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LEVETIRACETAM MYLAN 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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Package Leaflet: Information for the patient

Levetiracetam Mylan
100 mg/ml oral solution

levetiracetam
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.

What is in this leaflet

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

1. What Levetiracetam Mylan is and what
it is used for

Levetiracetam 100 mg/ml oral solution contains
levetiracetam, which 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 Mylan
Do not take Levetiracetam:

• If you are allergic to levetiracetam or any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to medicines known as
‘pyrrolidone derivatives’ such as piracetam or
ethosuximide (used in the treatment of epilepsy) or
povidone (an ingredient in some medicines).

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 that your
dose should be adjusted.
• If you have severe liver problems as your doctor may
need to carry out some blood tests and he/she may
decide that your dose should be adjusted.
During treatment:
• 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 thoughts
of harming or killing yourself, please contact
your doctor.

Children and adolescents

During treatment:
• if you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor.
Levetiracetam must not be used on its own
(monotherapy) by children and adolescents below
16 years.

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
Levetiracetam may not work as effectively if you
take it with some macrogol containing oral laxatives
(medicines used to treat constipation). If you need to
take these medicines together you should take oral
laxatives containing macrogol one hour before or one
hour after taking this medicine.

Levetiracetam with alcohol

As a safety precaution, do not take levetiracetam
with alcohol.

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 or pharmacist for advice before taking
this medicine.
Pregnancy
Levetiracetam should not be used during
pregnancy unless clearly necessary. It is not known
if levetiracetam will harm your unborn baby.
Levetiracetam has shown unwanted reproductive
side effects in animals at dose levels higher than you
would take to control your seizures.
If you are a woman of child-bearing age and not
using contraception, talk to your doctor before taking
this medicine.
Breast-feeding
Levetiracetam can pass into breast milk and could
cause side effects in your baby. Therefore breastfeeding is not recommended during treatment.

Levetiracetam contains methyl
parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol

Levetiracetam includes methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) which
may cause allergic reactions (possibly delayed).
Levetiracetam also contains maltitol liquid. If you have
been told by your doctor that you have an intolerance
to some sugars, talk to your doctor before taking
this medicine.

3. How to take Levetiracetam Mylan

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 by mouth (orally) 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.
You may take Levetiracetam with or without food.

Monotherapy

Dose in adults and adolescents (from 16 years
of age):
Measure the appropriate dosage using the 10 ml
syringe included in the package for patients 4 years
and above.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two
equally divided doses, each individual dose being
measured between 5 ml (500 mg) and 15 ml
(1500 mg).
When you first start taking levetiracetam, your doctor
will prescribe you a lower dose for 2 weeks before
giving you the lowest recommended dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
Measure the appropriate dosage using the 10 ml
syringe included in the package for patients 4 years
and above.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two
equally divided doses, each individual dose being
measured between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children 6 months and older :

Your doctor will prescribe the most appropriate
pharmaceutical form of levetiracetam according to
the age, weight and dose.
The oral solution is more appropriate for infants and
children under the age of 6 years.

TBC

For children 6 months to 4 years,

measure the appropriate dosage using the 3 ml
syringe included in the package.

For children above 4 years,

measure the appropriate dosage using the 10 ml
syringe included in the package.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two
equally divided doses, each individual dose being
measured between 0.1 ml (10 mg) and 0.3 ml (30 mg),
per kg bodyweight of the child (see table below for
dosing examples).

Dose in children 6 months and older:
Starting dose:
0.1 ml/kg twice
daily
6 kg
0.6 ml twice daily
8 kg
0.8 ml twice daily
10 kg
1 ml twice daily
15 kg
1.5 ml twice daily
20 kg
2 ml twice daily
25 kg
2.5 ml twice daily
From 50 kg 5 ml twice daily
Weight

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):

For infants 1 month to less than 6 months, measure
the appropriate dosage using the 1 ml syringe
included in the package.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two
equally divided doses, each individual dose being
measured between 0.07 ml (7 mg) and 0.21 ml
(21 mg), per kg bodyweight of the infant (see table
below for dose examples).

