.
• Skin changes (e.g., skin redness).
• Hair loss.
• Urinary tract infection.
• General malaise, weakness, or chills.
• Weight loss.
• Muscle pain, limb pain, muscle weakness.
• Bone metabolism disorder.
• Increased bone proteins.
• Flushing, coldness in extremities.
• Slower or irregular heartbeat.
• Extreme drowsiness.
• Sedation.
• Motor neurological disorder involving muscle contractions causing twisting, repetitive movements, or abnormal postures. Symptoms may include tremors, pain, and cramps.
• Drug toxicity.
• Anxiety.

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low blood sodium levels due to inappropriate antidiuretic hormone (ADH) secretion).
• Reduced platelet count, increasing the risk of bleeding or bruising.
• Severe back or stomach pain (caused by inflammation of the pancreas).
• Reduced white blood cell count, making infections more likely.
• Red spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, red and inflamed eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis).
• Initially flu-like symptoms, facial rash, generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic manifestations (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.
• Hives (itchy skin rash).

The use of eslicarbazepine is associated with an ECG (electrocardiogram) abnormality called PR interval prolongation. Adverse effects related to this ECG abnormality may occur (e.g., fainting and slowed heart rate).

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine. Please speak with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eslicarbazepine Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, the bottle, and the carton after the letters EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Eslicarbazepina Normon

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

Appearance of the medicinal product and contents of the container

Eslicarbazepina Normon 800 mg tablets are white, oblong, biconvex, with a score line on one side and engraved marking on the other. The tablet can be divided into equal doses.

The tablets are packaged in blister packs, contained in cardboard boxes of 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of the most recent revision of this package leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/