Levebon
PACKAGE LEAFLET: INFORMATION FOR THE USER
<Levebon>250 mg film-coated tablets.
<Levebon> 500 mg film-coated tablets.
<Levebon> 750 mg film-coated tablets.
<Levebon>1000 mg film-coated tablets.
Levetiracetam
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
What <Levebon> is and what it is used for
What you need to know before you take <Levebon>
How to take <Levebon>
Possible side effects
How to store <Levebon>
Contents of the pack and other information
1. What <Levebon>is and what it is used for
<Levebon>film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
<Levebon>is used:
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on its own in patients from 16 years of age with newly diagnised epilepsy, to treat partial onset seizures with or without secondary generalisation.
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as an add-on to other antiepileptic medicines to treat:
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partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age
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myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy.
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primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy
2. What you need to know before you take <Levebon>
Do not take <Levebon>
if you are allergic to levetiracetam or any of the other ingredients of this medicine (listed in Section 6).
Warnings and Precautions
Talk to your doctor before taking <Levebon><Levebon>
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If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.
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If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
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If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.
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A small number of people being treated with anti-epileptics such as <Levebon> have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Other medicines and <Levebon>
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
<Levebon>with food, drink and alcohol
You may take <Levebon>with or without food. As a safety precaution, do not take <Levebon>with alcohol.
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.
<Levebon>should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. <Levebon>has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.
Breast-feeding is not recommended during treatment.
Driving and using machines
<Levebon>may impair your ability to drive or operate any tools or machinery, as <Levebon>may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Important information about some of the ingredients of <Levebon>750 mg film-coated tablets:
<Levebon>750 mg film-coated tablets contain Sunset Yellow FCF (E110). Sunset Yellow FCF (E110) is a coloring agent which may cause allergic reactions.
3. How to take <Levebon>
Always take this medicineexactly as your doctor has told you. Check with your doctor if you are not sure.
<Levebon>must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Take the number of tablets following your doctor’s instructions.
Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3000 mg each day.
When you will first start taking <Levebon>, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Example: if your daily dose is 2000 mg, you must take one 1000 mg tablet in the morning and one 1000 mg tablet in the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 1000 mg and 3000 mg each day.
Example: if your daily dose is 2000 mg, you must take one 1000 mg tablet in the morning and one 1000 mg tablet in the evening.
Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form according to age, weight and dose.
An oral solution is a presentation more appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child one 250 mg tablet in the morning and one 250 mg tablet in the evening
Dose in infants (1 month to less than 6 months):
An oral solution is a presentation more appropriate to infants.
Method of administration:
Swallow <Levebon>tablets with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:
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<Levebon> is used as a chronic treatment. You should continue <Levebon> treatment for as long as your doctor has told you.
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Do not stop your treatment without your doctor’s advice as this could increase your seizures. Should your doctor decide to stop your <Levebon> treatment, he/she will instruct you about the gradual withdrawal of <Levebon>.
If you take more <Levebon>than you should:
The possible side effects of an overdose of <Levebon>are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more tablets than you should.
Your doctor will establish the best possible treatment of overdose.
If you forget to take <Levebon>:
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking <Levebon>:
If stopping treatment, as with other antiepileptic medicines, <Levebon>should be discontinued gradually to avoid an increase of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicinecan cause side effects, although not everybody gets them.
Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.
Very common:may affect more than 1 user in 10
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nasopharyngitis;
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somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100
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anorexia (loss of appetite);
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depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
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convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling);
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vertigo (sensation of rotation);
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cough;
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abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
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rash;
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asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000
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decreased number of blood platelets, decreased number of white blood cells;
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weight decrease, weight increase;
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suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
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amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
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diplopia (double vision), vision blurred;
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liver function test abnormal;
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hair loss, eczema, pruritus;
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muscle weakness, myalgia (muscle pain);
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injury.
Rare: may affect 1 to 10 users in 10,000
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infection;
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decreased number of all blood cell types;
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severe hypersensitivity reactions (DRESS);
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decreased blood sodium concentration;
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suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
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uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesias (hyperactivity);
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pancreatitis;
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hepatic failure, hepatitis;
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skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via <the national reporting system listed in Appendix V*>. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store <Levebon>
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton box and bottle/blister after EXP:. The expiry date refers to the last day of the 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.
6. Contents of the pack and other information
What <Levebon>contains
The active substance is called levetiracetam.
250 mg
Each tablet contains 250 mg levetiracetam.
The other ingredients are:
Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.
Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Indigo Carmine Aluminium Lake (E132)
500 mg
Each tablet contains 500 mg levetiracetam.
The other ingredients are:
Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.
Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Iron Oxide Yellow (E172)
750 mg
Each tablet contains 750 mg levetiracetam.
The other ingredients are:
Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.
Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Sunset Yellow FCF Aluminium Lake (E110), Iron Oxide Red (E172)
1000 mg
Each tablet contains 1000 mg levetiracetam.
The other ingredients are:
Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.
Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b),
What <Levebon>looks like and contents of the pack
250 mg: The film-coated tablets are blue coloured, capsule shaped tablets with deep notch on one side. The tablets can be divided into equal doses.
500 mg: The film-coated tablets are yellow coloured, capsule shaped tablets with deep notch on one side. The tablets can be divided into equal doses.
750 mg: The film-coated tablets are orange coloured, capsule shaped tablets with deep notch on one side. The tablets can be divided into equal doses.
1000 mg: The film-coated tablets are white coloured, capsule shaped tablets with deep notch on one side. The tablets can be divided into equal doses.
<Levebon>film-coated tablets are supplied in blister packs and bottles.
Blister packs contain 10, 20, 30, 50, 60, 90, 100, 120 and 200 film-coated tablets.
Bottles contain 10, 20, 30, 50, 60, 90, 100, 120 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
[To be completed nationally.]
Manufacturer
[To be completed nationally.]
This medicinal product is authorised in the Member States of the EEA under the following names:
[To be completed nationally]
This leaflet was last revised in 2014-06-03