Dose in infants (1 month to less than 6 months):
Starting dose:
Weight 0.07 ml/kg twice
daily
4 kg
0.3 ml twice daily
5 kg
0.35 ml twice daily
6 kg
0.45 ml twice daily
7 kg
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:

After measuring the correct dose with an appropriate
syringe, Levetiracetam Mylan may be diluted in a glass
of water or baby’s bottle and can be taken with or
without food.

Instruction for use:

Instruction for use for 1 ml and 3 ml
syringes with an adaptor
Open the bottle and push the syringe
adaptor firmly into the bottle neck
(Figure 1).
Take the syringe and pull back the
plunger a little way (Figure 2).
TBC
Push the tip of the syringe into the
adaptor opening. Push the plunger
down slowly to introduce air inside the
bottle (Figure 3).

Driving and using machines

Levetiracetam may impair your ability to drive or
operate any tools or machinery, as it may make you
feel sleepy or dizzy. This is more likely to happen at the
beginning of your 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.

Description Levetiracetam 1000 mg / 10 ml 3 ml,1 ml
Component Type Leaflet
Affiliate Item Code 1072090
Superceded Affiliate Item Code 942221
TrackWise PR No. 1072090
MA No. PL 04569/1569

Turn the bottle upside down with the
syringe still in place (Figure 4).

Date: 06 Mar 2017

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 298743
Trackwise Proof No. 4
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

1

Time: 10:55
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 440 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

Pull the plunger down and fill the
syringe with a quantity of solution
slightly beyond the prescribed dose
(Figure 5).
If any bubbles appear in the syringe
keep the bottle upside down and
slightly push in the plunger and pull it
back again. Repeat until there are no
bubbles in the syringe (Figure 6).
Push the plunger in slowly to the
graduation mark corresponding to the
quantity in millilitres (ml) prescribed by
your doctor (Figure 7).
Turn the bottle the right way up and
remove the syringe (Figure 8).

For young children gently put the tip of
the syringe into the child´s mouth to the
inside of the cheek. Push the plunger
in slowly and allow the child to swallow
the content of the syringe (Figure 9).
The content of the syringe can also be
emptied in a glass of water or baby´s
bottle. Be sure that your child drinks the
whole contents of the glass or bottle.
Wash the syringe with water after use
and close the bottle with the plastic
screw cap (Figure 10).

If you take more Levetiracetam than you should

The possible side effects of an overdose of
levetiracetam are sleepiness, agitation, aggression,
decreased 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

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, 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.
Tell your doctor immediately, stop taking
Levetiracetam and go to your nearest hospital
casualty department straight away if you have any
of the following serious side effects; you may need
medical attention:
Common (may affect up to 1 in 10 people):
• fits (convulsion).
Uncommon (may affect up to 1 in 100 people):
• attempting to harm or kill yourself (suicide attempt),
thoughts of harming or killing yourself (suicidal
ideation), mental disorder, changes in behaviour
(abnormal behaviour), seeing, feeling or hearing
things that are not there (hallucination)
• decreased number of white blood cells (leukopenia)
– you may notice an increase in infections such as
sore throat, mouth ulcers etc. with fever.
Rare (may affect up to 1 in 1,000 people):
• suicide
• 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 of rash causing
skin peeling in more than 30 % of the body surface
(toxic epidermal necrolysis)
• weakness, feel light-headed or dizzy or have
difficulty breathing, as these may be signs of
a serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue and throat
(Quincke's oedema)
• flu-like symptoms and a rash on the face followed
by an extended rash with a high temperature,
increased levels of liver enzymes seen in blood
tests and an increase in a type of white blood cell
(eosinophilia) and enlarged lymph nodes (swollen
glands) (Drug Reaction with Eosinophilia and
Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness,
nausea (feeling sick), vomiting (being sick),
confusion and swelling in the legs, ankles or feet, as
these may be signs of sudden decrease of kidney
function
• inflammation of the pancreas (pancreatitis). You may
feel sick and have upper abdominal swelling and
pain that radiates into the back
• liver failure or inflammation of the liver(hepatic
failure/hepatitis). You may feel sick, notice yellowing
of the skin and eyes, and have abdominal pain and
swelling
• decreased number of all blood cell types
(pancytopenia) – you may notice an increase in
infections such as sore throat, mouth ulcers etc.
with fever, an increase in unexpected bruising or
bleeding, or feel tired, breathless and weak
• rhabdomyolysis (breakdown of muscle tissue) and
associated blood creatine phosphokinase increase
seen in blood tests. You may notice muscle pain
or weakness with dark (tea-coloured) urine. This
side effect is more common in Japanese patients
compared to non-Japanese patients.

