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LEVETIRACETAM ZENTIVA 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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Package leaflet: Information for the patient

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.

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

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.

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 Zentiva 250 mg, 500 mg,
750 mg and 1000 mg film-coated tablets 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.
Example: if your daily dose is 1000 mg, your
reduced starting dose is 2 tablets of 250 mg
in the morning and 2 tablets of 250 mg in the
evening.

Levetiracetam is used:
 on its own in adults and adolescents from
16 years of age with newly diagnosed
epilepsy, to treat a certain form of epilepsy.
Epilepsy is a condition where patients have
repeated fits (seizures). Levetiracetam is
used for the epilepsy form in which the fits
initially affect only one side of the brain, but
could thereafter extend to larger areas on
both sides of the brain (partial onset seizures
with or without secondary generalization).
Levetiracetam has been given to you by your
doctor to reduce the number of fits.
 as an add-on to other antiepileptic medicines
to treat:

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

o partial onset seizures with or without
generalisation in adults, adolescents,
children and infants from one month of age.
o myoclonic seizures (short, shock-like jerks
of a muscle or group of muscles) in adults
and adolescents from 12 years of age with
juvenile myoclonic epilepsy
o primary generalised tonic-clonic seizures
(major fits, including loss of consciousness)
in adults and adolescents from 12 years of
age with idiopathic generalised epilepsy (the
type of epilepsy that is thought to have a
genetic cause).

might take 2 tablets of 250 mg in the morning
and 2 tablets of 250 mg in the evening.
Dose in infants (1 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.
Oral solution is a formulation more appropriate
to infants and children under the age of 6 years
and to children and adolescents (from 6 to
17 years) weighing less than 50kg and when
tablets don’t allow accurate dosage.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LEVETIRACETAM

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

Do not take Levetiracetam:
 If you are allergic to levetiracetam,
pyrrolidone derivatives or any of the other
ingredients of this medicine (listed in section
6).

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.

Warnings and precautions
Talk to your doctor 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.
 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.

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

Children and adolescents
 Levetiracetam is not indicated in children
and adolescents below 16 years on its own
(monotherapy).

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.

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 stop taking Levetiracetam
If stopping treatment, as with other antiepileptic
medicines, levetiracetam should be
Do not take macrogol (a drug used as a
laxative) for one hour before and one hour after discontinued gradually to avoid an increase
taking levetiracetam as this may result in a loss of seizures. Should your doctor decide to
stop your levetiracetam treatment, he/she will
of its effect.
instruct you about the gradual withdrawal of
levetiracetam.
Taking Levetiracetam with food, drink and
If you have any further questions on the use of
alcohol
this medicine, ask your doctor or pharmacist.
You may take levetiracetam with or without
food. As a safety precaution, do not take
levetiracetam with alcohol.
1

