ZEBINIX 400 mg Таблетки

Содержание инструкции

1. Zebinix 200 mg tablets
   1. What is Zebinix and what is it used for
   2. What you need to know before you take Zebinix
   3. How to take Zebinix
   4. Possible side effects
   5. How to store Zebinix
   6. Contents of the pack and other information
2. Zebinix 400 mg tablets
   1. What is Zebinix and what is it used for
   2. What you need to know before taking Zebinix
   3. How to take Zebinix
   4. Possible side effects
   5. How to store Zebinix
   6. Package contents and other information
3. Zebinix 600 mg tablets
   1. What is Zebinix and what is it used for
   2. What you need to know before you take Zebinix
   3. How to take Zebinix
   4. Possible side effects
   5. How to store Zebinix
   6. Contents of the pack and other information
4. Zebinix 800 mg tablets
   1. What is Zebinix and what is it used for
   2. What you need to know before taking Zebinix
   3. How to take Zebinix
   4. Possible side effects
   5. How to store Zebinix
   6. Contents of the pack and other information
5. Zebinix 50 mg/mL oral suspension
   1. What is Zebinix and what is it used for
   2. What you need to know before taking Zebinix
   3. How to take Zebinix
   4. Possible side effects
   5. How to store Zebinix
   6. Package contents and other information

Zebinix 200 mg tablets

Eslicarbazepine acetate

Read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zebinix is and what it is used for
• 2. What you need to know before you take Zebinix
• 3. How to take Zebinix
• 4. Possible side effects
• 5. How to store Zebinix
• 6. Contents of the pack and other information

1. What is Zebinix and what is it used for

Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics, used to treat epilepsy,
a condition that involves the occurrence of repeated seizures or epileptic attacks.
Zebinix is used:

• alone (as monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy) in adult, adolescent and children over 6 years of age who have seizures that affect a part of the brain (partial seizures). These seizures may be followed, but not necessarily, by a seizure that affects the whole brain (secondary generalization)

Zebinix has been prescribed by your doctor to reduce the 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 blisters or peeling of the skin and/or mucous membranes, a rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction
• if you experience confusion, worsening of seizures or a decrease in level of consciousness, possible signs of low sodium levels in the blood.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe kidney disease
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can cause this effect, talk to your doctor.
• if you suffer from a heart condition such as heart failure or myocardial infarction, or in case of any heart rhythm disorder
• if you suffer from seizures that start with a widespread electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptics have had self-harming (hurting themselves) or suicidal thoughts. If at any time during the intake of Zebinix you should have thoughts of this kind, contact your doctor immediately.
Zebinix may cause dizziness and/or drowsiness, especially at the beginning of treatment. When taking Zebinix, take special care to avoid accidental injuries, such as falls.
Take special care with Zebinix:
After marketing, serious and potentially fatal skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Zebinix.
If you develop a severe rash or other skin symptoms (see section 4), stop taking Zebinix and seek immediate medical attention.
In patients of Chinese Han or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by analyzing a blood sample from these patients. Your doctor will be able to advise you whether blood tests are necessary before taking Zebinix.

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

Other medicines and Zebinix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some of them may interfere with the way Zebinix works or Zebinix may interfere with their effect. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) because the dose may need to be adjusted.
• carbamazepine (a medicine used to treat epilepsy) because the dose may need to be adjusted and the following side effects of Zebinix may occur more frequently: double vision, abnormal coordination and dizziness.
• hormonal contraceptives (such as the pill) because Zebinix may make these less effective.
• simvastatin (a medicine used to lower cholesterol levels) because the dose may need to be adjusted.
• rosuvastatin, a medicine used to lower cholesterol levels.
• the anticoagulant warfarin.
• antidepressants based on monoamine oxidase inhibitors (MAOIs).
• 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 section ‘Pregnancy and breastfeeding’ for advice on contraception.

Pregnancy and breastfeeding
It is not recommended to take Zebinix during pregnancy, as the effects of Zebinix on pregnancy and the unborn child are unknown.
If you are planning a pregnancy, talk to your doctor before stopping your contraceptive use and starting pregnancy. The doctor may decide to change the treatment.
Data relating to the use of eslicarbazepine acetate in pregnant women are limited.
Research has shown an increased risk of congenital malformations and neurological development problems (brain development) in the children of women who take antiepileptic medicines, especially if more than one antiepileptic medicine is taken at the same time.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking the medicine without discussing it with your doctor. If you stop taking the medicine without consulting your doctor, you may experience seizures that may be dangerous for you and the unborn child. The doctor may decide to change the treatment.
If you are a woman of childbearing potential and are not planning a pregnancy, use effective contraceptive measures during treatment with Zebinix. Zebinix may alter the way hormonal contraceptives work, such as the birth control pill, and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of contraception while taking Zebinix. Talk to your doctor, who will discuss with you the most suitable contraceptive methods to use during treatment with Zebinix. If you stop treatment with Zebinix, continue to use effective contraceptive measures until the end of your current menstrual cycle.
If you take Zebinix during pregnancy, your child is also at risk of bleeding problems shortly after birth. Your doctor may administer a medicine to you and your child to prevent these problems.
Do not breastfeed during treatment with Zebinix. It is not known whether this medicine passes into breast milk.

Driving and using machines
Zebinix may cause dizziness or drowsiness and change your vision, especially at the beginning of treatment. In these cases, do not drive and do not use tools or machinery.

3. How to take Zebinix

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to the maintenance dose. The doctor will decide whether to have you take this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Based on your response to Zebinix, the dose may be increased up to 1,200 mg once a day. If you are taking
Zebinix alone, your doctor may consider whether you can benefit from a dose of 1,600 mg once a
day.
Patients with kidney problems
If you have kidney problems, you will generally receive a lower dose of Zebinix. The doctor will determine the dose
suitable for you. Zebinix is not recommended if you have severe kidney problems.
Elderly (over 65 years of age)
If you are elderly and are taking Zebinix alone, the 1,600 mg dose is not suitable for you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before
increasing it to the maintenance dose.

Maintenance dose
Based on your response to Zebinix, the dose may be increased by 10 mg per kg of body weight, at
intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is

• 1,200 mg once a day.

Children weighing ≥60 kg
Children weighing 60 kg or more should take the same dose as adults.
Other dosage forms of the medicine, such as oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
How to administer the medicine
Zebinix is for oral use. Swallow the tablet with a glass of water.
Zebinix tablets can be taken with or without food.
If you have difficulty swallowing the tablet whole, you can crush it, add it to a small amount
of water or applesauce, and take the entire dose immediately.
The tablet can be divided into equal doses.

If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you may potentially be at risk of having more
seizures; or, you may experience an irregular or faster heartbeat. Contact your doctor
or go to the hospital immediately if you experience any of the above symptoms.
Bring the medicine packaging with you to let the doctor know what you have taken.