• signs of serious mental changes or if someone
around you notices signs of confusion, somnolence
(sleepiness), amnesia (loss of memory), memory
impairment (forgetfulness), abnormal behaviour
or other neurological signs including involuntary
or uncontrolled movements. These could be
symptoms of an encephalopathy.

Other possible side effects

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 in 10 people):
• inflammation and congestion of the nasal passages
and of the upper part of the throat (nasopharyngitis)
• sleepiness (somnolence), headache.
Common (may affect up to 1 in 10 people):
• loss of appetite (anorexia)
• feeling depressed, hostile or aggressive, feeling
anxious (anxiety), difficulty falling and staying asleep
at night (insomnia), feeling nervous or irritable
• balance disorder (equilibrium disorder), a sensation
of unsteadiness (dizziness), lethargy, involuntary
trembling (tremor)
• a sensation of rotation and loss of balance (vertigo)
• cough
• abdominal pain, diarrhoea, indigestion (dyspepsia),
being sick (vomiting), feeling sick (nausea)
• rash
• weakness and lack of energy (asthenia/fatigue).
Uncommon (may affect up to 1 in100 people):
• decreased number of blood platelets, which may be
seen in blood tests (thrombocytopenia).
• weight decrease, weight increase
• anger, confusion, panic attack, emotional instability/
mood swings, agitation
• loss of memory (amnesia), forgetfulness (memory
impairment), impaired coordinated movements
(abnormal coordination/ataxia), tingling
(paraesthesia), disturbance in attention (loss of
concentration)
• double vision (diplopia), vision blurred
• liver function test abnormal
• hair loss, which may be reversible (alopecia),
eczema, itchy skin (pruritus)
• muscle weakness, muscle pain (myalgia)
• injury.
Rare (may affect up to 1 in 1,000 people):
• infection
• decreased blood sodium concentration
(hyponatraemia)
• personality disorders (behavioural problems),
thinking abnormal (slow thinking, unable to
concentrate)
• uncontrollable muscle spasms affecting the head,
torso and limbs (choreoathetosis), difficulty in
controlling movements (dyskinesia), hyperactivity
(hyperkinesia).

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 Mylan

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.
Store in the original container in order to protect
from light.
Do not use after 4 months of first opening the bottle.
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, citric
acid monohydrate (both used for pH adjustment),
methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ammonium
glycyrrhizate, glycerol (E422), maltitol liquid (E965),
acesulfame potassium (E950), grape flavour (contains
propylene glycol), purified water.

What Levetiracetam looks like and contents of
the pack

Levetiracetam 100 mg/ml oral solution is a clear, faint
coloured solution.
The 300 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
3 ml oral syringe (graduated every 0.1 ml) and an
adaptor for the syringe.
The 300 ml glass bottle of Levetiracetam (for infants
aged 1 month to less than 6 months) is packed
in a cardboard box containing a 1 ml oral syringe
(graduated every 0.05 ml) and an adaptor for
the syringe.

Marketing Authorisation Holder
Mylan,
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom

Manufacturer

Balkanpharma-Troyan AD
1 Krayrechna Str,
Troyan 5600
Bulgaria
This leaflet was last revised in March 2017.

