ESLICARBAZEPINE NORMON 400 mg TABLETS

2. What you need to know before taking Eslicarbazepine Normon

Do not take Eslicarbazepine Normon:

• If you are allergic to eslicarbazepine acetate, other carboxamide derivatives (e.g., 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 blisters or peeling of the skin and/or mucous membranes, rash, swallowing or breathing difficulties, 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 consciousness, which could be signs of low blood salt levels.

Inform your doctor:

• If you have kidney problems. Your doctor may need to adjust the 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 medication that may cause an ECG (electrocardiogram) anomaly called a 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 heart attack, or have any heart rhythm disorder.
• If you experience seizures that start with an extended electrical discharge that affects both sides of the brain.

A small number of people taking antiepileptics 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, particularly at the start of treatment. Be careful while taking eslicarbazepine to avoid accidental injuries, such as falls.

Be careful with eslicarbazepine

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 skin symptom (see section 4), stop taking eslicarbazepine and consult your doctor or seek immediate medical attention.

In patients of Thai and Chinese Han ethnic origin, 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 on the need for this blood test before taking eslicarbazepine.

Children

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

Other medications and Eslicarbazepine Normon

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

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

See the "Pregnancy and breastfeeding" section for recommendations on contraception.

Pregnancy and breastfeeding

Eslicarbazepine is not recommended during pregnancy, as its effects on pregnancy and the unborn child are unknown.

If you plan to become pregnant, consult your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There are limited data on the use of eslicarbazepine acetate in pregnant women.

Studies have shown an increased risk of congenital defects and problems with neurological development (brain development) in children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at the same 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 could be dangerous for you and your unborn child. Your doctor may decide to change your treatment.

If you are a woman of childbearing age and do not plan to become pregnant, you should use an effective contraceptive method during treatment with eslicarbazepine. Eslicarbazepine may affect the functioning of hormonal contraceptives, such as birth control pills, and make them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective forms of contraception while taking eslicarbazepine. Discuss with your doctor the type of contraceptive most suitable for you to use while taking eslicarbazepine. If you stop taking eslicarbazepine, you should continue to use an effective contraceptive method until the end of your current menstrual cycle. If you take eslicarbazepine during pregnancy, your baby is also 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 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.

Eslicarbazepine Normon contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

3. How to take Eslicarbazepine Normon

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

Initial 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, 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.

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.

Patients over 65 years old

If you are an elderly person taking eslicarbazepine in monotherapy, the dose of 1,600 mg is not suitable for you.

Children over 6 years old

Initial 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 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 pharmaceutical 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 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 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 heart is beating irregularly or faster. Contact your doctor or go to the hospital immediately if you experience any of these symptoms. Take the medication package 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 make up for forgotten doses.

If you stop taking Eslicarbazepine Normon

Do not suddenly stop taking the tablets. 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, the 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 medication, 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, discontinue the administration of eslicarbazepine and inform a doctor or go to a hospital immediately, as urgent medical treatment may be needed:

• 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 frequent adverse effects (may affect more than 1 in 10 people) are:

• Dizziness or drowsiness.

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

• Clumsiness.
• 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, 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 levels of salts (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.
• Bad 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.
• Nosebleeds.
• 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., redness of the skin).
• Hair loss.
• Urinary tract infection.
• General malaise, weakness, or chills.
• Weight loss.
• Muscle pain, pain in limbs, muscle weakness.
• Bone metabolism disorder.
• Increased bone proteins.
• Redness (flushing), 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:

• Reduction of platelets that increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Reduction of white blood cells that makes 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 that 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 that causes 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 antidiuretic hormone (ADH)).

The use of eslicarbazepine is associated with an ECG (electrocardiogram) anomaly called an increase in the 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 structurally related antiepileptic medications, such as carbamazepine and oxcarbazepine. Consult your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or take steroids.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 after 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 any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofEslicarbazepine Normon

• The active ingredient is eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine acetate.
• The other ingredients are povidone, anhydrous colloidal silica, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Package Contents

Eslicarbazepine Normon 400 mg tablets are white, oblong, and biconvex, engraved with "E400" and scored on one side and smooth on the other side, with a diameter of 14.4 mm x 7.2 mm ±10%. The tablet can be divided into equal doses.

The tablets are packaged in blister packs, in cardboard boxes of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: September 2023

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