ESLICARBAZEPINE NORMON 800 mg TABLETS

1. What is Eslicarbazepina Normon and what is it 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 where the person has repeated seizures or fits.

Eslicarbazepina Normon is used:

• As the only medicine (monotherapy) in adults with newly diagnosed epilepsy;
• Together with other antiepileptic medicines (adjunctive therapy) in adults, adolescents and children over 6 years old who have epileptic seizures (fits) that affect only part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalisation).

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

2. What you need to know before you take Eslicarbazepina Normon

Do not take Eslicarbazepina Normon

• If you are allergic to eslicarbazepine acetate, to other carbamazepine derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
• If you have a certain type of heart rhythm disorder (second or third degree atrioventricular block).

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine.

Tell your doctor immediately:

• If you develop blisters or peeling of the skin and/or mucous membranes, rash, problems with swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction;
• If you become confused, your seizures get worse or you lose consciousness, which could be signs of low blood levels of salts.

Tell your doctor:

• If you have kidney problems. Your doctor may need to adjust your dose. Eslicarbazepine is not recommended in patients with severe kidney disease;
• If you have liver problems. Eslicarbazepine is not recommended in patients with severe liver problems;
• If you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) called prolonged PR interval. If you are not sure if the medicines you are taking may cause this effect, discuss this with your doctor;
• If you have any heart disease such as heart failure or heart attack, or have any heart rhythm disorder;
• If you have seizures that start with an electrical discharge that spreads to both sides of the brain.

A small number of people taking antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

Eslicarbazepine may make you feel dizzy and/or drowsy, particularly at the start of treatment. Be extra careful while taking eslicarbazepine to avoid accidental injury, such as falls.

Be extra careful with this medicine

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

If you develop a severe rash or other sign of skin reaction (see section 4), stop taking this medicine and contact your doctor or seek medical attention immediately.

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

Children

Eslicarbazepine should not be given to children under 6 years old.

Taking Eslicarbazepina Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way eslicarbazepine works, or eslicarbazepine may affect the way other medicines work. Tell your doctor if you are taking:

• Phenytoin (a medicine used to treat epilepsy), as your doctor may need to adjust your dose.
• Carbamazepine (a medicine used to treat epilepsy), as your doctor may need to adjust your dose, and the following side effects of eslicarbazepine may occur more frequently: double vision, abnormal coordination and dizziness.
• Hormonal contraceptives (such as the pill) as eslicarbazepine may reduce their effectiveness.
• Simvastatin (a medicine used to lower cholesterol levels), as your doctor may need to adjust your dose.
• Rosuvastatin, a medicine used to lower cholesterol levels.
• The anticoagulant warfarin.
• Antidepressants, monoamine oxidase inhibitors (MAOIs).
• Do not take oxcarbazepine (a medicine used to treat epilepsy) with eslicarbazepine, as it is not known if it is safe to take these two medicines together.

See the section “Pregnancy and breast-feeding” for recommendations on contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Eslicarbazepine acetate should not be used during pregnancy, as its effects on pregnancy and the unborn child are not known.

If you are planning to become pregnant, talk to your doctor before stopping your contraceptive 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 problems with brain development (brain development) in children of women taking antiepileptic medicines, particularly when taking more than one antiepileptic medicine at the same time.

If you become pregnant, contact your doctor immediately. Do not stop taking your medicine until you have discussed this with your doctor. Stopping your medicine suddenly may cause you to have more seizures, which could be harmful to you and your unborn child. Your doctor may decide to change your treatment.

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

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

Do not breast-feed while taking eslicarbazepine acetate. It is not known if it passes into breast milk.

Driving and using machines

Eslicarbazepine may cause dizziness, drowsiness and affect your vision, particularly at the start of treatment. If this happens to you, do not drive or use any tools or machines.

Eslicarbazepina 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 Eslicarbazepina Normon

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Starting dose

400 mg once a day 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 a day.

Depending on how you respond to eslicarbazepine, your 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.

Patient 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 disease.

Elderly patients (over 65 years old)

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

Children over 6 years old

Starting 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 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 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 medicine, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

Eslicarbazepina Normon is taken by mouth. Swallow the tablet with a glass of water.

Eslicarbazepina 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 immediately.

The tablet can be divided into equal doses.

If you take more Eslicarbazepina 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 heart is beating irregularly or faster. Contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken. Take the medicine package with you, so that the doctor knows what you have taken.

If you forget to take Eslicarbazepina Normon

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

If you stop taking Eslicarbazepina Normon

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects may be very serious. If they appear, stop administering eslicarbazepine and inform a doctor or go to a hospital immediately, as you may need urgent medical treatment:

• Blisters or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of the lips, face, eyelids, throat, or tongue. These could be signs of an allergic reaction.

The very commonadverse effects (may affect more than 1 in 10 people) are:

• Dizziness or drowsiness.

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

• Feeling of instability, or spinning or floating.
• Nausea or vomiting.
• Headache.
• Diarrhea.
• Double vision or blurred vision.
• Difficulty concentrating.
• Feeling of fatigue or decreased energy.
• Tremor.
• Skin rash.
• Blood tests showing low sodium levels.
• Decreased appetite.
• Difficulty sleeping.
• Difficulty with movement coordination (ataxia).
• Weight gain.

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

• Clumsiness.
• Allergy.
• Constipation.
• Seizures.
• Underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, increased tongue size, fine and brittle nails and 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 reduction in the number of red blood cells.
• Dehydration.
• Changes in eye movements, blurred vision, or red eyes.
• Suffering from falls.
• Heat burn.
• Poor memory or forgetfulness.
• Crying, feeling of depression, nervousness, or confusion, lack of interest or emotions.
• Inability to speak, write, or understand spoken or written language.
• Agitation.
• Attention deficit/hyperactivity.
• 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 smell.
• Ringing in the ears.
• Difficulty hearing.
• Swelling of legs and arms.
• Acidity, stomach discomfort, abdominal pain, bloating, and abdominal discomfort or dry mouth.
• Black stools.
• Gingivitis or tooth pain.
• Sweating or dry skin.
• Itching.
• Changes in skin (e.g., skin redness).
• 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.
• Flushing (blushing), cold in the extremities.
• Slower or irregular heartbeats.
• Extreme drowsiness.
• Sedation.
• Motor neurological disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps.
• Drug toxicity.
• Anxiety.

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

• 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)).
• Reduced platelet count, which increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Reduced white blood cell count, making infections more likely.
• Reddish spots or circular patches often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes, which may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Initially flu-like symptoms, rash on the face, 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).

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

Bone disorders, including osteopenia and osteoporosis (thinning of the bones), and fractures have been reported with antiepileptic drugs structurally related to 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Eslicarbazepine Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the blister pack, bottle, and carton after the letters CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Eslicarbazepine Normon

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

Appearance of the Product and Package Contents

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

The tablets are packaged in blister packs, 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 Last Revision of this Prospectus:September 2024

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