Zebinix 50 mg/ml suspension oral
Introduction
Leaflet: information for the user
Zebinix 50 mg/ml oral suspension
eslicarbazepine acetate
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What is Zebinix and what is it used for
Zebinix contains the active ingredient eslicarbazepine acetate.
Zebinix belongs to a group of medications called antiepileptics, used to treat epilepsy, a disease where the affected person has seizures or repeated convulsive crises.
Zebinix is used:
- as a single medication (monotherapy) in adult patients with newly diagnosed epilepsy;
- in combination with other antiepileptic medications (adjunctive therapy) in adult, adolescent, and children over 6 years old who suffer from seizures (convulsions) affecting a part of the brain (partial seizures). These seizures may be followed or not by a seizure affecting the entire brain (secondary generalization).
Your doctor has prescribed Zebinix to reduce the number of seizures.
2. What you need to know before starting Zebinix
- if you are allergic to eslicarbazepine acetate, other carboxamide derivatives (such as carbamazepine or oxcarbazepine, medications used to treat epilepsy), or any of the other components of this medication (listed in section 6);
- if you have a certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Zebinix.
Inform your doctor immediately:
- if you experience blisters or peeling of the skin and/or mucous membranes, 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 decreased consciousness, which may be signs of low blood levels of salts.
Inform your doctor:
- if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended for patients with severe kidney disease;
- if you have liver problems. Zebinix is not recommended for patients with severe liver disease;
- if you are taking any medication that may cause an abnormality in the ECG (electrocardiogram) called prolonged PR interval. If you are unsure whether the medications you are taking may cause this effect, discuss it with your doctor;
- if you have any heart disease, such as heart failure or myocardial infarction, or any alteration of heart rhythm;
- if you have seizures that begin with a widespread electrical discharge affecting both sides of the brain.
A small number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If this occurs while taking Zebinix, contact your doctor immediately.
Zebinix may cause dizziness and/or disorientation, particularly at the start of treatment. Be extra careful while taking Zebinix to avoid accidental injuries, such as falls.
Be extra careful with Zebinix
In the post-marketing experience, severe skin reactions and potentially life-threatening reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, 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 Thai and Chinese Han ethnic origin, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by blood analysis. Your doctor will advise on the need for this blood test before taking Zebinix.
Children
Zebinix should not be administered to children under 6 years old.
Taking Zebinix with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is to ensure that none of them interfere with the way Zebinix works, or that Zebinix interferes with the effect of such medications. Inform your doctor if you are taking:
- phenytoin (a medication used to treat epilepsy), as the dose may need to be adjusted;
- carbamazepine (a medication used to treat epilepsy), as the dose may need to be adjusted, and the following Zebinix side effects may occur more frequently: double vision, abnormal coordination, and dizziness;
- hormonal contraceptives (such as the birth control pill) as Zebinix may reduce their effectiveness;
- simvastatin (a medication used to reduce cholesterol levels), as the dose may need to be adjusted;
- rosuvastatin, a medication used to reduce cholesterol levels;
- the anticoagulant warfarin;
- monoamine oxidase inhibitors (MAOIs) antidepressants;
- do not take oxcarbazepine (a medication used to treat epilepsy) with Zebinix, as it is unknown whether it is safe to take these two medications together.
See the section “Pregnancy and breastfeeding” for recommendations on contraception.
Pregnancy and breastfeeding
Zebinix is not recommended for use during pregnancy, as the effects of Zebinix on pregnancy and the fetus are unknown.
If you intend to become pregnant, discuss this with your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.
Headline data are limited on the use of eslicarbazepine acetate in pregnant women.
Research has shown an increased risk of congenital defectsand neurological development problems (brain development)in the children of women taking antiepileptic medications, particularly when taking more than one antiepileptic medication at a time.
If you are or think you may be pregnant, inform your doctor immediately. Do not stop taking your medication until you have discussed this with your doctor. Stopping your medication without consulting your doctor may cause seizures, which can be hazardous to you and your unborn child. Your doctor may decide to change your treatment.
If you are a fertile woman and are not planning to become pregnant, use an effective contraceptive method during treatment with Zebinix. Zebinix may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective in preventing pregnancy. Therefore, it is recommended to use other safe and effective contraceptive methods while taking Zebinix. Discuss this with your doctor, who will advise on the most suitable contraceptive method for you while taking Zebinix. If you stop taking Zebinix, continue using an effective contraceptive method until the end of the current menstrual cycle. If you take Zebinix during pregnancy, your baby may also be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medication to prevent this.
