LEVETIRACETAM 500 MG FILM-COATED TABLETS

Active substance: LEVETIRACETAM

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Package leaflet: Information for the patient
Levetiracetam 500 mg film-coated tablets
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 doctoror 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 pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1.What Levetiracetam tablet is and what it is used for
2. What you need to know before you take Levetiracetam tablet
3. How to take Levetiracetam tablet
4. Possible side effects
5. How to store Levetiracetam tablet
6. Contents of the pack and other information

1. What Levetiracetam tablet is and what it is used for
Levetiracetam 500 mg film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam tablet 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:
o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of
age
o myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
o 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 tablet
Do not take Levetiracetam tablet
- 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 tablet
• If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be 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 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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Levetiracetam with food, drink and alcohol
You may take Levetiracetam tablets with or without food. As a safety precaution,do not take Levetiracetam with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor.
Levetiracetam should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is
unknown.
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 may impair your ability to drive or operate any tools or machinery, as Levetiracetam 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.

3. How to take Levetiracetam tablet
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 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 3,000 mg each day.
When you will first start taking Levetiracetam, 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 2 tablets in the morning and 2 tablets 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 3,000 mg each day.
Example: if your daily dose is 1,000 mg, you must take one tablet in the morning and one 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 of Levetiracetam according to the age, weight and
dose.
A levetiracetam 100 mg/ml 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.
Dose in infants (1 month to less than 6 months):
A levetiracetam 100 mg/ml oral solution is a presentation more appropriate to infants.
Method of administration:
Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).
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 treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam.
If you take more Levetiracetam 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:

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PHARMACODE AREA

Levetiracetam 500 mg
film-coated tablets

Levetiracetam 500 mg
film-coated tablets

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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 Levetiracetam:
If stopping treatment, as with other antiepileptic medicines, Levetiracetam tablet 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.
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 reaction (DRESS);
• decreased blood sodium concentration;
• severe reduction in number of white blood cells which makes infections more likely;
• 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).
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet.
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 report side effects directly via the Yellow Card Scheme at 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 tablets
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 carton box and 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 Levetiracetam tablet contains
The active substance is called levetiracetam. Each tablet contains 500 mg of levetiracetam.
The other ingredients are:
Tablet core: Croscarmellose sodium, Maize starch, Povidone K- 30, Silica colloidal anhydrous, Magnesium stearate.
Film-coating: Hypromellose 6cP (E464) Titanium dioxide (E171), Macrogol 400, Iron Oxide Yellow (E172)
What Levetiracetam tablets looks like and contents of the pack
Levetiracetam 500 mg film-coated tablets are yellow, capsule shaped, biconvex, length: 17.4 mm to 17.8 mm, width: 7.4
mm to 7.8 mm and thickness: 5.3 mm to 5.9 mm, film-coated tablets plain on both sides.
Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200
film-coated tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom

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S & D Pharma CZ, Spol. Sr. o,
Theodor 28, 27308 Pchery, (Pharmosa. S. facility),
Czech Republic
This leaflet was last revised in 12/2014

UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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