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LEVETIRACETAM DR REDDYS 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam Dr. Reddy’s 250 mg, 500 mg, 750 mg, 1000 mg
film-coated Tablets
Levetiracetam
Read all of this leaflet carefully before you or your child 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
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 a certain form of epilepsy.
Epilepsy is a condition where the 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 seizure with or without
secondary generalisation). 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:
− partial onset seizures with or without
generalisation in adults, adolescents,
children and infants from one month of
age.
− 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.
− 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).

2. What you need to know before
you take Levetiracetam
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).

Warnings and 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.
• 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.

Children and adolescents

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

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use any other medicines.
Do not take macrogol (a drug used as laxative)
for one hour before and one hour after taking
levetiracetam as this may results in a loss of its
effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine.
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 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 750mg film-coated
Tablets contain Sunset Yellow FCF
(E110)

Sunset yellow FCF aluminium lake (E110)
colouring agent may cause allergic reactions.

3. How to take Levetiracetam
Always take this medicine exactly as your
doctor or pharmacist has told you to. Check
with your doctor or pharmacist if you are not
sure.
Take the number of tablets following your
doctor’s instructions.
Levetiracetam must be taken twice a day, once
in the morning and once in the evening, at
about the same time each day.

Monotherapy
Dose in adults and adolescents (from 16
years of age):
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
(500 mg each day) during 2 weeks before
giving you the lowest general dose of 1000 mg.
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.

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 (1 month 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.
A levetiracetam 100 mg/ml oral solution is a
formulation more appropriate to infants and
children under the age of 6 years and to
children and adolescent (from 6 to 17 years)
weighing less than 50kg and when tablets don’t
allow accurate dosage.
Method of administration:
Swallow Levetiracetam tablets with a sufficient
quantity of liquid (e.g. a glass of water). You
may take Levetiracetam with or without food.
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.

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.

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 stopping treatment, as with other antiepileptic
medicines, Levetiracetam should be
discontinued gradually to avoid an increase of
seizures.
Should your doctor decide to stop your
Levetiracetam treatment, he/she will instruct
you about the gradual withdrawal of
Levetiracetam.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
The most frequently reported side effects are
nasopharyngitis, somnolence (sleepiness),
headache, fatigue and dizziness. At the
beginning of the treatment or at dose increase
side effects like sleepiness, tiredness and
dizziness may be more common. These effects
should however decrease over time.
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 (lack of energy and
enthusiasm), 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 a 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]);
• decreased blood sodium concentration;
• 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;



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 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 help provide more
information on the safety of this medicine.

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
stated on the carton box and blister after EXP.
The expiry date refers to the last day of the
month.
This medicine 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 tablets contain

The active substance is called levetiracetam.
Each film-coated tablet contains 250 mg;
500 mg; 750 mg; 1000 mg levetiracetam.
The other ingredients are:
Tablet core: povidone K-30; silica, colloidal
anhydrous; magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium
dioxide (E171), macrogol / PEG 3350, Talc
(E553b).
Levetiracetam 250 mg also contains: indigo
carmine aluminium lake (E132);
Levetiracetam 500 mg also contains: iron oxide
yellow (E172);
Levetiracetam 750 mg also contains: sunset
yellow FCF aluminium lake (E110), iron oxide
red (E172).

What Levetiracetam tablets look like
and contents of the pack

Levetiracetam 250 mg tablets: Blue, filmcoated, modified capsule shape, biconvex
tablets debossed with “LVC” on one side and
“250” on other side, ‘2’ and ‘50’ separated with
a bisect line. The tablet can be divided into
equal halves.
Levetiracetam 500 mg tablets: Yellow, filmcoated, modified capsule shape, biconvex
tablets debossed with “LVC” on one side and
“500” on other side, ‘5’ and ‘00’ separated with
a bisect line. The tablet can be divided into
equal halves.
Levetiracetam 750 mg tablets: Orange, filmcoated, modified capsule shape, biconvex
tablets debossed with “LVC” on one side and
“750” on other side, ‘7’ and ‘50’ separated with
a bisect line. The tablet can be divided into
equal halves.
Levetiracetam 1000 mg tablets: White, filmcoated, oval shape, biconvex tablets debossed
with “LVC” on one side and “1000” on other
side, ‘10’ and ‘00’ separated with a bisect line.
The tablet can be divided into equal halves.
Pack sizes: 20, 30, 50, 60, 100 or 200 filmcoated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview
Road, Beverley, East Yorkshire, HU17 0LD,
United Kingdom
This medicinal product is authorized in
Member States of the EEA under the
following names:
Germany: Levetiracetam beta
250/500/750/1000 mg Filmtabletten
United Kingdom: Levetiracetam Dr. Reddy’s
250/500/750/1000 mg film-coated Tablets
This leaflet was last revised in 05/2016

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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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