Zebinix 800 mg tablets

Zebinix belongs to a group of medicines called anti-epileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.

Zebinix is used in adult patients who are already taking other anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

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

Do not take Zebinix if:

• you are allergic (hypersensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients
• you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block)

Take special care with Zebinix

Contact your doctor immediately if:

• you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be signs of an allergic reaction.
• you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels

Please tell your doctor if:

• you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe renal disease.
• you have liver problems. Zebinix is not recommended in patients with severe liver problems.
• you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
• you suffer from a heart disease such as heart failure or heart attack.
• you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Zebinix to avoid accidental injury (fall).

A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor immediately.

Children
Zebinix is not to be given to children and adolescents.

Taking other medicines

• Tell your doctor if you are taking phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted.
• Tell your doctor if you are taking carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness.
• Tell your doctor if you are taking simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted.
• Tell your doctor if you are taking the blood thinner - warfarin.
• Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.
• Tell your doctor if you are taking hormonal/oral contraceptives. Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
• 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.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.

Taking Zebinix with food and drink
Zebinix tablets may be taken with or without food.

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or planning to become pregnant. You must only take Zebinix during pregnancy if your doctor tells you.

Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines. On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

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

See ?Taking other medicines? section for advice about contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

Always take Zebinix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults
There are two dosing regimes for adults:

Dose when you start treatment

400 mg dose once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Maintenance dose

Theusual maintenance dose is 800 mg once daily.
Depending on how you respond to Zebinix, your dose may be increased to 1200 mg once daily.

Elderly (over 65 years of age)
If you are elderly your doctor will decide the suitable dose for you.

Patients with kidney problems
If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Patients with liver problems
The dose is the same as for adults. However, Zebinix is not recommended if you have severe liver problems. Please talk to your doctor if you are unsure about the dose you should be taking.

Method and route of administration
Swallow the tablet with a glass of water.

If you take more Zebinix than you should
If you accidently take more Zebinix than you should, tell a doctor or go to a hospital accident and emergency department immediately. Take the medicine pack with you. This is so the doctor knows what you have taken.

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

If you stop taking Zebinix

Do not stop taking your tablets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take Zebinix for. Should your doctor decide to stop your treatment with Zebinix your dose will usually be reduced gradually. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

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

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

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment :

• Rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be signs of an allergic reaction

The frequency of possible side effects listed below is defined as using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

Very common side effects are:

• Feeling dizzy or sleepy

Common side effects are:

• Feeling unsteady or having a sensation of spinning or floating
• Feeling sick or vomiting
• Headache
• Diarrhoea
• Seeing double or blurred vision
• Difficulty in concentration
• Feeling low in energy or tired
• Shaking
• Clumsiness
• Skin rash
• Numbness and tingling in hands and feet

Uncommon side effects are:

• Hypersensitivity
• Worsening of seizures
• Underactive thyroid gland.Symptoms include cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature.
• Increased levels of circulating fats in your blood
• Difficulty in sleeping
• Liver problems
• High or low blood pressure or a fall in blood pressure on standing up
• Blood tests showing that you have low levels of salts or sodium in your blood or a reduction in red blood cells
• Dehydration
• Eye movement changes, fuzzy vision, red eye or eye pain
• Having falls
• Poor memory or forgetfulness
• Crying, feeling depressed, nervous or confused, lack of interest or emotion
• Inability to speak or write or understand spoken or written language
• Agitated
• Mood changes or hallucinations
• Difficulty in speaking
• Nosebleed
• Weight loss and general ill health (Cachexia)
• Feeling numb in any part of your body
• Burning sensation
• Disturbances in the sense of smell and/or tasting
• Ear pain or ringing in the ears
• Swelling in your legs and arms
• Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth
• Blood in faeces
• Inflamed gums, mouth inflammation or toothache
• Painful swallowing
• Sweating or having dry skin
• Nail or skin changes (e.g. red skin)
• Hair loss
• Having irregular periods
• Increased urine production during night time
• Feeling generally unwell or having chills
• Increased or decreased appetite
• Weight loss or extreme weight gain
• Muscle pain
• Back pain or neck pain
• Cold limbs
• Faster, slower or irregular heart beat
• Feeling sleepy
• Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping.
• Irritable Bowel Syndrome (IBS). Symptoms include chronic abdominal cramps and diarrhoea or constipation.

Rare side effects are:

• Reduction in blood platelets which increases risk of bleeding or bruising
• Severe pain in the back and stomach
• Reduction in white blood cells which makes infections more likely

The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Zebinix after the expiry date, which is stated on the blister package, bottle and the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Zebinix contains

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

What Zebinix looks like and contents of the pack

Zebinix 800 mg tablets are white and oblong. The tablets have ?ESL 800?engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.

The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIAL - Portela & Cª, S.A., À Av. da Siderurgia Nacional
4745-457 S. Mamede do Coronado
Portugal
tel: +351 22 986 61 00
fax: +351 22 986 61 99
e-mail: info@bial.com

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

BelgiëBelgiqueBelgien Eisai Europe Ltd TélTel 32 0 2 735 45 34 LuxembourgLuxemburg Eisai Europe Ltd. TélTel 32 0 2 735 45 34 BelgiqueBelgien

Magyarország Eisai GesmbH Tel. 36 1 230 43 20 BIAL-Portela C., S.A. Te. 351 22 986 61 00

eská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 Malta BIAL-Portela C., S.A. Tel 351 22 986 61 00 Il-Portugall

Danmark Eisai AB Tlf 46 0 8 501 01 600 Sverige Nederland Eisai Europe Ltd. TélTel 32 0 2 735 45 34 BelgiëBelgique

Deutschland Eisai GmbH Tel 49 0 69 66 58 50 Norge Eisai AB Tlf 46 0 8 501 01 600 Sverige

Österreich Eisai GesmbH Tel 43 0 1 535 1980-0 Eesti BIAL-Portela C, S.A. Tel 351 22 986 61 00 Portugal

Arriani Pharmaceuticals S.A. 30 210 668 3000 Polska BIAL-Portela C, S.A. Tel. 351 22 986 61 00 Portugália

España BIAL Industrial Farmacéutica, S.A. Portugal BIAL-Portela C., S.A.

Tel 34 94 443 80 00 Tel. 351 22 986 61 00

France Eisai SAS Tél 33 1 47 67 00 05 România BIAL-Portela C, S.A. Tel 351 22 986 61 00 Portugalia

Ireland Eisai Ltd. Tel 440 208 600 1400 United Kingdom Slovenija BIAL-Portela C, S.A. Tel 351 22 986 61 00 Portugalska

Ísland Eisai AB Sími 46 0 8 501 01 600 Svíjóð Slovenská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 eská republika

Italia Eisai S.r.l. Tel 39 02 518 1401 SuomiFinland Eisai AB PuhTel 46 0 8 501 01 600 Ruotsi

Sverige Eisai AB Tel 46 0 8 501 01 600 BIAL-Portela C, S.A. 351 22 986 61 00

United Kingdom Eisai Ltd. Tel 44 0 208 600 1400 Latvija BIAL-Portela C, S.A. Tel 351 22 986 61 00 Portugle

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

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