Eslicarbazepine acetate Aurovitas 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eslicarbazepine acetate Aurovitas 800 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

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

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Eslicarbazepina acetato Aurovitas is and what it is used for

Eslicarbazepina acetato Aurovitas contains the active substance eslicarbazepina acetato.

This medicine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsive fits.

Eslicarbazepine is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• together with other antiepileptic medicines (adjunctive therapy) in adults, adolescents, and children over 6 years of age who have epileptic seizures (convulsions) affecting one part of the brain (partial seizures). These seizures may or may not be followed by a seizure affecting the entire brain (secondary generalization).

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

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

Do not take Eslicarbazepine acetate Aurovitas:

• if you are allergic to eslicarbazepine acetate or to 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 starting this medicine.

Tell your doctor immediately:

• if you develop blisters or skin peeling 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.
• if you experience confusion, worsening of seizures, or decreased level of consciousness, which could be signs of low blood salt levels.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust your dose. Eslicarbazepine is not recommended in patients with severe renal disease.
• if you have liver problems. Eslicarbazepine is not recommended in patients with severe liver disease.
• if you are taking any medicine that may cause an abnormality on the ECG (electrocardiogram) called PR interval prolongation. If you are unsure whether your medicines may cause this effect, discuss it with your doctor.
• if you have any heart condition such as heart failure or heart attack, or have any heart rhythm disturbances.
• if you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medicines have had suicidal thoughts or thoughts about harming themselves. If this happens to you while taking eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may cause dizziness and/or drowsiness, especially at the start of treatment. Take special care while taking eslicarbazepine to avoid accidental injury, such as falls.

Take special care with eslicarbazepine:

In post-marketing experience, serious and potentially life-threatening skin reactions have been reported in patients treated with eslicarbazepine, including Stevens-Johnson Syndrome / toxic epidermal necrolysis, and 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 origin and Han Chinese ethnic group, 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 about the need for such a blood test before starting eslicarbazepine.

Children

Eslicarbazepine must not be given to children aged 6 years or younger.

Other medicines and Eslicarbazepine acetate Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because some medicines may interfere with how eslicarbazepine works, or eslicarbazepine may interfere with the effect of other medicines.

Tell your doctor if you are taking:

• Phenytoin (a medicine used to treat epilepsy), as your dose may need to be adjusted;
• Carbamazepine (a medicine used to treat epilepsy), as your dose may need adjustment, and the following side effects of eslicarbazepine may occur more frequently: double vision, abnormal coordination, and dizziness;
• Hormonal contraceptives (such as the oral contraceptive pill), as eslicarbazepine may reduce their effectiveness;
• Simvastatin (a medicine used to lower cholesterol levels), as your dose may need adjustment;
• Rosuvastatin, a medicine used to lower cholesterol levels;
• The anticoagulant warfarin;
• Monoamine oxidase inhibitor (MAOI) antidepressants;
• Do not take oxcarbazepine (a medicine used to treat epilepsy) together with eslicarbazepine, as it is not known whether it is safe to take these two medicines together.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine.

The use of eslicarbazepine is not recommended during pregnancy, as the effects of eslicarbazepine on pregnancy and the unborn child are unknown.

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

If you are or think you may be pregnant, inform your doctor immediately. Do not stop taking your medicine 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 potential and are not planning to become pregnant, you must use an effective method of contraception during treatment with eslicarbazepine. Eslicarbazepine may affect the effectiveness of hormonal contraceptives, such as the oral contraceptive pill, making them less effective in preventing pregnancy.

Therefore, you are advised to use other safe and effective forms of contraception while taking eslicarbazepine. Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking eslicarbazepine. If treatment with eslicarbazepine is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle.

If you take eslicarbazepine during pregnancy, your baby may also be 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. 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 occurs, do not drive or operate tools or machinery.

Eslicarbazepine acetate Aurovitas contains sodium

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

3. How to take Eslicarbazepine Acetate Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults

Starting dose

400 mg once daily 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 daily.

Depending on your response to eslicarbazepine, the dose may be increased to 1,200 mg once daily. If you are taking eslicarbazepine alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once daily.

Patients with renal problems

If you have kidney problems, you will generally be given a lower dose of eslicarbazepine. Your doctor will determine the correct dose for you. Eslicarbazepine is not recommended if you have severe renal impairment.

Elderly patients (over 65 years of age)

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

Children over 6 years of age

Starting dose

The starting dose is 10 mg per kg of body weight once daily 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 a maximum of 30 mg per kg of body weight. The maximum dose is 1,200 mg once daily.

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. Please consult your doctor or pharmacist.

