Leaflet: information for the user

Eslicarbazepine Tecnigen 800 mg tablets EFG

eslicarbazepine acetate

Read this 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 must not give it to others 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 leaflet. See section 4.

This medication contains the active ingredient acetate of eslicarbazepine.

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

This medication is used:

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

Do not take Eslicarbazepina Tecnigen

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine.

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 electrolytes.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Eslicarbazepine is not recommended for patients with severe kidney disease;
• if you have liver problems. Eslicarbazepine 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 prolonged 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 generalized 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 eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may cause dizziness and/or drowsiness, particularly at the beginning of treatment. Be extra careful while taking eslicarbazepine to avoid accidental injuries, such as falls.

Be extra careful with Eslicarbazepina Tecnigen

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 eslicarbazepine.

If you develop a severe rash or other skin symptoms (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 severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by blood analysis. Your doctor will advise on the need for this blood test before taking eslicarbazepine.

Children

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

Other medications and Eslicarbazepina Tecnigen

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 interfere with the way eslicarbazepine works, or if eslicarbazepine interferes with the effect of such medications. Inform your doctor if you are taking:

• phenytoin (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 eslicarbazepine adverse effects may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as the birth control pill) as eslicarbazepine may reduce their effectiveness;
• 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;
• monoamine oxidase inhibitors (MAOIs);
• do not take oxcarbazepine (a medication used for the treatment of epilepsy) with eslicarbazepine, 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

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

If you intend to become pregnant, discuss it 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 acetate of eslicarbazepine 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 may be pregnant, inform your doctor immediately. Do not stop taking your medication until you have discussed it 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 acetate of eslicarbazepine. Acetate of eslicarbazepine 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 to use other safe and effective forms of contraception while taking eslicarbazepine. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable to use while taking acetate of eslicarbazepine. If you stop treatment with acetate of eslicarbazepine, continue using an effective contraceptive method until the end of the current menstrual cycle.

If you take acetate of 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 medication to prevent this.

Do not breastfeed while taking acetate of eslicarbazepine. 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 use any tools or machinery.

Eslicarbazepina Tecnigen contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 recommended 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 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 and older)

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

Use in children

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.

The tablet can be split into equal doses.

If you take more Eslicarbazepine Tecnigen 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 heartbeat is irregular or faster. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Bring the packaging of the medication 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eslicarbazepine Tecnigen

If you forget to take a tablet, take it as soon as you remember and continue as recommended. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eslicarbazepine Tecnigen

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, you will usually be gradually reduced the dose. 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 a doctor or go to the hospital immediately, as you may need 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 side effectsvery frequent(can affect more than 1 in 10 people) are:

• dizziness or drowsiness.

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

• feeling unsteady, or feeling like you are spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double vision or blurred vision
• difficulty concentrating
• feeling tired or decreased energy
• trembling
• rash
• blood tests showing low sodium levels
• loss of appetite
• difficulty sleeping
• difficulty with coordination of movements (ataxia).
• weight gain

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

• ataxia
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, increased size of the tongue, nails, or hair, and low body temperature
• liver problems
• high blood pressure or intense increase in blood pressure
• low blood pressure, or decreased blood pressure when standing
• blood tests showing low levels of salts (including chloride), or a decrease in the number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• experiencing falls
• burns
• bad memory or forgetfulness
• crying, feeling depressed, nervous, or confused, lack of interest or emotions
• difficulty speaking, writing, or understanding spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling or numbness in any part of the body
• migraine
• heat
• abnormal sensation to the touch
• alterations in sense of smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• heartburn, stomach discomfort, abdominal pain, swelling, and abdominal discomfort or dry mouth
• black stools
• inflammation of gums or tooth pain
• sweating or dry skin
• itching
• changes in skin (e.g., redness of the skin)
• hair loss
• urinary tract infection
• general feeling of illness, weakness, or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• redness (flushing), coldness in extremities
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• neurological motor disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps
• medication toxicity
• anxiety.

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

• reduction of platelets that increases the risk of bleeding or bruising
• intense pain in the back or stomach (caused by inflammation of the pancreas)
• reduction of white blood cells that makes infections more likely
• macules, red spots, or circular patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes, and may be preceded by fever and/or symptoms similar to the flu (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• initially symptoms similar to the flu, 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 (rash with itching)

• lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)).

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

There have been reports of bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures 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 of 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:https://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 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. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt,ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Eslicarbazepine Tecnigen

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

Appearance of the product and contents of the packaging

Eslicarbazepine Tecnigen tablets are oval-shaped, 9.2 x 19 mm, white to off-white in color, scored, and marked with the engraving “IC” on one face.

The tablets are packaged in PVC-Aluminum blisters, in carton boxes of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd Floor.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78-80

IS-220 Hafnarfjordur

Iceland

Last review date of this leaflet:March 2022

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