1072090

Description Levetiracetam 1000 mg / 10 ml 3 ml,1 ml
Component Type Leaflet
Affiliate Item Code 1072090
Superceded Affiliate Item Code 942221
TrackWise PR No. 1072090
MA No. PL 04569/1569

Date: 06 Mar 2017

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 298743
Trackwise Proof No. 4
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

1

Time: 10:55
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 440 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

Package Leaflet: Information for the patient

Levetiracetam Mylan
100 mg/ml oral solution
(levetiracetam)

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.

What is in this leaflet

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

1. What Levetiracetam Mylan is and what it
is used for
Levetiracetam 100 mg/ml oral solution contains
levetiracetam, which 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 Mylan
Do not take Levetiracetam:

• If you are allergic to levetiracetam or any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to medicines known as
‘pyrrolidone derivatives’ such as piracetam or
ethosuximide (used in the treatment of epilepsy)
or povidone (an ingredient in some medicines).

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 that your
dose should be adjusted.
• If you have severe liver problems as your doctor may
need to carry out some blood tests and he/she may
decide that your dose should be adjusted.
During treatment:
• 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
thoughts of harming or killing yourself, please
contact your doctor.

Children and adolescents

During treatment:
• if you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor.
Levetiracetam must not be used on its own
(monotherapy) by children and adolescents
below 16 years.

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.
Levetiracetam may not work as effectively if you
take it with some macrogol containing oral laxatives
(medicines used to treat constipation). If you need
to take these medicines together you should take
oral laxatives containing macrogol one hour before
or one hour after taking this medicine.

Levetiracetam with alcohol

As a safety precaution, do not take levetiracetam
with alcohol.

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 or pharmacist for advice before taking
this medicine.

Pregnancy

Levetiracetam should not be used during
pregnancy unless clearly necessary. It is not known

Description Levetiracetam_1000 mg_10 ml_10 ml
Component Type Leaflet
Affiliate Item Code 1072137
Superceded Affiliate Item Code 942229
TrackWise PR No. 1072137
MA No. PL 04569/1569
Packing Site/Printer

Actavis Balkanpharma-Troyan AD (Troyan - BG)

Supplier Code TBC

if levetiracetam will harm your unborn baby.
Levetiracetam has shown unwanted reproductive
side effects in animals at dose levels higher than you
would take to control your seizures.
If you are a woman of child-bearing age and not
using contraception, talk to your doctor before
taking this medicine.

Breast-feeding
Levetiracetam can pass into breast milk and could cause
side effects in your baby. Therefore 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 or dizzy. This is more likely to happen at
the beginning of your 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 includes methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) which
may cause allergic reactions (possibly delayed).
Levetiracetam also contains maltitol liquid. If you have
been told by your doctor that you have an intolerance
to some sugars, talk to your doctor before taking
this medicine.

3. How to take Levetiracetam Mylan
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 by mouth (orally)
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.
You may take Levetiracetam with or without food.

Monotherapy
Dose in adults and adolescents (from 16 years of age): TBC
Measure the appropriate dosage using the 10 ml syringe
included in the package for patients 4 years and above.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two equally
divided doses, each individual dose being measured
between 5 ml (500 mg) and 15 ml (1500 mg).
When you first start taking levetiracetam, your doctor
will prescribe you a lower dose for 2 weeks before
giving you the lowest recommended dose.

Add-on therapy
Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:

Measure the appropriate dosage using the 10 ml syringe
included in the package for patients 4 years and above.
The recommended dose:
Levetiracetam Mylan is taken twice daily, in two equally
divided doses, each individual dose being measured
between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children 6 months and older :

Your doctor will prescribe the most appropriate
pharmaceutical form of levetiracetam according to the
age, weight and dose.
The oral solution is more appropriate for infants and
children under the age of 6 years.
For children 6 months to 4 years, measure the
appropriate dosage using the 3 ml syringe included in
the package.
For children above 4 years, measure the appropriate
dosage using the 10 ml syringe included in the package.

