Zebinix

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Zebinix
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Zebinix
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Anti epileptics
  • Żona terapewtika:
  • Epilepsy
  • Indikazzjonijiet terapewtiċi:
  • Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.,
  • Sommarju tal-prodott:
  • Revision: 25

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000988
  • Data ta 'l-awtorizzazzjoni:
  • 20-04-2009
  • Kodiċi EMEA:
  • EMEA/H/C/000988
  • L-aħħar aġġornament:
  • 24-05-2019

Rapport ta 'Valutazzjoni Pubblika

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United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/416346/2018

EMEA/H/C/000988

Zebinix (eslicarbazepine acetate)

An overview of Zebinix and why it is authorised in the EU

What is Zebinix and what is it used for?

Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or

without secondary generalisation. This is a type of epilepsy where too much electrical activity in one

side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted

hearing, sense of smell or vision, numbness or a sudden sense of fear. Secondary generalisation

occurs when the overactivity later reaches the whole brain. Zebinix can be taken on its own, in newly

diagnosed epilepsy, or can be added to existing antiepileptic medicines.

Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing

therapies, to treat partial-onset seizures with or without secondary generalisation.

Zebinix contains the active substance eslicarbazepine acetate.

How is Zebinix used?

Zebinix can only be obtained with a prescription. It is available as tablets (200 mg, 400 mg, 600 mg

and 800 mg) and as a suspension to be taken by mouth.

For adults and children weighing 60 kg or more, treatment is started at a dose of 400 mg once a day,

before increasing it to the standard dose of 800 mg once a day after one or two weeks. In children

weighing less than 60 kg, the starting dose is 10 mg per kg body weight once a day. The dose is then

increased after one or two weeks to 20 mg/kg per day and then to 30 mg/kg per day, based on the

patient’s response. For adults who take Zebinix on its own, a dose up to 1,600 mg may be used. For

children and adults who use Zebinix in combination with other medicines the maximum dose is

1,200 mg once a day.

Zebinix should not be used in patients with severe kidney problems and the dose should be adjusted in

moderately impaired kidney function.

For more information about using Zebinix, see the package leaflet or contact your doctor or

pharmacist.

Zebinix (eslicarbazepine acetate)

EMA/416346/2018

Page 2/3

How does Zebinix work?

The active substance in Zebinix, eslicarbazepine acetate, is converted into eslicarbazepine in the body.

Epilepsy is caused by excessive electrical activity in the brain. For electrical impulses to travel along

nerves there needs to be a rapid movement of sodium into the nerve cells. Eslicarbazepine is thought

to work by blocking ‘voltage-gated sodium channels’, which stops sodium entering the nerve cells. This

reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.

What benefit of Zebinix have been shown in studies?

Three main studies compared Zebinix with placebo (a dummy treatment) in 1,050 adults with partial-

onset seizures that were not controlled by other medicines. All of the patients also received other

epilepsy medicines. Looking at the results of the three studies taken together, Zebinix 800 mg and

1,200 mg were more effective than placebo at reducing the number of seizures, when used as add-on

to other epilepsy medicines. At the start of the study, patients had around 13 seizures per month. Over

the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix

800 mg and Zebinix 1,200 mg respectively, compared with 11.7 per month in those taking placebo.

Another study compared Zebinix taken on its own with another epilepsy medicine, carbamazepine, in

815 newly diagnosed adults. Zebinix was effective, although slightly less than carbamazepine, at

reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not

prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months

compared with 76% of patients taking carbamazepine (300 out of 397 patients).

The effects of Zebinix were also studied in children with partial-onset seizures. In these studies, all the

children also received other epilepsy medicines. In one study involving 123 children aged 6 to 16

years, Zebinix over 12 weeks halved the number of seizures in 51% of patients (42 out of 83). This

compared with 25% of patients (10 out of 40) on placebo. A second study in children aged 2 to 18

years did not find a difference between Zebinix and placebo, this was explained by the fact that lower

doses were used.

What are the risks associated with Zebinix?

In clinical trials, around half of the patients treated with Zebinix experienced side effects. Side effects

were usually mild to moderate in intensity and occurred mostly in the first week of treatment. For

adults, the most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness,

somnolence (sleepiness), headache and nausea. Severe skin reactions, including Stevens-Johnson

syndrome, have also been reported with Zebinix.

Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of

the other ingredients or other carboxamide derivatives (medicines with a similar structure to

eslicarbazepine acetate, such as carbamazepine or oxcarbazepine). It must not be used in people with

second or third degree atrioventricular block (a problem with electrical transmission in the heart).

For the full list of side effects and restrictions with Zebinix, see the package leaflet.

Why is Zebinix authorised?

The European Medicines Agency decided that Zebinix’s benefits are greater than its risks and that it be

authorised for use in the EU.

Zebinix (eslicarbazepine acetate)

EMA/416346/2018

Page 3/3

What measures are being taken to ensure the safe and effective use of

Zebinix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Zebinix have been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of Zebinix are continuously monitored. Side effects reported with

Zebinix are carefully evaluated and any necessary action taken to protect patients.

Other information about Zebinix

Zebinix received a marketing authorisation valid throughout the EU on 21 April 2009.

Further information on Zebinix can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports.

This summary was last updated in 06-2018.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Zebinix 200 mg tablets

Eslicarbazepine acetate

Read all of this leaflet carefully before you or your child start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zebinix is and what it is used for

What you need to know before you take Zebinix

How to take Zebinix

Possible side effects

How to store Zebinix

Contents of the pack and other information

1.

What Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children

patients above 6 years of age who are experiencing seizures that affect one part of the brain

(partial seizure). These seizures may or may not be followed by a seizure affecting all of the

brain (secondary generalisation)

Zebinix has been given to you by your doctor to reduce your number of seizures.