Do not breastfeed while taking Zebinix. The effects of Zebinix on breast milk are unknown.
Driving and operating machinery
Zebinix may cause dizziness, disorientation, and affect your vision, particularly at the start of treatment. If this occurs, do not drive or operate any tools or machinery.
Zebinix contains parahydroxybenzoic acid methyl ester (E218) and sulfites
Zebinix oral suspension contains parahydroxybenzoic acid methyl ester (E218), which may cause delayed allergic reactions, and sulfites, which may cause rare but severe allergic reactions and bronchospasm (sudden feeling of choking).
3. How to take Zebinix
Adults
Initial treatment dose
400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide if you should take this dose for one or two weeks.
Maintenance dose
The usual maintenance dose is 800 mg once a day.
In accordance with how you respond to Zebinix, the dose may be increased to 1,200 mg once a day. If you are taking Zebinix alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once a day.
Patients with kidney problems
If you have kidney problems, you will usually be given a lower dose of Zebinix. Your doctor will determine the correct dose for you. Zebinix is not recommended if you have severe kidney problems.
Older adults (65 years and older)
If you are an older adult and taking Zebinix as monotherapy, the 1,600 mg dose is not suitable for you.
Children over 6 years of age
Initial treatment dose
The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing to the maintenance dose.
Maintenance dose
Depending 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 ≥ 60 kg
Children with a body weight of 60 kg or more should take the same dose as adults.
The oral suspension, another pharmaceutical form of the medication, may be more suitable for administration in children. Consult your doctor or pharmacist.
Form and route of administration
Zebinix is administered orally.
Zebinix oral suspension can be taken with or without food.
Shake well before use.
Always use the oral syringe provided to take your medication.
Instructions for use:
Step 1. Remove from the carton box, the bottle, the oral syringe, and the bottle adapter.
Step 2. Shake the bottle for at least 10 seconds and remove the child-resistant safety cap by pressing it down and turning it counterclockwise (to the left).
Step 3. Insert the adapter into the open bottle neck. You may need to apply some pressure to insert it securely. Once inserted, the adapter should not be removed from the bottle. The bottle can be closed with the cap still in place.
Step 4. To facilitate the process, mark the desired volume on the syringe by moving the plunger. Insert the tip of the oral syringe into the bottle adapter, keeping the bottle upright. Push the plunger all the way down. This will create pressure inside the bottle that will help to dispense the suspension into the syringe.
Step 5: Hold the syringe in place and turn the bottle upside down.
Draw the desired volume from the syringe by pulling the plunger down slowly.
Step 6: If you see any air bubbles in the syringe, push the plunger up enough to expel the large air bubbles. Draw the desired volume from the syringe by pulling the plunger down slowly.
Step 7. Turn the bottle upright and remove the syringe from the bottle. Be careful not to push the plunger down while removing the syringe from the bottle.
Step 8. Replace the bottle cap by turning it clockwise (to the right).
Step 9. Place the syringe in your mouth against the inner cheek. Press the plunger down slowly to release the Zebinix into your mouth.
Step 10: Rinse the syringe after each use in a clean glass of water. Repeat this cleaning process three times.
Store, in the carton box, the bottle and oral syringe together, until the next use.
If you take more Zebinix than you should
If you accidentally take more Zebinix than you should, you are at potential risk of having more seizures; or you may feel that your heart is beating irregularly or faster. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Bring the medication packaging with you, so the doctor knows what you have taken.
If you forget to take Zebinix
If you forget to take a dose, take it as soon as you remember and continue as usual. Do not take a double dose to compensate for the missed doses.
If you interrupt treatment with Zebinix
Do not suddenly stop taking the oral suspension. If you do, you are at risk of having more seizures. Your doctor will decide for how long you should take Zebinix. If your doctor decides to stop your treatment with Zebinix, they will usually reduce your dose gradually. It is essential that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.
If you have any other doubts about using this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
The following side effects can be very serious. If they occur, stop taking Zebinix and inform your doctor or go to the hospital immediately, as you may need urgent medical treatment:
- blistering or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat, or tongue. These could be signs of an allergic reaction.
The side effectsvery common(can affect more than 1 in 10 people) are:
- dizziness or somnolence.
The side effectscommon(can affect up to 1 in 10 people) are:
- feeling unsteady, or feeling like you are spinning or floating;
- nausea or vomiting;
- headache;
- diarrhea;
- double vision or blurred vision;
- difficulty concentrating;
- feeling tired or decreased energy;
- tremor;
- skin rash;
- blood tests showing low sodium levels;
- decreased appetite;
- difficulty sleeping;
- difficulty with coordination of movements (ataxia);
- weight gain.
