How does it work?
Zebinix tablets contain the active ingredient eslicarbazepine, which is a medicine that is used to treat epilepsy. It works by stabilising electrical activity in the brain.
The brain and nerves are made up of many nerve cells that communicate with each other through electrical signals. These signals must be carefully regulated for the brain and nerves to function properly. When abnormally rapid and repetitive electrical signals are released in the brain, the brain becomes over-stimulated and normal function is disturbed. This results in fits or seizures.
Eslicarbazepine prevents epileptic fits by preventing the excessive electrical activity in the brain. It is thought to achieve this by preventing sodium from entering nerve cells when they begin to fire rapid and repetitive electrical signals. A build up of sodium in the nerve cells is necessary for the electrical signal to build up and be passed on to other nerve cells. As eslicarbazepine prevents this, it helps stabilise the electrical activity in the brain.
What is it used for?
Zebinix tablets are used as an add-on therapy for people who are already taking other antiepileptics to treat partial seizures, with or without secondary generalised tonic-clonic seizures.
How do I take it?
- Follow the instructions given by your doctor. The dose prescribed for you will depend on your kidney function, how well your seizures are controlled by the medicine and any other medicines you may be taking.
- Zebinix tablets are taken once a day and can be taken either with or without food.
- It is important to take your medication regularly, as directed by your doctor, because missing doses can trigger seizures in some people. If you have trouble remembering to take your medicine you should ask your pharmacist for advice. You may find a pill reminder box helpful.
- You should not suddenly stop taking this medicine unless your doctor tells you to, as suddenly stopping treatment is likely to make your seizures return or get worse. If this medicine is stopped, it should normally be done gradually, under the supervision of your specialist.
- This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activities, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
- Drinking alcohol while taking this medicine may increase the risk of drowsiness.
- This medicine decreases the effectiveness of the contraceptive pill, mini-pill, implant, patch and vaginal ring. Your doctor will probably recommend that you use a different form of contraception, such as a contraceptive injection or IUS, or non-hormonal methods such as condoms, to prevent pregnancy while taking this medicine. It is important to get advice on contraception from your doctor. See below for more information on how this medicine affects contraceptives and pregnancies.
- This medicine can sometimes cause the amount of sodium in the blood to fall (a condition called hyponatraemia). People with kidney disease and people taking other medicines that can reduce the amount of sodium in the blood (such as diuretics or desmopressin) should have regular blood tests to check the amount of sodium in their blood while taking this medicine. You should tell your doctor if you notice any unusual drowsiness, confusion or worsening of your seizures while taking this medicine, as these could be signs that your sodium level is too low.
- Medicines related to this one may rarely cause serious skin rashes, which may be life-threatening and require treatment in hospital. For this reason you should consult your doctor immediately if you develop a rash, skin peeling, itching, or other unexplained skin reaction while taking this medicine.
- There may be a small increased risk of suicidal thoughts and behaviour in people taking antiepileptic medicines such as eslicarbazepine. For this reason, it is very important to seek medical advice if you, or someone else taking this medicine, experience any changes in mood, distressing feelings, or thoughts about suicide or self-harm at any point while taking this medicine. For more information speak to your doctor or pharmacist.
Use with caution in
- Elderly people.
- People with mild to moderately decreased kidney or liver function.
- People with an abnormal heart rhythm seen as a 'prolonged PR interval' on a heart monitoring trace (ECG).
- People taking other medicines that can cause a prolonged PR interval (your doctor will know which to look out for).
- People with an underactive thyroid gland (hypothyroidism).
Not to be used in
- People who are allergic to the related antiepileptic medicines carbamazepine or oxcarbazepine.
- People with a serious defect in the heart's electrical message pathways, resulting in decreased function of the heart (2nd or 3rd degree atrioventricular block).
- Children and adolescents under 18 years old.
- This medicine is not recommended for people with severely decreased kidney or liver function, as it has not been studied in people with these problems.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- It is very important for women with epilepsy to talk to the doctor responsible for their epilepsy treatment before becoming pregnant. Antiepileptic medicines are associated with an increased risk of developmental disorders and malformations in the baby. However, stopping antiepileptic treatment during pregnancy runs the risk of the mother having seizures, which can harm both the mother and the foetus. This risk may be higher than that from continuing the medication. It is important that all the risks and benefits of treatment are weighed up. Seek medical advice from your doctor.
- Women who decide to try for a baby while taking this medicine should start taking folic acid daily as soon as contraception is stopped, as this may reduce the risk of neural tube defects such as spina bifida in the baby. Ask your doctor for advice on the dose to take - it may be recommended that you take 5mg daily.