2.

What you need to know before you take Zebinix

Do not take Zebinix

if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g.

carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other

ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or third degree

atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or

breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs

of an allergic reaction.

if you suffer from confusion, worsening of seizures or decreased consciousness which can be

signs of low blood salt levels.

Please tell your doctor:

if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not

recommended in patients with severe renal disease.

if you have liver problems. Zebinix is not recommended in patients with severe liver problems.

if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram)

called increased PR interval. If you are not sure if the medicines you are taking could have this

effect, discuss with your doctor.

if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm

disorder.

if you suffer from seizures that begin with a widespread electric discharge that involves both

sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing

themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor

immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take

special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic

epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been

reported in post-marketing experience in patients treated with Zebinix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and

contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with

carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these

patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below.

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes

with their effect.

Tell your doctor if you are taking:

phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;

carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the

following side effects of Zebinix may occur in higher frequency: seeing double, abnormal

coordination and dizziness;

hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less

effective;

simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;

rosuvastatin, a medicine used to lower cholesterol level;

the blood thinner - warfarin;

tricyclic antidepressants e.g. amitriptyline;

do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known

whether it is safe to take these medicines together.

Pregnancy and breast-feeding’ section for advice about contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an

increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand,

effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to

both the mother and the unborn child.

Do not breast-feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore, it

is recommended that you use other forms of safe and effective contraception, when taking Zebinix up

to the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of

treatment. If this happens to you, do not drive or use any tools or machines.

3.

How to take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will

decide whether you will be given this dose for one or two weeks.

Maintenance dose

usual maintenance dose is 800 mg once daily.

Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you

are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once

daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work

out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age

Dose when you start treatment

The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before

increasing to the maintenance dose.

Maintenance dose

Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at

intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once

daily.

Children with ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor

or pharmacist.

Method and route of administration

Zebinix is for oral use. Swallow the tablet with a glass of water.

Zebinix tablets may be taken with or without food.

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular

weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department

immediately. Take the medicine pack with you. This is 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 carry on as usual. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Zebinix

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your

doctor will decide how long you should take Zebinix. Should your doctor decide to stop your

treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment

is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a

doctor or go to a hospital immediately, as you may need urgent medical treatment

:

blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing

problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic

reaction.

Very common

(may affect more than 1 in 10

people) side effects are:

Feeling dizzy or sleepy.

Common

(may affect up to 1 in 10 people) side effects are:

Feeling unsteady or having a sensation of spinning or floating;

Feeling sick or vomiting;

Headache;

Diarrhoea;

Seeing double or blurred vision;

Difficulty in concentration;

Feeling low in energy or tired;

Shaking;

Skin rash;

Blood tests showing that you have low levels of sodium in your blood;

Decrease of appetite;

Difficulty in sleeping;

Difficulty in coordinating movements (ataxia).

Uncommon

(may affect up to 1 in 100 people) side effects are:

Clumsiness;

Allergy;

Constipation;

Seizures;

Underactive thyroid gland.

Symptoms include decreased level of thyroid hormone levels (seen in

blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body

temperature;

Liver problems;

High blood pressure or severe increase in blood pressure;

Low blood pressure or a fall in blood pressure on standing up;

Blood tests showing that you have low levels of salts (including chloride) in your blood or a

reduction in red blood cells;

Dehydration;

Eye movement changes, fuzzy vision or red eye;

Having falls;

Thermal burn;

Poor memory or forgetfulness;

Crying, feeling depressed, nervous or confused, lack of interest or emotion;

Inability to speak or write or understand spoken or written language;

Agitation;

Attention deficit/ hyperactivity disorder;

Irritability;

Mood changes or hallucinations;

Difficulty in speaking;

Nosebleed;

Chest pain;

Tingling and/or feeling numb in any part of your body;

Migraine;

Burning sensation;

Abnormal sense of touch;

Disturbances in the sense of smell;

Ringing in the ears;

Hearing difficulty;

Swelling in your legs and arms;

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;

Charcoal (dark) stool;

Inflamed gums or toothache;

Sweating or having dry skin;

Itching;

Skin changes (e.g. red skin);

Hair loss;

Urinary tract infection;

Feeling generally weak, unwell or having chills;

Weight loss;

Muscle pain, pain in limbs, muscular weakness;

Bone metabolism disorder;

Increased bone proteins;

Flushing, cold limbs;

Slower or irregular heart beat;

Feeling extremely sleepy;

Sedation;

Neurological movement disorder where your muscles contract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pain, cramping;

Medicine toxicity;

Anxiety.

Not known

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

Reduction in blood platelets which increases risk of bleeding or bruising;

Severe pain in the back and stomach (caused by inflamation of the pancreas);

Reduction in white blood cells which makes infections more likely;

Reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded

by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);

Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver

enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also

known as DRESS or drug hypersensitivity syndrome);

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower

legs;

Urticaria (skin rash with itching).

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat)

may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the

bone) and fractures with structurally related antiepileptics medicines like carbamazepine and

oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment,

have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Zebinix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister, bottle and the carton after

EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Zebinix contains

The active substance is eslicarbazepine acetate. Each tablet contains 200 mg of eslicarbazepine

acetate.

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Zebinix looks like and contents of the pack

Zebinix 200 mg tablets are white and oblong. The tablets have ‘ESL 200’engraved on one side and are

scored on the other side, with a length of 11 mm. The tablet can be divided into equal doses.

The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE

bottles with child resistant closure in cardboard boxes containing 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª

, S.A.,

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00

fax: +351 22 986 61 99

e-mail: info@bial.com

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Eisai Europe Ltd

Tél/Tel: + 32 (0) 2 502 58 04

Luxembourg/Luxemburg

Eisai Europe Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

България

BIAL-Portela & Cª., S.A.

