LEVETIRACETAM 500 MG FILM-COATED TABLETS

Active substance: LEVETIRACETAM

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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
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. 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 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
TABLETS
Levetiracetam Tablets are used in adults and in children over 6 years of age.

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Do not take Levetiracetam Tablets
− If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of
Levetiracetam Tablets.
Warning and precautions
Talk to your doctor or pharmacist 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 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 Tablets have
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.
Levetiracetam 750 mgTablets contains Sunset Yellow (E110)
Sunset Yellow (E110) colouring agent may cause allergic reactions.
3. HOW TO TAKE LEVETIRACETAM TABLETS
Always take Levetiracetam Tablets exactly as your doctor has told you. You should check
with your doctor 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.
Take the number of tablets following your doctor’s instructions.
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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 Tablets, your doctor will prescribe you a lower
dose during 2 weeks before giving you the lowest general dose.
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.
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 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 oral solution is a presentation more appropriate to infants.
(*) Levetiracetam oral solution is not available in Dexcel Pharma Ltd. product line but is
available on the market from other manufacturers.
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, 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 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.

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If you stop taking Levetiracetam Tablets:
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levetiracetam Tablets can cause side effects, although not everybody gets
them.
Tell your doctor if you have any of the following and they worry you.
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.
The frequency of possible side effects listed below is defined using the following convention:
Very common:may affect more than 1 user in 10 people
Common:may affect up to 1 in 10 people
Uncommon:may affect up to 1 in 100 people
Rare:may affect up to 1 in 1000 people
Very rare:may affect up to 1 in 10,000 people
Not known:frequency cannot be estimated from the available data
Very common:
• nasopharyngitis;
• somnolence (sleepiness), headache
Common:
• 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:
• 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, 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;
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• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.
Rare:
• infection;
• decreased number of all blood cellstypes;
• 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.
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.
Do not store above 25°C.
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 contains
The active substance is called levetiracetam.
Each Levetiracetam 250 mg Tablet contains 250 mg of levetiracetam.
Each Levetiracetam 500 mg Tablet contains 500 mg of levetiracetam.
Each Levetiracetam 750 mg Tablet contains 750 mg of levetiracetam.
Each Levetiracetam 1000 mg Tablet contains 1000 mg of levetiracetam.

The other ingredients are:

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Tablet core: microcrystalline cellulose, povidone, silica colloidal anhydrous, croscarmellose
sodium and glyceryl behenate.
Film-coating: Polyvinyl alcohol partially hydrolyzed, macrogol 3350, talc, titanium dioxide
(E171) and carnauba wax.
Levetiracetam 250 mg film-coated tablets also contains: indigo carmine lake (E132).
Levetiracetam 500 mg film-coated tablets also contains: yellow iron oxide (E172).
Levetiracetam 750 mg film-coated tablets also contains: sunset yellow (E110) and red iron
oxide (E172).
What Levetiracetam Tablets looks like and contents of the pack
Levetiracetam 250 mg film-coated tablets are blue, oblong, biconvex tablets, scored on one
side.
Levetiracetam 500 mg film-coated tablets are yellow, oblong, biconvex tablets, scored on one
side.
Levetiracetam 750 mg film-coated tablets are orange, oblong, biconvex tablets, scored on one
side.
Levetiracetam 1000 mg film-coated tablets are white, oblong, biconvex tablets, scored on one
side.
The tablets can be divided into equal halves.
Levetiracetam tablets are available in packs containing 60 tablets.
Marketing Authorisation Holder and Manufacturer
Dexcel®-Pharma Ltd.
7 Sopwith way, Drayton fields, Daventry, Northamptonshire, NN11 8PB, UK.
This leaflet was last revised in December 2012.

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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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