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LEVETIRACETAM BLUEFISH 1000 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





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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Levetiracetam is and what it is used for
Before you take Levetiracetam
How to take Levetiracetam
Possible side effects
How to store Levetiracetam
Further 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 alone in the treatment of
partial onset seizures with or without secondary
generalisation in patients from 16 years of age,
with newly diagnosed epilepsy.
Levetiracetam is used in patients who are
already taking another antiepileptic medicine
• in the treatment of partial onset seizures,
with or without generalisation in adults
children and infants from 1 month age.
• in the treatment of myoclonic seizures in
patients from 12 years of age with juvenile
myoclonic epilepsy.
• in the treatment of primary generalised
tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic
generalized epilepsy.
2. Before you take Levetiracetam

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Do not take Levetiracetam:
• if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of
Levetiracetam.
Take special care with 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.
Taking other medicines:
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Taking Levetiracetam with food and drink
You may take Levetiracetam with or without
food. As a safety precaution, do not take Levetiracetam with alcohol.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant or if you think you may be
pregnant, please inform your doctor.
Levetiracetam should not be used during
pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. 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 Levetiractam exactly as your doctor
has told you. You should check with your doctor
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
Dosage in adults and adolescents (12 to 17 years)
weighing 50 kg or more:
250 mg 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.
Dosage in infants (6 to 23 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 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 per kg
bodyweight and 60 mg per kg bodyweight
each day.

Dose in infants (1 month to less than 6 months):
An oral solution is a presentation more appropriate to infants
Administration:
Swallow Levetiracetam Tablets 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

170 mm
The frequency of possible side effects listed
below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from
the available data)
Very common:
• somnolence (sleepiness);
• asthenia/fatigue (tiredness).
Common:
• infection, nasopharyngitis;
• decreased number of blood platelets;
• anorexia (loss of appetite), weight increase;
• agitation, depression, emotional instability/
mood swings, hostility or aggression, insomnia, nervousness or irritability, personality
disorders (behavioral problems), thinking
abnormal (slow thinking, unable to concentrate);
• dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity),
ataxia (impaired coordinated movements),
tremor (involuntary trembling), amnesia (loss
of memory), balance disorder (equilibrium
disorder), disturbance in attention (loss of
concentration),
memory
impairment
(forgetfulness);
• diplopia (double vision), vision blurred;
• vertigo (sensation of rotation);
• cough (increase of pre-existing cough);
• abdominal
pain,
nausea,
dyspepsia
(indigestion), diarrhoea, vomiting;
• rash, eczema, pruritus;
• myalgia (muscle pain);
• accidental injury.
Not known:
• decreased number of red blood cells, and/or
white blood cells;
• weight loss;
• abnormal behaviour, anger, anxiety, confusion, hallucination, mentaldisorder, suicide,
suicide attempt and suicidal ideation;
• paraesthesia (tingling); difficulty in controlling movements, uncontrollable muscle
spasms affecting the head, torso and limbs;
• pancreatitis, hepatic failure, hepatitis, liver
function test abnormal;
• hair loss; blistering of the skin, mouth, eyes
and genital area, skin eruption.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

550 mm

5. How to store Levetiracetam
Keep out of reach and sight of children.
• This medicinal product does not require any
special storage conditions.
• Do not use Levetiracetam after expiry date,
which is stateddatestated on carton box and
blister. The expiry date refers to the last day
of that month. after EXP:.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further 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 look 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 PVCAluminium 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 Holder and Manufacturer:
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:
List of proposed (invented) names and
marketing authorization holder in the
concerned member states:
Member state
Austria
Czech Republic
Denmark
France

Greece

Germany
Hungary
Ireland
Italy

Netherlands
Poland
Portugal
Romania
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
500 mg /1000 mg
επικαλυμμένα με λεπηό
υμένιο διζκία
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
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 approved in 10/2011

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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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