Teл.: + 351 22 986 61 00

(Португалия)

Magyarország

Eisai Ltd

Tel.: + 44 (0)845 676 1400

(Nagy-Britannia)

Česká republika

Eisai GesmbH organizační složka

Tel: +420 242 485 839

Malta

BIAL-Portela & Cª., S.A.

Tel: + 351 22 986 61 00

(Il-Portugall)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Nederland

Eisai B.V.

Tél/Tel: + 31 (0) 900 575 3340

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Eesti

BIAL-Portela & Cª, S.A.

Tel: +351 22 986 61 00

(Portugal)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

Ελλάδα

Arriani Pharmaceuticals S.A.

Τηλ: + 30 210 668 3000

Polska

BIAL-Portela & Cª, S.A.

Tel.: + 351 22 986 61 00

(Portugália)

España

Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96

Portugal

BIAL-Portela & Cª., S.A.

Tel.: + 351 22 986 61 00

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Hrvatska

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugal)

România

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalia)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Slovenija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalska)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GesmbH organizační složka

Tel: + 420 242 485 839

(Česká republika)

Italia

Eisai S.r.l.

Tel: + 39 02 518 1401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi)

Κύπρος

BIAL-Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00

(Πορτογαλία)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugāle)

Lietuva

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalija)

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Zebinix 400 mg tablets

Eslicarbazepine acetate

Read all of this leaflet carefully before you or your child start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zebinix is and what it is used for

What you need to know before you take Zebinix

How to take Zebinix

Possible side effects

How to store Zebinix

Contents of the pack and other information

1.

What Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children

patients above 6 years of age, who are experiencing seizures that affect one part of the brain

(partial seizure). These seizures may or may not be followed by a seizure affecting all of the

brain (secondary generalisation).

Zebinix has been given to you by your doctor to reduce your number of seizures.

2.

What you need to know before you take Zebinix

Do not take Zebinix

if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g.

carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other

ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or third degree

atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or

breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs

of an allergic reaction.

if you suffer from confusion, worsening of seizures or decreased consciousness which can be

signs of low blood salt levels.

Please tell your doctor:

if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not

recommended in patients with severe renal disease.

if you have liver problems. Zebinix is not recommended in patients with severe liver problems.

if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram)

called increased PR interval. If you are not sure if the medicines you are taking could have this

effect, discuss with your doctor.

if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm

disorder.

if you suffer from seizures that begin with a widespread electric discharge that involves both

sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing

themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor

immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take

special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic

epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been

reported in post-marketing experience in patients treated with Zebinix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and

contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with

carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these

patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below.

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes

with their effect.

Tell your doctor if you are taking:

phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;

carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the

following side effects of Zebinix may occur in higher frequency: seeing double, abnormal

coordination and dizziness;

hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less

effective;

simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;

rosuvastatin, a medicine used to lower cholesterol level;

the blood thinner - warfarin;

tricyclic antidepressants e.g. amitriptyline;

do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known

whether it is safe to take these medicines together.

See ‘Pregnancy and breast-feeding’ section for advice about contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an

increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand,

effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to

both the mother and the unborn child.

Do not breast-feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore it is

recommended that you use other forms of safe and effective contraception, when taking Zebinix up to

the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of

treatment. If this happens to you, do not drive or use any tools or machines.

3.

How to take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will

decide whether you will be given this dose for one or two weeks.

Maintenance dose

usual maintenance dose is 800 mg once daily.

Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you

are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once

daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work

out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age

Dose when you start treatment

The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before

increasing to the maintenance dose.

Maintenance dose

Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at

intervals of one or two weeks, up to 30 mg per kg body weight. The maximum is 1,200 mg once

daily.

Children with ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor

or pharmacist.

Method and route of administration

Zebinix is for oral use. Swallow the tablet with a glass of water.

Zebinix tablets may be taken with or without food.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular

weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department

immediately. Take the medicine pack with you. This is 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 carry on as usual. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Zebinix

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your

doctor will decide how long you should take Zebinix. Should your doctor decide to stop your

treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment

is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a

doctor or go to a hospital immediately, as you may need urgent medical treatment

:

blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing

problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic

reaction.

Very common

(may affect more than 1 in 10 people) side effects are:

Feeling dizzy or sleepy.

Common

(may affect up to 1 in 10 people) side effects are:

Feeling unsteady or having a sensation of spinning or floating;

Feeling sick or vomiting;

Headache;

Diarrhoea;

Seeing double or blurred vision;

Difficulty in concentration;

Feeling low in energy or tired;

Shaking;

Skin rash;

Blood tests showing that you have low levels of sodium in your blood;

Decrease of appetite;

Difficulty in sleeping;

Difficulty in coordinating movements (ataxia).

Uncommon

(may affect up to 1 in 100 people) side effects are:

Clumsiness;

Allergy;

Constipation;

Seizures;

Underactive thyroid gland.

Symptoms include decreased level of thyroid hormone levels (seen in

blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body

temperature;

Liver problems;

High blood pressure or severe increase in blood pressure;

Low blood pressure or a fall in blood pressure on standing up;

Blood tests showing that you have low levels of salts (including chloride) in your blood or a

reduction in red blood cells;

Dehydration;

Eye movement changes, fuzzy vision or red eye;

Having falls;

Thermal burn;

Poor memory or forgetfulness;

Crying, feeling depressed, nervous or confused, lack of interest or emotion;

Inability to speak or write or understand spoken or written language;

Agitation;

Attention deficit/ hyperactivity disorder;

Irritability;

Mood changes or hallucinations;

Difficulty in speaking;

Nosebleed;

Chest pain;

Tingling and/or feeling numb in any part of your body;

Migraine;

Burning sensation;

Abnormal sense of touch;

Disturbances in the sense of smell;

Ringing in the ears;

Hearing difficulty;

Swelling in your legs and arms;

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;

Charcoal (dark) stool;

Inflamed gums or toothache;

Sweating or having dry skin;

Itching;

Skin changes (e.g. red skin);

Hair loss;

Urinary tract infection;

Feeling generally weak, unwell or having chills;

Weight loss;

Muscle pain, pain in limbs, muscular weakness;

Bone metabolism disorder;

Increased bone proteins;

Flushing, cold limbs;

Slower or irregular heart beat;

Feeling extremely sleepy;

Sedation;

Neurological movement disorder where your muscles contract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pain, cramping;

Medicine toxicity;

Anxiety.

