What Zebinix 800 mg Tablets is used for and how to use it
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Zebinix 800 mg Tablets - Consumer Medicine Information

Manufacture: Eisai inc.
Country: United States
Condition: Seizures (Convulsions)
Class: Dibenzazepine anticonvulsants
Form: Tablets
Ingredients: eslicarbazepine acetate, povidone K29/32, croscarmellose sodium and magnesium stearate

Eslicarbazepine acetate

What Zebinix is and What It is Used For

Zebinix contains the active substance eslicarbazepine acetate.

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.

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 Contents of the Pack and Other Information);
  • if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and Precautions

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.

Talk to your doctor or pharmacist before taking 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.
  • if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.

Please tell your doctor:

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

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

In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children and Adolescents

Zebinix is not to be given to children and adolescents.

Other Medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.

Tell your doctor if you are taking:

  • phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
  • carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness;
  • hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective;
  • simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;
  • rosuvastatin, a medicine used to lower cholesterol level;
  • the blood thinner - warfarin;
  • tricyclic antidepressants e.g. amitriptyline;
  • Do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known whether it is safe to take these medicines together.

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

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of eslicarbazepine acetate in pregnant women. Research has shown an increased risk of birth defects in children of women taking 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.

Zebinix may make hormonal contraceptives such as the contraceptive pill less effective. Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.

Driving and Using Machines

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

How to Take Zebinix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

There are two dosing regimes for adults:

Dose when you start treatment

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

Maintenance dose

The usual maintenance dose is 800 mg once daily.

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

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.

Method and Route of Administration

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

Zebinix tablets may be taken with or without food.

The tablet can be divided into equal doses.

If You Take More Zebinix Than You Should

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

If You Forget to Take Zebinix

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

If You Stop Taking Zebinix

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

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

Possible Side Effects

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

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

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

Very Common Side Effects (Affects More Than 1 User in 10 People) Side Effects Are

  • Feeling dizzy or sleepy.

Common (May Affect Up to 1 in 10 People) Side Effects Are

  • Feeling unsteady or having a sensation of spinning or floating;
  • Feeling sick or vomiting;
  • Headache;
  • Diarrhoea;
  • Seeing double or blurred vision;
  • Difficulty in concentration;
  • Feeling low in energy or tired;
  • Shaking;
  • Skin rash;
  • Blood tests showing that you have low levels of sodium in your blood;
  • Decrease of appetite;
  • Difficulty in sleeping;
  • Difficulty in coordinating movements (ataxia).

Uncommon (May Affect Up to 1 in 100 People) Side Effects Are

  • Clumsiness;
  • Hypersensitivity;
  • Constipation;
  • Seizures;
  • Underactive thyroid gland. Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature;
  • Liver problems;
  • High blood pressure or severe increase in blood pressure;
  • Low blood pressure or a fall in blood pressure on standing up;
  • Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;
  • Dehydration;
  • Eye movement changes, fuzzy vision or red eye;
  • Having falls;
  • Thermal burn;
  • Poor memory or forgetfulness;
  • Crying, feeling depressed, nervous or confused, lack of interest or emotion;
  • Inability to speak or write or understand spoken or written language;
  • Agitation;
  • Attention deficit/ hyperactivity disorder;
  • Irritability;
  • Mood changes or hallucinations;
  • Difficulty in speaking;
  • Nosebleed;
  • Chest pain;
  • Tingling and/or feeling numb in any part of your body;
  • Migraine;
  • Burning sensation;
  • Abnormal sense of touch;
  • Disturbances in the sense of smell;
  • Ringing in the ears;
  • Hearing difficulty;
  • Swelling in your legs and arms;
  • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
  • Charcoal (dark) stool;
  • Inflamed gums or toothache;
  • Sweating or having dry skin;
  • Pruritus;
  • Skin changes (e.g. red skin);
  • Hair loss;
  • Urinary tract infection;
  • Feeling generally weak, unwell or having chills;
  • Weight loss;
  • Muscle pain, pain in limbs, muscular weakness;
  • Bone metabolism disorder;
  • Osteocalcin increased;
  • Flushing, cold limbs;
  • Slower or irregular heart beat;
  • Feeling extremely sleepy;
  • Sedation;
  • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping;
  • Drug toxicity.

Rare (May Affect Up to 1 in 1,000 People) Side Effects Are

  • Reduction in blood platelets which increases risk of bleeding or bruising;
  • Severe pain in the back and stomach (caused by inflamation of the pancreas);
  • Reduction in white blood cells which makes infections more likely.

Not Known (Frequency Cannot Be Estimated From Available Data) Side Effects Are

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): signs and symptoms may include skin rash, fever, fatigue, swelling of lymph glands, increase of eosinophils (type of white blood cells) and abnormalities in liver, kidney or lung function; DRESS may develop weeks after treatment initiation.

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

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related anti-epileptics drugs like carbamazepine and oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below).

Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Zebinix

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

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

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the Pack and Other Information

What Zebinix Contains

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

What Zebinix Looks Like and Contents of the Pack

Zebinix 800 mg tablets are white and oblong. The tablets have ‘ESL 800’engraved on one side and are scored on the other side. The tablet can be divided into equal doses.

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:

België/Belgique/Belgien
Eisai Europe Ltd
Tél/Tel: + 32 (0) 2 502 58 04

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

Česká republika
Eisai GesmbH organizační složka
Tel: +420 242 485 839

Danmark
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)

Deutschland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50

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

Ελλάδα
Arriani Pharmaceuticals S.A.
Τηλ: + 30 210 668 3000

España
BIAL Industrial Farmacéutica, S.A.
Tel: + 34 94 443 80 00

France
Eisai SAS
Tél: + (33) 1 47 67 00 05

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

Ireland
Eisai Ltd.
Tel: + 44(0) 208 600 1400
(United Kingdom)

Ísland
Eisai AB
Sími: + 46 (0) 8 501 01 600
(Svíþjóð)

Italia
Eisai S.r.l.
Tel: + 39 02 518 1401

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

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)

Luxembourg/Luxemburg
Eisai Europe Ltd.
Tél/Tel: + 32 (0) 2 502 58 04
(Belgique/Belgien

Magyarország
Eisai Ltd
Tel.: + 44 (0)845 676 1400
(Nagy-Britannia)

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

Nederland
Eisai B.V.
Tél/Tel: + 31 (0) 900 575 3340

Norge
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)

Österreich
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0

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

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

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

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

Slovenská republika
Eisai GesmbH organizační složka
Tel: + 420 242 485 839
(Česká republika)

Suomi/Finland
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi)

Sverige
Eisai AB
Tel: + 46 (0) 8 501 01 600

United Kingdom
Eisai Ltd.
Tel: + 44 (0) 208 600 1400