The recommended dose:
Levetiracetam Mylan is taken twice daily, in two equally
divided doses, each individual dose being measured
between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg
bodyweight of the child (see table below for dosing
examples).

Dose in children 6 months and older:
Starting dose:
0.1 ml/kg twice
daily
6 kg
0.6 ml twice daily
8 kg
0.8 ml twice daily
10 kg
1 ml twice daily
15 kg
1.5 ml twice daily
20 kg
2 ml twice daily
25 kg
2.5 ml twice daily
From 50 kg 5 ml twice daily
Weight

Dose in infants (1 month to less than 6 months):
For infants 1 month to less than 6 months,
measure the appropriate dosage using the 1 ml syringe
included in the package.

The recommended dose:
Levetiracetam Mylan is taken twice daily, in two equally
divided doses, each individual dose being measured
between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg
bodyweight of the infant (see table below for dose
examples).

Dose in infants (1 month to less than 6 months):
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

After measuring the correct dose with an appropriate
syringe, Levetiracetam Mylan may be diluted in a glass
of water or baby’s bottle and can be taken with or
without food.

Date: 03 Mar 17
No. of colours

SAP No. N/A

Colours

Trackwise Proof No. 4
Glams Proof No. N/A
Client Market United Kingdom

Maximum dose:
TBC
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:

Pharma Code TBC

Vendor Job No. 457858

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

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Instruction for use:
Instruction for use for 10 ml syringes
Open the bottle. Before starting the
measuring procedure make sure that
the transparent dosing body of the
syringe as well as the white plunger
are in the bottom most position.
Place the syringe into the bottle. To
measure the dosing quantity, use one
hand to hold the dosing body and
the other hand to pull up the plunger
until you reach the graduation mark
corresponding to the quantity in
millilitres (ml) prescribed by your
doctor (Figure 1).
Pull the syringe by the dosing body
out of the bottle (Figure 2).

Empty the contents of the syringe into
a glass of water by pushing down the
plunger. Be sure to drink the whole
contents of the glass. The contents of
the syringe can also be given directly
from the syringe into the mouth or
emptied onto a spoon (Figure 3).

Wash the syringe with water after use
and close the bottle with the plastic
screw cap (Figure 4).

If you take more Levetiracetam than you should

The possible side effects of an overdose of levetiracetam
are sleepiness, agitation, aggression, decreased
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

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, 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.

Tell your doctor immediately, stop taking
Levetiracetam and go to your nearest hospital
casualty department straight away if you have
any of the following serious side effects; you
may need medical attention:
Common (may affect up to 1 in 10 people):
• fits (convulsion).
Uncommon (may affect up to 1 in 100 people):
• attempting to harm or kill yourself (suicide attempt),
thoughts of harming or killing yourself (suicidal
ideation), mental disorder, changes in behaviour
(abnormal behaviour), seeing, feeling or hearing
things that are not there (hallucination)
• decreased number of white blood cells
(leukopenia) – you may notice an increase in infections
such as sore throat, mouth ulcers etc. with fever.
Rare (may affect up to 1 in 1,000 people):
• suicide
• 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 of rash causing skin peeling
in more than 30 % of the body surface (toxic
epidermal necrolysis)
• weakness, feel light-headed or dizzy or have difficulty
breathing, as these may be signs of a serious allergic
(anaphylactic) reaction
• swelling of the face, lips, tongue and throat
(Quincke's oedema)
• flu-like symptoms and a rash on the face followed by
an extended rash with a high temperature, increased
levels of liver enzymes seen in blood tests and an
increase in a type of white blood cell (eosinophilia) and
enlarged lymph nodes (swollen glands) (Drug Reaction
with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness,
nausea (feeling sick), vomiting (being sick), confusion
and swelling in the legs, ankles or feet, as these may
be signs of sudden decrease of kidney function
• inflammation of the pancreas (pancreatitis). You may
feel sick and have upper abdominal swelling and pain
that radiates into the back
• liver failure or inflammation of the liver(hepatic
failure/hepatitis). You may feel sick, notice yellowing of
the skin and eyes, and have abdominal pain and swelling
• decreased number of all blood cell types
(pancytopenia) – you may notice an increase in
infections such as sore throat, mouth ulcers etc. with
fever, an increase in unexpected bruising or bleeding,
or feel tired, breathless and weak