Not known

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

Reduction in blood platelets which increases risk of bleeding or bruising;

Severe pain in the back and stomach (caused by inflamation of the pancreas);

Reduction in white blood cells which makes infections more likely;

Reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded

by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);

Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver

enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also

known as DRESS or drug hypersensitivity syndrome);

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower

legs;

Urticaria (skin rash with itching).

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat)

may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the

bone) and fractures with structurally related antiepileptics medicines like carbamazepine and

oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment,

have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Zebinix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Zebinix contains

The active substance is eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine

acetate.

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Zebinix looks like and contents of the pack

Zebinix 400 mg tablets are white, circular and biconvex. The tablets have ‘ESL 400’engraved on one

side and are scored on the other side, with a diameter of 11 mm.

The tablets are packaged in blisters in cardboard boxes containing 7, 14 or 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª

, S.A.,

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00

fax: +351 22 986 61 99

e-mail: info@bial.com

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Eisai Europe Ltd

Tél/Tel: + 32 (0) 2 502 58 04

Luxembourg/Luxemburg

Eisai Europe Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

България

BIAL-Portela & Cª., S.A.

Teл.: + 351 22 986 61 00

(Португалия)

Magyarország

Eisai Ltd

Tel.: + 44 (0) 845 676 1400

(Nagy-Britannia)

Česká republika

Eisai GesmbH organizační složka

Tel: +420 242 485 839

Malta

BIAL-Portela & Cª., S.A.

Tel: + 351 22 986 61 00

(Il-Portugall)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Nederland

Eisai B.V.

Tél/Tel: + 31 (0) 900 575 3340

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Eesti

BIAL-Portela & Cª, S.A.

Tel: +351 22 986 61 00

(Portugal)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

Ελλάδα

Arriani Pharmaceuticals S.A.

Τηλ: + 30 210 668 3000

Polska

BIAL-Portela & Cª, S.A.

Tel.: + 351 22 986 61 00

(Portugália)

España

Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96

Portugal

BIAL-Portela & Cª., S.A.

Tel.: + 351 22 986 61 00

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Hrvatska

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugal)

România

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalia)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Slovenija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalska)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GesmbH organizační složka

Tel: + 420 242 485 839

(Česká republika)

Italia

Eisai S.r.l.

Tel: + 39 02 518 1401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi)

Κύπρος

BIAL-Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00

(Πορτογαλία)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugāle)

Lietuva

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalija)

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Zebinix 600 mg tablets

Eslicarbazepine acetate

Read all of this leaflet carefully before you or your child start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zebinix is and what it is used for

What you need to know before you take Zebinix

How to take Zebinix

Possible side effects

How to store Zebinix

Contents of the pack and other information

1

What Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children

patients above 6 years of age, who are experiencing seizures that affect one part of the brain

(partial seizure). These seizures may or may not be followed by a seizure affecting all of the

brain (secondary generalisation).

Zebinix has been given to you by your doctor to reduce your number of seizures.

2

What you need to know before you take Zebinix

Do not take Zebinix

if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g.

carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other

ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or third degree

atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or

breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs

of an allergic reaction.

if you suffer from confusion, worsening of seizures or decreased consciousness which can be

signs of low blood salt levels.

Please tell your doctor:

if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not

recommended in patients with severe renal disease.

if you have liver problems. Zebinix is not recommended in patients with severe liver problems.

if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram)

called increased PR interval. If you are not sure if the medicines you are taking could have this

effect, discuss with your doctor.

if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm

disorder.

if you suffer from seizures that begin with a widespread electric discharge that involves both

sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing

themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor

immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take

special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic

epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been

reported in post-marketing experience in patients treated with Zebinix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and

contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with

carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these

patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below.

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes

with their effect.

Tell your doctor if you are taking:

phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;

carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the

following side effects of Zebinix may occur in higher frequency: seeing double, abnormal

coordination and dizziness;

hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less

effective;

simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;

rosuvastatin, a medicine used to lower cholesterol level;

the blood thinner - warfarin;

tricyclic antidepressants e.g. amitriptyline;

do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known

whether it is safe to take these medicines together.

See ‘Pregnancy and breast-feeding’ section for advice about contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an

increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand,

effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to

both the mother and the unborn child.

Do not breast-feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore it is

recommended that you use other forms of safe and effective contraception, when taking Zebinix up to

the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of

treatment. If this happens to you, do not drive or use any tools or machines.

3

How to take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will

decide whether you will be given this dose for one or two weeks.

Maintenance dose

usual maintenance dose is 800 mg once daily.

Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you

are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once

daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work

out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age

Dose when you start treatment

The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before

increasing to the maintenance dose.

Maintenance dose

Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at

intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once

daily.

Children with ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor

or pharmacist.

Method and route of administration

Zebinix is for oral use. Swallow the tablet with a glass of water.

Zebinix tablets may be taken with or without food.

The tablet can be divided into equal doses.

