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LEVETIRACETAM MYLAN 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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Package leaflet: Information for the patient
Levetiracetam Generics 250 mg Film-coated Tablets
Levetiracetam Generics 500 mg Film-coated Tablets
Levetiracetam Generics 750 mg Film-coated Tablets
Levetiracetam Generics 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 Generics is and what it is used for
2.
What you need to know before you take Levetiracetam Generics
3.
How to take Levetiracetam Generics
4.
Possible side effects
5.
How to store Levetiracetam Generics
6.
Contents of the pack and other information
1.

What Levetiracetam Generics is and what it is used for

Levetiracetam Generics Film-coated Tablets contains the active substance levetiracetam, which is an
antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Generics 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 Generics is used for the epilepsy form in which the fits initially affect only one side
of the brain, but could then extend to larger areas on both sides of the brain (partial onset seizures
with or without secondary generalization). Levetiracetam Generics 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 Generics

Do not take Levetiracetam Generics:

if you are allergic to levetiracetam, other pyrrolidone derivatives or any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam Generics:

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if
your dose should be adjusted.
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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 thoughts,
please contact your doctor.
Children and adolescents
If you notice any slow down in the growth or unexpected puberty development of your child, please
contact your doctor.
Levetiracetam is not intended for use on its own (monotherapy) in children and adolescents below 16
years.
Other medicines and Levetiracetam Generics
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines, including medicines obtained without a prescription.
It is especially important to inform your doctor if you are taking:

methotrexate (a medicine for psoriasis, inflammation and some cancers).

macrogol (a medicine for constipation). You should not take macrogol for one hour before and
one hour after taking levetiracetam as this may decrease its effect.

probenecid (medicine for gout).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Levetiracetam Generics should not be used during pregnancy unless clearly necessary, as there is a
risk of harm to your unborn child.
Breast-feeding is not recommended during treatment as levetiracetam passes into breast milk.
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.

3.

How to take Levetiracetam Generics

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Take the number of tablets following your doctor’s instructions.
Levetiracetam Generics must be taken twice a day, once in the morning and once in the evening, at
about the same time each day.
Swallow Levetiracetam Mylan tablets with a sufficient quantity of liquid (e.g. a glass of water). You
may take this medicine with or without food.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Monotherapy
Dose in adults and adolescents (from 16 years of age):
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General dose: between 1000 mg and 3000 mg each day.
When you will first start taking Levetiracetam Generics, 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 1000 mg and 3000 mg each day.
Example: if your daily dose is 1000 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.
An oral solution may be available which 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 50 kg
and when tablets do not allow accurate dosing.
Duration of treatment:

Levetiracetam Generics is used as a chronic treatment. You should continue Levetiracetam
Generics 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 Generics than you should
The possible side effects of an overdose of Levetiracetam Generics 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 Generics
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 Generics
If stopping treatment, as with other antiepileptic medicines, Levetiracetam Generics should be
discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your
treatment with this medicine, he/she will instruct you about a gradual withdrawal.
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 a sore nose or throat (nasopharyngitis), sleepiness
(somnolence), headache, fatigue and dizziness. At the beginning of treatment or at dose increase, side
effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment
or at dosage increase. These effects should however decrease over time.

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Tell your doctor immediately, or go to your nearest emergency department, if you experience:


weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a
serious allergic (anaphylactic) reaction



swelling of the face, lips, tongue and throat (Quincke’s oedema)



flu-like symptoms and a rash on the face followed by an extended rash with a high
temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia
and Systemic Symptoms [DRESS]).



symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in
the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function



a skin rash which may form blisters and look 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)



a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic
epidermal necrolysis)



signs of serious mental changes or if someone around you notices signs of confusion,
somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness),
abnormal behaviour or other neurological signs including involuntary or uncontrolled
movements). These could be symptoms of an encephalopathy.




thinking about suicide or attempting suicide
severe abdominal pain that spreads to the back, which may be signs of a swollen pancreas.

Tell your doctor straight away if you notice any of the following, as you may need medical
attention.
Uncommon (may affect up to 1 in 100 people):

increased signs of infection such as sore throat, fever, mouth ulcers, which may be caused by a
reduction in white blood cells
Rare (may affect up to 1 in 1,000 people)

signs of liver problems such as abdominal pain, fever, pale stools or dark urine, yellowing of
the skin and eyes

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase
increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.
Other side effects include:
Very common: may affect more than 1 in 10 people
 nasopharyngitis (sore nose or throat)
 somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 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
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rash
asthenia/fatigue (weakness/tiredness).

Uncommon: may affect up to 1 in 100 people
 decreased number of blood platelets, causing you to bruise or bleed more easily or for longer than
usual
 weight decrease, weight increase
 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: may affect up to 1 in 1,000 people
 decreased number of all blood cell types
 infection
 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)
 decreased blood sodium concentration.
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 Generics

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.
This medicinal product 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 any medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Levetiracetam Generics contains
- The active substance is levetiracetam. Each film-coated tablet contains either 250 mg, 500 mg,
750 mg or 1000 mg levetiracetam.

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-

The other ingredients are: Tablet core: Povidone; microcrystalline cellulose; croscarmellose
sodium; magnesium stearate; sodium laurilsulfate; colloidal anhydrous silica. Film coat:
titanium dioxide (E171); polydextrose; hypromellose; triacetin; macrogol 8000, macrogol 400.

What Levetiracetam Generics looks like and contents of the pack
Film-coated Tablet
250 mg tablet: A white film-coated, round, biconvex, beveled-edge tablet marked with “M” above the
score and “613” below the score on one side of the tablet and blank on the other side.
500 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked with “M”
on the left of the score and “615” on the right of the score on one side of the tablet and blank on the
other side.
750 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked with “M”
on the left of the score and “617” on the right of the score on one side of the tablet and blank on the
other side.
1000 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked with “M”
on the left of the score and “619” on the right of the score on one side of the tablet and blank on the
other side.
Levetiracetam Generics Film-coated Tablets are packed in blister packs containing 20, 30, 60, 100 and
200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
This leaflet was last revised in 01/2017.

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Expand Transcript

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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