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LEVETIRACETAM BLUEFISH 250 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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170 mm

United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE USER
Levetiracetam 250 mg Film-coated tablets
Levetiracetam 500 mg Film-coated tablets
Levetiracetam 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 or nurse.
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 anyside effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

In this leaflet:
1. What Levetiracetam is and what it is used for
2. What do 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
generalization.
- 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
mpilepsy.
• primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of age
with idiopathic generalized epilepsy.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LEVETIRACETAM

550 mm

Do not take Levetiracetam:
• if you are allergic (hypersensitive) to
levetiracetam or any of the other ingredients
of this medicine (listed in Section 6).
Warnings & 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 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
anti-epileptics such as Levetiracetam have
had thoughts of harming or killing
themselves. If you have any symptoms of
depression and/or suicidal ideation, please
contact your doctor.
Other medicines and Levetiracetam :
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, including medicines obtained without
a prescription.
Taking Levetiracetam with food and drink
and alcohol
You may take Levetiracetam with or without
food. As a safety precaution, do not take
Levetiracetam with alcohol.
Pregnancy and breast-feeding and fertility:
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant think you may be pregnant
please inform your doctor.
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
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.
3. HOW TO TAKE LEVETIRACETAM
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Levetiractam must be taken twice a day, once in
the morning and once in the evening, at about the
same time each day.
Take the number of tablets following your
doctor’s instructions.
Monotherapy
Dose in adults and adolescents (from 16 years
of age):
250 mg Tablet:
General dose: between 1000 mg (4 tablets) and
3,000 mg (12 tablets) 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 2 tablets in the morning and 2 tablets in the
evening
500 mg Tablet:
General dose: between 1000 mg (2 tablets) and
3,000 mg (6 tablets) 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 2,000 mg, you
must take 2 tablets in the morning and 2 tablets
in the evening.
1000 mg Tablet:
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 2,000 mg, you
must take 1 tablet in the morning and 1 tablet in
the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
250 Tablet : General dose: between 1,000 mg (4
tablets) and 3,000 mg (12 tablets) each day.
Example: if your daily dose is 1,000 mg, you must
take 2 tablets in the morning and 2 tablets in the
evening.
500 mg Tablet :
General dose: between 1,000 mg (2 tablets) and
3,000 mg (6 tablets) each day.
Example: if your daily dose is 1,000 mg, you must
take one tablet in the morning and one tablet in
the evening.
1000 mg Tablet:
General dose: between 1,000 mg and 3,000 mg
each day.
Example: if your daily dose is 2,000 mg, you must
take one tablet in the morning and one tablet in
the evening.
Dose in infants ( 6 to23 months) in 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 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 per kg
bodyweight and 60 mg per kg bodyweight
each day.
Example : a general dose of 20 mg per kg
bodyweight each day, you must give your 25 kg
child 1 tablet in the morning and 1 tablet in the
evening.
Dose in infants (1 month to less than 6 months):
An oral solution is a presentation more
appropriate to infants
Method of administration:
Swallow Levetiracetam with a sufficient quantity
of liquid (e.g. a glass of water).
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 forget to take Levetiracetam
Do not take a double dose to make up for a
forgotten tablet. Contact your doctor if you have
missed one or more doses
If you take more Levetiracetam than you
should
The possible side effects of an overdose of
Levetiractam Tablet 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 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.

170 mm
Very common: may affect more than 1 user in 10
• nasopharyngitis
• somnolence (sleepiness); headache
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;
• suicide, personality disorders (behavioural
problems), thinking abnormal (slow
thinking, unable to concentrate);
• decreased blood sodium concentration;
• 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).
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.

550 mm

5. HOW TO STORE LEVETIRACETAM






Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry
date which is stated on carton box and blister
after EXP.
The expiry date refers to the last day of that
month.
This medicinal product does not require any
special storage conditions.
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 tablet contains:
The active ingredient is Levetiracetam.
Each film-coated tablet contains 250 mg /500 mg/
1000 mg of Levetiracetam.
The other ingredients are:
Tablet core: Croscarmellose Sodium, Povidone
K-30, Silica, colloidal anhydrous, Magnesium
Stearate (E470b)
Film-coating contains:
250 mg:
Polyvinyl alcohol – part hydrolyzed, Titanium
dioxide (E171), Macrogol (3350), Talc
500 mg:
Polyvinyl alcohol – part hydrolyzed, Titanium
dioxide (E171), Macrogol (3350), Talc, Iron
oxide yellow (E172)
1000 mg:
Polyvinyl alcohol – part hydrolyzed, Titanium
dioxide (E171), Macrogol (3350), Talc
What Levetiracetam tablet looks like and
contents of the pack
250 mg:
The film-coated tablets are white to off white,
oval, biconvex, debossed ‘L 64’ and break line
on one side and plain on the other side.
500 mg:
The film-coated tablets are yellow coloured,
oval, biconvex, debossed ‘L 65’ and break line
on one side and plain on the other side.
1000 mg:
The film-coated tablets are white to off white,
oval, biconvex, debossed ‘L 67’ and break line
on one side and plain on the other side.
Pack size (s)
Levetiracetam Film-Coated tablets 250 mg,
500 mg and 1000 mg are packed in
PVC-Aluminium Blister pack. The blisters are
further pack in to carton with leaflet in the
following pack size :
250 mg: 20, 30, 50, 60, 100, 200 pack sizes
500 mg: 30, 50, 60, 100, 120, 200 pack sizes
1000 mg: 30, 50, 60, 100, 200 pack sizes
Not all pack sizes may be marketed

Marketing Authorisation
Manufacturer:

Holder

and

Bluefish Pharmaceuticals AB
Torsgatan 11
111 23 Stockholm
Sweden
Medical information
For UK residents only: if you have any questions
or would like more information, call our Medical
Information Department on 0808 178 9241
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Member state
Austria
Czech Republic
Denmark
France

Germany
Hungary
Ireland
Italy
Netherlands
Poland
Portugal
Slovak Republic
Spain

Sweden (RMS)
United Kingdom

Proposed (invented)
names
Levetiracetam Bluefish
500 mg/1000 mg
Filmtabletten
Levetiracetam Bluefish
250 mg/500 mg/1000 mg
potahované tablety
Levetiracetam Bluefish
LEVETIRACETAM
BLUEFISH 250 mg/
500 mg/1000 mg comprimé
pelliculé
Levetiracetam Bluefish
250 mg/500 mg/750 mg/
1000 mg Filmtabletten
Levetiracetam Bluefish
250 mg/500 mg filmtabletta
Levetiracetam Bluefish
250 mg/500 mg/1000 mg
film-coated tablets
Levetiracetam Bluefish
500 mg/1000 mg compresse
rivestite con film
Levetiracetam Bluefish
250 mg/500 mg/1000 mg
filmomhulde tabletten
Levetiracetam Bluefish
Levetiracetam Bluefish
Levetiracetam Bluefish
250 mg/500 mg/1000 mg
filmom obalené tablety
Levetiracetam Bluefish
250 mg/500 mg/1000 mg
comprimidos recubiertos
con película EFG
Levetiracetam Bluefish
Levetiracetam 250 mg/
500 mg/1000 mg
film-coated tablets

The leaflet was last revised in 07.05.2014.

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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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