Summary of Product Characteristics: Information for the User

Eslicarbazepine acetate 800 mg EFG tablets

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. Do 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 cinfa to reduce the number of seizures.

Do not take eslicarbazepine cinfa

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine cinfa

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 sodium levels in the blood.

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 abnormal 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 happens while taking eslicarbazepine, contact your doctor immediately.

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

Be extra careful with eslicarbazepine cinfa.

In the post-marketing experience, severe skin reactions and potentially life-threatening conditions, 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 a blood test. 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.

Taking eslicarbazepine cinfa with other medicines

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 eslicarbazepine works, or if eslicarbazepine may interfere 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 side effects of eslicarbazepine 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), a type of antidepressant;
• 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

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

If you intend 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 eslicarbazepine 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 can 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 eslicarbazepine acetate. Eslicarbazepine acetate may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective for preventing pregnancy. Therefore, it is recommended to use other safe and effective contraceptive methods while taking eslicarbazepine acetate. Discuss this with your doctor, who will advise on the most suitable contraceptive method for you to use while taking eslicarbazepine acetate. If you stop treatment with eslicarbazepine acetate, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take eslicarbazepine acetate during pregnancy, your baby may be at risk of bleeding immediately after birth. Your doctor may give you and your baby a medication to prevent this.

Do not breastfeed while taking eslicarbazepine acetate. It is unknown whether it passes into breast milk.

Driving and operating machinery

Eslicarbazepine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Eslicarbazepine cinfa contains sodium.

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

Eslicarbazepine cinfa contains hydrogenated ricinoleic acid.

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated ricinoleic acid.

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 alone (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 to30 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 form of the medication, may bemore suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

Eslicarbazepine cinfa 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 cinfa 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 heartbeat is irregular 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested

If you forget to take eslicarbazepine cinfa

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 cinfa

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 taking eslicarbazepine and inform your 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 common(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 like you are spinning or floating.
• nausea or vomiting.
• headache.
• diarrhea.
• double vision or blurred vision.
• difficulty concentrating.
• feeling tired or a decrease in energy.
• tremor.
• skin rash.
• blood tests showing low sodium levels.
• decreased appetite.
• difficulty sleeping.
• difficulty with coordination of movements (ataxia).
• weight gain.

The side effectsnot common(can 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, increased size of the tongue, nails, or 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 low blood pressure when standing up.
• 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.
• burning sensation.
• abnormal sensation to the touch.
• alterations in 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 the gums or pain in the teeth.
• sweating or dry skin.
• itching.
• changes in the skin (for example, 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.
• neuromuscular alteration 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 (skin 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 (for example, fainting and slowing of heartbeats).

Bone disorders, including osteopenia and osteoporosis (bone thinning), and fractures have been reported with antiepileptic drugs related in structure 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.Reporting side effects can help provide more information about 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.Deposit the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. In case of 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 cinfa

• The active ingredient is acetate of eslicarbazepine. Each tablet contains 800 mg of acetate of eslicarbazepine.
• The other components are croscarmelose sodium, microcrystalline cellulose, hydroxypropyl cellulose, anhydrous colloidal silica, hydrogenated ricin oil, and magnesium stearate.

Appearance of the product and content of the container

Eslicarbazepine cinfa tablets are oblong, biconvex, white, scored on one face, and marked with “E” on the other face.

Tablets are packaged in PVC-PVDC/ALU blisters, in cardboard boxes of 20, 30, 60, or 90 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: April 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84717/P_84717.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84717/P_84717.html