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LEVETIRACETAM BEACON 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Package Leaflet: Information for the patient
Levetiracetam 100 mg/ml oral solution
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. See section 4.
What is in this leaflet:
1. What Levetiracetam is and what it is used for
2. What you need to know before you take
Levetiracetam
3. How to take Levetiracetam
4. Possible side effects
5. How to store Levetiracetam
6. Contents of the pack and other information
1.

What Levetiracetam is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine
used to treat seizures in epilepsy).

Levetiracetam oral solution also contains maltitol liquid
(E965). If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3.

How to take Levetiracetam

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 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.
Monotherapy
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.
Add-on therapy

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 treatment 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 adolesecents
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

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.

2.

Weight

Starting dose: 0.1
ml/kg twice daily

6 kg
8 kg
10 kg
15 kg
20 kg
25 kg
From 50 kg

0.6 ml twice daily
0.8 ml twice daily
1 ml twice daily
1.5 ml twice daily
2 ml twice daily
2.5 ml twice daily
5 ml twice daily

What you need to know before you take
Levetiracetam

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
• 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 antiepileptics 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, including
medicines obtained without a prescription.
Taking Levetiracetam with food, drink and alcohol
You may take Levetiracetam with or without food. As a
safety precaution, do not take Levetiracetam 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 should not be used during pregnancy
unless clearly necessary. A risk of birth defects for your
unborn child cannot be completely excluded.
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 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 contains methyl
parahydroxybenzoate and maltitol
Levetiracetam oral solution includes methyl
parahydroxybenzoate (E218) which may cause allergic
reactions (possibly delayed).

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.
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 provided in the
cardboard box.
Maximum dose:
0.3 ml/kg twice
daily
1.8 ml twice daily
2.4 ml twice daily
3 ml twice daily
4.5 ml twice daily
6 ml twice daily
7.5 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.
Weight
4 kg
5 kg
6 kg
7 kg

Starting dose: 0.07
ml/kg twice daily
0.3 ml twice daily
0.35 ml twice daily
0.45 ml twice daily
0.5 ml twice daily

Maximum dose: 0.21
ml/kg twice daily
0.85 ml twice daily
1.05 ml twice daily
1.25 ml twice daily
1.5 ml twice daily

Method of Administration:
Levetiracetam may be diluted in a glass of water or
baby’s bottle
Instructions for use:
• Open the bottle : press the cap and turn it
anticlockwise (figure 1)
• Separate the adaptor from the syringe (figure 2)
Insert the adaptor into the bottle neck. Ensure it is
well fixed.



Take the syringe and put it in the adaptor opening
(figure 2). Turn the bottle upside down (figure 3)









Fill the syringe with a small amount of solution by
pulling the piston down (figure 4 a), then push the
piston upward in order to remove any possible
bubble (figure 4 b) Pull the piston down to the
graduation mark corresponding to the quantity in
milliliters (ml) prescribed by your doctor (figure 4 c).

Turn the bottle the right way up. Remove the
syringe from the adaptor.
Empty the contents of the syringe in a glass of
water or baby’s bottle by pushing the piston to the
bottom of the syringe (figure 5).
Drink the whole contents of the glass/baby’s bottle.
Close the bottle with the plastic screw cap.
Wash the syringe with water (figure 6)

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 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 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
dose.
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: 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 1,000
• 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), paraethesia
(tingling), disturbance in attention (loss of
concentration);







diplopia (double vision), vision blurred;
liver function test abnormal;
hair loss, eczema, pruritis;
muscle weakness, myalgia (muscle pain);
injury.

Rare: may affect 1 to 10 users in 10,000
• 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. 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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on
the carton box and bottle after EXP:
The expiry date refers to the last day of the month.
Do not use after 4 months of first opening the bottle.
Store in the original container in order to protect from
light.
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 called Levetiracetam. Each ml
contains 100 mg of levetiracetam.
The other ingredients are:
Sodium citrate (for pH adjustment), Citric acid
monohydrate (for pH adjustment), Methyl
parahydroxybenzoate (E218), Glycerol (E422),
Acesulfame potassium (E950), Maltitol liquid (E965),
Raspberry liquid, Purified water
What Levetiracetam looks like and the contents of
the pack
Levetiracetam 100mg/ml oral solution is a clear liquid
The 300 ml glass bottle of Levetiracetam (for children
aged 4 years and above, adolescents and adults) is
packed in a cardboard box containing a 10ml oral
syringe (graduated every 0.25 ml) and an adaptor for
the syringe.
The 150 ml glass bottle of Levetiracetam (for infants
and young children aged from 6 months to less than 4
years) is packed in a cardboard box containing a 3ml
oral syringe (graduated every 0.1 ml) and an adaptor
for the syringe.
The 150 ml glass bottle of Levetiracetam (for infants
aged 1 month to less than 6 months) is packed in a
cardboard box containing a 1ml oral syringe
(graduated every 0.05 ml) and an adaptor for the
syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Beacon
Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells,
TN1 1YG, UK
Manufacturer: Remedica Ltd, Limassol Industrial
Estate, CY-3508- Limassol, Cyprus
This leaflet was last revised in March 2014

HARD TO READ? CALL
01892 600930 FOR HELP

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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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