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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17780/1146.
Eslicarbazepine Zentiva 200mg tablets
Eslicarbazepine Zentiva 200 mg tablets
eslicarbazepine acetate
1. What Eslicarbazepine Zentiva is and what it is used for
2. What you need to know before you use Eslicarbazepine Zentiva
3. How to use Eslicarbazepine Zentiva
4. Possible side effects
5. How to store Eslicarbazepine Zentiva
6. Contents of the pack and other information
The name of your medicine is Eslicarbezapine Zentiva 200mg Tablets (called Eslicarbazepine Zentiva throughout this leaflet).
Eslicarbazepine Zentiva contains the active substance eslicarbazepine acetate. Eslicarbazepine Zentiva belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Eslicarbazepine Zentiva is used:
Eslicarbazepine Zentiva has been given to you by your doctor to reduce your number of seizures.
Talk to your doctor or pharmacist before taking Eslicarbazepine Zentiva.
Contact your doctor immediately:
Please tell your doctor:
A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, when taking Eslicarbazepine Zentiva, contact your doctor immediately.
Eslicarbazepine Zentiva may make you feel dizzy and/ or drowsy, particularly at the beginning of treatment.
Take special care when taking Eslicarbazepine Zentiva to avoid accidental injury, such as fall.
Take special care with Eslicarbazepine Zentiva:
Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with eslicarbazepine acetate.
If you develop a serious rash or another skin symptoms (see section 4), stop taking Eslicarbazepine Zentiva and contact your doctor or seek medical attention immediately.
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 Eslicarbazepine Zentiva.
Eslicarbazepine Zentiva is not to be given to children aged 6 years and below.
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 Eslicarbazepine Zentiva works or how Eslicarbazepine Zentiva interferes with their effect. Tell your doctor if you are taking:
See ‘Pregnancy and breast-feeding’ section for advice about contraception.
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 antiepileptic medicines. On the other hand effective antiepileptic 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 Eslicarbazepine Zentiva. It is not known whether it passes into breast milk.
Eslicarbazepine Zentiva 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 Eslicarbazepine Zentiva up to the end of the current menstrual cycle after stopping treatment.
Eslicarbazepine Zentiva 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 Eslicarbazepine Zentiva , your dose may be increased to 1,200 mg once daily. If you are taking Eslicarbazepine Zentiva on its own, your doctor may consider you can benefit of a dose of 1,600 mg once daily.
Patients with kidney problems
If you have kidney problems you will usually be given a lower dose of Eslicarbazepine Zentiva. Your doctor will work out the correct dose for you. Eslicarbazepine Zentiva is not recommended if you have severe kidney problems.
Elderly (over 65 years of age)
If you are elderly and taking Eslicarbazepine Zentiva on its own the dose of 1,600 mg is not a suitable dose for you
Children above 6 years of age
Dose when you start treatment
The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before increasing to the maintenance dose.
Maintenance dose
Depending on the response to Eslicarbazepine Zentiva, the dose may be increased by 10 mg per kg body weight, at intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once daily.
Children with ≥60 kg
Children with 60 kg or more body weight should take the same dose as adults.
Other form of the medicine, like oral suspension, maybe more suitable for children. Ask your doctor or pharmacist.
Method and route of administration
Eslicarbazepine Zentiva is for oral use. Swallow the tablet with a glass of water. Eslicarbazepine Zentiva tablets may be taken with or without food. The tablet can be divided into equal doses.
If you accidently take more Eslicarbazepine Zentiva than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster. Contact a doctor or go to a hospital immediately if you experience any of the above symptoms. Take the medicine pack with you. This is so the doctor knows what you have taken.
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.
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 Eslicarbazepine Zentiva. Should your doctor decide to stop your treatment with Eslicarbazepine Zentiva 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.
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 Eslicarbazepine Zentiva and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:
Very common (may affect more than 1 in 10 people) side effects are:
Common (may affect up to 1 in 10 people) side effects are:
Uncommon (may affect up to 1 in 100 people) side effects are:
Not known (frequency cannot be estimated from available data) side effects are:
The use of Eslicarbazepine Zentiva 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 antiepileptics medicines like carbamazepine and oxcarbazepine.
Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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, 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.
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
White to off-white tablets, oval and biconvex, 11.3 mm in length with I debossed on one side and a break score on both sides. The tablet can be divided into equal doses.
The tablets are packaged in transparent blisters in cardboard boxes containing 10 tablets per blister, with pack sizes of 20 and 60 tablets, or HDPE containers with child resistant closure in cardboard boxes containing 60 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in March 2022
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