Description Levetiracetam_1000 mg_10 ml_10 ml
Component Type Leaflet
Affiliate Item Code 1072137
Superceded Affiliate Item Code 942229
TrackWise PR No. 1072137
MA No. PL 04569/1569
Packing Site/Printer

Actavis Balkanpharma-Troyan AD (Troyan - BG)

Supplier Code TBC

• rhabdomyolysis (breakdown of muscle tissue) and
associated blood creatine phosphokinase increase
seen in blood tests. You may notice muscle pain
or weakness with dark (tea-coloured) urine. This
side effect is more common in Japanese patients
compared to non-Japanese patients.
• signs of serious mental changes or if someone
around you notices signs of confusion, somnolence
(sleepiness), amnesia (loss of memory), memory
impairment (forgetfulness), abnormal behaviour or
other neurological signs including involuntary or
uncontrolled movements. These could be symptoms
of an encephalopathy.

Other possible side effects

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 in 10 people):
• inflammation and congestion of the nasal passages
and of the upper part of the throat (nasopharyngitis)
• sleepiness (somnolence), headache.
Common (may affect up to 1 in 10 people):
• loss of appetite (anorexia)
• feeling depressed, hostile or aggressive, feeling
anxious (anxiety), difficulty falling and staying asleep
at night (insomnia), feeling nervous or irritable
• balance disorder (equilibrium disorder), a sensation
of unsteadiness (dizziness), lethargy, involuntary
trembling (tremor)
• a sensation of rotation and loss of balance (vertigo)
• cough
• abdominal pain, diarrhoea, indigestion (dyspepsia),
being sick (vomiting), feeling sick (nausea)
• rash
• weakness and lack of energy (asthenia/fatigue).
Uncommon (may affect up to 1 in100 people):
• decreased number of blood platelets, which may be
seen in blood tests (thrombocytopenia).
• weight decrease, weight increase
• anger, confusion, panic attack, emotional
instability/mood swings, agitation
• loss of memory (amnesia), forgetfulness (memory
impairment), impaired coordinated movements
(abnormal coordination/ataxia), tingling
(paraesthesia), disturbance in attention (loss of
concentration)
• double vision (diplopia), vision blurred
• liver function test abnormal
• hair loss, which may be reversible (alopecia), eczema,
itchy skin (pruritus)
• muscle weakness, muscle pain (myalgia)
• injury.
Rare (may affect up to 1 in 1,000 people):
• infection
• decreased blood sodium concentration
(hyponatraemia)
• personality disorders (behavioural problems), thinking
abnormal (slow thinking, unable to concentrate)
• uncontrollable muscle spasms affecting the head,
torso and limbs (choreoathetosis), difficulty in
controlling movements (dyskinesia), hyperactivity
(hyperkinesia).

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 Mylan
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.
Store in the original container in order to protect
from light.
Do not use after 4 months of first opening the bottle.
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, citric
acid monohydrate (both used for pH adjustment),
methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ammonium glycyrrhizate,
glycerol (E422), maltitol liquid (E965), acesulfame
potassium (E950), grape flavour (contains propylene
glycol), purified water.

What Levetiracetam looks like and contents of
the pack
Levetiracetam 100 mg/ml oral solution is a clear, faint
coloured solution.
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 10 ml oral
syringe (graduated every 0.25 ml).

Marketing Authorisation Holder
Mylan,
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom

Manufacturer
Balkanpharma-Troyan AD
1 Krayrechna Str,
Troyan 5600
Bulgaria

This leaflet was last revised in
March 2017.
1072137

Date: 03 Mar 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 457858
Trackwise Proof No. 4
Glams Proof No. N/A
Client Market United Kingdom

1

Time: 18:30
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
160 x 440 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand Transcript

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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