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LEVETIRACETAM GLENMARK 1000 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM FORM I

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Package leaflet:
Information for the user
Levetiracetam Glenmark 250 mg
Film-Coated Tablets
Levetiracetam Glenmark 500 mg
Film-Coated Tablets
Levetiracetam Glenmark 750 mg
Film-Coated Tablets
Levetiracetam Glenmark 1000 mg
Film-Coated Tablets
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,
pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
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. W
 hat Levetiracetam is and what it is used
for
Levetiracetam film-coated tablets are an antiepileptic
medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam is used:
• on its own in patients 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 patients from one month of age
- myoclonic seizures in patients from 12 years of age
with juvenile myoclonic epilepsy
- primary generalised tonic-clonic seizures in patients
from 12 years of age with idiopathic generalised
epilepsy.

2. What you need to know before you take
Levetiracetam
Do not take Levetiracetam:
• if you are allergic to levetiracetam or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse 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 slowdown 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 antiepileptics 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.
Other medicines and Levetiracetam
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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
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 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.
Levetiracetam 750 mg contains Sunset yellow FCF
(E110)
May cause allergic reactions.
The other strengths of Levetiracetam tablets do not
contain this ingredient.

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, 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):
General dose: between 1,000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam, you doctor
will prescribe you a lower dose during 2 weeks before
giving you the lowest general dose.
250 mg:
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:
Example: if your daily dose is 2,000 mg, you must take 2
tablets in the morning and 2 tablets in the evening.
750 mg:
Example: if your daily dose is 3,000 mg, you must take 2
tablets in the morning and 2 tablets in the evening.
1000 mg:
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
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.
250 mg:
Example: if your daily dose is 1,000 mg, you must take 2
tablets of in the morning and 2 tablets in the evening.
500 mg:
Example: if your daily dose is 1,000 mg, you must take 1
tablet in the morning and 1 tablet in the evening.
750 mg:
Example: if your daily dose is 1,500 mg, you must take 1
tablet in the morning and 1 tablet in the evening.
1000 mg:
Example: if your daily dose is 2,000 mg, you must take 1
tablet in the morning and 1 tablet 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 the
age, weight and dose.
Levetiracetam 100 mg/mg 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.
250 mg:
Example: a general dose of 20 mg per kg bodyweight
each day, you must give your 25 kg child 1 tablet of in the
morning and 1 tablet in the evening.
Dose in infants (1 month to less than 6 months):
Levetiracetam 100 mg/ml oral solution is a presentation
more appropriate to infants.
Method of administration:
Swallow Levetiracetam tablets with a sufficient quantity
of liquid (e.g. a glass of water).
250 mg:
The score line is only there to help you break the tablet if
you have difficulty swallowing it whole.
500 mg:
The tablet can be divided into equal doses.
750 mg:
The score line is only there to help you break the tablet if
you have difficulty swallowing it whole.
1000 mg:
The tablet can be divided into equal doses.
Duration of treatment:
• Levetiracetam is used as a chronic treatment. You
should continue Levetiracetam treatment for as long as
your doctor has told you.



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

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor if you have any of the following and they
worry you.
Some of the side effects like 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.
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:
• nasopharyngitis;
• somnolence (sleepiness), headache.
Common:
• 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, diarrhea, dyspepsia (indigestion), ,
vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon:
• 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,
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.
Rare:
• infection;
• decreased number of red blood cells, and/or white
blood cells;
• 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;
• blistering of the skin, mouth, eyes and genital area,
skin eruption.
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet.

5. How to store Levetiracetam
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
storage conditions.
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 that month.
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.

6. Contents of the pack and other information
What Levetiracetam contains
The active substance is levetiracetam.
Each Film-coated tablet contains 250 mg of levetiracetam.
Each Film-coated tablet contains 500 mg of levetiracetam.
Each Film-coated tablet contains 750 mg of levetiracetam.
Each Film-coated tablet contains 1000 mg of
levetiracetam.
The other ingredients are:
Tablet core:
Maize starch, Croscarmellose sodium, Povidone (K 30),
Silica colloidal anhydrous, Talc and Magnesium Stearate.
Tablet coating:
Polyvinyl alcohol, Titanium dioxide (E171), Macrogol
3350, Talc and colourants*.

The colourants are:
250 mg: Indigo carmine (E132).
500 mg: Iron oxide yellow (E172)
750 mg: Sunset yellow FCF (E110), Iron oxide red
(E172).
1000 mg: no additional colourant.
What Levetiracetam looks like and contents of the
pack
Levetiracetam 250 mg film-coated tablets are blue
coloured, oblong shaped, scored on one side film-coated
tablets debossed with “H” on one side and “87” on other
side.
Levetiracetam 500 mg film-coated tablets are yellow
coloured, oblong shaped, scored on one side, film-coated
tablets debossed with “H” on one side and “88” on the
other.
Levetiracetam 750 mg film-coated tablets are orange
coloured, oblong shaped, scored on one side, film-coated
tablets debossed with “H” on one side and “90” on the
other side.
Levetiracetam 1000 mg film-coated tablets are white
coloured, oblong shaped, scored on one side, film-coated
tablets debossed with “H” on one side and “91” on the
other side.
Levetiracetam is supplied in the following pack sizes:
Levetiracetam 250 mg are available in blister packs
containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 filmcoated tablets.
Levetiracetam 500 mg are available in blister packs
containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 filmcoated tablets.
Levetiracetam 750 mg are available in blister packs
containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 filmcoated tablets.
Levetiracetam 1000 mg are available in blister packs
containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 filmcoated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex, HA3 0BU
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This leaflet was last revised in 08/2015.

PRODUCT:

Amends:

Levetiracetam Glenmark 250,
500, 750, 1000 mg FCT UK

Cutter Guide
Black

Times New Roman ALL 9 pts
body copy (min)

Approval:

6
5.8.15

Signed (digitally)

gc

GM0286

Artwork Signoff(digitally):

9.4.15
Leaflet (PIL)
260x245 mm

Internal proof approval

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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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