Zebinix 800 mg comprimidos
Introduction
Package Leaflet: Information for the User
Zebinix 800 mg Tablets
eslicarbazepine acetate
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this package leaflet, as 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 harm them.
- If you experience any side effects, talk to your doctor or pharmacist. 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, used for the treatment of 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 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 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 generalized 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 origin and the Han Chinese ethnic group, the risk of severe skin reactions associated with carbamazepine or chemically related compounds may be predicted by a blood test. Your doctor will advise you on the need for this blood test before taking Zebinix.
Children
Zebinix should not be administered to children under 6 years of age.
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 for the treatment of epilepsy), as you may need to adjust the dose;
- carbamazepine (a medication used for the treatment of epilepsy), as you may need to adjust the dose, 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 you may need to adjust the dose;
- rosuvastatin, a medication used to reduce cholesterol levels;
- the anticoagulant warfarin;
- monoamine oxidase inhibitors (MAOIs);
- do not take oxcarbazepine (a medication used for the treatment of 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
If you plan 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.
There is limited data on the use of eslicarbazepine acetate in pregnant women.
Research has shown an increased risk of congenital defects and neurological development problems (brain development) in 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 dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you are a fertile woman and do not plan 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 forms of safe and effective contraception while taking Zebinix.Discuss this with your doctor, who will discuss with you the type of contraceptive most suitable for use 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 immediately after birth. Your doctor may give you and your baby a medication to prevent this.
Do not breastfeed while taking Zebinix. It is unknown whether it passes into breast milk.
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 use any tools or machinery.
3. How to take Zebinix
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
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.
The dose may be increased to 1,200 mg once a day based on how you respond to Zebinix. 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 old
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
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. Swallow the tablet with a glass of water.
Zebinix can be taken with or without food.
If you have difficulty swallowing the entire tablet, you can crush it and add it to a small amount of water or apple sauce to take it 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 are at risk of having more seizures; or you may feel that your heartbeat is irregular 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 tablet, take it as soon as you remember and continue as usual. Do not take a double dose to make up for the missed doses.
If you interrupt treatment with Zebinix
Do not suddenly stop taking the tablets. 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, you will usually be gradually reduced the dose. It is essential that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.
If you have any other questions about the use of 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 of instability, or feeling like you are spinning or floating;
- nausea or vomiting;
- headache;
- diarrhea;
- double vision or blurred vision;
- difficulty concentrating;
- feeling of fatigue 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 blood pressure decreased when standing;
- blood tests showing low levels of salts (including chloride), or a decrease 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. Symptoms include tremors, pain, and cramps;
- medication toxicity;
- anxiety.
The side effects ofunknown frequency(cannot be estimated from 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, mouth ulcers, 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 heart rate) may occur.
Bone disorders, including osteopenia and osteoporosis (bone thinning), and fractures have been reported with antiepileptic drugs structurally related 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 blister pack, bottle, and box after the letters CAD. The expiration date is the last day of the month indicated.
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 packaging 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 tablet contains 800 mg of eslicarbazepine acetate.
- The other components are povidone K29/32, croscarmellose sodium, and magnesium stearate.
Appearance of the product and contents of the pack
Zebinix 800 mg tablets are white and oblong, with a length of 19 mm. The tablets have the inscription “ESL 800” engraved on one face and are scored on the opposite side. The tablet can be divided into equal doses.
The tablets are packaged in blisters, in cardboard boxes of 20, 30, 60, or 90 tablets, or in multiple packs containing 180 (2 x 90) tablets, and in HDPE bottles with child-resistant closures, in cardboard boxes of 90 tablets.
Only some pack sizes may be marketed.
Marketing authorization holder and manufacturer responsible
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]
Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien BIAL-Portela & Cª., S.A. Tel/Tel: + 351 22 986 61 0 (Portugal) | Luxembourg/Luxemburg BIAL-Portela & Cª., S.A. Tel/Tel: + 351 22 986 61 00 (Portugal) |
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