If you forget to take Zebinix
If you forget to take a tablet, take it as soon as you remember and continue as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Zebinix
Do not suddenly stop taking the tablets. You would run the risk of having a greater
number of seizures. The doctor will decide how long you should take Zebinix. If the doctor decides to
stop treatment with Zebinix, they will generally reduce the dosage gradually. It is important
to complete the treatment as directed by the doctor, otherwise the symptoms may worsen.
If you have any questions about 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 you experience any of them, stop taking Zebinix and tell your doctor or go to hospital immediately: you may need urgent medical treatment.

• Blisters or peeling of the skin and/or mucous membranes, skin rash, problems with swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction

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

• dizziness or sleepiness

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

• feeling unsteady, spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling of low energy or fatigue
• tremor
• skin rash
• blood tests showing low levels of sodium
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• poor thyroid activity. Symptoms include reduced thyroid hormone level (seen in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails and hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high or severely increased blood pressure
• low blood pressure or a drop in pressure when getting up
• blood tests showing low levels of salt (including chloride) or a reduction in the number of red blood cells
• dehydration
• altered eye movements, blurred vision or red eye
• falls
• burn
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotion
• inability to speak or write or to understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling and/or numbness in any part of the body
• migraine
• burning sensation
• abnormal sense of touch
• disturbances of the sense of smell
• ringing in the ears
• difficulty hearing
• swelling of the legs or arms
• heartburn, stomach discomfort, abdominal pain, stomach bloating and discomfort in the mouth or dry mouth
• dark stools (presence of blood in the stool)
• inflamed gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. reddened skin)
• hair loss
• urinary tract infection
• feeling generally unwell or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorders
• increased bone protein
• hot flushes, cold extremities
• slower or irregular heartbeat
• feeling of extreme sleepiness
• sedation
• neurological movement disorders involving muscle contractions causing twisting and repetitive movements or abnormal postures. Symptoms include tremor, pain, cramps
• drug toxicity
• anxiety.

Side effects with unknown frequency(frequency cannot be estimated from available data) are:

• reduced platelets, which increases the risk of bleeding or bruising;
• severe back pain and stomach pain (caused by inflammation of the pancreas);
• reduced white blood cells, which increases the risk of infections;
• reddish, target-like or circular spots, often with blisters in the centre, on the trunk, skin peeling, ulcers (sores) in the mouth, throat, nose, genitals and eyes, red and swollen eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face and then spreading to other parts of the body, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome);
• severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• hives (itchy skin rash);
• lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).

The use of Zebinix is associated with an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. Side effects associated with this ECG abnormality (e.g. fainting or slowed heartbeat) may occur.
There have been cases of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine.
Consult your doctor or pharmacist if you are on long-term antiepileptic therapy, have a history of osteoporosis, or are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex 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, the bottle and the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zebinix contains

• The active ingredient is eslicarbazepine acetate. Each tablet contains 200 mg of eslicarbazepine acetate.
• The other ingredients are povidone K29/32, sodium croscarmellose and magnesium stearate.

Description of the appearance of Zebinix and contents of the pack
Zebinix 200 mg tablets are white and oblong. On one side is imprinted the inscription
‘ESL 200’ and on the other side there is a groove, the length is 11 mm. The tablet can be divided into
equal doses.
The tablets are packaged in blisters inside cardboard boxes containing 20 or 60
tablets, and in HDPE bottles with a child-resistant closure inside 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: [email protected]
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Luxembourg/Luxemburg
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

България
BIAL-Portela & Cª., S.A.
Teл.: + 351 22 986 61 00
(Португалия)

Magyarország
BIAL-Portela & Cª., S.A.
Tel.: + 351 22 986 61 00
(Portugália)

Česká republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Malta
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Il-Portugall)

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Nederland
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Deutschland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Österreich
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: + 30 210 668 3000

Eesti
BIAL-Portela & Cª, S.A.
Tel: +351 22 986 61 00
(Portugal)

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
BIAL-Portela & Cª., S.A.
Tél: + 351 22 986 61 00
(Portugal)

România
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalia)

Hrvatska
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenija
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalska)

Ireland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenská republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugalsko)

Ísland
Nordicinfu Care AB
Sími: +46 (0) 8 601 24 40

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Italia
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Sverige
Nordicinfu Care AB
Tel: +46 (0) 8 601 24 40

Κύπρος
BIAL-Portela & Cª, S.A.
Τηλ: + 351 22 986 61 00
(Πορτογαλία)

United Kingdom
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

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)
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Zebinix 400 mg tablets

Eslicarbazepine acetate

Read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zebinix is and what it is used for
• 2. What you need to know before you take Zebinix
• 3. How to take Zebinix
• 4. Possible side effects
• 5. How to store Zebinix
• 6. Contents of the pack and other information

1. What is Zebinix and what is it used for

Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics, used to treat epilepsy,
a condition that involves the occurrence of repeated seizures or epileptic attacks.
Zebinix is used:

• alone (as monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy) in adult, adolescent and children over 6 years of age who have seizures that affect part of the brain (partial seizures). These seizures may be followed, but not necessarily, by a seizure that affects the whole brain (secondary generalization)

Zebinix has been prescribed by your doctor to reduce the number of seizures.

2. What you need to know before taking 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 blisters or peeling of the skin and/or mucous membranes, a rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction
• if you experience confusion, worsening of seizures or a decrease in level of consciousness, possible signs of low sodium levels in the blood.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe kidney disease
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can cause this effect, talk to your doctor.
• if you suffer from a heart condition such as heart failure or myocardial infarction, or in case of any heart rhythm disorder
• if you suffer from seizures that begin with a widespread electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptics have had self-harming (hurting themselves) or suicidal thoughts. If at any time during your treatment with Zebinix you should have thoughts of this kind, contact your doctor immediately.
Zebinix may cause dizziness and/or drowsiness, especially at the beginning of treatment. When taking Zebinix, take particular care to avoid accidental injuries, such as falls.
Take particular care with Zebinix:
After marketing authorization, serious and potentially fatal skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Zebinix.
If you develop a severe rash or other skin symptoms (see section 4), stop taking Zebinix and consult your doctor or seek medical attention immediately.
In patients of Chinese Han or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by analyzing a blood sample from these patients. Your doctor will be able to advise you whether blood tests are necessary before taking Zebinix.

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

Other medicines and Zebinix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some of them may interfere with the way Zebinix works or Zebinix may interfere with their effect. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) because the dose may need to be adjusted.
• carbamazepine (a medicine used to treat epilepsy) because the dose may need to be adjusted and the following undesirable effects of Zebinix may occur more frequently: double vision, abnormal coordination and dizziness.
• hormonal contraceptives (such as the pill) as Zebinix may make these less effective.
• simvastatin (a medicine used to lower cholesterol levels) because the dose may need to be adjusted.
• rosuvastatin, a medicine used to lower cholesterol levels.
• the anticoagulant warfarin.
• antidepressants based on monoamine oxidase inhibitors (MAOIs).
• 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 section ‘Pregnancy and breastfeeding’ for advice on contraception.

