Label: information for the user

Eslicarbazepine acetate Aurovitas 800 mg tablets EFG

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

Eslicarbazepina acetate Aurovitas contains the active ingredient eslicarbazepine acetate.

This medicine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a disease where the affected person has seizures or repeated convulsive crises.

Eslicarbazepine is used:

• as a single medication (monotherapy) in adult patients with newly diagnosed epilepsy;
• together with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and children over 6 years old who suffer from epileptic seizures (convulsions) that affect a part of the brain (partial seizures). These seizures may be followed or not by a seizure that affects the entire brain (secondary generalization).

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

Do not take Eslicarbazepina acetato Aurovitas:

• if you are allergic to eslicarbazepina acetate or to other carboxamide derivatives (such as carbamazepine or oxcarbazepine, medications used for the treatment of epilepsy), or to 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, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat, or tongue. These may be signs of an allergic reaction.
• if you experience confusion, worsening of seizures, or decreased consciousness, which may be signs of low blood levels of salts.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepina is not recommended for patients with severe kidney disease.
• if you have liver problems. Eslicarbazepina is not recommended for patients with severe liver disease.
• if you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) called increased 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 myocardial infarction, or have any alteration of heart rhythm.
• if you have seizures that begin with a widespread electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If this occurs while taking eslicarbazepina, contact your doctor immediately.

Eslicarbazepina may cause dizziness and/or drowsiness, particularly at the start of treatment. Be particularly careful while taking eslicarbazepina to avoid accidental injuries, such as falls.

Be especially careful with eslicarbazepina:

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

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

In patients of Thai and Chinese Han ethnic origin, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by a blood test. Your doctor will advise you on the need for this blood test before taking eslicarbazepina.

Children

Eslicarbazepina should not be administered to children under 6 years of age.

Other medications and Eslicarbazepina acetate Aurovitas

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

Inform your doctor if you are taking:

• Phenitoin (a medication used for the treatment of epilepsy), as you may need to adjust the dose;
• Carbamazepine (a medication used for the treatment of epilepsy), as you may need to adjust the dose, and the following adverse effects of eslicarbazepina may occur more frequently: double vision, abnormal coordination, and dizziness;
• Oral contraceptives (such as the birth control pill) as eslicarbazepina may reduce the effectiveness of these;
• Simvastatin (a medication used to reduce cholesterol levels), as you may need to adjust the dose;
• Rosuvastatin, a medication used to reduce cholesterol levels;
• The anticoagulant warfarin;
• Monamine oxidase inhibitors (MAOIs);
• Do not take oxcarbazepine (a medication used for the treatment of epilepsy) with eslicarbazepina, as it is unknown whether it is safe to take these two medications together.

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

Pregnancy and breastfeeding

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

Eslicarbazepina is not recommended for use during pregnancy, as its effects on pregnancy and the fetus are unknown.

If you plan to become pregnant, discuss this with 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 eslicarbazepina acetate in pregnant women. Research has shown an increased risk of congenital defects and neurological development problems (brain development) in the children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at a time.

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

If you are a fertile woman and are not planning to become pregnant, you should use an effective contraceptive method during treatment with eslicarbazepina. Eslicarbazepina may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective in preventing pregnancy.

Therefore, it is recommended that you use other safe and effective forms of contraception while taking eslicarbazepina. Discuss this with your doctor, who will advise you on the type of contraceptive most suitable for use while taking eslicarbazepina. If you stop taking eslicarbazepina, continue using an effective contraceptive method until the end of the current menstrual cycle.

If you take eslicarbazepina during pregnancy, your baby may also be 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 eslicarbazepina. It is unknown whether it passes into breast milk.

Driving and operating machinery

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

Eslicarbazepina acetate Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Initial treatment dose

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide if you should take this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once a day.

In accordance with 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 your dose to 1,600 mg once a day.

Patients 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 problems.

Older adults (65 years or older)

If you are an older adult and taking eslicarbazepine in monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years old

Initial treatment 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 your 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 entire tablet, 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, there are medications available with other concentrations of eslicarbazepine acetate.

If you take more Eslicarbazepine acetate Aurovitas than you should

If you accidentally take more eslicarbazepine than you should, you are at potential 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. Bring the medication packaging 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 compensate for the missed doses.

If you interrupt treatment with Eslicarbazepine acetate Aurovitas

Do not suddenly stop taking the tablets. If you do, you are at risk of having more seizures. Your doctor will decide for 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 essential that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects can be very serious. If they occur, stop administering eslicarbazepine and inform your doctor or go to the hospital immediately, as you may need 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.

Side effectsvery frequent(can affect more than 1 in 10 people) are:

Side effectscommon(can affect up to 1 in 10 people) are:

Side effectsinfrequent(can affect up to 1 in 100 people) are:

Side effects ofunknown frequency(cannot be estimated from available data) are:

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

Bone disorders, including osteopenia and osteoporosis (bone thinning), and fractures have been reported with antiepileptic drugs structurally related to eslicarbazepine, 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 side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and themedications that you do not need at the SIGRE Pointof the pharmacy. In case of doubt,ask your pharmacist how to dispose of the packaging and the medications that you do not need. By doing so, you will help protect the environment.

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 contents of the package

White to off-white, oblong-shaped tablets, approximately 19 mm x 9.8 mm in length, biconvex, uncoated, engraved with "E" and "T" on either side of the groove 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.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora, Lisboa

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon, Rhone

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Eslicarbazepin PUREN 800 mg Tabletten

Spain:Eslicarbazepine acetate Aurovitas 800 mg tablets EFG

France:ESLICARBAZEPINE ACETATE ARROW 800 mg, scored tablet

Italy:Eslicarbazepine acetate Aurobindo

Portugal:Acetato de Eslicarbazepina Generis

Sweden:Eslicarbazepine acetate Aurobindo

Last review date of this leaflet:November 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).