The side effectsuncommon(can affect up to 1 in 100 people) are:
- clumsiness of movements;
- allergy;
- constipation;
- seizures;
- underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, increased size of the tongue, nails, or hair, and low body temperature;
- liver problems(such as increased liver enzymes);
- high blood pressure or intense increase in blood pressure;
- low blood pressure, or decreased blood pressure when standing up;
- blood tests showing low levels of salts (including chloride), or a reduction in the number of red blood cells;
- dehydration;
- changes in eye movements, blurred vision, or red eyes;
- experiencing falls;
- burns;
- extreme drowsiness;
- sedation;
- neurological motor disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Among the symptoms are tremors, pain, and cramps;
- medication toxicity;
- anxiety.
The side effects ofunknown frequency(cannot be estimated from the available data) are:
- reduction of platelets that increases the risk of bleeding or hematomas;
- intense pain in the back or stomach (caused by inflammation of the pancreas);
- reduction of white blood cells that makes infections more likely;
- red or circular patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes that may be preceded by fever and/or symptoms similar to the flu (Stevens-Johnson syndrome/toxic epidermal necrolysis);
- initially symptoms similar to the flu, rash on the face, generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other body conditions (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
- severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles, or lower legs;
- urticaria (skin rash with itching);
- lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)).
The use of Zebinix is associated with an ECG anomaly called an increase in the PR interval. Side effects associated with this ECG anomaly (such as fainting and slowing of the heart rate) may occur.
Bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures, have been reported with antiepileptic drugs related in structure to carbamazepine and oxcarbazepine. Talk to your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or take steroids.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Zebinix
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the bottle and on the box after the letters CAD. The expiration date is the last day of the month indicated.
Once you have opened the bottle, do not use it for more than 2 months.
No special storage conditions are required.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
- The active ingredient is eslicarbazepine acetate. Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
- The other components are xanthan gum (E415), macrogol stearate 100, methyl parahydroxybenzoate (E218), sodium saccharin (E954), artificial Tutti-Frutti flavor (contains maltodextrin, propylene glycol, natural and artificial flavor, and gum arabic (E414)), flavor masking (contains propylene glycol, water, and natural and artificial flavor), and purified water.
Appearance of the product and contents of the package
Zebinix 50 mg/ml is a white to off-white suspension.
The oral suspension is packaged in amber-colored glass bottles with HDPE safety closures, which contain 200 ml of oral suspension, packaged in cardboard boxes. Each cardboard box contains a graduated polypropylene syringe, 10 ml, with graduations of 0.2 ml, and a copolymer adapter for the bottle.
Holder of the marketing authorization and responsible for manufacturing
BIAL - Portela & Cª , S.A.,
À Av. da Siderurgia Nacional,
4745-457 S. Mamede do Coronado
Portugal
telephone: +351 22 986 61 00
fax: +351 22 986 61 99
email: [email protected]
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien BIAL-Portela & Cª., S.A. Tel: + 351 22 986 61 0 (Portugal) | Luxembourg/Luxemburg BIAL-Portela & Cª., S.A. Tel: +351 22 986 61 00 (Portugal) |
Unknown BIAL-Portela & Cª., S.A. Tel: + 351 22 986 61 00 (Unknown) | Magyarország BIAL-Portela & Cª., S.A. Tel: + 351 22 986 61 0 (Portugália) |
Ceská 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. 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 |
Eesti BIAL-Portela & Cª, S.A. Tel: +351 22 986 61 00 (Portugal) | Österreich BIAL-Portela & Cª., S.A. Tel: + 351 22 986 61 00 (Portugal) |
Ελλάδα ΑΡΡΙΑΝΙΦΑΡΜΑΚΕΥΤΙΚΗΑ.E. Tel: + 30 210 668 3000 | Polska BIAL-Portela & Cª, S.A. Tel.: + 351 22 986 61 00 (Portugália) |
España Laboratorios BIAL, S.A. Tel: + 34 91562 41 96 | Portugal BIAL-Portela & Cª., S.A. Tel.: + 351 22 986 61 00 |
France BIAL-Portela & Cª., S.A. Tel: + 351 22 986 61 00 (Portugal) | România BIAL-Portela & Cª, S.A. Tel: + 351 22 986 61 00 (Portugalia) |
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. Tel: + 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 (Portugale) | |
Lietuva BIAL-Portela & Cª, S.A. Tel: + 351 22 986 61 00 (Portugalija) |
Last review date of this leaflet: <{MM YYYY}>
Thedetailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.
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