Pregnancy and breastfeeding
It is not recommended to take Zebinix during pregnancy, as the effects of Zebinix on pregnancy and the unborn child are unknown.
If you are planning a pregnancy, consult your doctor before stopping your contraception and starting pregnancy. Your doctor may decide to change your treatment.
Data relating to the use of eslicarbazepine acetate in pregnant women are limited.
Research has shown an increased risk of congenital malformations and neurological development problems (brain development) in the children of women who take antiepileptic medicines, especially if more than one antiepileptic medicine is taken at the same time.
If you are pregnant or think you may be pregnant, inform your doctor immediately. Do not stop taking the medicine without discussing it with your doctor. If you stop taking the medicine without consulting your doctor, you may experience seizures which may be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing potential and are not planning a pregnancy, use effective contraceptive measures during treatment with Zebinix. Zebinix may alter the way hormonal contraceptives, such as the contraceptive pill, work and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of contraception while taking Zebinix. Talk to your doctor, who will discuss with you the most suitable contraceptive methods to use during treatment with Zebinix. If you stop taking Zebinix, continue to use effective contraceptive measures until the end of your current menstrual cycle.
If you take Zebinix during pregnancy, your child is also at risk of bleeding problems shortly after birth. Your doctor may administer a medicine to you and your child to prevent these problems.
Do not breastfeed during treatment with Zebinix. It is not known whether this medicine passes into breast milk.

Driving and using machines
Zebinix may cause dizziness or drowsiness and change your vision, especially at the beginning of treatment. In these cases, do not drive and do not use tools or machinery.

3. How to take Zebinix

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to the maintenance dose. Your doctor will decide whether to have you take this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Based on your response to Zebinix, the dose may be increased to 1,200 mg once a day. If you are taking Zebinix alone, your doctor may consider whether you can benefit from a dose of 1,600 mg once a day.
Patients with kidney problems
If you have kidney problems, you will generally receive a lower dose of Zebinix. Your doctor will determine the appropriate 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 alone, the 1,600 mg dose is not suitable for you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing it to the maintenance dose.

Maintenance dose
Based on your response to Zebinix, the dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is

• 1,200 mg once a day.

Children weighing ≥60 kg
Children weighing 60 kg or more should take the same dose as adults.
Other formulations of the medicine, such as oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
How to administer the medicine
Zebinix is for oral use. Swallow the tablet with a glass of water.
Zebinix tablets can be taken with or without food.
If you have difficulty swallowing the tablet whole, you can crush it, add it to a small amount of water or applesauce, and take the entire dose immediately.
The score line is to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you potentially run the risk of having more seizures; or, you may experience an irregular or faster heartbeat. Contact your doctor or go to the hospital immediately if you experience any of the symptoms mentioned above.
Bring the medicine packaging with you to let your doctor know what you have taken.

If you forget to take Zebinix
If you forget to take a tablet, take it as soon as you remember and continue as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Zebinix
Do not suddenly stop taking the tablets. You would run the risk of having more seizures. Your doctor will decide how long you should take Zebinix. If your doctor decides to stop treatment with Zebinix, they will usually reduce the dosage gradually. It is important to complete the treatment as directed by your doctor, otherwise your symptoms may worsen.
If you have any questions about using 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 you experience any of these, stop taking Zebinix and tell your doctor or go to hospital immediately: you may
need urgent medical treatment.

• Blisters or peeling of the skin and/or mucous membranes, skin rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction

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

• dizziness or drowsiness

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

• feeling unstable, spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling of low energy or fatigue
• tremor
• skin rash
• blood tests showing low levels of sodium
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• poor thyroid activity. Symptoms include reduced thyroid hormone level (seen in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails and hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high or severely increased blood pressure
• low blood pressure or a drop in blood pressure when standing up
• blood tests showing low levels of salt (including chloride) or a reduction in the number of red blood cells
• dehydration
• abnormal eye movements, blurred vision or red eye
• falls
• burn
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotion
• inability to speak or write or to understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling and/or numbness in any part of the body
• migraine
• burning sensation
• abnormal sense of touch
• disturbances of the sense of smell
• ringing in the ears
• hearing difficulties
• swelling of the legs or arms
• heartburn, stomach discomfort, abdominal pain, stomach bloating and discomfort in the mouth or dry mouth
• dark stools (presence of blood in the stools)
• inflamed gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. reddened skin)
• hair loss
• urinary tract infection
• feeling generally unwell or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorders
• increased bone protein
• hot flushes, cold extremities
• slower or irregular heartbeat
• feeling of extreme sleepiness
• sedation
• neurological movement disorders involving muscle contractions causing twisting and repetitive movements or abnormal postures. Symptoms include tremor, pain, cramps
• drug toxicity
• anxiety.

Side effects with unknown frequency(frequency cannot be estimated from available data)
are:

• reduced platelets, which increases the risk of bleeding or bruising;
• severe back pain and stomach pain (caused by inflammation of the pancreas);
• reduced white blood cells, which increases the likelihood of infections;
• reddish, target-like or circular spots, often with blisters in the centre, on the trunk, skin peeling, ulcers (sores) in the mouth, throat, nose, genitals and eyes, red and swollen eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face and then spreading to other parts of the body, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome);
• severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• urticaria (itchy skin rash);
• lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).

The use of Zebinix is associated with an abnormality on the ECG (electrocardiogram) called prolongation
of the PR interval. Side effects associated with this ECG abnormality (e.g.
fainting or slowed heartbeat) may occur.
There have been cases of bone disorders including osteopenia and osteoporosis (thinning of the bones) and
fractures with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine.
Consult your doctor or pharmacist if you are on long-term antiepileptic therapy, if you have a history of
osteoporosis, or if you are taking 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 through the national reporting system detailed in Annex 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 box after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zebinix contains

• The active ingredient is eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine acetate.
• The other ingredients are povidone K29/32, sodium croscarmellose and magnesium stearate.

Description of the appearance of Zebinix and package contents
Zebinix 400 mg tablets are round, white and biconvex. One side is imprinted with the inscription
‘ESL 400’ and the other side has a groove, the diameter is 11 mm.
The tablets are packaged in blisters inside 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: [email protected]
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Luxembourg/Luxemburg
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

България
BIAL-Portela & Cª., S.A.
Teл.: + 351 22 986 61 00
(Португалия)

Magyarország
BIAL-Portela & Cª., S.A.
Tel.: + 351 22 986 61 00
(Portugália)

Česká republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Malta
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Il-Portugall)

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Nederland
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Deutschland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Österreich
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: + 30 210 668 3000

Eesti
BIAL-Portela & Cª, S.A.
Tel: +351 22 986 61 00
(Portugal)

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
BIAL-Portela & Cª., S.A.
Tél: + 351 22 986 61 00
(Portugal)

România
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalia)

Hrvatska
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenija
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalska)

Ireland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenská republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugalsko)

