ESLICARBAZEPINE ACETATE AUROVITAS 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Eslicarbazepine acetate Aurovitas 800 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Eslicarbazepine acetate Aurovitas and what is it used for

Eslicarbazepine acetate Aurovitas contains the active substance eslicarbazepine acetate.

This medicine 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 adults with newly diagnosed epilepsy;
• in combination with other antiepileptic medicines (adjunctive therapy) in adults, adolescents and children over 6 years of age who suffer from epileptic seizures (seizures) that affect only a part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalization).

Your doctor has prescribed Eslicarbazepine acetate Aurovitas to reduce the number of seizures.

2. What you need to know before you take Eslicarbazepine acetate Aurovitas

Do not take Eslicarbazepine acetate Aurovitas:

• if you are allergic to eslicarbazepine acetate or other carboxamide 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 (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking 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 not sure if 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 electrical discharge that affects both sides of the brain.

A small number of people taking antiepileptics have had thoughts of harming or killing themselves. If this happens while you are 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 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. 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 acetate Aurovitas

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

Tell your doctor if you are taking:

• Phenytoin (a medicine used to treat epilepsy), as you may need to adjust the dose;
• Carbamazepine (a medicine used to treat epilepsy), as you 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 contraceptive pill) as eslicarbazepine may reduce their effectiveness;
• Simvastatin (a medicine used to lower cholesterol levels), as you 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 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 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 is limited data on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations and neurodevelopmental problems (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 without talking to your doctor may cause seizures, which can 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 are not planning to become pregnant, you must use a reliable method of contraception during treatment with eslicarbazepine. Eslicarbazepine may affect the effectiveness of hormonal contraceptives, such as the contraceptive pill, and make them less effective in preventing pregnancy.

Therefore, you are advised to use other safe and effective methods of contraception while taking eslicarbazepine. Talk to your doctor, who will discuss with you the most suitable contraceptive method to use while taking eslicarbazepine. If you stop taking eslicarbazepine, you should continue to use a reliable 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 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, do not drive or use any tools or machines.

Eslicarbazepine acetate Aurovitas contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Eslicarbazepine acetate Aurovitas

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 only (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.

Elderly patients (over 65 years of age)

If you are an elderly patient and are taking eslicarbazepine in 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. 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.

For doses that cannot be achieved with eslicarbazepine, medicines with other concentrations of eslicarbazepine acetate are available.

If you take more Eslicarbazepine acetate Aurovitas 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 immediately to a hospital if you experience any of these symptoms. Take the medicine package with you, so that 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eslicarbazepine acetate Aurovitas

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 acetate Aurovitas

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, the dose will usually be reduced gradually. It is important that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.

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 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 frequentadverse effects (may affect more than 1 in 10 people) are:

• Dizziness or drowsiness.

The frequentadverse 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 infrequentadverse 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;
• Mood changes 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., 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;
• 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:

• Decreased platelet count that increases the risk of bleeding or bruising;
• Severe back or stomach pain (caused by pancreatitis);
• Decreased white blood cell count that makes infections more likely;
• Reddish patches or circular spots often with central blisters on the trunk, skin peeling, ulcers in the mouth, 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, 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 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 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 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 does not appear 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 acetate Aurovitas

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

Do not use this medicine after the expiration date that appears on the packaging and blister after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Eslicarbazepine acetate Aurovitas

• The active ingredient is eslicarbazepine acetate.

Each tablet contains 800 mg of eslicarbazepine acetate.

• The other excipients are: anhydrous colloidal silica, crospovidone, magnesium stearate, povidone, sodium carboxymethylcellulose type A.

Appearance of the Product and Package Contents

White to off-white, oblong tablets, approximately 19 mm x 9.8 mm in length, biconvex, uncoated, scored with "E" and "T" on either side of the break line on one side and "800" on the other side. The tablet can be divided into equal doses.

Eslicarbazepine acetate Aurovitas is available in blister packs.

Package sizes: 20, 30, 40, 50, 60, 70, 80, 90, and 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora, Lisboa

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon, Rhone

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Eslicarbazepin PUREN 800 mg Tabletten

Spain: Eslicarbazepina acetato Aurovitas 800 mg tablets EFG

France: ESLICARBAZEPINE ACETATE ARROW 800 mg, scored tablet

Italy: Eslicarbazepina acetato Aurobindo

Portugal: Acetato de Eslicarbazepina Generis

Sweden: Eslicarbazepine acetate Aurobindo

Date of the Last Revision of this Prospectus:November 2022

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/).