skin, particularly around the mouth, nose,
eyes and genitals (Stevens-Johnson
syndrome), and a more severe form causing
Like all medicines, this medicine can cause
skin peeling in more than 30 % of the body
side effects, although not everybody gets them.
surface (toxic epidermal necrolysis)
Tell your doctor immediately, or go to your
 decreased blood sodium concentration.
nearest emergency department, if you
 rhabdomyolysis (breakdown of muscle
experience:
tissue) and associated blood creatine
• weakness, feel light-headed or dizzy or have
phosphokinase increase. Prevalence is
difficulty breathing, as these may be signs of
significantly higher in Japanese patients
a serious allergic (anaphylactic) reaction
when compared to non-Japanese patients.
• swelling of the face, lips, tongue and throat
(Quincke’s oedema)
Reporting of side effects
• flu-like symptoms and a rash on the face
If you get any side effects, talk to your doctor
followed by an extended rash with a high
or pharmacist. This includes any possible side
temperature, increased levels of liver
enzymes seen in blood tests and an increase effects not listed in this leaflet.
You can also report side effects directly via the
in a type of white blood cell (eosinophilia)
Yellow Card Scheme at: www.mhra.gov.uk/
and enlarged lymph nodes (Drug Reaction
yellowcard. By reporting side effects you can
with Eosinophilia and Systemic Symptoms
help provide more information on the safety of
[DRESS]).
this medicine.
• symptoms such as low urine volume,
tiredness, nausea, vomiting, confusion and
5. HOW TO STORE LEVETIRACETAM
swelling in the legs, ankles or feet, as this
may be a sign of sudden decrease of kidney
Keep this medicine out of the sight and reach
function
of children.
• a skin rash which may form blisters and
look like small targets (central dark spots
Do not use this medicine after the expiry date
surrounded by a paler area, with a dark ring
which is stated on the carton box and blister
around the edge) (erythema multiforme)
after EXP:. The expiry date refers to the last
• a widespread rash with blisters and peeling
day of the month.
skin, particularly around the mouth, nose,
This medicinal product does not require any
eyes and genitals (Stevens-Johnson
special storage conditions
syndrome)
• a more severe form of rash causing skin
Do not throw away any medicines via
peeling in more than 30% of the body
wastewater or household waste. Ask your
surface (toxic epidermal necrolysis)
pharmacist how to throw away medicines
• signs of serious mental changes or if
you no longer use. These measures will help
someone around you notices signs of
protect the environment.
confusion, somnolence (sleepiness),
amnesia (loss of memory), memory
impairment (forgetfulness), abnormal
6. CONTENTS OF THE PACK AND OTHER
behaviour or other neurological signs
INFORMATION
including involuntary or uncontrolled
movements). These could be symptoms of
What Levetiracetam contains
an encephalopathy.
The active substance is levetiracetam.
Levetiracetam Zentiva 250 mg: each filmThe most frequently reported side effects are
coated tablet contains 250 mg levetiracetam.
nasopharyngitis, somnolence (sleepiness),
Levetiracetam Zentiva 500 mg: each filmheadache, fatigue and dizziness. At the
coated tablet contains 500 mg levetiracetam.
beginning of the treatment or dose increase
Levetiracetam Zentiva 750 mg: each filmside effects like sleepiness, tiredness and
coated tablet contains 750 mg levetiracetam.
dizziness may be more common. These effects Levetiracetam Zentiva 1000 mg: each filmshould however decrease over time.
coated tablet contains 1000 mg levetiracetam.
4. POSSIBLE SIDE EFFECTS

Very common (may affect more than 1 user
in 10 people):
 nasopharyngitis
 somnolence (sleepiness), headache

Common (may affect 1 to 10 users in 100
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)
Uncommon (may affect 1 to 10 users in
1,000 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
 elevated/abnormal values in liver function
test
 hair loss, eczema, pruritus
 muscle weakness, myalgia (muscle pain)
 injury
Rare (may affect 1 to 10 users in 10,000
people):
 infection
 decreased number of all blood cell types
 severe allergic reactions (DRESS,
anaphylactic reaction [severe and important
allergic reaction], Quincke’s oedema
[swelling of the face, lips, tongue and throat])
 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
 liver failure, hepatitis
 sudden decrease in kidney function
 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

The other ingredients are:
Tablet core
Povidone 30, Croscarmellose sodium, Silica,
colloidal anhydrous, Sodium stearyl fumarate
Tablet coating
Hypromellose 2910/5, Macrogol 6000, Talc,
Titanium dioxide (E-171), Simeticone emulsion
(water, purified 67.4 %, simeticone 30.0 %,
methylcellulose 2.5 %, sorbic acid 0.1 %)
Levetiracetam Zentiva 250 mg also contains
Indigo carmine aluminium lake (E-132).
Levetiracetam Zentiva 500 mg also contains
Iron oxide yellow (E-172).
Levetiracetam Zentiva 750 mg also contains
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, with length approx.
12.6 mm and width approx. 6.1 mm, scored on
both sides.
Levetiracetam Zentiva 500 mg: Yellow oblong
film-coated tablet, with length approx.
16.1 mm and width approx. 7.6 mm, scored on
both sides.
Levetiracetam Zentiva 750 mg: Orange oblong
film-coated tablet, with length approx.
18.6 mm and width approx. 8.6 mm, scored on
both sides.
Levetiracetam Zentiva 1000 mg: White to
off-white oblong, film-coated tablet, with length
approx. 19.1 mm and width approx. 10.1 mm,
scored on both sides.
The score line is not intended for breaking the
tablet.
Levetiracetam Zentiva 250, 500, 750, 1000 mg
is packed in PVC/Al blisters with 20, 30, 60,
100, 200 tablets.
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.
Manufacturer
Zentiva, k.s., Praha, Česká republika
This leaflet was updated in January 2017.

ZV/575 09

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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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