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LEVETIRACETAM SYNTHON 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Levetiracetam Synthon 750 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 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.

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

Taking Levetiracetam with food and drink
You may take Levetiracetam with or without food. As a safety precaution, do
not take levetiracetam with alcohol.

1. WHAT Levetiracetam Synthon IS AND WHAT IT IS
USED FOR

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.

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
1 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.

Pregnancy and breast-feeding
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.

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 750 mg tablets contain Sunset Yellow FCF (E110)
Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

3. How to take Levetiracetam Synthon
2. What you need to know before you take
Levetiracetam Synthon
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 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 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.


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 number of tablets following your doctor’s instructions.
Monotherapy
Dose in adults and adolescents (from 16 years of age):
• General dose: between 1,000 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 3,000 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 1,000 mg and 3,000 mg each day.
Example: if your daily dose is 1,500 mg, you must take 1 tablet in the
morning and 1 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.
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):
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 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.
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
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
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.
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.
Very common side effects (may affect more than 1 in 10 people)
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 (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 decreased, 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 • 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 red blood cells and/or white blood cells
• 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
• blistering of the skin, mouth, eyes and genital area, skin eruption.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

5. HOW TO STORE Levetiracetam Synthon
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 that
month.
This medicinal product 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 contains
The active substance is levetiracetam.
Each tablet contains 750 mg of levetiracetam.
• The other ingredient(s) are:
Tablet core: colloidal anhydrous silica, hydroxypropyl cellulose, low
substituted microcrystalline cellulose, magnesium stearate
Film-coating of the 750 mg tablets: Opadry II Orange 85F23452 (polyvinyl
alcohol, macrogol (PEG 3350), talc, titanium dioxide (E171), iron oxide red
(E172), sunset yellow FCF (E110)).
What Levetiracetam looks like and contents of the pack
Levetiracetam 750 mg film-coated tablets are orange, oblong, biconvex
coated tablets, scored on both sides and debossed with L9TT and 750 on
one side.
The scoreline is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
The cardboard boxes contain 10, 20, 30, 50, 60, 100, 120 and 200
film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
Manufacturer:
Synthon Hispania, S.L., C/Castelló, 1 - Polígono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona, Spain
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road,
London, W4 5RG.
This leaflet was last revised in December 2013

P0217

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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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