Package Leaflet: Information for the User

Esran 800 mg film-coated 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

This medication contains the active ingredient eslicarbazepine acetate.

Eslicarbazepine acetate 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:

• as a single medication (monotherapy) in adult patients with newly diagnosed epilepsy,
• along with other antiepileptic medications (adjunctive therapy) in adult, adolescent, and children over 6 years old who suffer from epileptic seizures (convulsions) that affect a part of the brain (partial seizures). These seizures may be followed or not by a seizure that affects the entire brain (secondary generalization).

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

Do not take Esran:

• if you are allergic to eslicarbazepine acetate, other carboxamide derivatives (such as carbamazepine or oxcarbazepine, used for the treatment of epilepsy), or any of the other components of this medication (listed in section 6),
• if you have a certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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. This medication is not recommended for patients with severe kidney disease.
• If you have liver problems. This medication 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 seizure 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 this medication, contact your doctor immediately.

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

Be extra careful with Esran

During post-marketing experience in patients treated with this medication, 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.

If you develop a severe rash or other skin symptoms (see section 4), stop taking this medication 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 of these patients. Your doctor will advise you on the need for this blood test before taking Esran.

Children

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

Other medications and Esran

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 this medication works, or if this medication 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 this medication may occur more frequently: double vision, abnormal coordination, and dizziness,
• hormonal contraceptives (such as the birth control pill) as this medication may reduce the effectiveness of these,
• 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 this medication, 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

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

If you plan 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 eslicarbazepine acetate in pregnant women.

Research has shown an increased risk of congenital defects and neurological development problems (brain development) in 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 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 Esran. 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 Esran. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable for use while taking Esran. If you stop taking eslicarbazepine, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take Esran during pregnancy, your baby may also 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 Esran. It is unknown whether it passes into breast milk.

Driving and operating machinery

This medication may cause dizziness, drowsiness, and affect your vision, particularly at the start of treatment. If this happens, do not drive or operate any tools or machinery.

Follow exactly the administration instructions of this medication as 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.

The dose may be increased to 1,200 mg once a day, depending on how you respond to Esran. If you are taking this medication 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. This medication is not recommended if you have severe kidney problems.

Patients over 65 years old

If you are an older person and taking Esran in 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

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

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

Esran can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Esran than you should

If you accidentally take more Esran 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.

If you forget to take Esran

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 dose.

If you interrupt treatment with Esran

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 this medication. If your doctor decides to stop treatment with this medication, the dose will usually be gradually reduced. 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 Esran 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 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 like you're 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 coordinating movements (ataxia).
• weight gain

The side effectsinfrequent(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 decreased blood pressure 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 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 discomfort, or dry mouth
• black stools
• inflammation of the gums or pain in the teeth
• sweating or dry skin
• itching
• changes in the skin (such as redness of the skin)
• hair loss
• urinary tract infection
• general feeling of illness, weakness, or chills
• weight loss
• muscle pain, pain in the limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• redness, coldness in the extremities
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• neuromuscular alteration where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include trembling, pain, and cramps
• medication toxicity
• anxiety.

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

• reduction of platelets, increasing the risk of bleeding or hematomas.
• intense pain in the back or stomach (caused by inflammation of the pancreas).
• reduction of white blood cells, making 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 causing swelling of the face, throat, hands, feet, ankles, or lower legs.
• urticaria (skin rash with itching).
• lethargy, confusion, muscle spasms, or 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 this medicine is associated with an ECG anomaly called increased PR interval. Side effects associated with this ECG anomaly may occur (such as 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 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 national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: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 box after the letters 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 containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Esran

• The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are: sodium croscarmellose, povidone K30, magnesium stearate.

Product appearance and container content

White tablets, in capsule form, biconvex, scored on one face, with the "Medochemie logo" engraved on the other face, with dimensions of 19x10 mm. The tablet can be divided into equal doses.

The tablets are packaged in ALU/ALU blisters.

Container sizes: available in 20, 30, 60, 90, and 180 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Medochemie Ltd.,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Responsible manufacturer:

MEDOCHEMIE LTD (FACTORY AZ)

2 - Michael Erakleous, Agios Athanassios Industrial ST

Limassol, 4101, Cyprus

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

Last review date of this leaflet: May 2022

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