Ísland
Nordicinfu Care AB
Sími: +46 (0) 8 601 24 40

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Italia
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Sverige
Nordicinfu Care AB
Tel: +46 (0) 8 601 24 40

Κύπρος
BIAL-Portela & Cª, S.A.
Τηλ: + 351 22 986 61 00
(Πορτογαλία)

United Kingdom
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

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)
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Zebinix 600 mg tablets

Eslicarbazepine acetate

Read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zebinix is and what it is used for
• 2. What you need to know before you take Zebinix
• 3. How to take Zebinix
• 4. Possible side effects
• 5. How to store Zebinix
• 6. Contents of the pack and other information

1. What is Zebinix and what is it used for

Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics, used to treat epilepsy,
a condition that involves the occurrence of repeated seizures or epileptic attacks.
Zebinix is used:

• alone (as monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy) in adult, adolescent and children over 6 years of age who have seizures that affect part of the brain (partial seizures). These seizures may be followed, but not necessarily, by a seizure that affects the whole brain (secondary generalization)

Zebinix has been prescribed by your doctor to reduce the 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 for the treatment of 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 blisters or peeling of the skin and/or mucous membranes, a rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction
• if you experience confusion, a worsening of seizures or a decrease in the level of consciousness, possible signs of low sodium levels in the blood.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe kidney disease
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can cause this effect, talk to your doctor.
• if you suffer from a heart condition such as heart failure or myocardial infarction, or in case of any heart rhythm disorder
• if you suffer from seizures that begin with a widespread electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptics have had self-harm (hurting themselves) or suicidal thoughts. If at any time during taking Zebinix you should have thoughts of this kind, contact your doctor immediately.
Zebinix may cause dizziness and/or drowsiness, especially at the beginning of treatment. When taking Zebinix, take special care to avoid accidental injuries, such as falls.
Take particular care with Zebinix:
After marketing authorization, serious and potentially fatal skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Zebinix.
If you develop a severe rash or other skin symptoms (see section 4), stop taking Zebinix and seek immediate medical attention or medical care.
In patients of Chinese Han or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by analyzing a blood sample from these patients. Your doctor will be able to advise you whether it is necessary to have blood tests before taking Zebinix.

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

Other medicines and Zebinix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some of them may interfere with the way Zebinix works or Zebinix may interfere with their effect. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) because the dose may need to be adjusted.
• carbamazepine (a medicine used to treat epilepsy) because the dose may need to be adjusted and the following undesirable effects of Zebinix may occur more frequently: double vision, abnormal coordination and dizziness.
• hormonal contraceptives (such as the pill) as Zebinix may make these less effective.
• simvastatin (a medicine used to lower cholesterol levels) because the dose may need to be adjusted.
• rosuvastatin, a medicine used to lower cholesterol levels.
• the anticoagulant warfarin.
• antidepressants based on monoamine oxidase inhibitors (MAOIs).
• 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 section ‘Pregnancy and breastfeeding’ for advice on contraception.

Pregnancy and breastfeeding
It is not recommended to take Zebinix during pregnancy, as the effects of Zebinix on pregnancy and the unborn child are unknown.
If you are planning a pregnancy, talk to your doctor before stopping your contraception and starting to become pregnant. Your doctor may decide to change your treatment.
Data relating to the use of eslicarbazepine acetate in pregnant women are limited.
Research has shown an increased risk of congenital malformations and neurological development problems (brain development) in the children of women who take antiepileptic medicines, especially if more than one antiepileptic medicine is taken at the same time.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking the medicine without discussing it with your doctor. If you stop taking the medicine without consulting your doctor, you may experience seizures which may be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing potential and are not planning a pregnancy, use effective contraceptive measures during treatment with Zebinix. Zebinix may alter the way hormonal contraceptives work, such as the contraceptive pill (birth control pill), and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of contraception while taking Zebinix. Talk to your doctor, who will discuss with you the most suitable contraceptive methods to use during treatment with Zebinix. If you stop taking Zebinix, continue to use effective contraceptive measures until the end of your current menstrual cycle.
If you take Zebinix during pregnancy, your child may also be at risk of bleeding problems shortly after birth. Your doctor may give a medicine to you and your child to prevent these problems.
Do not breastfeed during treatment with Zebinix. It is not known whether this medicine passes into breast milk.

Driving and using machines
Zebinix may cause dizziness or drowsiness and change your vision, especially at the beginning of treatment. In these cases, do not drive and do not use tools or machines.

3. How to take Zebinix

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to the maintenance dose. The doctor will decide whether to have you take this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Based on your response to Zebinix, the dose may be increased up to 1,200 mg once a day. If you are taking
Zebinix alone, your doctor may consider whether you can benefit from a dose of 1,600 mg once a
day.
Patients with kidney problems
If you have kidney problems, you will generally receive a lower dose of Zebinix. The doctor will determine the dose
suitable 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 alone, the 1,600 mg dose is not suitable for you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before
increasing it to the maintenance dose.

Maintenance dose
Based on your response to Zebinix, the dose may be increased by 10 mg per kg of body weight, at
intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is

• 1,200 mg once a day.

Children weighing ≥60 kg
Children weighing 60 kg or more should take the same dose as adults.
Other formulations of the medicine, such as oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
Route of administration
Zebinix is for oral use. Swallow the tablet with a glass of water.
Zebinix tablets can be taken with or without food.
If you have difficulty swallowing the tablet whole, you can crush it, add it to a small amount
of water or applesauce, and take the entire dose immediately.
The tablet can be divided into equal parts.

If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you may potentially be at risk of having more
seizures; or, you may experience an irregular or faster heartbeat. Contact your doctor
or go to the hospital immediately if you experience any of the symptoms listed above.
Bring the medicine packaging with you to let the doctor know what you have taken.

If you forget to take Zebinix
If you forget to take a tablet, take it as soon as you remember and continue as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Zebinix
Do not suddenly stop taking the tablets. You would run the risk of having more
seizures. The doctor will decide how long you should take Zebinix. If the doctor decides to
stop treatment with Zebinix, they will generally reduce the dosage gradually. It is important
to complete the treatment as directed by the doctor, otherwise the symptoms may worsen.
If you have any questions about using 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 you experience any of them stop taking Zebinix and tell your doctor or go to hospital immediately: you may need urgent medical treatment.

• Blisters or peeling of the skin and/or mucous membranes, skin rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction

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

• dizziness or drowsiness

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

• feeling unsteady, spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling weak or tired
• tremor
• skin rash
• blood tests showing low levels of sodium
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• poor thyroid activity. Symptoms include reduced thyroid hormone level (seen in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails or hair and low body temperature
• liver problems (such as increased liver enzymes)
• high or severely increased blood pressure
• low blood pressure or a drop in blood pressure when standing up
• blood tests showing low levels of salt (including chloride) or a decrease in the number of red blood cells
• dehydration
• altered eye movements, blurred vision or red eye
• falls
• burn
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotion
• inability to speak or write or to understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleed
• chest pain
• tingling and/or numbness in any part of the body
• migraine
• burning sensation
• abnormal sense of touch
• taste disturbances
• ringing in the ears
• hearing difficulties
• swelling of the legs or arms
• heartburn, stomach discomfort, abdominal pain, stomach bloating and dry or sore mouth
• dark stools (presence of blood in the stool)
• inflamed gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. reddened skin)
• hair loss
• urinary tract infection
• feeling generally unwell or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorders
• increased bone protein
• hot flushes, cold extremities
• slower or irregular heartbeat
• feeling extremely sleepy
• sedation
• neurological movement disorders involving muscle contractions causing twisting and repetitive movements or abnormal postures. Symptoms include tremor, pain, cramps
• drug toxicity
• anxiety.

