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LEVETIRACETAM AMNEAL 500 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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

1. What Levetiracetam Amneal is and what it is used for


Levetiracetam Amneal film-coated tablets are an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Amneal 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:
• partial onset seizures with or without generalisation in adults, adolescents, children and infants
from one month of age
• myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic
epilepsy.
• primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with
idiopathic generalised epilepsy.

2. What you need to know before you take Levetiracetam Amneal
Do not take Levetiracetam Amneal:
–– 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 or pharmacist before taking Levetiracetam Amneal:
–– 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 Amneal 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 Amneal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Levetiracetam Amneal with food, drink and alcohol
You may take Levetiracetam Amneal with or without food. As a safety precaution, do not take
Levetiracetam Amneal with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor.
Levetiracetam Amneal should not be used during pregnancy unless clearly necessary. The potential risk
to your unborn child is unknown. Levetiracetam Amneal 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.

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Driving and using machines:
Levetiracetam Amneal may impair your ability to drive or operate any tools or machinery, as Levetiracetam
Amneal 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 Amneal750 mg contains Sunset Yellow FCF (E110):
Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

3. How to take Levetiracetam Amneal


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Levetiracetam Amneal 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 and 3,000 mg each day.
When you will first start taking Levetiracetam Amneal, your doctor will prescribe you a lower dose during
2 weeks before giving you the lowest general dose.
250mg
Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.
500mg
Example: if your daily dose is 2,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.
750mg
Example: if your daily dose is 3,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.
1000mg
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.
250mg
Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.
500mg
Example: if your daily dose is 1,000 mg, you must take one tablet in the morning and one tablet in the
evening.
750mg
Example: if your daily dose is 1,500 mg, you must take one tablet in the morning and one tablet in the
evening.
1000mg
Example: if your daily dose is 2,000 mg, you must take one tablet in the morning and one 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 Amneal according
to the age, weight and dose.
A Levetiracetam Amneal 100 mg/ml 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.
250mg
Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet in the
morning and 1 tablet in the evening.
Dose in infants (1 month to less than 6 months):
A Levetiracetam Amneal 100 mg/ml oral solution is a presentation more appropriate to infants.
Method of administration:
Swallow Levetiracetam Amneal tablets with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:
–– Levetiracetam Amneal is used as a chronic treatment. You should continue Levetiracetam Amneal
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 Amneal treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam Amneal.
If you take more Levetiracetam Amneal than you should:
The possible side effects of an overdose of Levetiracetam Amneal 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.

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If you forget to take Levetiracetam Amneal:
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 Amneal:
If stopping treatment, as with other antiepileptic medicines, Levetiracetam Amneal 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.
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 in 10 people
–– nasopharyngitis;
–– 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,
tremor (involuntary trembling);
–– vertigo (sensation of rotation);
–– cough;
–– abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
–– rash;
–– asthenia/fatigue (tiredness).
Uncommon: may affect up to 1 in 100 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;
–– liver function test abnormal;
–– hair loss, eczema, pruritus;
–– muscle weakness, myalgia (muscle pain);
–– injury.
Rare: may affect up to1 in 1,000 people
–– 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 multiform), 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).

6. Contents of the pack and other information
What Levetiracetam Amneal contains
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: Maize starch, Silica colloidal anhydrous (E551), Povidone (K-30) (E1201), Talc (E553b),
Magnesium stearate (E470b).
Film-coating:
250 mg: Hypromellose 3cp & 6cp (E464), Titanium Dioxide (E 171), Macrogol 4000, Indigo carmine
aluminium lake (E132).
500 mg: Hypromellose 3cp & 6cp (E464), Titanium Dioxide (E 171), Macrogol 4000, Iron oxide yellow
(E172).
750 mg: Hypromellose 3cp & 6cp (E464), Titanium Dioxide (E 171), Macrogol 4000, Indigo carmine
aluminium lake (E132), Sunset yellow aluminium lake (E110), Iron oxide red. (E172)
1000 mg: Hypromellose 5 cp (E464), Titanium Dioxide (E 171), Macrogol 400.

What Levetiracetam Amneal looks like and contents of the pack
Film-coated tablet.
Levetiracetam Amneal 250 mg film-coated tablets
Blue oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘10’
on one side and plain on the other side. The tablet can be divided into equal doses.
Levetiracetam Amneal 500 mg film-coated tablets
Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘11’
on one side and plain on the other side. The tablet can be divided into equal doses.
Levetiracetam Amneal 750 mg film-coated tablets
Orange oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and
‘12’ on one side and plain on the other side. The tablet can be divided into equal doses.
Levetiracetam Amneal 1000 mg film-coated tablets
White modified oval shaped, biconvex film-coated tablets debossed with a deep break line separating ‘E’
and ‘13’ on one side and plain on the other side. The tablet can be divided into equal doses.
Levetiracetam Amneal film-coated tablets are packaged in PVC/PE/PVdC – Aluminium foil blister pack or
HDPE bottle with polypropylene cap pack.
Pack size:
250 mg film-coated tablets
Blister pack: 10, 20, 30, 50, 60, 100 & 200 film-coated tablets
Bottle pack: 30 & 500 film-coated tablets
500 mg, 750 mg & 1000 mg film-coated tablets
Blister pack: 10, 30, 50, 60, 100 & 200 film-coated tablets
Bottle pack: 30 & 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

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



Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Keep this medicine out of the sight and reach of children.


This leaflet was last revised in: 06/2014

5. How to store Levetiracetam Amneal

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, blister & bottle label
after EXP. The expiry date refers to the last day of the 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.



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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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