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LEVETIRACETAM BRISTOL LAB 1000 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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270 mm

Levetiracetam Bristol Lab 250 mg film-coated tablets
Levetiracetam Bristol Lab 500 mg film-coated tablets
Levetiracetam Bristol Lab 750 mg film-coated tablets
Levetiracetam Bristol Lab 1000 mg film-coated tablets

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 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 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 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.
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, have
recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for one
hour before and one hour after taking levetiracetam as
this may results in a loss 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 750mg contains Sunset Yellow FCF
(E110)
Sunset yellow FCF (E110 colouring agent), which may
cause allergic reactions.
3. How to take Levetiracetam
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Take the number of tablets following your doctor's
instructions.
Levetiracetam must be taken twice a day, once in the
morning and once in the evening, at about the same time
each day.
250mg and 750mg tablets: The score line is only to
facilitate breaking for ease of swallowing and not to
divide into equal doses.
500mg and 1000mg tablets: The tablets can be divided
into equal halves
Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3,000 mg each day.
When you will first start taking levetiracetam, your
doctor will prescribe you a lower dose (500 mg each day)
during 2 weeks before giving you the lowest general dose
of 1000 mg.

Example: if your daily dose is 1000 mg, your reduced
starting dose is 2 tablets of 250 mg in the morning and 2
tablets of 250 mg in the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
General dose: between 1,000 mg and 3,000 mg each day.
Example: if your daily dose is 1,000 mg, you might take 2
tablets of 250 mg in the morning and 2 tablets of 250 mg
in the evening.
Dose in infants (1 month to 23 months), children (2 to
11 years) and adolescents (12 to 17 years) weighing
less than 50 kg:
Your doctor will prescribe the most appropriate
pharmaceutical form of levetiracetam according to the
age, weight and dose.
Levetiracetam 100 mg/ml oral solution is a formulation
more appropriate to infants and children under the age of
6 years and to children and adolescent (from 6 to 17
years) weighing less than 50 kg and when tablets don't
allow accurate dosage.
Method of administration tablets:
Swallow Levetiracetam with a sufficient quantity of
liquid (e.g. a glass of water). You may take levetiracetam
with or without food.
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 tablets than you
should. Your doctor will establish the best possible
treatment of overdose.
If you forget to take Levetiracetam:
Contact your doctor if you have missed one or more
doses.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Levetiracetam:
If stopping treatment, Levetiracetam should be
discontinued gradually to avoid an increase of 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
product, 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, or go to your nearest
emergency department, if you experience:
• 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)

240 mm

Package leaflet: Information for the user

• 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 (Drug Reaction with
Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness,
nausea, vomiting, confusion and swelling in the legs,
ankles or feet, as this may be a sign of sudden
decrease of kidney function
• a skin rash which may form blisters and look 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)
• a more severe form of rash causing skin peeling in
more than 30% of the body surface (toxic epidermal
necrolysis)
• 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.
The most frequently reported side effects are
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 in 10 people
• nasopharyngitis
• somnolence (sleepiness); headache
Common: may affect up to 1 in 10 people
• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety,
insomnia, nervousness or irritability
• convulsion, balance disorder (equilibrium disorder),
dizziness (sensation of unsteadiness), lethargy (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 up to 1 in 100 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 up to 1 in 1,000 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
• sudden decrease in kidney function
• 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).
• rhabdomyolysis (breakdown of muscle tissue) and
associated blood creatine phosphokinase increase.
Prevalence is significantly higher in Japanese
patients when compared to non-Japanese patients.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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
• Keep this medicine out of the sight and reach of
children.
• This medicinal product does not require any special
storage conditions.
• Do not use this medicine after the expiry date stated
on the carton box and blister after “EXP.” The expiry
date refers to the last day of that month.
• 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 to protect the environment
6. Contents of the pack and other information
What Levetiracetam contains
The active substance is Levetiracetam.
Each 250 mg tablet contains 250 mg Levetiracetam.
Each 500 mg tablet contains 500 mg Levetiracetam.
Each 750 mg tablet contains 750 mg Levetiracetam.
Each 1000 mg tablet contains 1000 mg Levetiracetam.