Side effects with unknown frequency(frequency cannot be estimated from available data) are:

• reduced platelets, which increases the risk of bleeding or bruising;
• severe back pain and stomach pain (caused by inflammation of the pancreas);
• reduced white blood cells, which increases the likelihood of infections;
• reddish, target-like or circular patches, often with blisters in the centre, on the trunk, skin peeling, ulcers (sores) in the mouth, throat, nose, genitals and eyes, red and swollen eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face and then spreading to other parts of the body, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome);
• severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• urticaria (itchy skin rash);
• lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).

The use of Zebinix is associated with an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. Side effects associated with this ECG abnormality (e.g. fainting or slowed heartbeat) may occur.
There have been cases of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine.
Consult your doctor or pharmacist if you are on long-term antiepileptic therapy, if you have a history of osteoporosis, or if you are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex 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, the bottle and the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zebinix contains

• The active ingredient is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine acetate.
• The other ingredients are povidone K29/32, sodium croscarmellose and magnesium stearate.

Description of the appearance of Zebinix and contents of the pack
Zebinix 600 mg tablets are white and oblong. On one side is imprinted the inscription
‘ESL 600’ and on the other side there is a groove, the length of which is 17.3 mm. The tablet can be divided into
two equal doses.
The tablets are packaged in blisters inside cardboard boxes containing 30 or 60
tablets, and in HDPE bottles with a child-resistant closure inside 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: [email protected]
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Luxembourg/Luxemburg
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

България
BIAL-Portela & Cª., S.A.
Teл.: + 351 22 986 61 00
(Португалия)

Magyarország
BIAL-Portela & Cª., S.A.
Tel.: + 351 22 986 61 00
(Portugália)

Česká republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Malta
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Il-Portugall)

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Nederland
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Deutschland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Österreich
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: + 30 210 668 3000

Eesti
BIAL-Portela & Cª, S.A.
Tel: +351 22 986 61 00
(Portugal)

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
BIAL-Portela & Cª., S.A.
Tél: + 351 22 986 61 00
(Portugal)

România
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalia)

Hrvatska
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenija
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalska)

Ireland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenská republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugalsko)

Ísland
Nordicinfu Care AB
Sími: +46 (0) 8 601 24 40

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Italia
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Sverige
Nordicinfu Care AB
Tel: +46 (0) 8 601 24 40

Κύπρος
BIAL-Portela & Cª, S.A.
Τηλ: + 351 22 986 61 00
(Πορτογαλία)

United Kingdom
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

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)
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Zebinix 800 mg tablets

Eslicarbazepine acetate

Read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zebinix is and what it is used for
• 2. What you need to know before you take Zebinix
• 3. How to take Zebinix
• 4. Possible side effects
• 5. How to store Zebinix
• 6. Contents of the pack and other information

1. What is Zebinix and what is it used for

Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics, used to treat epilepsy,
a condition that involves the occurrence of repeated seizures or epileptic attacks.
Zebinix is used:

• alone (as monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy) in adult, adolescent and children over 6 years of age who have seizures that affect part of the brain (partial seizures). These seizures may be followed, but not necessarily, by a seizure that affects the whole brain (secondary generalization)

Zebinix has been prescribed by your doctor to reduce the number of seizures.

2. What you need to know before taking 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 blisters or peeling of the skin and/or mucous membranes, a rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction
• if you experience confusion, worsening of seizures or a decrease in level of consciousness, possible signs of low sodium levels in the blood.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe kidney disease
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can cause this effect, talk to your doctor.
• if you suffer from a heart condition such as heart failure or heart attack, or if you have any heart rhythm disorder
• if you suffer from seizures that start with a widespread electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptics have had thoughts about self-harm or suicide. If at any time during your treatment with Zebinix you should have thoughts of this kind, contact your doctor immediately.
Zebinix may cause dizziness and/or drowsiness, especially at the beginning of treatment. When taking
Zebinix, be particularly careful to avoid accidental injuries, such as falls.
Take particular care with Zebinix:
After marketing, serious and potentially fatal skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Zebinix.
If you develop a severe rash or other skin symptoms (see section 4), stop
taking Zebinix and seek immediate medical attention.
In patients of Chinese Han or Thai origin, the risk of severe skin reactions associated with
carbamazepine or chemically related compounds can be predicted by analyzing a sample of
blood from these patients. Your doctor will be able to advise you whether blood tests are necessary before
taking Zebinix.

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

Other medicines and Zebinix
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because some of them may interfere with the way Zebinix works or Zebinix may interfere with their effect. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) because the dose may need to be adjusted.
• carbamazepine (a medicine used to treat epilepsy) because the dose may need to be adjusted and the following side effects of Zebinix may occur more frequently: double vision, abnormal coordination and dizziness.
• hormonal contraceptives (such as the pill) as Zebinix may make these less effective.
• simvastatin (a medicine used to lower cholesterol levels) because the dose may need to be adjusted.
• rosuvastatin, a medicine used to lower cholesterol levels.
• the anticoagulant warfarin.
• antidepressants based on monoamine oxidase inhibitors (MAOIs).
• 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 section ‘Pregnancy and breastfeeding’ for advice on contraception.

Pregnancy and breastfeeding
It is not recommended to take Zebinix during pregnancy, as the effects of Zebinix on pregnancy and
the unborn child are unknown.
If you are planning a pregnancy, talk to your doctor before stopping your contraception
and becoming pregnant. Your doctor may decide to change your treatment.
Data relating to the use of eslicarbazepine acetate in pregnant women are limited.
Research has shown an increased risk of congenital malformations and neurological development problems (brain development) in children of women who take antiepileptic medicines,
especially if more than one antiepileptic medicine is taken at the same time.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not
stop taking the medicine without discussing it with your doctor. If you stop taking the
medicine without consulting your doctor, you may experience seizures which can be
dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing potential and are not planning a pregnancy, use effective
contraceptive measures during treatment with Zebinix. Zebinix can alter the way hormonal
contraceptives work, such as the contraceptive pill, and make them less effective
in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of
contraception while taking Zebinix. Talk to your doctor, who will discuss with you the most
suitable contraceptive methods to use during treatment with Zebinix. If you stop treatment with
Zebinix, continue to use effective contraceptive measures until the end of your current menstrual cycle.
If you take Zebinix during pregnancy, your child is also at risk of bleeding problems
shortly after birth. Your doctor may give you and your child a medicine to prevent these problems.
Do not breastfeed during treatment with Zebinix. It is not known whether this medicine passes into breast milk.

