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LEVETIRACETAM SANDOZ 250 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levetiracetam 250 mg Film-coated Tablets

SZ00000LT000

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 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

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 is an antiepileptic medicine (a medicine
used to treat seizures in epilepsy).
This medicine 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 1
month 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

child cannot be completely excluded. This medicine 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.

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.
Levetiracetam 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.

What you need to know before you take
Levetiracetam

Monotherapy

Do NOT take Levetiracetam:
• if you are allergic (hypersensitive) to levetiracetam or
any of the other ingredients of this medicine (listed in
Section 6).

Dose in adults and adolescents (from 16 years of age):
General dose: between 1,000 mg and 3,000 mg each day.
When you first start taking Levetiracetam, your doctor
will prescribe you a lower dose for 2 weeks before
giving you the lowest general dose.

Warnings and precautions
Talk to your doctor before taking Levetiracetam if you:
• have kidney problems, follow your doctor’s
instructions, your dose may need to be adjusted.
• notice any slow down in the growth of your child or
unexpected puberty development, please contact
your doctor.
• notice an increase in seizure severity (e.g. increased
number), please contact your doctor.
• have any symptoms of depression and / or suicidal
ideation, please contact your doctor. A small number
of people being treated with antiepileptics such as
Levetiracetam have had thoughts of harming or killing
themselves.

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.
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 (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 age,
weight and dose.

Other medicines and Levetiracetam
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

Levetiracetam with food, drink and alcohol
You can take Levetiracetam with or without food. As a
safety precaution, do not take Levetiracetam with alcohol.

Levetiracetam 100 mg/ml oral solution is a presentation
more appropriate to infants and children under the age
of 6 years.

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. A risk of birth defects for your unborn

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 might give your 25 kg child 1 tablet of
250 mg in the morning and 1 tablet of 250 mg in the
evening.
Continued on the next page >>

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Dose in infants (1 month to less than 6 months):
Levetiracetam 100 mg/ml oral solution is a presentation
more appropriate to infants.

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).

Method of 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 the 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 your doctor decides to stop your
treatment, he/she will instruct you to gradually
withdraw the treatment.

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: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

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 have taken more tablets than
you should. Your doctor will establish the best possible
treatment of overdose.

5

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 tablet.

If you stop taking Levetiracetam
If you are stopping treatment, as with other antiepileptic
medicines, Levetiracetam should be discontinued
gradually to avoid an increase in seizures.

Keep this medicine out of the sight and reach of children.
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 the month. The
shelf life after first opening of the bottle is 100 days.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

How to store Levetiracetam

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.

Possible side effects

Store in the original package in order to protect from
moisture.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

6

Some side effects such as 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.

Contents of the pack and other
information

What Levetiracetam Film-coated Tablets contain
The active substance is called levetiracetam.

Very common: may affect more than 1 in 10 people
• nasopharyngitis;
• somnolence (sleepiness), headache.

The other ingredients are:
Tablet core: povidone K25, cellulose microcrystalline,
croscarmellose sodium, crospovidone (type A), silica
colloidal anhydrous, talc, magnesium stearate.

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,
tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion),
vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Film-coating: hypromellose, hydroxypropylcellulose,
macrogol type 6000, titanium dioxide (E171), talc, indigo
carmine (E132).
Levetiracetam 250 mg Film-coated Tablets are
packaged in OPA/Al/PVC - Al blisters placed into
cardboard boxes containing 10, 20, 28, 30, 50, 50 x 1,
60, 100, 120 and 200 film-coated tablets or HDPE
bottles with polypropylene screw cap and silicagel
capsule placed into cardboard boxes containing 10, 20,
30, 50, 60, 100, 120 and 200 film-coated tablets.
Not all pack sizes may be marketed.

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;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Each film-coated tablet contains 250 mg levetiracetam.

What Levetiracetam looks like and contents of the pack
Light blue, oval, biconvex film-coated tablets, scored on
both sides, debossed with LVT / 250 on one side.
The tablet can be divided into equal halves.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.

Manufacturer:
Lek Pharmaceuticals d.d.Verovškova 57, 1526,
Ljubljana, Slovenia or LEK S.A., ul. Podlipie 16, 95-010
Stryków, Poland or LEK S.A., ul. Domaniewska 50 C,
02-672 Warszawa, Poland or Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472
Targu-Mures, Romania.

Rare: may affect up to 1 in 1,000 people
• infection;
• decreased number of all blood cell types;
• severe hypersensitivity reactions (DRESS);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems),

This leaflet was last revised in 01/2016.

Artwork Proof Box
Ref: V017 - Register additional pack sizes
Proof no.
004.0

Date prepared:
15/01/2016

Colours:
Black
Black 20%
Dimensions: 165 x 310 mm

Font size:
8pt
Fonts:
Helvetica

SZ00000LT000

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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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