ESLICARBAZEPINE NORMOGEN 400 mg TABLETS

Introduction

Package Leaflet: Information for the User

EslicarbazepineNormogen 400 mg tablets EFG

eslicarbazepine acetate

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Eslicarbazepine Normogen and what is it used for

Eslicarbazepine Normogen contains the active substance eslicarbazepine acetate.

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

Eslicarbazepine is used:

• As the only medicine (monotherapy) in adult patients with newly diagnosed epilepsy.
• In combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and child patients above 6 years of age who suffer from seizures (fits) that affect only a part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the entire brain (secondary generalization).

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

2. What you need to know before taking Eslicarbazepine Normogen

Do not take Eslicarbazepine Normogen:

• If you are allergic to eslicarbazepine acetate, to other carbamide 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 suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Tell your doctor immediately:

• If you develop 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.
• If you experience confusion, worsening of seizures, or decreased 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 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 medicine that may cause an abnormality in the ECG (electrocardiogram) called a prolonged PR interval. If you are unsure whether the medicines 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 have 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 contact your doctor or seek medical attention immediately.

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 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 of age.

Other medicines and Eslicarbazepine Normogen

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 the dose.
• Carbamazepine (a medicine 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 the pill) as eslicarbazepine may reduce their effectiveness.
• Simvastatin (a medicine used to lower cholesterol levels), as your doctor may need to adjust the dose.
• Rosuvastatin, a medicine used to lower cholesterol levels.
• The anticoagulant warfarin.
• Antidepressant monoamine oxidase inhibitors (MAOIs).
• Do not take oxcarbazepine (a medicine used to treat epilepsy) with eslicarbazepine, as it is not known whether it is safe to take these two medicines together.

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

Pregnancy and breast-feeding

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

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

If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking your medicine until you have talked to your doctor. Stopping your medicine suddenly may cause 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 should use an effective method of contraception during treatment with eslicarbazepine. Eslicarbazepine 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. If you stop taking eslicarbazepine, you should continue to use an effective method of contraception until the end of your current menstrual cycle. If you take eslicarbazepine during pregnancy, your baby is also at risk of having 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. It is not known whether eslicarbazepine 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 Normogen contains sodium

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

3. How to take Eslicarbazepine Normogen

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

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.

Patient over 65 years of age

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

Children over 6 years of age

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 medicine, may be more suitable for administration in children. Talk to your doctor or pharmacist.

Form and route of administration

Eslicarbazepine is taken by mouth. 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 Normogen 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 medicine package with you, so the doctor knows what you have taken.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eslicarbazepine Normogen

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 forgotten doses.

If you stop taking Eslicarbazepine Normogen

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 your doctor tells you; otherwise, your symptoms may get worse.

If you have any further questions on 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 all people suffer from them.

The following adverse effects can 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 in 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 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.
• 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 discomfort, weakness, or chills.
• Weight loss.
• Muscle pain, pain in limbs, muscle weakness.
• Bone metabolism disorder.
• Increased bone proteins.
• Flush (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:

• Decrease in platelets that increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Decrease in 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.
• Hives (itchy skin rash).
• 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 increased PR interval. Adverse effects associated with this ECG anomaly may occur (e.g., fainting and slowing of heartbeats).

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. 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 that is not listed in this leaflet. 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 Normogen

Keep this medicine out of the 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 Normogen

• 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 Normogen 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 Leaflet:

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/