Driving and using machines
Zebinix may cause dizziness or drowsiness and change your vision, especially at the beginning of
treatment. In these cases, do not drive and do not use tools or machines.

3. How to take Zebinix

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to the maintenance dose. The doctor will decide whether to have you take this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Based on your response to Zebinix, the dose may be increased to 1,200 mg once a day. If you are taking
Zebinix alone, your doctor may consider whether you can benefit from a dose of 1,600 mg once a
day.
Patients with kidney problems
If you have kidney problems, you will generally receive a lower dose of Zebinix. The doctor will determine the dose
suitable 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 alone, the 1,600 mg dose is not suitable for you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before
increasing it to the maintenance dose.

Maintenance dose
Based on your response to Zebinix, the dose may be increased by 10 mg per kg of body weight, at
intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is

• 1,200 mg once a day.

Children weighing ≥60 kg
Children weighing 60 kg or more should take the same dose as adults.
Other dosage forms of the medicine, such as oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
How to administer the medicine
Zebinix is for oral use. Swallow the tablet with a glass of water.
Zebinix tablets can be taken with or without food.
If you have difficulty swallowing the tablet whole, you can crush it, add it to a small amount
of water or applesauce, and take the entire dose immediately.
The tablet can be divided into equal parts.

If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you may potentially be at risk of having more
seizures; or, you may experience an irregular or faster heartbeat. Contact your doctor
or go to the hospital immediately if you experience any of the symptoms listed above.
Bring the medicine packaging with you to let the doctor know what you have taken.

If you forget to take Zebinix
If you forget to take a tablet, take it as soon as you remember and continue as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Zebinix
Do not suddenly stop taking the tablets. You would run the risk of having more
seizures. The doctor will decide how long you should take Zebinix. If the doctor decides to
stop the treatment with Zebinix, they will generally reduce the dosage gradually. It is important
to complete the treatment as directed by the doctor, otherwise the symptoms may worsen.
If you have any questions about 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 you experience any of them, stop taking Zebinix and talk to a doctor or go to hospital immediately: you may
need urgent medical treatment.

• Blisters or peeling of the skin and/or mucous membranes, skin rash, problems swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction

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

• dizziness or drowsiness

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

• feeling unsteady, spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling tired or weak
• tremor
• skin rash
• blood tests showing low levels of sodium
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• poor thyroid activity. Symptoms include reduced thyroid hormone level (seen in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high or severely increased blood pressure
• low blood pressure or a drop in pressure when standing up
• blood tests showing low levels of salt (including chloride) or a decrease in the number of red blood cells
• dehydration
• altered eye movements, blurred vision or red eye
• falls
• burn
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotions
• inability to speak or write or to understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling and/or numbness in any part of the body
• migraine
• burning sensation
• abnormal sense of touch
• disturbances of the sense of smell
• ringing in the ears
• hearing difficulties
• swelling of the legs or arms
• heartburn, stomach discomfort, abdominal pain, stomach bloating and dry mouth or mouth discomfort
• dark stools (presence of blood in the stools)
• inflamed gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. reddened skin)
• hair loss
• urinary tract infection
• feeling generally unwell or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorders
• increased bone proteins
• hot flushes, cold extremities
• slow or irregular heartbeat
• feeling extremely sleepy
• sedation
• neurological movement disorders involving muscle contractions that cause twisting and repetitive movements or abnormal postures. Symptoms include tremor, pain, cramps
• drug toxicity
• anxiety.

Side effects of unknown frequency(frequency cannot be estimated based on available data)
are:

• reduced platelets, which increases the risk of bleeding or bruising;
• severe back pain and stomach pain (caused by inflammation of the pancreas);
• reduced white blood cells, which increases the likelihood of infections;
• reddish, target-like or circular patches, often with blisters in the centre, on the trunk, skin peeling, ulcers (sores) in the mouth, throat, nose, genitals and eyes, red and swollen eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face and then spreading to other parts of the body, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome);
• severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• urticaria (itchy skin rash);
• lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).

The use of Zebinix is associated with an abnormality on the ECG (electrocardiogram) called prolongation
of the PR interval. Side effects associated with this ECG abnormality (e.g.
fainting or slowing of the heartbeat) may occur.
There have been cases of bone disorders including osteopenia and osteoporosis (thinning of the bones) and
fractures with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine.
Consult your doctor or pharmacist if you are on long-term antiepileptic therapy, if you have a history of
osteoporosis, or if you are taking steroids.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system indicated in Annex 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, the bottle and the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zebinix contains

• The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other ingredients are povidone K29/32, sodium croscarmellose and magnesium stearate.

Description of the appearance of Zebinix and contents of the pack
Zebinix 800 mg tablets are white and oblong. ‘ESL 800’ is imprinted on one side and there is a groove on the other side, the length is 19 mm. The tablet can be divided into two
equal doses.
The tablets are packaged in blisters inside cardboard boxes containing 20 or 30, 60 or 90
tablets or in HDPE bottles with
child-resistant closure inside 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: [email protected]
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Luxembourg/Luxemburg
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

България
BIAL-Portela & Cª., S.A.
Teл.: + 351 22 986 61 00
(Португалия)

Magyarország
BIAL-Portela & Cª., S.A.
Tel.: + 351 22 986 61 00
(Portugália)

Česká republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Malta
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Il-Portugall)

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Nederland
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Deutschland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Österreich
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: + 30 210 668 3000

Eesti
BIAL-Portela & Cª, S.A.
Tel: +351 22 986 61 00
(Portugal)

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
BIAL-Portela & Cª., S.A.
Tél: + 351 22 986 61 00
(Portugal)

România
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalia)

Hrvatska
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenija
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalska)

Ireland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenská republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugalsko)

Ísland
Nordicinfu Care AB
Sími: +46 (0) 8 601 24 40

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Italia
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Sverige
Nordicinfu Care AB
Tel: +46 (0) 8 601 24 40

Κύπρος
BIAL-Portela & Cª, S.A.
Τηλ: + 351 22 986 61 00
(Πορτογαλία)

United Kingdom
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

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)
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Zebinix 50 mg/mL oral suspension

Eslicarbazepine acetate

Read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zebinix is and what it is used for
• 2. What you need to know before you take Zebinix
• 3. How to take Zebinix
• 4. Possible side effects
• 5. How to store Zebinix
• 6. Contents of the pack and other information

1. What is Zebinix and what is it used for

Zebinix contains the active ingredient eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics, used to treat epilepsy,
a condition that involves the occurrence of repeated seizures or epileptic attacks.
Zebinix is used:

• alone (as monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (add-on therapy) in adult, adolescent and children over 6 years of age who have seizures that affect part of the brain (partial seizures). These seizures may be followed, but not necessarily, by a seizure that affects the whole brain (secondary generalization)

Zebinix has been prescribed by your doctor to reduce the number of seizures.

