Levetiracetam Jubilant 500 Mg Film-Coated Tablets
Package leaflet: information for the user
Levetiracetam 250 mg film-coated tablets Levetiracetam 500 mg film-coated tablets Levetiracetam 750 mg film-coated tablets Levetiracetam 1000 mg film-coated tablets
Jubilant
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
1. What Levetiracetam film-coated tablets are and what they are used for
2. What you need to know before you take Levetiracetam film-coated tablets
3. How to take Levetiracetam film-coated tablets
4. Possible side effects
5. How to store Levetiracetam film-coated tablets
6. Contents of the pack and other information
1. What Levetiracetam film-coated tablets are and what they are used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam is used:
• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation.
• as an add-on to other antiepileptic medicines to treat:
■ partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age
■ myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
■ 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 Levetiracetam film-coated tablets Do not take Levetiracetam film-coated tablets
• If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam film-coated tablets.
• If you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose shouldbe adjusted.
• If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.
• A small number of people being treated with anti-epileptics such as Levetiracetam film-coated tablets 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 Levetiracetam film-coated tablets
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Levetiracetam film-coated tablets with food, drink and alcohol
You may take Levetiracetam film-coated tablets with or without food. As a safety precaution, do not take Levetiracetam film-coated tablets with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, please inform your doctor.
Levetiracetam film-coated tablets should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam 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
Levetiracetam film-coated tablets may impair your ability to drive or operate any tools or machinery, as Levetiracetam film-coated tablets 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.
Levetiracetam 750 mg film-coated tablets contain sunset yellow FCF aluminium lake (E110).
Sunset yellow FCF aluminium lake (E110) colouring agent may cause allergic reactions.
3. How to take Levetiracetam film-coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam film-coated tablets 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 1,000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam film-coated tablets, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose. Example: if your daily dose is 1000 mg, you might take 2 tablets of250 mg in the morning and 2 tablets of250 mg in the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more
General dose: between 1,000 mg and 3,000 mg each day.
Example: if your daily dose is 1,000 mg, you might take 2 tablets of250 mg in the morning and 2 tablets of250 mg 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 of levetiracetam according to the 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: for a general dose of20 mg per kg bodyweight each day, you might give your 25 kg child 1 tablet of250 mg in the morning and 1 tablet of250 mg in the evening.
The dose should be administered with an oral solution formulation for children under 25 kg.
Dose in infants (1 month to less than 6 months)
An oral solution is a presentation more appropriate to infants.
Method ofadministration
Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Duration of treatment
• Levetiracetam is used as a chronic treatment. You should continue Levetiracetam treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor's advice as this could increase your seizures.
Should your doctor decide to stop your Levetiracetam film-coated tablets treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam film-coated tablets.
Ifyou take more Levetiracetam film-coated tablets than you should
The possible side effects of an overdose of levetiracetam 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 Levetiracetam film-coated tablets
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten tablet.
Ifyou stop taking Levetiracetam film-coated tablets
If stopping treatment, as with other antiepileptic medicines, Levetiracetam film-coated tablets should be discontinued gradually to avoid an increase of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can 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
• nasopharyngitis;
• somnolence (sleepiness), headache.
Cyprus
Denmark
Sweden
The Netherlands United Kingdom
Common: may affect 1 to 10 users in 100
• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000
• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal
coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), vision blurred;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.
Rare: may affect 1 to 10 users in 10,000
• infection;
• decreased number of all blood cell types;
• severe hypersensitivity reactions (DRESS);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• hepatic failure, hepatitis;
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Levetiracetam film-coated tablets
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP:”. The expiry date refers to the last day of that month.
• 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 Levetiracetam contains
• Levetiracetam 250 mg film-coated tablets
o The active substance is levetiracetam. Each tablet contains 250 mg. o The other ingredients are: Povidone, Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Polyvinyl alcohol partially hydrolized, Titanium dioxide, Macrogol 3350, Talc, Indigo carmine aluminium lake.
• Levetiracetam 500 mg film-coated tablets
o The active substance is levetiracetam. Each tablet contains 500 mg. o The other ingredients are: Povidone, Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Polyvinyl alcohol partially hydrolyzed, Titanium dioxide, Macrogol 3350, Talc, Iron oxide yellow.
• Levetiracetam 750 mg film-coated tablets
o The active substance is levetiracetam. Each tablet contains 750 mg. o The other ingredients are: Povidone, Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Polyvinyl alcohol partially hydrolyzed, Titanium dioxide, Macrogol 3350, Talc, Sunset yellow FCF aluminium lake (E110), Iron oxide red.
• Levetiracetam 1000 mg film-coated tablets
o The active ingredient is levetiracetam. Each tablet contains 1000 mg. o The other ingredients are: Povidone, Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Polyvinyl alcohol partially hydrolyzed, Titanium dioxide, Macrogol 3350, Talc.
What Levetiracetam looks like and contents of the pack
Levetiracetam 250 mg film-coated tablets
Levetiracetam 250 mg film-coated tablets are blue coloured, oblong shaped, film-coated tablets, with a scoreline on one side and, debossed with “250” on the other side ofthe tablet.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets are available in blister packs of 20, 30, 50, 60, 100 and 200 film-coated tablets.
Levetiracetam 500 mg film-coated tablets
Levetiracetam 500 mg film-coated tablets are yellow coloured, oblong shaped, film-coated tablets, with a scoreline on one side and, debossed with “500” on the other side ofthe tablet.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets are available in blister packs of 10,20,30,50,60,100,120 and 200 tablets. Levetiracetam 750 mg film-coated tablets
Levetiracetam 750 mg film-coated tablets are orange coloured, oblong shaped, film-coated tablets, with a scoreline on one side and, debossed with “750” on the other side ofthe tablet.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets are available in blister packs of20,30,50,60,80,100 and 200 tablets. Levetiracetam 1000 mg film-coated tablets
Levetiracetam 1000 mg film-coated tablets are white coloured, oblong shaped, film-coated tablets, with a scoreline on one side and, debossed with “1000” on the other side of the tablet.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets are available in blister packs of 10,20,30,50,60,100 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
Manufacturer
PSI supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
Levetiracetam Jubilant film-coated tablets Levetiracetam Jubilant filmovertrukne tabletter Levetiracetam Jubilant filmdragerade tabletter Levetiracetam Jubilant filmomhulde tabletten Levetiracetam Jubilant film-coated tablets