Method and route of administration

Eslicarbazepine is administered orally. Swallow the tablet with a glass of water.

Eslicarbazepine may be taken with or without food.

If you have difficulty swallowing the tablet whole, you may crush it and mix it with a small amount of water or apple puree, and take it immediately.

The tablet may 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 may be at risk of having more seizures; or you may feel that your heartbeat is irregular or faster than normal. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Take the medicine packaging with you so that the doctor knows what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 then continue as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Eslicarbazepine Acetate Aurovitas

Do not suddenly stop taking the tablets. If you do, you may be at risk of having more seizures. Your doctor will decide for how long you should take eslicarbazepine. If your doctor decides to discontinue your treatment with eslicarbazepine, your 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may be very serious. If they occur, stop taking eslicarbazepine and contact a doctor or go to a hospital immediately, as you may require urgent medical treatment:

• Skin blistering or peeling 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.

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

• Dizziness or drowsiness.

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

• Feeling unsteady, spinning, or floating;
• Nausea or vomiting;
• Headache;
• Diarrhea;
• Double or blurred vision;
• Difficulty concentrating;
• Feeling tired or reduced energy;
• Tremor;
• Skin rash;
• Blood tests showing low sodium levels;
• Decreased appetite;
• Difficulty sleeping;
• Difficulty coordinating movements (ataxia);
• Weight gain.

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

• Clumsiness of movements;
• Allergy;
• Constipation;
• Seizures;
• Underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), cold intolerance, enlarged tongue, brittle and thin nails or hair, and low body temperature;
• Liver problems (such as increased liver enzymes);
• High blood pressure or a marked increase in blood pressure;
• Low blood pressure, or decreased blood pressure upon standing;
• Blood tests showing low levels of salts (including chloride), or reduced number of red blood cells;
• Dehydration;
• Changes in eye movements, blurred vision, or red eyes;
• Falls;
• Thermal burns;
• Poor memory or forgetfulness;
• Crying, feeling depressed, 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;
• Tingling or numbness sensation anywhere in the body;
• Migraine;
• Burning sensation;
• Abnormal sensation to touch;
• Changes in sense of smell;
• Ringing in the ears;
• Hearing difficulty;
• Swelling of arms and legs;
• Heartburn, stomach discomfort, abdominal pain, bloating and abdominal discomfort, or dry mouth;
• Black stools;
• Swollen gums or toothache;
• Sweating or dry skin;
• Itching;
• Skin changes (e.g., skin redness);
• Hair loss;
• Urinary tract infection;
• General malaise, weakness, or chills;
• Weight loss;
• Muscle pain, limb pain, muscle weakness;
• Bone metabolism disorder;
• Increased bone proteins;
• Flushing, cold extremities;
• Slower or irregular heartbeats;
• Extreme drowsiness;
• Sedation;
• Motor neurological disorder involving muscle contractions causing twisting movements, repetitive motions, or abnormal postures. Symptoms may include tremors, pain, and cramps;
• Drug toxicity;
• Anxiety.

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Reduction in platelets, increasing the risk of bleeding or bruising;
• Severe back or stomach pain (caused by inflammation of the pancreas);
• Reduction in white blood cells, making infections more likely;
• Reddish spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital, or eye ulcers, red and inflamed eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome / toxic epidermal necrolysis);
• Initially flu-like symptoms, facial rash, generalized rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic manifestations (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;
• Hives (itchy skin rash);
• Lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low blood sodium levels due to inappropriate antidiuretic hormone (ADH) secretion).

Use of eslicarbazepine is associated with an ECG (electrocardiogram) abnormality called PR interval prolongation. Adverse effects related to this ECG abnormality may occur (e.g., fainting and slowed heart rate).

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine. Speak with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eslicarbazepine acetate Aurovitas

• The active substance is eslicarbazepine acetate.

Each tablet contains 800 mg of eslicarbazepine acetate.

• The other ingredients are: colloidal anhydrous silica, crospovidone, magnesium stearate, povidone, sodium carboxymethyl starch type A.

Appearance of the product and contents of the pack

White to off-white, oblong tablets, approximately 19 mm x 9.8 mm, biconvex, uncoated, marked with "E" and "T" on each side of the breakline 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.

Pack sizes:

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

Only some pack 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 medicinal product 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 comprimidos EFG

France: ESLICARBAZEPINE ACETATE ARROW 800 mg, comprimé sécable

Italy: Eslicarbazepina acetato Aurobindo

Portugal: Acetato de Eslicarbazepina Generis

Sweden: Eslicarbazepine acetate Aurobindo

Date of the most recent revision of this leaflet: November 2022

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