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LEVETIRACETAM ASTRON 1000MG FILM COATED TABLETS

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PATIENT INFORMATION LEAFLET
Patient information leaflet
Levetiracetam 250mg film coated tablets
Levetiracetam 500mg film coated tablets
Levetiracetam 750mg film coated tablets
Levetiracetam 1000mg 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 gets serious 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 Tablet is and what it is 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 Tablet is and what it is used for
Levetiracetam tablet 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 infantsfrom one
month of age.
• myoclonic seizures in adults and adolescentsfrom 12 years of age with juvenile myoclonic epilepsy
• primary generalised tonic-clonic seizures in adults and adolescentsfrom 12 years of age with idiopathic
generalised epilepsy

2. What you need to know before you take Levetiracetam Tablets
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 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 ideation, 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 Tablet with food, drink and alcohol
You may take Levetiracetam Tablets with or without food. As a safety precaution, do not take Levetiracetam
Tablet 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 Tablet should not be used during pregnancy unless clearly necessary. The potential risk to your
unborn child is unknown. Levetiracetam Tablet 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
Tablet 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 Levetiracetam Tablet
Levetiracetam 750 mg Tablet contains Sunset Yellow FCF (E110). Sunset Yellow FCF (E110) coloring agent
may cause allergic reactions. The other strengths of Levetiracetam tablets do not contain this ingredient.

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 Tablet 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 (4 tablets of 250 mg or 2 tablets of 500 mg or 1 tablet of 1000 mg) and 3,000
mg (12 tablets of 250 mg or 6 tablets of 500 mg or 4 tablets of 750 mg or 3 tablets of 1000 mg) each day.
When you will first start taking Levetiracetam Tablet , 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 must take 2 tablets of 250 mg in the morning and 2 tablets of 250
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 (4 tablets of 250 mg or 2 tablets of 500 mg or 1 tablet of 1000 mg) and 3,000
mg (12 tablets of 250 mg or 6 tablets of 500 mg or 4 tablets of 750 mg or 3 tablets of 1000 mg) each day.

Example: if your daily dose is 1,000 mg, you must take 2 tablets of 250 mg in the morning and 2 tablets of
250 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.
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.
Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet
of 250 mg in the morning and 1 tablet of 250 mg in the evening.
Dose in infants (1 month to less than 6 months):
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 forget to take a dose of Levetiracetam Tablet
Do not take a double dose to make up for a forgotten tablet. Contact your doctor if you have missed one or
more doses.
If you take more Levetiracetam Tablet 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 stop taking Levetiracetam Tablet
If stopping treatment, as with other antiepileptic medicines, Levetiracetam 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.

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 red blood cells and/or white blood cells;
• 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 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. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Tablet
• 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 expiry date, which is stated on carton box and blister. 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 Tablet contains:
The active ingredient is called Levetiracetam.
Each film-coated tablet contains 250 mg /500 mg/750 mg/1000 mg of Levetiracetam.
The other ingredients are:
Croscarmellose Sodium, Povidone K-30, Silica, colloidal anhydrous, Magnesium Stearate (E470b)
Film-coating contains:
250 mg:
Poly (vinyl alcohol), Titanium dioxide (E171), Macrogol 3350, Talc
500 mg:
Poly (vinyl alcohol), Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide yellow (E172)
750 mg:
Poly (vinyl alcohol), Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide red (E172), sunset yellow
FCF aluminum lake (E110)
1000 mg:
Poly (vinyl alcohol), Titanium dioxide (E171), Macrogol 3350, Talc
What Levetiracetam Tablet look like and contents of the pack
250mg:
White to off white, oval, biconvex, film coated tablet, debossed ‘L 64’ and break line on one side and plain on
the other side.
500mg:
Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65’ and break line on one side and plain on
the other side.
750mg:
Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66’ and break line on one side and plain on the
other side.
1000mg:
White to off white, oval, biconvex, film coated tablet, debossed ‘L 67’ and break line on one side and plain on
the other side.
Levetiracetam Film-Coated tablets 250mg, 500mg, 750mg and 1000mg are packed in PVC/Aluminum Blister
pack. The blisters are further pack in to carton with leaflet in pack size of 10, 20, 30, 50, 60, 100 and 200
tablets per pack.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:
Marketing authorization Holder:
Astron Research Limited, Sage house, 319 Pinner road, North Harrow HA1 4HF, Middlesex, United Kingdom
Manufacturer:
Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow HA1 4HF, Middlesex, United
Kingdom
Or
Cemelog-BRS Kft., H2040 Budaörs, Vasút u. 13., Hungary
The leaflet was last revised in 03/2014.

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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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