The other ingredients are:
Tablet core:
Maize starch, Croscarmellose sodium, Povidone
(kollidon 30), Silica colloidal anhydrous, Talc and
Magnesium Stearate.
Tablet coating:
Levetiracetam Bristol Lab 250 mg film-coated tablets:
Talc, Polyvinyl alcohol, Indigo carmine (E132),
Macrogol (3350) and Titanium dioxide (E171).
Levetiracetam Bristol Lab 500 mg film-coated tablets:
Talc, Polyvinyl alcohol, Yellow Iron Oxide (E172),
Macrogol 3350 and Titanium dioxide (E171).
Levetiracetam Bristol Lab 750 mg film-coated tablets:
Talc, Polyvinyl alcohol, Sunset yellow FCF (E110),
Macrogol (3350) and Titanium dioxide (E171), Iron
oxide red (E172).
Levetiracetam Bristol Lab 1000 mg film-coated tablets:
Talc, Polyvinyl alcohol, Macrogol (3350) and
Titanium dioxide (E171).
What Levetiracetam tablets look like and contents of
the pack
Levetiracetam Bristol Lab 250 mg film-coated tablets are
blue coloured, oblong shaped, film-coated tablets scored
on one side, debossed with “H” on one side and "87" on
other side.
Levetiracetam Bristol Lab 500 mg film-coated tablets are
yellow coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“88” on the other side.
Levetiracetam Bristol Lab 750 mg film-coated tablets are
orange coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“90” on the other side.
Levetiracetam Bristol Lab 1000 mg film-coated tablets
are white coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“91” on the other side.
Levetiracetam is available in the cardboard boxes
containing 10, 20, 30, 50, 60, 100 and 200 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road Berkhamsted,
Hertfordshire, HP4 1EG, UK
Telephone: 0044 (0) 1442 200922, Fax: 0044 (0) 1442 873717
Email
: info@bristol-labs.co.uk

Levetiracetam Bristol Lab 250 mg
film-coated tablets; PL 17907/0388
Levetiracetam Bristol Lab 500 mg
film-coated tablets; PL 17907/0389
Levetiracetam Bristol Lab 750 mg
film-coated tablets; PL 17907/0390
Levetiracetam Bristol Lab 1000 mg
film-coated tablets; PL 17907/0391
This leaflet was last revised in March 2017.
To request a copy of this leaflet in a braille, large print or
audio format, please contact the marketing authorisation
holder at the address above (or telephone, fax, email).

V3 04-04-17 D0

240 mm

270 mm

30 mm

270 mm

Levetiracetam Bristol Lab 250 mg film-coated tablets
Levetiracetam Bristol Lab 500 mg film-coated tablets
Levetiracetam Bristol Lab 750 mg film-coated tablets
Levetiracetam Bristol Lab 1000 mg film-coated tablets

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 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 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 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.
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, have
recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for one
hour before and one hour after taking levetiracetam as
this may results in a loss 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 750mg contains Sunset Yellow FCF
(E110)
Sunset yellow FCF (E110 colouring agent), which may
cause allergic reactions.
3. How to take Levetiracetam
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Take the number of tablets following your doctor's
instructions.
Levetiracetam must be taken twice a day, once in the
morning and once in the evening, at about the same time
each day.
250mg and 750mg tablets: The score line is only to
facilitate breaking for ease of swallowing and not to
divide into equal doses.
500mg and 1000mg tablets: The tablets can be divided
into equal halves
Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking levetiracetam, your
doctor will prescribe you a lower dose (500 mg each day)
during 2 weeks before giving you the lowest general dose
of 1000 mg.
Example: if your daily dose is 1000 mg, your reduced
starting dose is 2 tablets of 250 mg in the morning and 2
tablets of 250 mg in the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
General dose: between 1,000 mg and 3,000 mg each day.
Example: if your daily dose is 1,000 mg, you might take 2
tablets of 250 mg in the morning and 2 tablets of 250 mg
in the evening.
Dose in infants (1 month to 23 months), children (2 to
11 years) and adolescents (12 to 17 years) weighing
less than 50 kg:
Your doctor will prescribe the most appropriate
pharmaceutical form of levetiracetam according to the
age, weight and dose.
Levetiracetam 100 mg/ml oral solution is a formulation
more appropriate to infants and children under the age of
6 years and to children and adolescent (from 6 to 17
years) weighing less than 50 kg and when tablets don't
allow accurate dosage.
Method of administration tablets:
Swallow Levetiracetam with a sufficient quantity of
liquid (e.g. a glass of water). You may take levetiracetam
with or without food.
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 tablets than you
should. Your doctor will establish the best possible
treatment of overdose.
If you forget to take Levetiracetam:
Contact your doctor if you have missed one or more
doses.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Levetiracetam:
If stopping treatment, Levetiracetam should be
discontinued gradually to avoid an increase of 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
product, 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, or go to your nearest
emergency department, if you experience:
• weakness, feel light-headed or dizzy or have difficulty

260 mm

Package leaflet: Information for the user












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 (Drug Reaction with
Eosinophilia and Systemic Symptoms [DRESS])
symptoms such as low urine volume, tiredness,
nausea, vomiting, confusion and swelling in the legs,
ankles or feet, as this may be a sign of sudden
decrease of kidney function
a skin rash which may form blisters and look 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)
a more severe form of rash causing skin peeling in
more than 30% of the body surface (toxic epidermal
necrolysis)
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.

