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LEVETIRACETAM SCIECURE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM

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Package Leaflet: Information for the user
Levetiracetam Sciecure 100 mg/ml concentrate for solution for infusion
Levetiracetam
Read all of this leaflet carefully before you or your child are given 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 is and what it is used for
2.
What you need to know before you are given Levetiracetam
3.
How Levetiracetam is given
4.
Possible side effects
5.
How to store Levetiracetam
6.
Contents of the pack and other information

1.

What Levetiracetam is and what it is used for

Levetiracetam is an antiepileptic 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 a certain form of epilepsy. Epilepsy is a condition where the
patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in
which the fits initially affect only one side of the brain, but could thereafter extend to
larger areas on both sides of the brain (partial onset seizure with or without
secondary generalisation). Levetiracetam 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 and
children from 4 years 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).
Levetiracetam concentrate for solution for infusion is an alternative for patients when
administration of the antiepileptic oral Levetiracetam medicine is temporarily not feasible.

2.

What you need to know before you are given Levetiracetam

Do not use Levetiracetam

if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other
ingredients of this medicine (listed in Section 6).

Warnings and precautions
Talk to your doctor before you are given 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 slow down in the growth or unexpected puberty development of your
child, 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.
Children and adolescents

Levetiracetam is not indicated in children and adolescents below 16 years on it’s own
(monotherapy)
Other medicines and Levetiracetam
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking
levetiracetam as this may results in a reduction of its effect.
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 for advice before taking this medicine.
Levetiracetam should not be used during pregnancy unless clearly necessary. A risk of birth
defects for your unborn child cannot be completely excluded. 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 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.
Levetiracetam contains sodium
One maximum single dose of Levetiracetam concentrate for solution for infusion contains
2.49 mmol (or 57.21mg) of sodium (0.83 mmol (or 19.07 mg) of sodium per vial). This
should be taken into consideration if you are on a controlled sodium diet.

3.

How Levetiracetam is given

A doctor or a nurse will administer you Levetiracetam as an intravenous infusion.
Levetiracetam must be administered twice a day, once in the morning and once in the
evening, at about the same time each day.
The intravenous formulation is an alternative to your oral administration. You can switch
from film-coated tablets or from an oral solution to the intravenous formulation or reverse
directly without dose adaptation. Your total daily dose and frequency of administration
remain identical.
Monotherapy

Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3,000 mg each day.
When you are first start given 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 children (4 to 11 years) and adolescents (12 to 17 years) weighing less than
50 kg:
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Method and route of administration
Levetiracetam is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and
infused over 15 minutes.
For doctors and nurses, more detailed direction for the proper use of Levetiracetam is
provided in section 6.
Duration of treatment

There is no experience with administration of intravenous levetiracetam for a longer
period than 4 days.
If you stop using Levetiracetam
If stopping treatment, as with other antiepileptic medicines, Levetiracetam should be
discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop
your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of
Levetiracetam.
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 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.

The most frequently reported adverse reactions were nasopharyngitis, somnolence
(sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose
increase side effects like sleepiness, tiredness and dizziness may be more common. These
effects should however decrease over time.
Very common: may affect more than 1 user in 10 people
 nasopharyngitis;
 somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100 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;

rash;

asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000 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;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.
Rare: may affect 1 to 10 users in 10,000 people

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic
reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

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;
liver failure, hepatitis;
sudden decrease in kidney function;
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).
rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine
phosphokinase increase. Prevalence is significantly higher in Japanese patients when
compared to non-Japanese patients.

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 national
reporting system listed in the Yellow Card Scheme 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

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 vial and carton box after
EXP:. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6.

Contents of the pack and other information

What Levetiracetam contains
The active substance is levetiracetam.
Each ml of solution for infusion contains 100 mg of levetiracetam.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride,
water for injections.
What Levetiracetam looks like and contents of the pack
Levetiracetam concentrate for solution for infusion is a clear, colorless, liquid. Levetiracetam
concentrate for solution for infusion is packed in a cardboard box of 10 vials of 5 ml.
Marketing Authorisation Holder
Sciecure Pharma Ltd
47 Bloomfield Close, Knaphill, Woking, Surrey, UK, GU21 2BL
Manufacturer
Pharmathen SA
6, Dervanakion Str; Pallini Attiki, 15351
Greece
This leaflet was last revised in 02/2017

The following information is intended for healthcare professionals only:

One vial of Levetiracetam concentrate for solution for infusion contains 500 mg levetiracetam
(5 ml concentrate for solution for infusion of 100 mg/ml). See Table 1 for the recommended
preparation and administration of Levetiracetam concentrate for solution for infusion to
achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Table 1. Preparation and administration of Levetiracetam concentrate for solution for infusion
Dose

Withdrawal Volume

250 mg
500 mg
1000 mg
1500 mg

2.5 ml(half 5 ml vial)
5 ml (one 5 ml vial)
10 ml (two 5 ml vials)
15 ml (three 5 ml vials)

Volume of
Diluent
100 ml
100 ml
100 ml
100 ml

Infusion
Time
15 minutes
15 minutes
15 minutes
15 minutes

Frequency of
administration
Twice daily
Twice daily
Twice daily
Twice daily

Total Daily
Dose
500 mg/day
1000 mg/day
2000 mg/day
3000 mg/day

This medicinal product is for single use only any unused solution should be discarded.
In use shelf life: from a microbiological point of view, the product should be used
immediately after dilution. If not used immediately, in-use storage time and conditions prior to
use are the responsibility of the user and would normally not be longer than 24 hours at 2 to
8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Levetiracetam concentrate for solution for infusion was found to be physically compatible and
chemically stable when mixed with the following diluents for at least 24 hours and stored in
PVC bags at controlled room temperature 15-25°C.
Diluents:

Sodium chloride 9 mg/ml (0.9 %) solution for injection

Lactated Ringer's solution for injection

Dextrose 50 mg/ml (5 %) solution for injection

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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