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LEVETIRACETAM-LUPIN 250MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Levetiracetam-Lupin 250mg, 500mg, 750mg and 1000mg FilmCoated 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 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 Tablets is and what it is used for
2. What you need to know before you take Levetiracetam Tablets
3. How to take Levetiracetam Tablets
4. Possible side effects
5. How to store Levetiracetam Tablets
6. Contents of the pack and other information
1. What Levetiracetam tablets is and what it is used for
Levetiracetam film-coated tablets are an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).
Levetiracetam Tablets 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
generalization.
• As an add-on to other antiepileptic medicines to treat:
• partial onset seizures with or without generalization 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 generalized epilepsy.
2. What you need to know before you take Levetiracetam tablets
Do not take Levetiracetam Tablets:
• if you are allergic (hypersensitive) to levetiracetam 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
tablets
• 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.
Other medicines and levetiracetam tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Levetiracetam with food, drink and alcohol
You can take these tablets with or without food. As a safety
precaution, do not take Levetiracetam Tablets with alcohol.
Pregnancy, breast-feeding and fertility
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 750mg tablets contains Sunset yellow
The coating on Levetiracetam 750 mg tablets contains 0.13mg Sunset
yellow FCF (E110) per tablet which may cause allergic reactions.
3. How to take Levetiracetam tablets
Always take this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
Levetiracetam tablets 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, your doctor will
prescribe you a lower dose during 2 weeks before, giving you the
lowest general dose.

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 50kg:
Your doctor will prescribe the most appropriate pharmaceutical form
of levetiracetam according to the age, weight and dose.
Levetiracetam 100mg/ml oral solution is a presentation more
appropriate to infants and children under the age of 6 years.
General dose: between 20mg per/kg bodyweight and 60mg per/kg
bodyweight each day.
Dosage in infants (1 month to less than 6 months):
Levetiracetam 100mg/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).
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 treatment, he/she will
instruct you about the gradual withdrawal of levetiracetam tablets.
If you take more Levetiracetam tablets 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 tablets:
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 tablets:
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 or pharmacist.
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: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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, diarrhoea, 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, 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
Rare
• decreased blood sodium concentration;
• 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;
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
Website: 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 Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton 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 Tablets contains
The active substance is levetiracetam. Each tablet contains 250mg ,
500mg, 750mg or 1000mg levetiracetam.
The other ingredients are:
Common Tablet Core:
Maize starch, silica, colloidal anhydrous, croscarmellose sodium,
povidone K30, cellulose, microcrystalline, talc and magnesium
stearate.
Levetiracetam 250mg Tablets are coated with: Opadry 84F80803
containing polyvinyl alcohol-part.hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc and Indigo carmine
aluminium lake (E132).
Levetiracetam 500mg Tablets are coated with: Opadry 84F82508
containing polyvinyl alcohol-part.hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc and iron oxide yellow
(E172).
Levetiracetam 750mg Tablets are coated with: Opadry 84F84674
containing polyvinyl alcohol-part.hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc, iron oxide yellow
(E172), iron oxide red (E172) and sunset yellow FCF aluminium lake
(E110).
Levetiracetam 1000mg Tablets are coated with: Opadry 84F58775

containing polyvinyl alcohol-part.hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000 and talc.
What Levetiracetam Tablets look like and contents of the pack:
• Levetiracetam 250mg tablets are blue, oblong shaped, biconvex
film coated tablet debossed with “250” on one side and score line
on the other side. The tablets can be divided into equal doses.
• Levetiracetam 500mg tablets are yellow, oblong shaped, biconvex
film coated tablet debossed with “500” on one side and score line
on the other side. The tablets can be divided into equal doses.
• Levetiracetam 750mg tablets are peach coloured, oblong shaped,
biconvex film coated tablet debossed with “750” on one side and
score line on the other side. The tablets can be divided into equal
doses.
• Levetiracetam 1000mg tablets are white to off white, oblong
shaped, biconvex film coated tablet debossed with “1000” on one
side and score line on one side. The tablets can be divided into
equal doses.
Levetiracetam tablets are available in blister packs containing 10, 20,
30, 50, 60, 100, 120 and 200 tablets* packaged in cartons.
* Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Ltd.
Victoria Court
Bexton Road
Knutsford
Cheshire, WA16 0PF
UK
The leaflet was last revised in 04/2014
Manufacturer Code No. GO/DRUGS/654

ID#: 234095

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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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