The most frequently reported side effects are
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 in 10 people
• nasopharyngitis
• somnolence (sleepiness); headache
Common: may affect up to 1 in 10 people
• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety,
insomnia, nervousness or irritability
• convulsion, balance disorder (equilibrium disorder),
dizziness (sensation of unsteadiness), lethargy (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 up to 1 in 100 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 up to 1 in 1,000 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
• sudden decrease in kidney function
• 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).
• rhabdomyolysis (breakdown of muscle tissue) and
associated blood creatine phosphokinase increase.
Prevalence is significantly higher in Japanese
patients when compared to non-Japanese patients.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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
• Keep this medicine out of the sight and reach of
children.
• This medicinal product does not require any special
storage conditions.
• Do not use this medicine after the expiry date stated
on the carton box and blister after “EXP.” The expiry
date refers to the last day of that month.
• 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 to protect the environment
6. Contents of the pack and other information
What Levetiracetam contains
The active substance is Levetiracetam.
Each 250 mg tablet contains 250 mg Levetiracetam.
Each 500 mg tablet contains 500 mg Levetiracetam.

Each 750 mg tablet contains 750 mg Levetiracetam.
Each 1000 mg tablet contains 1000 mg Levetiracetam.
The other ingredients are:
Tablet core:
Maize starch, Croscarmellose sodium, Povidone
(kollidon 30), Silica colloidal anhydrous, Talc and
Magnesium Stearate.
Tablet coating:
Levetiracetam Bristol Lab 250 mg film-coated tablets:
Talc, Polyvinyl alcohol, Indigo carmine (E132),
Macrogol (3350) and Titanium dioxide (E171).
Levetiracetam Bristol Lab 500 mg film-coated tablets:
Talc, Polyvinyl alcohol, Yellow Iron Oxide (E172),
Macrogol 3350 and Titanium dioxide (E171).
Levetiracetam Bristol Lab 750 mg film-coated tablets:
Talc, Polyvinyl alcohol, Sunset yellow FCF (E110),
Macrogol (3350) and Titanium dioxide (E171), Iron
oxide red (E172).
Levetiracetam Bristol Lab 1000 mg film-coated tablets:
Talc, Polyvinyl alcohol, Macrogol (3350) and
Titanium dioxide (E171).
What Levetiracetam tablets look like and contents of
the pack
Levetiracetam Bristol Lab 250 mg film-coated tablets are
blue coloured, oblong shaped, film-coated tablets scored
on one side, debossed with “H” on one side and "87" on
other side.
Levetiracetam Bristol Lab 500 mg film-coated tablets are
yellow coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“88” on the other side.
Levetiracetam Bristol Lab 750 mg film-coated tablets are
orange coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“90” on the other side.
Levetiracetam Bristol Lab 1000 mg film-coated tablets
are white coloured, oblong shaped, film-coated tablets
scored on one side, debossed with “H” on one side and
“91” on the other side.
Levetiracetam is available in the cardboard boxes
containing 10, 20, 30, 50, 60, 100 and 200 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road Berkhamsted,
Hertfordshire, HP4 1EG, UK
Telephone: 0044 (0) 1442 200922, Fax: 0044 (0) 1442 873717
Email
: info@bristol-labs.co.uk

Levetiracetam Bristol Lab 250 mg
film-coated tablets; PL 17907/0388
Levetiracetam Bristol Lab 500 mg
film-coated tablets; PL 17907/0389
Levetiracetam Bristol Lab 750 mg
film-coated tablets; PL 17907/0390
Levetiracetam Bristol Lab 1000 mg
film-coated tablets; PL 17907/0391
This leaflet was last revised in March 2017.
To request a copy of this leaflet in a braille, large print or
audio format, please contact the marketing authorisation
holder at the address above (or telephone, fax, email).
V11 04-04-17 D0

260 mm

30 mm

270 mm

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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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