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular

weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department

immediately. Take the medicine pack with you. This is 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 carry on as usual. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Zebinix

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your

doctor will decide how long you should take Zebinix. Should your doctor decide to stop your

treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment

is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a

doctor or go to a hospital immediately, as you may need urgent medical treatment

:

blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing

problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic

reaction.

Very common

(may affect more than 1 in 10 people) side effects are:

Feeling dizzy or sleepy.

Common

(may affect up to 1 in 10 people) side effects are:

Feeling unsteady or having a sensation of spinning or floating;

Feeling sick or vomiting;

Headache;

Diarrhoea;

Seeing double or blurred vision;

Difficulty in concentration;

Feeling low in energy or tired;

Shaking;

Skin rash;

Blood tests showing that you have low levels of sodium in your blood;

Decrease of appetite;

Difficulty in sleeping;

Difficulty in coordinating movements (ataxia).

Uncommon

(may affect up to 1 in 100 people) side effects are:

Clumsiness;

Allergy;

Constipation;

Seizures;

Underactive thyroid gland.

Symptoms include decreased level of thyroid hormone levels (seen in

blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body

temperature;

Liver problems;

High blood pressure or severe increase in blood pressure;

Low blood pressure or a fall in blood pressure on standing up;

Blood tests showing that you have low levels of salts (including chloride) in your blood or a

reduction in red blood cells;

Dehydration;

Eye movement changes, fuzzy vision or red eye;

Having falls;

Thermal burn;

Poor memory or forgetfulness;

Crying, feeling depressed, nervous or confused, lack of interest or emotion;

Inability to speak or write or understand spoken or written language;

Agitation;

Attention deficit/ hyperactivity disorder;

Irritability;

Mood changes or hallucinations;

Difficulty in speaking;

Nosebleed;

Chest pain;

Tingling and/or feeling numb in any part of your body;

Migraine;

Burning sensation;

Abnormal sense of touch;

Disturbances in the sense of smell;

Ringing in the ears;

Hearing difficulty;

Swelling in your legs and arms;

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;

Charcoal (dark) stool;

Inflamed gums or toothache;

Sweating or having dry skin;

Itching;

Skin changes (e.g. red skin);

Hair loss;

Urinary tract infection;

Feeling generally weak, unwell or having chills;

Weight loss;

Muscle pain, pain in limbs, muscular weakness;

Bone metabolism disorder;

Increased bone proteins;

Flushing, cold limbs;

Slower or irregular heart beat;

Feeling extremely sleepy;

Sedation;

Neurological movement disorder where your muscles contract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pain, cramping;

Medicine toxicity;

Anxiety.

Not known

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

Reduction in blood platelets which increases risk of bleeding or bruising;

Severe pain in the back and stomach (caused by inflamation of the pancreas);

Reduction in white blood cells which makes infections more likely;

Reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded

by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);

Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver

enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also

known as DRESS or drug hypersensitivity syndrome);

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower

legs;

Urticaria (skin rash with itching).

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat)

may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the

bone) and fractures with structurally related antiepileptics medicines like carbamazepine and

oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment,

have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Zebinix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Zebinix contains

The active substance is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine

acetate.

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Zebinix looks like and contents of the pack

Zebinix 600 mg tablets are white and oblong. The tablets have ‘ESL 600’engraved on one side and are

scored on the other side, with a length of 17.3 mm. The tablet can be divided into equal doses.

The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE

bottles with child resistant closure in cardboard boxes containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª

, S.A.,

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00

fax: +351 22 986 61 99

e-mail: info@bial.com

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Eisai Europe Ltd

Tél/Tel: + 32 (0) 2 502 58 04

Luxembourg/Luxemburg

Eisai Europe Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

България

BIAL-Portela & Cª., S.A.

Teл.: + 351 22 986 61 00

(Португалия)

Magyarország

Eisai Ltd

Tel.: + 44 (0)845 676 1400

(Nagy-Britannia)

Česká republika

Eisai GesmbH organizační složka

Tel: +420 242 485 839

Malta

BIAL-Portela & Cª., S.A.

Tel: + 351 22 986 61 00

(Il-Portugall)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Nederland

Eisai B.V.

Tél/Tel: + 31 (0) 900 575 3340

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Eesti

BIAL-Portela & Cª, S.A.

Tel: +351 22 986 61 00

(Portugal)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

Ελλάδα

Arriani Pharmaceuticals S.A.

Τηλ: + 30 210 668 3000

Polska

BIAL-Portela & Cª, S.A.

Tel.: + 351 22 986 61 00

(Portugália)

España

Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96

Portugal

BIAL-Portela & Cª., S.A.

Tel.: + 351 22 986 61 00

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Hrvatska

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugal)

România

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalia)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Slovenija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalska)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GesmbH organizační složka

Tel: + 420 242 485 839

(Česká republika)

Italia

Eisai S.r.l.

Tel: + 39 02 518 1401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi)

Κύπρος

BIAL-Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00

(Πορτογαλία)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugāle)

Lietuva

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalija)

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Zebinix 800 mg tablets

Eslicarbazepine acetate

Read all of this leaflet carefully before you or your child start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zebinix is and what it is used for

What you need to know before you take Zebinix

How to take Zebinix

Possible side effects

How to store Zebinix

Contents of the pack and other information

1.

What Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children

patients above 6 years of age, who are experiencing seizures that affect one part of the brain

(partial seizure). These seizures may or may not be followed by a seizure affecting all of the

brain (secondary generalisation).

Zebinix has been given to you by your doctor to reduce your number of seizures.

2.

What you need to know before you take Zebinix

Do not take Zebinix

if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g.

carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other

ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or third degree

atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or

breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs

of an allergic reaction.

if you suffer from confusion, worsening of seizures or decreased consciousness which can be

signs of low blood salt levels.

