LEVETIRACETAM SYNTHON 100 MG/ML ORAL SOLUTION
Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM
Levetiracetam Synthon 100 mg/ml oral solution
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 symptoms 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.
In this leaflet:
1. What Levetiracetam Synthon 100 mg/ml is and what it is
2. What you need to know before you take Levetiracetam
Synthon 100 mg/ml
3. How to take Levetiracetam Synthon 100 mg/ml
4. Possible side effects
5. How to store Levetiracetam Synthon 100 mg/ml
6. Contents of the pack and other information
1. WHAT Levetiracetam Synthon
100 mg/ml IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
Levetiracetam is used:
• on its own in patients 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
patients from one month of age
– myoclonic seizures in patients from 12 years of age with
juvenile myoclonic epilepsy
– primary generalised tonic-clonic seizures in patients from
12 years of age with idiopathic generalised epilepsy.
2. What you need to know before you
take Levetiracetam Synthon
Do not take Levetiracetam 100 mg/ml:
• If you are allergic (hypersenstive) to levetiracetam or
any of the other ingredients of this medicine (listed in
Warnings and precautions
Talk to your doctor or pharmacist before taking Levetiracetam
• If you suffer from kidney problems, follow your doctor’s
instructions. He/she may decide if your dose should be
• If you notice any slow down in the growth or unexpected
puberty development of your child, please contact your
• 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
Other medicines and Levetiracetam 100 mg/ml
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
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.
Levetiracetam 100 mg/ml contains methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and maltitol
Levetiracetam oral solution includes methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).
This medicine also contains maltitol, a type of sugar. If you
have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
3. How to take Levetiracetam Synthon
Always take this medicine exactly as your doctor has told you.
Check with your doctor 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 oral solution following your doctor’s instructions.
Dose in adults and adolescents (from 16 years of age):
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per 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.
Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
Dose in infants (6 to 23 months), children (2 to 11 years)
and adolescents (12 to 17 years) weighing less than
Your doctor will prescribe the most appropriate pharmaceutical
form of levetiracetam according to the age, weight and dose.
General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per
kg bodyweight each day, divided in 2 intakes per day. The exact
quantity of oral solution formulation should be delivered using
the syringe or pipette provided in the cardboard box.
0.1 ml/kg twice daily
0.3 ml/kg twice daily
Levetiracetam 100 mg/ml with food, drink and alcohol
You may take levetiracetam with or without food. As a safety
precaution, do not take levetiracetam with alcohol.
0.6 ml twice daily
1.8 ml twice daily
0.8 ml twice daily
2.4 ml twice daily
1 ml twice daily
3 ml twice daily
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine.
1.5 ml twice daily
4.5 ml twice daily
2 ml twice daily
6 ml twice daily
2.5 ml twice daily
7.5 ml twice daily
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.
From 50 kg 5 ml twice daily
15 ml twice daily
Dose in infants (1 month to less than 6 months):
General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg)
per kg bodyweight each day, divided in 2 intakes per day. The
exact quantity of oral solution formulation should be delivered
using the syringe provided in the cardboard box.
0.07 ml/kg twice daily
0.21 ml/kg twice daily
0.3 ml twice daily
0.85 ml twice daily
0.35 ml twice daily
1.05 ml twice daily
0.45 ml twice daily
1.25 ml twice daily
0.5 ml twice daily
1.5 ml twice daily
Method of administration:
Levetiracetam oral solution may be diluted in a glass of water
or baby’s bottle.
Instruction for use of the 300 ml bottle:
• Open the bottle: press the cap and turn it anticlockwise
• Separate the adaptor from the pipette (figure 2)
• Insert the pipette adaptor into the bottle neck (figure 3).
Ensure it is well fixed.
• Put the pipette in the bottle though the adaptor opening
• Fill the pipette with solution by pulling the piston up
• Pull the piston up to the graduation mark corresponding to
the quantity in milliliters (ml) prescribed by your doctor (figure
6). Remove the pipette from the adaptor.
• Empty the contents of the pipette into a glass of water or
baby’s bottle by pushing the piston to the bottom (figure 7).
• Drink the whole contents of the glass/ baby’s bottle.
• Close the bottle with the plastic screw cap. Wash the pipette
with water only (figure 8).
(sensation of rotation) • cough (increase of pre-existing cough)
• abdominal pain, nausea, dyspepsia (indigestion), diarrhoea,
vomiting • rash • asthenia/fatigue (tiredness).
Uncommon side effects (may affect up to 1 in 100 people)
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, 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 side effects (may affect up to 1 in 1,000 people)
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via You can also report
side effects directly via 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 Synthon
Duration of the 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.
Keep this medicine out of the sight and reach of children.
If you take more Levetiracetam 100 mg/ml than you
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 levetiracetam than you
should.Your doctor will establish the best possible treatment
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
If you forget to take Levetiracetam 100 mg/ml
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Levetiracetam 100 mg/ml
If stopping treatment, as with other antiepileptic medicines,
levetiracetam should be discontinued gradually to avoid an
increase of seizures.
If you have any further questions on the use of this medicinal
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor if you have any of the following and they
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 side effects (may affect more than 1 in
Nasopharyngitis • somnolence (sleepiness) • headache.
Common side effects (may affect up to 1 in 10 people)
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
Do not use this medicine after the expiry date which is stated
on the carton box and bottle after ‘EXP’. The expiry date refers
to the last day of that month.
This medicine does not require any special storage conditions.
Do not use after 4 months of first opening the bottle.
6. Contents of the pack and other
What Levetiracetam 100 mg/ml contains
• The active substance(s) is levetiracetam. Each ml contains
100 mg of levetiracetam.
• The other ingredient(s) are: sodium citrate, citric acid
monohydrate, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ammonium glycyrrhizate,
glycerol (E422), maltitol liquid (E965), acesulfame potassium
(E950), grape flavour, purified water.
Levetiracetam is packed in a 300 ml glass bottle in a cardboard
box. Each ml contains 100 mg of levetiracetam.
What Levetiracetam 100 mg/ml looks like and contents
of the pack
Levetiracetam 100 mg/ml oral solution is a clear liquid supplied
in a glass bottle packed in a cardboard box together with an
oral syringe or dosing pipette and adaptor:
300 ml supplied with a 10 ml dosing pipette for children aged
4 years and above, adolescents and adults (graduated every
Marketing Authorisation Holder:
Synthon BV, Microweg 22, 6545 CM Nijmegen,
Synthon Hispania, S.L., C/Castelló, 1 - Polígono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona, Spain
Consilient Health (UK) Ltd., 500 Chiswick High Road,
London, W4 5RG.
This leaflet was last revised in March 2014
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.