2. What you need to know before taking 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 blisters or peeling of the skin and/or mucous membranes, a rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These may be signs of an allergic reaction
• if you experience confusion, worsening of seizures or a decrease in the level of consciousness, possible signs of low sodium levels in the blood.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe kidney disease
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems
• if you are taking medicines that can cause an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. If you are not sure whether the medicines you are taking can cause this effect, talk to your doctor.
• if you suffer from a heart condition such as heart failure or myocardial infarction, or in case of any heart rhythm disorder
• if you suffer from seizures that begin with a widespread electrical discharge affecting both sides of the brain.

A small number of people treated with antiepileptics have had self-harming (hurting themselves) or suicidal thoughts. If at any time during the taking of Zebinix you should have thoughts of this kind, contact your doctor immediately.
Zebinix may cause dizziness and/or drowsiness, especially at the beginning of treatment. When taking Zebinix, take particular care to avoid accidental injuries, such as falls.
Take particular care with Zebinix:
After marketing authorisation, serious and potentially fatal skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Zebinix.
If you develop a severe rash or other skin symptoms (see section 4), stop taking Zebinix and seek immediate medical attention.
In patients of Chinese Han or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by analysing a blood sample from these patients. Your doctor will be able to advise you whether blood tests are necessary before taking Zebinix.

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

Other medicines and Zebinix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some of them may interfere with the way Zebinix works or Zebinix may interfere with their effect. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy) because the dose may need to be adjusted.
• carbamazepine (a medicine used to treat epilepsy) because the dose may need to be adjusted and the following undesirable effects of Zebinix may occur more frequently: double vision, abnormal coordination and dizziness.
• hormonal contraceptives (such as the pill) as Zebinix may make these less effective.
• simvastatin (a medicine used to lower cholesterol levels) because the dose may need to be adjusted.
• rosuvastatin, a medicine used to lower cholesterol levels.
• the anticoagulant warfarin.
• antidepressants based on monoamine oxidase inhibitors (MAOIs).
• 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 section ‘Pregnancy and breastfeeding’ for advice on contraception.

Pregnancy and breastfeeding
It is not recommended to take Zebinix during pregnancy, as the effects of Zebinix on pregnancy and the unborn child are unknown.
If you are planning a pregnancy, talk to your doctor before stopping your contraception and becoming pregnant. Your doctor may decide to change your treatment.
Data relating to the use of eslicarbazepine acetate in pregnant women are limited.
Research has highlighted an increased risk of congenital malformations and neurological development problems (brain development) in the children of women who take antiepileptic medicines, especially if more than one antiepileptic medicine is taken at the same time.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking the medicine without discussing it with your doctor. If you stop taking the medicine without consulting your doctor, you may experience seizures which may be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a woman of childbearing potential and are not planning a pregnancy, use effective contraceptive measures during treatment with Zebinix. Zebinix may alter the way hormonal contraceptives, such as the contraceptive pill, work and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective forms of contraception during the taking of Zebinix. Talk to your doctor, who will discuss with you the most suitable contraceptive methods to use during treatment with Zebinix. If you stop treatment with Zebinix, continue to use effective contraceptive measures until the end of your current menstrual cycle.
If you take Zebinix during pregnancy, your child is also at risk of bleeding problems shortly after birth. Your doctor may give you and your child a medicine to prevent these problems.
Do not breastfeed during treatment with Zebinix. It is not known whether this medicine passes into breast milk.

Driving and operating machinery
Zebinix may cause dizziness or drowsiness and alter your vision, especially at the beginning of treatment. In these cases, do not drive and do not use tools or machinery.

Zebinix oral suspension contains methyl parahydroxybenzoate (E218) and sulphites
Zebinix oral suspension contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (including delayed reactions), and sulphites, which can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Zebinix

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Adults

Starting dose
400 mg once a day for one or two weeks, before increasing it to reach the maintenance dose. The doctor will decide whether to have you take this dose for one or two weeks.

Maintenance dose
The usual maintenance dose is 800 mg once a day.
Based on your response to Zebinix, the dose may be increased up to 1,200 mg once a day. If you are taking Zebinix alone, your doctor may consider whether you can benefit from a dose of 1,600 mg once a day.
Patients with kidney problems
If you have kidney problems, you will generally receive a lower dose of Zebinix. The doctor will determine the appropriate dose for you. Zebinix is not recommended if you have severe kidney problems.
Elderly (over 65 years of age)
If you are elderly and are taking Zebinix alone, the 1,600 mg dose is not suitable for you.
Children over 6 years of age

Starting dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing it to reach the maintenance dose.

Maintenance dose
Based on your response to Zebinix, the dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to 30 mg per kg of body weight. The maximum dose is

• 1,200 mg once a day.

Children weighing ≥60 kg
Children weighing 60 kg or more should take the same dose as adults.
Other dosage forms of the medicine, such as oral suspension, may be more suitable for children.
Ask your doctor or pharmacist.
How to administer
Zebinix is for oral use.
The oral suspension of Zebinix can be taken with or without food.
Shake well before use.
Always use the attached oral administration syringe to take the medicine.

Instructions for use:
Step 1. Take the bottle, the oral administration syringe and the bottle adapter out of the box.
Step 2. Shake the bottle for at least 10 seconds and remove the child-resistant closure by pressing and turning counterclockwise (to the left).

Step 3. Insert the adapter into the neck of the bottle. You may need to apply slight pressure to secure it. Once inserted, the adapter should no longer be removed from the bottle. The bottle can be closed leaving the adapter in place.

Step 4. To make the operation easier, mark the volume to be drawn up by moving the plunger of the syringe. Insert the tip of the oral administration syringe into the opening of the adapter, keeping the bottle upright. Push the plunger all the way down. This creates pressure inside the bottle, which facilitates the withdrawal of the suspension, forcing it to pass from the bottle to the oral administration syringe.

Step 5: Hold the oral administration syringe firmly and turn the bottle upside down.
Gently pull the plunger of the oral administration syringe to reach the desired volume.

Step 6: If air bubbles are observed in the oral administration syringe, push the plunger upwards just enough to eliminate the larger air bubbles. Pull the plunger down again to the dose prescribed by the doctor.

Step 7. Return the bottle to the upright position and remove the oral administration syringe.
Be careful not to push the plunger while removing the oral administration syringe from the bottle.

Step 8. Close the bottle with its cap by turning it clockwise (to the right).

Step 9. Place the oral administration syringe in your mouth, directing it towards the inside of your cheek. Slowly press the plunger to release Zebinix into your mouth.
Step 10: After each use, rinse the empty oral administration syringe in a glass of clean water. Repeat this cleaning procedure 3 times.
Store the bottle and the oral administration syringe together in the box until the next use.