Please tell your doctor:

if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not

recommended in patients with severe renal disease.

if you have liver problems. Zebinix is not recommended in patients with severe liver problems.

if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram)

called increased PR interval. If you are not sure if the medicines you are taking could have this

effect, discuss with your doctor.

if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm

disorder.

if you suffer from seizures that begin with a widespread electric discharge that involves both

sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing

themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor

immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take

special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic

epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been

reported in post-marketing experience in patients treated with Zebinix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and

contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with

carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these

patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below.

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes

with their effect.

Tell your doctor if you are taking:

phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;

carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the

following side effects of Zebinix may occur in higher frequency: seeing double, abnormal

coordination and dizziness;

hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less

effective;

simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;

rosuvastatin, a medicine used to lower cholesterol level;

the blood thinner - warfarin;

tricyclic antidepressants e.g. amitriptyline;

do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known

whether it is safe to take these medicines together.

See ‘Pregnancy and breast-feeding’ section for advice about contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an

increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand,

effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to

both the mother and the unborn child.

Do not breast-feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore it is

recommended that you use other forms of safe and effective contraception, when taking Zebinix up to

the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of

treatment. If this happens to you, do not drive or use any tools or machines.

3.

How to take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will

decide whether you will be given this dose for one or two weeks.

Maintenance dose

usual maintenance dose is 800 mg once daily.

Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you

are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once

daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work

out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age

Dose when you start treatment

The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before

increasing to the maintenance dose.

Maintenance dose

Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at

intervals of one one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg

once daily.

Children ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor

or pharmacist.

Method and route of administration

Zebinix is for oral use. Swallow the tablet with a glass of water.

Zebinix tablets may be taken with or without food.

The tablet can be divided into equal doses.

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular

weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department

immediately. Take the medicine pack with you. This is 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 carry on as usual. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Zebinix

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your

doctor will decide how long you should take Zebinix. Should your doctor decide to stop your

treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment

is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a

doctor or go to a hospital immediately, as you may need urgent medical treatment

:

blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing

problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic

reaction.

Very common

(may affect more than 1 in 10 people) side effects are:

Feeling dizzy or sleepy.

Common

(may affect up to 1 in 10 people) side effects are:

Feeling unsteady or having a sensation of spinning or floating;

Feeling sick or vomiting;

Headache;

Diarrhoea;

Seeing double or blurred vision;

Difficulty in concentration;

Feeling low in energy or tired;

Shaking;

Skin rash;

Blood tests showing that you have low levels of sodium in your blood;

Decrease of appetite;

Difficulty in sleeping;

Difficulty in coordinating movements (ataxia).

Uncommon

(may affect up to 1 in 100 people) side effects are:

Clumsiness;

Allergy;

Constipation;

Seizures;

Underactive thyroid gland.

Symptoms include decreased level of thyroid hormone levels (seen in

blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body

temperature;

Liver problems;

High blood pressure or severe increase in blood pressure;

Low blood pressure or a fall in blood pressure on standing up;

Blood tests showing that you have low levels of salts (including chloride) in your blood or a

reduction in red blood cells;

Dehydration;

Eye movement changes, fuzzy vision or red eye;

Having falls;

Thermal burn;

Poor memory or forgetfulness;

Crying, feeling depressed, nervous or confused, lack of interest or emotion;

Inability to speak or write or understand spoken or written language;

Agitation;

Attention deficit/ hyperactivity disorder;

Irritability;

Mood changes or hallucinations;

Difficulty in speaking;

Nosebleed;

Chest pain;

Tingling and/or feeling numb in any part of your body;

Migraine;

Burning sensation;

Abnormal sense of touch;

Disturbances in the sense of smell;

Ringing in the ears;

Hearing difficulty;

Swelling in your legs and arms;

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;

Charcoal (dark) stool;

Inflamed gums or toothache;

Sweating or having dry skin;

Itching;

Skin changes (e.g. red skin);

Hair loss;

Urinary tract infection;

Feeling generally weak, unwell or having chills;

Weight loss;

Muscle pain, pain in limbs, muscular weakness;

Bone metabolism disorder;

Increased bone proteins;

Flushing, cold limbs;

Slower or irregular heart beat;

Feeling extremely sleepy;

Sedation;

Neurological movement disorder where your muscles contract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pain, cramping;

Medicine toxicity;

Anxiety.

Not known

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

Reduction in blood platelets which increases risk of bleeding or bruising;

Severe pain in the back and stomach (caused by inflamation of the pancreas);

Reduction in white blood cells which makes infections more likely;

Reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded

by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);

Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver

enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also

known as DRESS or drug hypersensitivity syndrome);

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower

legs;

Urticaria (skin rash with itching).

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat)

may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the

bone) and fractures with structurally related antiepileptics medicines like carbamazepine and

oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment,

have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Zebinix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Zebinix contains

The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine

acetate.

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Zebinix looks like and contents of the pack

Zebinix 800 mg tablets are white and oblong. The tablets have ‘ESL 800’engraved on one side and are

scored on the other side, with a length of 19 mm. The tablet can be divided into equal doses.

The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets or in

multipacks containing 180 (2x90) tablets, and in HDPE bottles with child resistant closure in

cardboard boxes containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª

, S.A.,

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00

fax: +351 22 986 61 99

e-mail: info@bial.com

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Eisai Europe Ltd

Tél/Tel: + 32 (0) 2 502 58 04

Luxembourg/Luxemburg

Eisai Europe Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

България

BIAL-Portela & Cª., S.A.

Teл.: + 351 22 986 61 00

(Португалия)

Magyarország

Eisai Ltd

Tel.: + 44 (0)845 676 1400

(Nagy-Britannia)

Česká republika

Eisai GesmbH organizační složka

Tel: +420 242 485 839

Malta

BIAL-Portela & Cª., S.A.

