Levetiracetam Sun
levetiracetam
levetiracetam
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
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 Levetiracetam SUN is and what it is used for
What you need to know before you are given Levetiracetam SUN
How Levetiracetam SUN is given
Possible side effects
How to store Levetiracetam SUN
Contents of the pack and other information
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam SUN 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
with other antiepileptic medicines (add-on therapy) 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 SUN concentrate for solution for infusion can be used when administration of oral levetiracetam is temporarily impossible.
if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor before you are given Levetiracetam SUN
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 slowdown in growth, or if there is unexpected puberty development in your child, please contact your doctor.
A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor.
If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour
aggravation of epilepsy
Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam SUN, see a doctor as soon as possible.
Levetiracetam SUN is not indicated in children and adolescents below 16 years on its own (monotherapy).
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.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor. A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.
Levetiracetam SUN 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.
One maximum single dose of Levetiracetam SUN concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.
A doctor or a nurse will administer you Levetiracetam SUN as an intravenous infusion.
Levetiracetam SUN 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 the oral formulation. You can be switched from one to the other without changing dose. Your total daily dose and frequency of administration remain the same.
Adjunctive therapy and Monotherapy (from 16 years of age).
When you will first start taking Levetiracetam SUN, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest daily dose.
Recommended dose: between 1000 mg and 3000 mg each day.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Levetiracetam SUN 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 SUN is provided in section 6.
There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
If stopping treatment, as with other antiepileptic medicines, Levetiracetam SUN should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam SUN treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam SUN.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 of the side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.
nasopharyngitis
somnolence (sleepiness), headache
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)
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
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)
delirium
encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms)
seizures may become worse or happen more often
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
change of the heart rhythm (Electrocardiogram)
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.
limp or difficulty walking
- combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
- The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injection.
Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.
Levetiracetam SUN concentrate for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.
2132 JH Hoofddorp The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501
Sun Pharmaceuticals Germany GmbH Hemmelrather Weg 201
51377 Leverkusen Deutschland
Tel. +49 214 403 99 0
Basics GmbH Hemmelrather Weg 201
51377 Leverkusen Deutschland
Tel. +49 214 403 99 0
Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55 08007 Barcelona
España
tel. +34 93 342 78 90
Sun Pharma France
11-15, Quai Dion Bouton 92800 Puteaux
France
tel. +33 (0) 1 41 44 44 50
Hrvatska
tel. +385 1 5584 604
Sun Pharma Italia Srl Viale Giulio Richard, 1 20143 Milano
Italia
tel. +39 02 33 49 07 93
Ranbaxy (Poland) Sp. Z o. o. ul. Kubickiego 11
02-954 Warszawa Polska
tel. +48 22 642 07 75
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj România
tel. +40 (264) 501 500
Lenis farmacevtika d.o.o. Litostrojska cesta 52
1000 Ljubljana Slovenija
tel. +386 (0)1 235 07 00
Ranbaxy UK Ltd
a Sun Pharma Company Millington Road 11 Hyde Park, Hayes 3
5th Floor
UB3 4AZ HAYES
United Kingdom
tel. +44 (0) 208 848 8688
Directions for the proper use of Levetiracetam SUN is provided in section 3.
One vial of Levetiracetam SUN concentrate contains 500 mg levetiracetam (5 ml concentrate of
100 mg/ml). See Table 1 for the recommended preparation and administration of Levetiracetam SUN concentrate 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 SUN concentrate
Dose | Withdrawal Volume | Volume of Diluent | Infusion Time | Frequency of administration | Total Daily Dose |
250 mg | 2.5 ml (half 5 ml vial) | 100 ml | 15 minutes | Twice daily | 500 mg/day |
500 mg | 5 ml (one 5 ml vial) | 100 ml | 15 minutes | Twice daily | 1000 mg/day |
1000 mg | 10 ml (two 5 ml vials) | 100 ml | 15 minutes | Twice daily | 2000 mg/day |
1500 mg | 15 ml (three 5 ml vials) | 100 ml | 15 minutes | Twice daily | 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 SUN concentrate 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