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LEVETIRACETAM MYLAN 100 MG/ML ORAL SOLUTION

Active substance(s): 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
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 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 adults, adolescents, children
and infants from one month of age
* myoclonic seizures in adults and adolescents
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

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:
• 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 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.

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.

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):

The recommended dose is between 10 ml (1,000 mg)
and 30 ml (3,000 mg) each day, divided into
two intakes per day.
When you first start taking levetiracetam, your doctor
will prescribe you a lower dose for 2 weeks before
giving you the lowest recommended dose.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.

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

The recommended dose is between 10 ml (1,000 mg)
and 30 ml (3,000 mg) each day, divided into
two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.

Dose in infants (6 to 23 months), children (2 to
11 years) and adolescents (12 to 17 years)
weighing less than 50 kg:

TBC

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.
The recommended dose is between 0.2 ml (20 mg)
and 0.6 ml (60 mg) per kilogram bodyweight each
day, divided into two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.

6 kg

Starting dose:
0.1 ml/kg twice
daily
0.6 ml twice daily

8 kg
10 kg
15 kg
20 kg
25 kg

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

From 50 kg 5 ml twice daily

15 ml twice daily

Dose in infants (1 month to less than 6 months):
The recommended dose is between 0.14 ml (14 mg)
and 0.42 ml (42 mg) per kilogram bodyweight each
day, divided into two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.
Weight

Starting dose:
0.07 ml/kg twice
daily

Maximum dose:
0.21 ml/kg twice
daily

4 kg

0.3 ml twice daily

0.85 ml twice daily

5 kg

0.35 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Method of administration:

Levetiracetam may be diluted in a glass of water or
baby’s bottle.

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).

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.

Take the syringe and pull back the
plunger a little way (Figure 2).
TBC

Breast-feeding

Levetiracetam can pass into breast milk and could
cause side effects in your baby. Therefore breastfeeding 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.

Push the tip of the syringe into
the adaptor opening. Push the
plunger down slowly to introduce
air inside the bottle (Figure 3).

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

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).

• 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.

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 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 causing skin peeling in more than
30 % of the body surface (toxic epidermal necrolysis)
or a serious allergic reaction (DRESS).

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
November 2015

720142

Package Leaflet: Information for the patient

Levetiracetam Mylan
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 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
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 adults, adolescents, children
and infants from one month of age
* myoclonic seizures in adults and adolescents
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

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:
• 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
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.

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.

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):

The recommended dose is between 10 ml
(1,000 mg) and 30 ml (3,000 mg) each day, divided
into two intakes per day.
When you first start taking levetiracetam, your
doctor will prescribe you a lower dose for 2 weeks
before giving you the lowest recommended dose.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.

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

TBC

The recommended dose is between 10 ml
(1,000 mg) and 30 ml (3,000 mg) each day, divided
into two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.

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.
The oral solution is more appropriate for infants and
children under the age of 6 years.
The recommended dose is between 0.2 ml (20 mg)
and 0.6 ml (60 mg) per kilogram bodyweight each
day, divided into two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.
Weight
6 kg
8 kg
10 kg
15 kg
20 kg
25 kg

Starting dose:
0.1 ml/kg twice
daily
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

From 50 kg 5 ml twice daily

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):
The recommended dose is between 0.14 ml (14 mg)
and 0.42 ml (42 mg) per kilogram bodyweight each
day, divided into two intakes per day.
The exact quantity of oral solution should be
measured using the oral syringe provided in the
cardboard box.
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

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

7 kg

1.5 ml twice daily

0.5 ml twice daily

Method of administration:

Levetiracetam may be diluted in a glass of water or
baby’s bottle.

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).

TBC

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 causing skin
peeling in more than 30 % of the body surface
(toxic epidermal necrolysis) or a serious allergic
reaction (DRESS).
• 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.

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

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.

This leaflet was last revised in
November 2015

720152

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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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