Tel: + 351 22 986 61 00

(Il-Portugall)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Nederland

Eisai B.V.

Tél/Tel: + 31 (0) 900 575 3340

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Eesti

BIAL-Portela & Cª, S.A.

Tel: +351 22 986 61 00

(Portugal)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

Ελλάδα

Arriani Pharmaceuticals S.A.

Τηλ: + 30 210 668 3000

Polska

BIAL-Portela & Cª, S.A.

Tel.: + 351 22 986 61 00

(Portugália)

España

Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96

Portugal

BIAL-Portela & Cª., S.A.

Tel.: + 351 22 986 61 00

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Hrvatska

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugal)

România

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalia)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Slovenija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalska)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GesmbH organizační složka

Tel: + 420 242 485 839

(Česká republika)

Italia

Eisai S.r.l.

Tel: + 39 02 518 1401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi)

Κύπρος

BIAL-Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00

(Πορτογαλία)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugāle)

Lietuva

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalija)

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Zebinix 50 mg/ml oral suspension

Eslicarbazepine acetate

Read all of this leaflet carefully before you or your child start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zebinix is and what it is used for

What you need to know before you take Zebinix

How to take Zebinix

Possible side effects

How to store Zebinix

Contents of the pack and other information

1.

What Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children

patients above 6 years of age, whoare experiencing seizures that affect one part of the brain

(partial seizure). These seizures may or may not be followed by a seizure affecting all of the brain

(secondary generalisation).

Zebinix has been given to you by your doctor to reduce your number of seizures.

2.

What you need to know before you take Zebinix

Do not take Zebinix

if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g.

carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other

ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or third degree

atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or

breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs

of an allergic reaction.

if you suffer from confusion, worsening of seizures or decreased consciousness which can be

signs of low blood salt levels.

Please tell your doctor:

if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not

recommended in patients with severe renal disease.

if you have liver problems. Zebinix is not recommended in patients with severe liver problems.

if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram)

called increased PR interval. If you are not sure if the medicines you are taking could have this

effect, discuss with your doctor.

if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm

disorder.

if you suffer from seizures that begin with a widespread electric discharge that involves both

sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing

themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor

immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take

special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic

epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been

reported in post-marketing experience in patients treated with Zebinix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and

contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with

carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these

patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below.

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes

with their effect.

Tell your doctor if you are taking:

phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;

carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the

following side effects of Zebinix may occur in higher frequency: seeing double, abnormal

coordination and dizziness;

hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less

effective;

simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;

rosuvastatin, a medicine used to lower cholesterol level;

the blood thinner - warfarin;

tricyclic antidepressants e.g. amitriptyline;

do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known

whether it is safe to take these medicines together.

Pregnancy and breast-feeding’ section for advice about contraception.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an

increased risk of birth defects in children of women taking antiepileptic medicines. On the other hand

effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to

both the mother and the unborn child.

Do not breast-feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore, it

is recommended that you use other forms of safe and effective contraception, when taking Zebinix up

to the end of the current menstrual cycle after stopping treatment.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of

treatment. If this happens to you, do not drive or use any tools or machines.

Zebinix contains methyl parahydroxybenzoate

(E218) and sulphites

Zebinix oral suspension contains

methyl parahydroxybenzoate (E218) which may cause allergic

reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions

and bronchospasm.

3.

How to take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults

Dose when you start treatment

400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will

decide whether you will be given this dose for one or two weeks.

Maintenance dose

usual maintenance dose is 800 mg once daily.

Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you

are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once

daily.

Patients with kidney problems

If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work

out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age)

If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age

Dose when you start treatment

The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before

increasing to the maintenance dose.

Maintenance dose

Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at

intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once

daily.

Children with ≥60 kg

Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor

or pharmacist.

Method and route of administration

Zebinix is for oral use.

Zebinix oral suspension may be taken with or without food.

Shake well before use.

Always use the oral syringe provided to take your medicine.

Instructions for use:

Step 1. Remove the bottle, the oral syringe and the bottle adapter from the box

Step 2. Shake the bottle for at least 10 seconds and remove the child resistant closure by pushing it

down and turning it counter-clockwise (to the left).

Step 3. Insert the bottle adapter in the bottle neck opening. You may need to apply some pressure to

insert it securely. Once inserted, the bottle adapter must not be removed from the bottle. The bottle can

be closed with the closure with the bottle adapter still in place.

Step 4. To ease the process you should mark the desired volume in the syringe by moving the plunger.

Insert the tip of the oral syringe into the bottle adapter opening, keeping the bottle upright. Push the

plunger all the way down. This will create pressure inside the bottle that will help the dosing of the

suspension, forcing it to leave from the bottle to the oral syringe.

Step 5: Hold the oral syringe in place and turn the bottle upside down.

Gently pull the plunger of the oral syringe to the desired volume.

Step 6: If you see any air bubbles in the oral syringe, push the plunger upwards just far enough to

completely push out any large air bubbles. Gently pull the plunger back downwards to the dose

prescribed by your doctor.

Step 7. Turn the bottle upright and remove the entire oral syringe from the bottle. Be careful, do not

push the plunger down when removing the oral syringe from the bottle.

Step 8. Replace the closure on the bottle by turning it clock-wise (to the right).

Step 9. Place the oral syringe into the mouth against the inside of the cheek. Press the plugger down

slowly to release Zebinix into the mouth.

Step 10: Rinse the empty oral syringe after each use into a glass of clean water. Repeat this cleaning

process 3 times.

Store the bottle and the oral syringe together in the carton until next use.

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you may feel or walk unsteady or have muscular

weakness on one side of the body. Tell a doctor or go to a hospital accident and emergency department

immediately. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Zebinix

If you forget to take a dose, take it as soon as you remember and carry on as usual. Do not take a

double dose to make up for a forgotten dose.

