Skip to Content

LEVETIRACETAM BRISTOL LAB 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

View full screen / Print PDF » Download PDF ⇩
Transcript
2026122

PACKAGE LEAFLET: INFORMATION FOR
THE USER
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
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.

• if you suffer from kidney problems, follow your
doctor's instructions. He/she may decide if your
dose should be adjusted.
• If you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor
• If you notice an increase in seizure severity (e.g.
increased number), please contact your
doctor.
• A small number of people being treated with antiepileptics such as levetiracetam have had thoughts
of harming or killing themselves. If you have any
symptoms of depression and/or suicidal ideation,
please contact your doctor.
Other medicines and Levetiracetam
Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
Levetiracetam with food, drink and alcohol
You may take levetiracetam with or without food. As a
safety precaution, do not take this medicine with alcohol.

What is in this leaflet:

Pregnancy and breast-feeding

1. What Levetiracetam is and what it is used for

Ask your doctor or pharmacist for advice before taking
any medicine.

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
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 patients 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
Do not take Levetiracetam:
• if you are allergic to levetiracetam or any of the
other ingredients of this medicine (listed in
section 6)
Warnings and Precautions
Talk to your doctor before taking Levetiracetam
Size: 270 x 240 mm
Folding Size : 135 x 30 mm
Spec.: 40 GSM Bible Paper Front & Back side printing.
Pharma Code: Front 936 Back 937
Colour: Single Colour (Pantone Black C)

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.

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 during 2 weeks
before giving you the lowest general dose.
Example: if your daily dose is 1000 mg, you must take
one 500 mg tablet in the morning and one 500 mg tablet
in the evening.
Add-on therapy
Dosage 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 must take
one tablet of 500mg in the morning and one tablet of
500mg in the evening.
Dosage 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.
An oral solution is a presentation more appropriate to
infants and children under the age of 6 years.
General dose: between 20 mg/kg bodyweight and 60
mg/kg bodyweight each day.
Example: a general dose of 20 mg per kg bodyweight
each day, you must give your 25 kg child one 250mg
Tablet in the morning and one 250mg Tablet in the
evening.
Dosage in infants (1 month to less than 6 months):

Breast-feeding is not recommended during treatment.

An oral solution is a presentation more appropriate to
infants.

Driving and using machines

Method of Administration:

Levetiracetam may impair your ability to drive or operate
any tools or machinery, as levetiracetam may make you
feel sleepy. This is more likely at the beginning of
treatment or after an increase in the dose. You should not
drive or use machines until it is established that your
ability to perform such activities is not affected.

Swallow Levetiracetam with a sufficient quantity of
liquid (e.g. a glass of water).

Levetiracetam 750mg contains Sunset Yellow FCF
(E110)
These tablets contain 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 if you are not sure.
Levetiracetam must be taken twice a day, once in the
morning and once in the evening, at about the same time
each day.
250mg and 750mg tablets: The score line is only to
facilitate breaking for ease of swallowing and not to
divide into equal doses.

Duration of treatment:
• Levetiracetam is used as a chronic treatment. You
should continue levetiracetam treatment for as long as
your doctor has told you.
• Do not stop your treatment without your doctor's
advice as this could increase your seizures. Should
your doctor decide to stop your levetiracetam
treatment, he/she will instruct you about the gradual
withdrawal of levetiracetam.
If you take more Levetiracetam than you should:
The possible side effects of an overdose of levetiracetam
are sleepiness, agitation, aggression, decrease of
alertness, inhibition of breathing and coma.
Contact your doctor if you took more tablets than you
should. Your doctor will establish the best possible
treatment of overdose.
If you forget to take Levetiracetam:

500mg and 1000mg tablets: The tablets can be divided
into equal halves

Contact your doctor if you have missed one or more
doses.

Take the number of tablets following your doctor's
instructions.

Do not take a double dose to make up for a forgotten
tablet.

If you stop taking Levetiracetam:
If stopping treatment, as with other antiepileptic
medicines, Levetiracetam should be discontinued
gradually to avoid an increase of seizures.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some of the side effects like sleepiness, tiredness and
dizziness may be more common at the beginning of the
treatment or at dose increase. These effects should
however decrease over time.
Very common: may affect more than 1 user in 10
• somnolence (sleepiness); headache
• nasopharyngitis
Common: may affect 1 to 10 users in 100
• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety,
insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder),
dizziness (sensation of unsteadiness), lethargy,
tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion),
vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1,000
• decreased number of blood platelets, decreased
number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental
disorder, abnormal behaviour, hallucination, anger,
confusion, panic attack, emotional instability/mood
swings, agitation;
• amnesia (loss of memory), memory impairment
(forgetfulness), abnormal coordination/ataxia
(impaired coordinated movements), paraesthesia
(tingling), disturbance in attention (loss of
concentration);
• diplopia (double vision), vision blurred;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.
Rare: may affect 1 to 10 users in 10,000





infection;
decreased number of all blood cell types;
severe hypersensitivity reactions (DRESS);
suicide, personality disorders (behavioural
problems), thinking abnormal (slow thinking,
unable to concentrate);
• uncontrollable muscle spasms affecting the head,
torso and limbs, difficulty in controlling
movements, hyperkinesia (hyperactivity);
• pancreatitis;
• hepatic failure, hepatitis;

• skin rash, which may form blisters and looks like
small targets (central dark spots surrounded by a
paler area, with a dark ring around the edge)
(erythema multiforme), a widespread rash with
blisters and peeling skin, particularly around the
mouth, nose, eyes and genitals (Stevens Johnson
syndrome), and a more severe form causing skin
peeling in more than 30% of the body surface (toxic
epidermal necrolysis).
• Decreased blood sodium concentration
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 after the expiry date stated on the carton
box and blister after “EXP.” The expiry date refers
to that last day of the 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.
Levetiracetam Bristol Lab 250 mg film-coated tablets:
Each Film-coated tablet contains 250 mg
Levetiracetam.
Levetiracetam Bristol Lab 500 mg film-coated tablets:
Each Film-coated tablet contains 500 mg
Levetiracetam.
Levetiracetam Bristol Lab 750 mg film-coated tablets:
Each Film-coated tablet contains 750 mg
Levetiracetam.
Levetiracetam Bristol Lab 1000 mg film-coated tablets:
Each Film-coated 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).
Levetiracetam film-coated tablets are packed in blisters
in cardboard boxes.
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 contain 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 Limited
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
This medicinal product is authorised in the Member
States of the EEA under the following names:
CZ - Levetiracetam Bristol Lab 250mg, 500mg, 750mg
and 1000mg potahované tablety.
DE - Levetiracetam axcount 250mg, 500mg, 750mg
and 1000mg filmtabletten
ES - Levetiracetam Brill Pharma 250mg, 500mg, 750mg
and 1000mg comprimidos recubiertos con película
SE - Levetiracetam Bristol Lab 250mg, 500mg, 750mg
and 1000mg filmdragerade tabletter
SK - Levetiracetam Bristol Lab 250mg, 500mg, 750mg
and 1000mg filmom obalené tablety
UK - Levetiracetam Bristol Lab 250mg, 500mg, 750mg
and 1000mg Film-coated tablets
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 September 2014

Expand view ⇕

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.

Hide