Eslicarbazepine Alter 800 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Eslicarbazepine Alter 800 mg tablets EFG

eslicarbazepine acetate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

Eslicarbazepine contains the active substance eslicarbazepine acetate.

Eslicarbazepine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsions.

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 pediatric patients over 6 years of age who experience epileptic seizures (convulsions) originating in 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 eslicarbazepine to reduce the number of seizures.

2. What you need to know before taking Eslicarbazepine Alter

Do not take Eslicarbazepine Alter

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (for example, carbamazepine or oxcarbazepine, medicines used to treat epilepsy), or to any of the other components of this medicine (listed in section 6);
• if you have a specific type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine.

Inform your doctor immediately:

• if you develop 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;
• if you experience confusion, worsening of seizures, or decreased level of consciousness, which could be signs of low blood levels of salts.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepine is not recommended in patients with severe renal impairment;
• if you have liver problems. Eslicarbazepine is not recommended in patients with severe hepatic impairment;
• if you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) known as PR interval prolongation. If you are unsure whether your current medications 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 disturbances in heart rhythm;
• if you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptic medicines have had thoughts of self-harm or suicide. If this occurs while you are taking eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may cause dizziness and/or drowsiness, especially at the beginning of treatment. Exercise particular caution while taking eslicarbazepine to avoid accidental injuries, 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 symptoms (see section 4), stop taking eslicarbazepine and consult your doctor or seek immediate medical attention.

In Thai patients and those of Han Chinese ethnicity, the risk of severe 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 whether such a blood test is necessary before starting eslicarbazepine.

Children

Eslicarbazepine should not be administered to children aged 6 years or younger.

Taking Eslicarbazepine Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This recommendation is in case any of them interfere with how eslicarbazepine works, or if eslicarbazepine interferes with the effect of those medicines. Inform 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 to be adjusted, 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), since eslicarbazepine may reduce their effectiveness;
• simvastatin (a medicine used to reduce cholesterol levels), as your dose may need to be adjusted;
• rosuvastatin, a medicine used to reduce 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 unknown whether it is safe to take these two medicines together.

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

Pregnancy and lactation

It is not recommended to use eslicarbazepine acetate if you are pregnant, as the effects of eslicarbazepine acetate on pregnancy and the developing 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 developmental problems (brain development) in children of women who take antiepileptic medicines, particularly when more than one antiepileptic medicine is taken at the same time.

If you are or think you might be pregnant, inform your doctor immediately. You must 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 should use an effective method of contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate 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 forms of safe and effective contraception while taking eslicarbazepine acetate.

Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking eslicarbazepine acetate. If treatment with eslicarbazepine acetate is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle. If you take eslicarbazepine acetate 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 acetate. It is unknown whether it passes into breast milk.

Driving and operating machinery

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

This medicine contains sodium This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which means it is essentially "sodium-free".

3. How to take Eslicarbazepine Alter

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 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.

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.

Oral suspension (another pharmaceutical form not available for this 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.

The tablet may be divided into equal doses.

If you take more Eslicarbazepine Alter 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 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eslicarbazepine Alter

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 interrupt treatment with Eslicarbazepine Alter

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 stop your treatment with eslicarbazepine, your dose will usually be gradually reduced. It is important that you complete your 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 will experience them.

The following adverse effects may be very serious. If any of these occur, stop taking eslicarbazepine and contact a doctor or go to a hospital immediately, as you may require urgent medical treatment:

• blistering 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.

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
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling tired or lack of energy
• tremor
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• problems with movement coordination (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 levels of thyroid hormones (detected in blood tests), intolerance to cold, enlarged tongue, brittle and thin nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or 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 smell
• tinnitus (ringing in the ears)
• hearing difficulty
• swelling of arms and legs
• heartburn, stomach discomfort, abdominal pain, bloating, abdominal discomfort, or dry mouth
• black stools
• gum inflammation 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
• redness (flushing), cold extremities
• slower or irregular heartbeat
• extreme drowsiness
• sedation
• motor neurological disorder involving muscle contractions causing twisting movements, repetitive movements, 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, widespread rash, high 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 causing swelling of the face, throat, hands, feet, ankles, or lower legs.
• Urticaria (itchy skin rash).
• Lethargy, confusion, muscle spasms, or a marked worsening of seizures (possible symptoms of low sodium levels in the blood 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eslicarbazepine Alter

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

Do not use this medicine after the expiry date stated on the blister pack and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Eslicarbazepine Alter

• The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are sodium croscarmellose, povidone, and magnesium stearate.

Appearance of the product and contents of the pack

Oblong, biconvex tablets, approximately 21 x 8.5 mm, scored on one side. The tablet can be divided into equal doses.

PVC-Aluminum blisters.

Packs of 30 or 60 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent review of this package leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/.