If you stop taking Zebinix

Do not stop taking your oral suspension suddenly. If you do, you are at risk of having more seizures.

Your doctor will decide how long you should take Zebinix. Should your doctor decide to stop your

treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment

is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a

doctor or go to a hospital immediately, as you may need urgent medical treatment

:

blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing

problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic

reaction.

Very common

(may affect more than 1 in 10

people) side effects are:

Feeling dizzy or sleepy.

Common

(may affect up to 1 in 10 people) side effects are:

Feeling unsteady or having a sensation of spinning or floating;

Feeling sick or vomiting;

Headache;

Diarrhoea;

Seeing double or blurred vision;

Difficulty in concentration;

Feeling low in energy or tired;

Shaking;

Skin rash;

Blood tests showing that you have low levels of sodium in your blood;

Decrease of appetite;

Difficulty in sleeping;

Difficulty in coordinating movements (ataxia).

Uncommon

(may affect up to 1 in 100 people) side effects are:

Clumsiness;

Allergy;

Constipation;

Seizures;

Underactive thyroid gland.

Symptoms include decreased level of thyroid hormone levels (seen in

blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body

temperature;

Liver problems;

High blood pressure or severe increase in blood pressure;

Low blood pressure or a fall in blood pressure on standing up;

Blood tests showing that you have low levels of salts (including chloride) in your blood or a

reduction in red blood cells;

Dehydration;

Eye movement changes, fuzzy vision or red eye;

Having falls;

Thermal burn;

Poor memory or forgetfulness;

Crying, feeling depressed, nervous or confused, lack of interest or emotion;

Inability to speak or write or understand spoken or written language;

Agitation;

Attention deficit/ hyperactivity disorder;

Irritability;

Mood changes or hallucinations;

Difficulty in speaking;

Nosebleed;

Chest pain;

Tingling and/or feeling numb in any part of your body;

Migraine;

Burning sensation;

Abnormal sense of touch;

Disturbances in the sense of smell;

Ringing in the ears;

Hearing difficulty;

Swelling in your legs and arms;

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;

Charcoal (dark) stool;

Inflamed gums or toothache;

Sweating or having dry skin;

Itching;

Skin changes (e.g. red skin);

Hair loss;

Urinary tract infection;

Feeling generally weak, unwell or having chills;

Weight loss;

Muscle pain, pain in limbs, muscular weakness;

Bone metabolism disorder;

Increased bone proteins;

Flushing, cold limbs;

Slower or irregular heart beat;

Feeling extremely sleepy;

Sedation;

Neurological movement disorder where your muscles contract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pain, cramping;

Medicine toxicity;

Anxiety.

Not known

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

Reduction in blood platelets which increases risk of bleeding or bruising;

Severe pain in the back and stomach (caused by inflamation of the pancreas);

Reduction in white blood cells which makes infections more likely;

Reddish target-like macules or circular patches often with central blisters on the trunk, skin

peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded

by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);

Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver

enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also

known as DRESS or drug hypersensitivity syndrome);

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower

legs;

Urticaria (skin rash with itching).

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat)

may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the

bone) and fractures with structurally related antiepileptics medicines like carbamazepine and

oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment,

have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Zebinix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the bottle and the carton after EXP.

The expiry date refers to the last day of that month.

Once you have opened the bottle, you must not use it longer than 2 months

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Zebinix contains

The active substance is eslicarbazepine acetate. Each ml of oral suspension contains 50 mg of

eslicarbazepine acetate.

The other ingredients are xanthan gum (E415), macrogol-100 stearate, methyl

parahydroxybenzoate (E218), saccharin sodium (E954), flavour tutti-frutti artificial (contains

maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking

flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water.

What Zebinix looks like and contents of the pack

Zebinix 50 mg/ml is an off-white to white oral suspension.

The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing

200 ml oral suspension, inside a cardboard box. Each cardboard box contains a 10 ml polypropylene

graduated syringe with 0.2 ml graduations, and a copolymer push-in bottle adapter.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª

, S.A.,

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00

fax: +351 22 986 61 99

e-mail: info@bial.com

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Eisai Europe Ltd

Tél/Tel: + 32 (0) 2 502 58 04

Luxembourg/Luxemburg

Eisai Europe Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

България

BIAL-Portela & Cª., S.A.

Teл.: + 351 22 986 61 00

(Португалия)

Magyarország

Eisai Ltd

Tel.: + 44 (0)845 676 1400

(Nagy-Britannia)

Česká republika

Eisai GesmbH organizační složka

Tel: +420 242 485 839

Malta

BIAL-Portela & Cª., S.A.

Tel: + 351 22 986 61 00

(Il-Portugall)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Nederland

Eisai B.V.

Tél/Tel: + 31 (0) 900 575 3340

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Eesti

BIAL-Portela & Cª, S.A.

Tel: +351 22 986 61 00

(Portugal)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

Ελλάδα

Arriani Pharmaceuticals S.A.

Τηλ: + 30 210 668 3000

Polska

BIAL-Portela & Cª, S.A.

Tel.: + 351 22 986 61 00

(Portugália)

España

Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96

Portugal

BIAL-Portela & Cª., S.A.

Tel.: + 351 22 986 61 00

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Hrvatska

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugal)

România

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalia)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Slovenija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalska)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GesmbH organizační složka

Tel: + 420 242 485 839

(Česká republika)

Italia

Eisai S.r.l.

Tel: + 39 02 518 1401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi)

Κύπρος

BIAL-Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00

(Πορτογαλία)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugāle)

Lietuva

BIAL-Portela & Cª, S.A.

Tel: + 351 22 986 61 00

(Portugalija)

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.