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LEVETIRACETAM MANX 100MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM FORM I

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Levetiracetam Manx 100mg/ml
Oral Solution
Read all of this leaflet carefully before you or your child 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
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 is it used for
Levetiracetam Manx 100mg/ml Oral Solution (hereinafter referred to as
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 a certain form of epilepsy.
Epilepsy is a condition where the patients have repeated fits
(seizures). Levetiracetam is used for the epilepsy form in which
the fits initially affect only one side of the brain, but could
thereafter extend to larger areas on both sides of the brain (partial
onset seizure with or without secondary generalisation).
Levetiracetam has been given to you by your doctor to reduce the
number of fits
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 (short, shock-like jerks of a muscle or
group of muscles) in adults and adolescents from 12 years of
age with juvenile myoclonic epilepsy
primary generalised tonic-clonic seizures (major fits, including
loss of consciousness) in adults and adolescents from 12 years
of age with idiopathic generalised epilepsy (the type of
epilepsy that is thought to have a genetic cause).

2. What you need to know before you take
Levetiracetam
Do not take Levetiracetam
If you are allergic to levetiracetam, pyrrolidone derivatives 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
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.
Children and adolescents
Levetiracetam is not indicated in children and adolescents below
16 years on its own (monotherapy).
Other medicines and Levetiracetam
Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
Do not take macrogol (a drug used as a laxative) for one hour before
and one hour after taking levetiracetam as this may result in a
reduction of its effect.
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.
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 it 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, propyl
parahydroxybenzoate and maltitol
Levetiracetam oral solution contains methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).
Levetiracetam oral solution also contains maltitol. If you have been
told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000mg and 3000mg each day.
When you first start taking Levetiracetam, your doctor will prescribe
you a lower dose (500mg each day) during 2 weeks before giving
you the lowest gereral dose of 1000mg.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50kg or
more:
General dose: between 10ml (1,000mg) and 30ml (3,000mg) 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 50kg:
Your doctor will prescribe the most appropriate pharmaceutical form
of Levetiracetam according to the age, weight and dose.
General dose: between 0.2ml (20mg) and 0.6ml (60mg) 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

Starting dose:
0.1ml/kg twice daily

Maximum dose:
0.3ml/kg twice daily

6kg

0.6ml twice daily

1.8ml twice daily

8kg

0.8ml twice daily

2.4ml twice daily

10kg

1ml twice daily

3ml twice daily

15kg

1.5ml twice daily

4.5ml twice daily

20kg

2ml twice daily

6ml twice daily

25kg

2.5ml twice daily

7.5ml twice daily

From 50kg

5ml twice daily

15ml twice daily

Dose in infants (1 month to less than 6 months):
General dose: between 0.14ml (14mg) and 0.42ml (42mg) 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

Starting dose:
0.07ml/kg twice daily

Maximum dose:
0.21ml/kg twice daily

4kg

0.3ml twice daily

0.85ml twice daily

5kg

0.35ml twice daily

1.05ml twice daily

6kg

0.45ml twice daily

1.25ml twice daily

7kg

0.5ml twice daily

1.5ml twice daily

Method of administration
Levetiracetam oral solution may be diluted in a glass of water or
baby's bottle. You may take Levetiracetam
with or without food.
1
Instructions for use:
Open the bottle: press the cap
and turn it anticlockwise
(see figure 1)
Separate the adaptor from the syringe (figure 2). Insert the
adaptor into the bottle neck (figure 3). Ensure it is well fixed.

2

3

Take the syringe and put it in the adaptor opening (figure 4).
Turn the bottle upside down (figure 5).

5

4

Fill the syringe with a small amount of solution by pulling the
piston down (figure 5A), then push the piston upward in order to
remove any possible bubble (figure 5B). Pull the piston down to
the graduation mark corresponding to the quantity in milliliters
(ml) prescribed by your doctor (figure 5C).

5B

5A

5C

Turn the bottle the right way up (figure 6A). Remove the syringe
from the adaptor (figure 6B).

6B

6A

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.

(continued overleaf)

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

300516-GLET001-PIL-04
Levetiracetam PIL - Side 1
650 x 280mm
30 May 2016
14136/04 PIL- Side 1.ai
1 Colour - Black

M1X

Empty the contents of the syringe in a glass
of water or baby's bottle by pushing the
piston to the bottom on the syringe (figure 7).

7
Drink the whole contents of the glass/baby's bottle
Close the bottle with the plastic screw cap
Wash the syringe with water only (figure 8).

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 Yellow Card Scheme at
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
8

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.
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 Levetiracetam 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, Levetiracetam should be discontinued gradually
to avoid an increase in seizures. Should your doctor decide to stop
your Levetiracetam treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam.
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. The most frequently reported adverse reactions
were nasopharyngitis, somnolence (sleepiness), headache, fatigue
and dizziness. At the beginning of the treatment or at dose increase
side effects like sleepiness, tiredness and dizziness may be more
common. These effects should however decrease over time.
Very common: may affect more than 1 user in 10 people
nasopharyngitis
somnolence (sleepiness), headache
Common: may affect 1 to 10 users in 100 people
anorexia (loss of appetite)
depression, hostility or aggression, insomnia, nervousness or
irritability
convulsion, balance disorder (equilibrium disorder), dizziness
(sensation of unsteadiness), lethargy (lack of energy and
enthusiasm), 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 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, 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
elevated/abnormal values in a liver function test
hair loss, eczema, pruritus
muscle weakness, myalgia (muscle pain)
injury
Rare: may affect 1 to 10 users in 10,000 people
infection
decreased number of all blood cell types
severe allergic reactions (DRESS, anaphylactic reaction [severe
and important allergic reaction], Quincke’s oedema (swelling of
the face, lips, tongue and throat))
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
liver 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)

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard
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 bottle, 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 oral solution contains
The active substance is called levetiracetam. Each ml contains 100mg
of levetiracetam.
The other ingredients 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.
What Levetiracetam looks like and contents of the pack
Levetiracetam 100mg/ml oral solution is a clear liquid.
The 300ml 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 0.25ml) and an
adaptor for the syringe.
The 200ml glass bottle (containing 150ml oral solution) 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 0.1ml) and an adaptor for the syringe.
The 200ml glass bottle (containing 150ml oral solution) 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 0.05ml) and an adaptor for the syringe.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick,
CV34 5YA, UK
Manufacturer
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA
3000, Malta
Other formats
To request a copy of this leaflet in braille, large print or audio please
call 01926 482511
This leaflet was last revised in May 2016
WIP URN: 300516-GLET001-PIL-04

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

300516-GLET001-PIL-04
Levetiracetam PIL - Side 2
650 x 280mm
30 May 2016
14136/04 PIL- Side 2.ai
1 Colour - Black

M1X

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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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