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LEVETIRACETAM ZENTIVA 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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levetiracetam with alcohol.

Package leaflet:
Information for the patient

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 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.

Levetiracetam Zentiva 250 mg,
500 mg, 750 mg and 1000 mg
film-coated tablets
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.

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.

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

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.
Levetiracetam must be taken twice a day, half
of the daily dose in the morning and half of the
daily dose in the evening, at about the same
time each day.
Take the number of tablets following your
doctor’s instructions.

1. WHAT LEVETIRACETAM IS AND WHAT
IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).

Monotherapy
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 during
2 weeks before giving you the lowest general
dose.

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:
o partial onset seizures with or without
generalisation in adults, adolescents,

children and infants from one month of
age.
o myoclonic seizures in adults and
adolescents from 12 years of age with
juvenile myoclonic epilepsy
o primary generalised tonic-clonic seizures
in adults and adolescents from 12 years of
age with idiopathic generalised epilepsy

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.
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 the age, weight and dose.
The dose should be administered as an oral
solution formulation for children under 25 kg.
General dose: between 20 mg per kg
bodyweight and 60 mg per kg bodyweight each
day.

Oral solution is a presentation more
appropriate to infants and children under the
age of 6 years.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LEVETIRACETAM
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 infants (1 month to less than 6
months):
An oral solution is a presentation more
appropriate to infants.

Warnings and precautions
Talk to your doctor before taking Levetiracetam

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

 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.

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.
The score line is not intended for breaking the
tablet.

Other medicines and Levetiracetam:
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

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

Taking Levetiracetam with food, drink and
alcohol
You may take levetiracetam with or without
food. As a safety precaution, do not take
1

best possible treatment of overdose.
If you forget to take Levetiracetam:
Contact your doctor if you have missed one or
more doses.

help provide more information on the safety of
this medicine.

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

Keep this medicine out of the sight and reach
of children.

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

Do not use this medicine after the expiry date
which is stated on the carton box and blister
after EXP:. The expiry date refers to the last
day of the month.

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

This medicinal product does not require any
special storage conditions.

5. HOW TO STORE LEVETIRACETAM

4. POSSIBLE SIDE EFFECTS

Do not throw away any medicines via
wastewater or household waste. Ask your
Like all medicines, this medicine can cause
pharmacist how to throw away medicines
side effects, although not everybody gets them. you no longer use. These measures will help
Some of the side effects like sleepiness,
protect the environment.
tiredness and dizziness may be more common
at the beginning of the treatment or at dose
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
increase. These effects should however
decrease over time.
What Levetiracetam contains
Very common (may affect more than 1 user The active substance is levetiracetam.
Levetiracetam Zentiva 250 mg: each filmin 10):
coated tablet contains 250 mg levetiracetam.
 nasopharyngitis
Levetiracetam Zentiva 500 mg: each film somnolence (sleepiness), headache
coated tablet contains 500 mg levetiracetam.
Levetiracetam Zentiva 750 mg: each filmCommon (may affect 1 to 10 users in 100):
coated tablet contains 750 mg levetiracetam.
 anorexia (loss of appetite)
 depression, hostility or aggression, anxiety, Levetiracetam Zentiva 1000 mg: each filmcoated tablet contains 1000 mg levetiracetam.
insomnia, nervousness or irritability
 convulsions, balance disorder (equilibrium
The other ingredients are:
disorder), dizziness (sensation of
Tablet core:
unsteadiness), lethargy, tremor
Povidone 30, Croscarmellose sodium, Silica,
(involuntary trembling)
colloidal anhydrous, Sodium stearyl fumarate
 vertigo (sensation of rotation)
Tablet coating:
 cough
Hypromellose 2910/5, Macrogol 6000, Talc,
 abdominal pain, diarrhoea, dyspepsia
Titanium dioxide (E-171), Simeticone emulsion
(indigestion), vomiting, nausea
(water, purified 67.4 %, simeticone 30.0 %,
 rash
methylcellulose 2.5 %, sorbic acid 0.1 %)
 asthenia/fatigue (tiredness)
Levetiracetam Zentiva 250 mg also contains
Uncommon (may affect 1 to 10 users in
Indigo carmine aluminium lake (E-132)
1,000):
Levetiracetam Zentiva 500 mg also contains
 decreased number of blood platelets,
Iron oxide yellow (E-172)
decreased number of white blood cells
Levetiracetam Zentiva 750 mg also contains
 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

Iron oxide red (E-172), Iron oxide yellow (E-172)
What Levetiracetam looks like and contents
of the pack
Film-coated tablet.
Levetiracetam Zentiva 250 mg: Blue oblong
film-coated tablet, scored on both sides.
Levetiracetam Zentiva 500 mg: Yellow oblong
film-coated tablet, scored on both sides.
Levetiracetam Zentiva 750 mg: Orange oblong
film-coated tablet, scored on both sides.
Levetiracetam Zentiva 1000 mg: White to offwhite oblong, film-coated tablet, scored on both
sides.
Levetiracetam Zentiva 250, 500, 750, 1000 mg
is packed in PVC/Al blisters with 20, 30, 60,
100, 200 tablets.

Rare (may affect 1 to 10 users in 10,000):
 infection
 decreased number of all blood cells 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.

It means 2, 3, 6, 10, 20 blisters, each
containing 10 tablets in one folding box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.

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 at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can

Manufacturer
Zentiva, k.s., Praha, Česká republika
This leaflet was updated in July 2014.

ZV/532 77

This line = the place a bend of a leaflet

10

8

direction of Code reading

2

10

direction of Code reading

back side without optical and look codes

Size :
160/400 mm
2
Bible paper 45 g/m
Optical code: design and location according artwork
text on the both sides of the leaflet

UNIVERSAL 160x400 mm - prekládaný

Master for leaflet print

Fiber direction

2

8

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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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