Package Insert: Information for the Patient

Bixcar 600 mg TabletsEFG

Eslicarbazepine Acetate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

This medication contains the active ingredient eslicarbazepine acetate.

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

Eslicarbazepine is used:

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

Do not take Bixcar

Warnings and precautions

Consult your doctor or pharmacist before starting to take eslicarbazepine.

Inform your doctor immediately:

Inform your doctor:

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 start of treatment. Be extra careful while taking eslicarbazepine to avoid accidental injuries, such as falls.

Be extra careful with eslicarbazepine

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 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.

Taking Bixcar with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is to ensure that none of these medications interfere with the way eslicarbazepine works, or that eslicarbazepine interferes with the effect of these medications. Inform your doctor if you are taking:

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 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 dangerous for 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 that you use other safe and effective forms of contraception while taking eslicarbazepine acetate. Discuss this with your doctor, who will advise on the type of contraceptive most suitable 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 problems 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 dizziness, drowsiness, and affect your vision, particularly at the start of treatment. If this occurs, do not drive or use any tools or machinery.

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. 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.

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 the 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 as monotherapy, the dose of 1,600 mg 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 (other pharmaceutical form not available for this 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 divided into equal doses.

If you take more Bixcar 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 forgot to take Bixcar

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 Bixcar

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 decreased energy
• trembling
• skin rash
• blood tests showing low sodium levels
• loss of 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 blood pressure decreased when standing up
• blood tests showing low levels of salts (including chloride), or a reduction in the number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• experiencing falls
• thermal burns
• poor memory or forgetfulness
• crying, feeling depressed, nervous, or confused, lack of interest or emotions
• inability to speak, write, or understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nasal bleeding
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning
• 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 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 back or stomach pain (caused by pancreatitis inflammation).
• reduction of white blood cells that makes infections more likely.
• red spots or circular patches often with central blisters on the trunk, skin peeling, mouth ulcers, 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, face rash, 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 the Spanish System for the 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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through drains or in the trash. Dispose of the packaging and the medicines that you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bixcar

• The active ingredient is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine acetate.
• The other components are sodium croscarmellose, povidone K30, and magnesium stearate.

Appearance of the product and content of the packaging

White, oblong, biconvex tablets, approximately 17 x 7.5 mm, scored on one face.The tablet can be divided into equal doses.

PVC-Aluminum blisters.

Package of 60 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet:

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