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
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.
What is in this leaflet:
1. What Levetiracetam tablets are and what they are used for
2. What you need to know before you take Levetiracetam tablets
3. How to take Levetiracetam tablets
4. Possible side effects
5. How to store Levetiracetam tablets
6. Contents of the pack and other information

1. What Levetiracetam tablets are and what they are used for
Levetiracetam tablets (as they will be called in the rest of this leaflet) contain 500 mg of
Levetiracetam in a film coated tablet.
Levetiracetam tablets are used in the treatment of epilepsy. They may be used:
• on their 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 tablets
Do not take Levetiracetam
• 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 tablets
• 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 tablets
have had thoughts of harming or killing themselves. If you have any symptoms of depression
and/or suicidal thoughts, please contact your doctor.
Other medicines and Levetiracetam tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Levetiracetam tablets with food, drink and alcohol
You may take Levetiracetam tablets with or without food. As a safety precaution, do not take
Levetiracetam tablets 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 tablets 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 tablets may impair your ability to drive or operate any tools or machinery, as
Levetiracetam 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.

3. How to take Levetiracetam 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 tablets must be taken twice a day, once in the morning and once in the evening, at
about the same time each day.
The tablets can be divided into equal halves.
Take the number of tablets following your doctor’s instructions.
Monotherapy (when you will only be given Levetiracetam tablets to treat your epilepsy)
Dose in adults and adolescents (from 16 years of age):
The usual starting dose is 500 mg each day, but your doctor may increase your dose to
between 1000 mg (2 tablets) and 3000 mg (6 tablets) a day depending on how you respond to
the medicine. Other strengths of levetiracetam are available, which your pharmacist may also
give you to make sure that you receive the right dose.
For example: if you are told to take 2000 mg each day, you will need to take four 500 mg
tablets each day. So, you would take 2 tablets in the morning and 2 tablets in the evening.
Add-on therapy (when your doctor gives you Levetiracetam tablets with another
medicine to treat your epilepsy)
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
The usual dose is between 1000 mg (2 tablets) and 3000 mg (6 tablets) a day.
For example: if you are told to take 1000 mg each day, you will need to take two 500 mg tablets
each day. So, you would 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 determine the dose depending on the child’s, or adolescent’s, weight. The usual
dose is between 20 mg and 60 mg for kilogram that the patient weighs. An oral solution may be
a presentation more appropriate to infant and children under the age of 6 years. Your doctor will
prescribe the most appropriate pharmaceutical form of levetiracetam according to the patient’s
age and weight.
For example: if your child weighs 25 kg, and the doctor prescribes 40 mg for each kilogram
that the patient weighs, then the dose is 1000 mg each day. This means that one tablet should
be given in the morning and one 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 Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:
• Levetiracetam tablets are used as a chronic treatment. You should continue Levetiracetam
tablets 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 tablets treatment, he/she will instruct
you about the gradual withdrawal of Levetiracetam tablets.

If you take more Levetiracetam tablets than you should:
The possible side effects of an overdose of Levetiracetam tablets are sleepiness, agitation,
aggression, reduced alertness, breathing difficulties and coma. If you, or someone you know,
take too many tablets, go to your hospital straightaway, taking this leaflet or the tablets with you.
The doctor will establish the best possible treatment of the overdose.
If you forget to take Levetiracetam 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.
If you stop taking Levetiracetam tablets:
If stopping treatment, as with other antiepileptic medicines, Levetiracetam tablets should be
discontinued gradually under the guidance of your doctor 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 (affects more than 1 user in 10):
• nasopharyngitis
• somnolence (sleepiness), headache
Common (affects 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 (increase of pre-existing cough)
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness)
Uncommon (affects 1 to 10 users in 1,000):
• decreased number of blood platelets, decreased number of white blood cells
• weight decrease, weight increase
• suicide attempt and suicidal thoughts, 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 (affects 1 to 10 users in 10,000):
• infection
• decreased number of red blood cells, and/or white blood cell changes in your liver function
(your doctor would find these from blood tests)
• suicide, personality disorders (behavioural problems), thinking abnormally (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
Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

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 stated on the carton box and blister 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.

6. Contents of the pack and other information
What Levetiracetam tablets contain
The active substance is called levetiracetam.
Each tablet contains 500 mg of levetiracetam.
The other ingredients are:
Tablet core: Maize starch, Colloidal anhydrous silica, Magnesium stearate, Talc, Povidone K 30.
Film-coating: Opadry 85F32004: Macrogol 3350, Yellow Iron Oxide (E172), Polyvinyl alcohol,
Titanium dioxide (E171), Talc.
Levetiracetam tablets are packed in blisters in cardboard boxes.
Each blister contains 10 tablets.
What Levetiracetam tablets look like and contents of the pack
Levetiracetam 500 mg film-coated tablets are yellow, oblong, scored and marked with the code
“500” on the same side.
The tablet can be divided into equal halves.
The cardboard boxes contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10), 120
(12x10) and 200 (20x10) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Rivopharm UK Ltd,
6th floor, 28 Kingsway,
London WC2B 6JR
United Kingdom
Manufacturer:
Laboratoires BTT
ZI de Krafft,
67150 Erstein,
France
Distributed by:
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex, CM6 3LY
This leaflet was last revised in 05/2013

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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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