- Women who continue to take antiepileptic medicine during a pregnancy should, wherever possible, be prescribed a single medicine in its lowest effective dose, to minimise the risk to the baby. Specialist medical advice must be sought.
- This medicine decreases the effectiveness of the contraceptive pill, mini-pill, implant, patch and vaginal ring. Your doctor will probably recommend that you use a different form of contraception, such as a contraceptive injection or IUS, to prevent pregnancy while taking this medicine. It is important to get advice on contraception from your doctor. See end of factsheet for more information on how this medicine affects contraceptives.
- It is not known if this medicine passes into breast milk. The manufacturer states that this medicine should not be used by women who are breastfeeding. Seek medical advice from your doctor. If you need treatment with this medicine your doctor may recommend that you bottlefeed rather than breastfeed your baby.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
Common (affect between 1 in 10 and 1 in 100 people)
- Blurred or double vision.
- Nausea and vomiting.
- Skin rash.
- Abnormal coordination.
- Problems concentrating.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Underactive thyroid gland (hypothyroidism).
- Disturbances of the gut such as dry mouth, indigestion or abdominal pain or bloating.
- Irritable bowel syndrome.
- Inflammation of the mouth and gums.
- Changes in appetite and body weight.
- Skin reactions such as, dryness, redness or excessive sweating.
- Hair loss.
- Low blood sodium levels (hyponatraemia).
- Swelling of the legs, ankles or face due to excess fluid retention (oedema).
- Needing to pass urine at night (nocturia).
- Changes in blood pressure.
- Changes in sense of smell, taste or hearing.
- Problems with the eyes, such as changes in the movement of the eye, red or painful eye.
- Difficulty sleeping (insomnia).
- Mood swings.
- Nervousness or agitation.
- Problems with speech.
- Memory problems.
- Pain in the muscles, back or neck.
- Tingling or numb sensations.
- Decreased heart rate (bradycardia).
- Liver disorders.
Very rare (affect less than 1 in 10,000 people)
- Inflammation of the pancreas (pancreatitis).
- Decrease in the number of platelets in the blood (thrombocytopenia).
- Low white blood cell count (leucopenia).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Eslicarbazepine increases the breakdown of the hormones found in the contraceptive pill, mini-pill, implant, patch and vaginal ring. This will make these forms of contraception less effective at preventing pregnancy. For this reason, your doctor will probably recommend that you use a different form of contraception that is not affected by eslicarbazepine to prevent pregnancy while taking this medicine. Examples include the contraceptive injection or IUS, or non-hormonal methods such as condoms. It is important to get advice on contraception from your doctor.
If you definately want to keep taking the pill for contraception, your doctor can prescribe a combination of two pills to give you a bigger dose of the hormones. (However, this is unlicensed.) If you do this, your doctor will also ask you to take the pill in a different way to normal. (For example, three packets back to back without a break, only a four day pill-free break and then three packets back to back again and so on. This is called tricycling and is also unlicensed.) The purpose of this is to reduce the number and duration of hormone free periods in which ovulation could happen and thus minimise the chances of the pill failing. If you do choose the pill as your only method of contraception, you must tell your doctor if you experience changes in your menstrual pattern (eg bleeding between periods), as this may indicate that the pill is becoming less effective at preventing pregnancy.
This medicine may reduce the anti-blood-clotting effects of the anticoagulant medicine warfarin. Your doctor may wish to monitor your blood clotting time (INR) more frequently while you are taking both medicines.
This medicine may reduce the blood level of the cholesterol-lowering medicine simvastatin. Your doctor may need to increase your simvastatin dose if you are taking both medicines and it seems the simvastatin is not working as well as it should be.
Eslicarbazepine may increase the blood levels of phenytoin in the blood, while phenytoin may decrease the effect of eslicarbazepine. If you are taking phenytoin with eslicarbazepine, your doctor may need to adjust your doses of both medicines.
Carbamazepine increases the breakdown of eslicarbazepine. If you are also taking carbamazepine your doctor may need to prescribe you a higher dose of eslicarbazepine. Taking carbamazepine in combination with eslicarbazepine may also increase the chance of specific side effects, such as double vision, poor coordination and dizziness.
The manufacturers recommend that this medicine is not used together with oxcarbazepine, which is a related antiepiletic medicine. This is because it is not known whether it is safe to take both of these medicines together.
It is recommended that people who are taking any antiepileptic medicines should avoid taking the herbal remedy St John's wort (Hypericum perforatum). This is because St John's wort may affect the level of antiepileptic medicines in the blood and could increase the risk of seizures.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain eslicarbazepine as the active ingredient.