If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you may potentially risk having more seizures; or, you may experience an irregular or faster heartbeat. Contact your doctor or go to the hospital immediately if you experience any of the symptoms mentioned above.
Bring the medicine packaging with you to let the doctor know 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 continue as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Zebinix
Do not suddenly stop taking the oral suspension. You would risk having a greater number of seizures. The doctor will decide how long you should take Zebinix. If the doctor decides to stop the treatment with Zebinix, they will generally reduce the dosage gradually. It is important to complete the treatment according to the doctor's instructions, otherwise the symptoms may worsen.
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 you experience any of them, stop taking Zebinix and tell your doctor or go to hospital immediately: you may need urgent medical treatment.

• Blisters or peeling of the skin and/or mucous membranes, skin rash, problems with swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These can be signs of an allergic reaction

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

• dizziness or drowsiness

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

• feeling unsteady, spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling weak or tired
• tremor
• skin rash
• blood tests showing low levels of sodium
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• poor thyroid activity. Symptoms include reduced thyroid hormone level (seen in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high or severely increased blood pressure
• low blood pressure or a drop in pressure when getting up
• blood tests showing low levels of salt (including chloride) or a reduction in the number of red blood cells
• dehydration
• abnormal eye movements, blurred vision or red eye
• falls
• burns
• poor memory or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotion
• inability to speak or write or to understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• changes in mood or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling and/or numbness in any part of the body
• migraine
• burning sensation
• abnormal sense of touch
• taste disturbances
• ringing in the ears
• hearing difficulties
• swelling of the legs or arms
• heartburn, stomach discomfort, abdominal pain, stomach bloating and dry mouth or mouth discomfort
• dark stools (presence of blood in the stool)
• inflamed gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. reddened skin)
• hair loss
• urinary tract infection
• feeling generally unwell or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorders
• increased bone protein
• hot flushes, cold extremities
• slower or irregular heartbeat
• feeling extremely sleepy
• sedation
• neurological movement disorders involving muscle contractions causing twisting and repetitive movements or abnormal postures. Symptoms include tremor, pain, cramps
• drug toxicity
• anxiety.

Side effects with unknown frequency(frequency cannot be estimated from available data) are:

• reduced platelets, which increases the risk of bleeding or bruising;
• severe back pain and stomach pain (caused by inflammation of the pancreas);
• reduced white blood cells, which increases the likelihood of infections;
• reddish, target-like or circular patches, often with blisters in the centre, on the trunk, skin peeling, ulcers (sores) in the mouth, throat, nose, genitals and eyes, red and swollen eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• initially flu-like symptoms, rash on the face and then spreading to other parts of the body, high temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome);
• severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• urticaria (itchy rash);
• lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion).

The use of Zebinix is associated with an abnormality on the ECG (electrocardiogram) called prolongation of the PR interval. Side effects associated with this ECG abnormality (e.g. fainting or slowed heartbeat) may occur.
There have been cases of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine.
Consult your doctor or pharmacist if you are on long-term antiepileptic therapy, if you have a history of osteoporosis, or if you are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 package after
Exp. The expiry date refers to the last day of that month.
After opening, the bottle should not be used for more than 2 months.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zebinix contains

• The active ingredient 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), sodium saccharin (E954), artificial tutti-frutti flavour (contains maltodextrin, propylene glycol, natural and artificial flavours and acacia gum (E414), masking flavour (contains propylene glycol, water and natural and artificial flavours), purified water.

Description of the appearance of Zebinix and package contents
Zebinix 50 mg/mL is an oral suspension of colour from whitish to white.
The oral suspension is packaged in amber glass bottles with child-resistant closures in
HDPE, containing 200 mL of oral suspension, inside a cardboard box. Each cardboard box contains a 10 mL polypropylene syringe, with graduations corresponding to
increments of 0.2 mL, and a quick-snap connector for the bottle.

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: [email protected]
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Luxembourg/Luxemburg
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

България
BIAL-Portela & Cª., S.A.
Teл.: + 351 22 986 61 00
(Португалия)

Magyarország
BIAL-Portela & Cª., S.A.
Tel.: + 351 22 986 61 00
(Portugália)

Česká republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Malta
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Il-Portugall)

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Nederland
BIAL-Portela & Cª., S.A.
Tél/Tel: + 351 22 986 61 00
(Portugal)

Deutschland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Österreich
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Ελλάδα
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: + 30 210 668 3000

Eesti
BIAL-Portela & Cª, S.A.
Tel: +351 22 986 61 00
(Portugal)

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
BIAL-Portela & Cª., S.A.
Tél: + 351 22 986 61 00
(Portugal)

România
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalia)

Hrvatska
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenija
BIAL-Portela & Cª, S.A.
Tel: + 351 22 986 61 00
(Portugalska)

Ireland
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

Slovenská republika
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugalsko)

Ísland
Nordicinfu Care AB
Sími: +46 (0) 8 601 24 40

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Italia
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portogallo)

Sverige
Nordicinfu Care AB
Tel: +46 (0) 8 601 24 40

Κύπρος
BIAL-Portela & Cª, S.A.
Τηλ: + 351 22 986 61 00
(Πορτογαλία)

United Kingdom
BIAL-Portela & Cª., S.A.
Tel: + 351 22 986 61 00
(Portugal)

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)
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Annex IV
Scientific conclusions and justification for the variation of the terms
of the marketing authorisation
Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee
(PRAC), the scientific conclusions of the Committee for Human Medicinal Products (CHMP) are as follows:
SIADH-like syndrome
Based on the available data on SIADH or SIADH-like syndrome – two cases were observed with a probable correlation and 13 cases with a possible causal correlation with ESL - the PRAC considers that the product information should be updated accordingly. The proposed text is in line
with the product information for other substances in the dibenzazepine family, namely
carbamazepine and oxcarbazepine.
Drug-related liver disorders
Based on the available data on drug-related liver disorders, six cases of increased gamma-glutamyltransferase with possible correlation with ESL according to RUCAM were observed.
Evidence of more severe drug-induced liver injury (DILI), namely acute hepatitis or hepatocellular injury, was not sufficient to establish a causal correlation. Only one case of more severe DILI (acute hepatitis) was observed, with positive de-challengeevidence
for ESL (possible according to RUCAM). Since an increase in transaminases can be accompanied
by an increase in GGT, it is recommended to use the more generic term "increased liver enzymes".
Use during pregnancy and in women of childbearing potential
Based on the available data on use during pregnancy and in women of childbearing potential, the PRAC
recommends updating the text in section 4.6. Currently, there is no statement regarding a recommendation or not to use ESL during pregnancy. In addition, the
information reported must be modified in line with the product information for other
antiepileptic drugs, which have recently been updated to reflect information on the risks
associated with use during pregnancy, on the need for effective contraceptive measures and on advising
women of childbearing potential and on possible interactions with hormonal contraceptives, in order to provide a
similar level of information.
The CHMP agrees with the scientific conclusions of the PRAC.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on eslicarbazepine acetate, the CHMP considers that the benefit/risk ratio of the medicinal product containing eslicarbazepine acetate is unchanged, subject to
the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.