Zebinix 200 mg comprimidos

Leaflet: information for the user

Zebinix 200 mg 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, consult 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.

Zebinix contains the active ingredient eslicarbazepine acetate.

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

Zebinix is used:

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

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

Do not take Zebinix:

• 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 Zebinix.

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 salts.

Inform your doctor:

A small number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If this occurs while taking Zebinix, contact your doctor immediately.

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

Be extra careful with Zebinix

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 Zebinix.

If you develop a severe rash or other skin symptoms (see section 4), stop taking Zebinix 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 Zebinix.

Children

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

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

See the section “Pregnancy and breastfeeding” for recommendations on contraception.

Pregnancy and breastfeeding

Zebinix is not recommended for use during pregnancy, as the effects of Zebinix 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 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 Zebinix. Zebinix 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 that you use other safe and effective forms of contraception while taking Zebinix. Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable for you to use while taking Zebinix. If you stop taking Zebinix, you should continue using an effective contraceptive method until the end of the current menstrual cycle. If you take Zebinix 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 Zebinix. It is unknown whether it passes into breast milk.

Driving and operating machinery

Zebinix may cause dizziness, disorientation, and affect your vision, particularly at the start of treatment. If this occurs, 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 Zebinix. If you are taking Zebinix 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 Zebinix. Your doctor will determine the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Older adults (65 years and older)

If you are an older adult and taking Zebinix 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

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 form of the medication, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

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

Zebinix can be taken with or without food.

If you have difficulty swallowing the entire tablet, you can crush it and add it to a small amount of water or apple sauce to take it immediately.

The tablet can be divided into equal doses.

If you take more Zebinix than you should

If you accidentally take more Zebinix 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 medication packaging with you, so the doctor knows what you have taken.

If you forget to take Zebinix

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 the missed dose.

If you interrupt treatment with Zebinix

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 Zebinix. If your doctor decides to stop your treatment with Zebinix, 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 questions 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 Zebinix and inform your doctor or go to the hospital immediately, as you may need urgent medical treatment:

The side effectsvery common(can affect more than 1 in 10 people) are:

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

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

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

The use of Zebinix is associated with an ECG anomaly called an increased PR interval. Side effects associated with this ECG anomaly may occur (e.g., 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 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 theAppendix V. 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, bottle, and box after the letters CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Zebinix

Appearance of the product and contents of the pack

Zebinix 200 mg tablets are white and oblong, with a length of 11 mm. The tablets have the inscription “ESL 200” engraved on one side and are scored on the opposite side. The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes of 20 or 60 tablets, and in HDPE bottles with a child-resistant safety closure, in cardboard boxes of 60 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional,

4745-457 S. Mamede do Coronado

Portugal

telephone: +351 22 986 61 00

fax: +351 22 986 61 99

email: [email protected]

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

Last update of this leaflet: <{MM AAAA}>

Thedetailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.