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LEVETIRACETAM ARROW APS 750 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam Arrow ApS 250, 500, 750 & 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 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.
What is in this leaflet:
1. What Levetiracetam Tablets are and what they are 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 ARE AND WHAT THEY ARE USED FOR
Levetiracetam is an anti-epileptic 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 partial onset seizures with or without secondary generalisation.
as an add-on to other antiepileptic medicines to treat:
o partial onset seizures with or without generalisation in adults, adolescents and
children with a bodyweight of at least 25 kg with epilepsy
o myoclonic seizures in adults and adolescents from 12 years of age with juvenile
myoclonic epilepsy
o primary generalised tonic-clonic seizures in adults and adolescents from 12 years of
age with idiopathic generalised epilepsy

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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
Levetiracetam Tablets (listed in section 6).
Warning and Precautions
Talk to your doctor before taking Levetiracetam Arrow 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
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Levetiracetam Tablets with food, drink and alcohol
You may take levetiracetam with or without food. As a safety precaution, do not take
levetiracetam with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor.
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 to happen 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 TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

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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 1000 mg (4 250 mg tablets, 2 500 mg tablets, 1 1000 mg tablet) and
3,000 mg (12 250 mg tablets, 6 500 mg tablets, 3 1000 mg tablets) 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, you must take 2 250 mg tablets in the morning and 2
250 mg tablets in the evening.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50kg or more:
General dose: between 1,000 mg (4 250 mg tablets, 2 500 mg tablets, 1 1000 mg tablet) and
3,000 mg (12 250 mg tablets, 6 500 mg tablets, 3 1000 mg tablets) each day.
Example: if your daily dose is 1000 mg, you must take 2 250 mg tablets in the morning and 2
250 mg tablets 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.
An 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.
Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg
child 1 250 mg tablet in the morning and 1 250 mg tablet in the evening.
Dose in infants (1 month to less than 6 months):
Levetiracetam 100 mg/ml 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 levetiracetam treatment, he/she will
instruct you about the gradual withdrawal of levetiracetam.

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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 dose.
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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, levetiracetam can cause side effects, although not everybody gets them.

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.

Very common (may affect more than 1 user in 10):
nasopharyngitis;
somnolence (sleepiness), headache;
Common (may affect 1 to 10 users in 100):
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):
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;

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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 1 to 10 users in 10,000):
infection;
decreased number of all blood cell types
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;
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).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.

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 stated on the carton box and blister after
“EXP”. The expiry date refers to the last day of that 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 protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Levetiracetam Tablets contain
The active substance is called levetiracetam.
Each tablet contains either 250, 500, 750 or 1000 mg of levetiracetam.

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The other ingredients are:
Tablet core: Maize starch, povidone, talc, purified, silica, colloidal anhydrous, magnesium
stearate
Film coating:
250 mg: Macrogol, poly(vinyl alcohol), talc, titanium dioxide (E 171), Indigo carmine
Aluminium Lake (E 132)
500 mg: Macrogol, poly(vinyl alcohol), talc, titanium dioxide (E 171), Iron oxide, yellow (E
172) and Indigo carmine Aluminium Lake (E 132)
750 mg: Macrogol, poly(vinyl alcohol), talc, titanium dioxide (E 171), Carmine (E 120) and
Quinoline yellow Aluminium Lake (E 104)
1000 mg: Macrogol, poly(vinylalcohol), talc and titanium dioxide (E 171)

What Levetiracetam Tablets look like and contents of the pack
Film-coated tablet.
Levetiracetam 250 mg tablets are blue, oval shaped coated tablets with ‘LE breakline 250’ on
one side and ‘ ’ on the other side. The tablet can be divided into equal halves.
Levetiracetam 500 mg tablets are yellow, oval shaped coated tablets with ‘LE breakline 500’
on one side and ‘ ’ on the other side. The tablet can be divided into equal halves.
Levetiracetam 750 mg tablets are orange, oval shaped coated tablets with ‘LE breakline 750’
on one side and ‘ ’ on the other side. The tablet can be divided into equal halves.
Levetiracetam 1000 mg tablets are white, oval shaped coated tablet with ‘LE breakline 1000’
on one side and ‘ ’ on the other side. The tablet can be divided into equal halves.
PVC/PVDC/lidding Aluminium foil blisters
Levetiracetam 250 mg tablets: in pack sizes of 20, 30, 50, 60, 100, 200 film-coated tablets per
carton.
Levetiracetam 500 mg tablets: in pack sizes of 10, 20, 30, 50, 60, 100, 120, 200 film-coated
tablets per carton.
Levetiracetam 750 mg tablets: in pack sizes of 20, 30, 50, 60, 80, 100, 200 film-coated tablets
per carton.
Levetiracetam 1000 mg tablets: in pack sizes of 10, 20, 30, 50, 60, 100, 200 film-coated
tablets per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow ApS, Sankt Peders Stræde 2,1, 4000 Roskilde, Denmark

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Manufacturer:
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Hal Far BBG 3000, Malta.

This leaflet was last revised in 12/2013

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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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