Package leaflet: Information for the patient

Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion

Levetiracetam

(referred to as Levetiracetam concentrate for solution for infusion)

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, pharmacist or nurse.

-    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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Levetiracetam concentrate for solution for infusion is and what it is used for

2.    What you need to know before you are given Levetiracetam concentrate for solution for infusion

3.    How Levetiracetam concentrate for solution for infusion is given

4.    Possible side effects

5.    How to store Levetiracetam concentrate for solution for infusion

6.    Contents of the pack and other information

1. What Levetiracetam concentrate for solution for infusion is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam concentrate for solution for infusion 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 with epilepsy

-    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 is temporarily not feasible.

2. What you need to know before you are given Levetiracetam concentrate for solution for infusion

Do not use Levetiracetam concentrate for solution for infusion:

•    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 concentrate for solution for infusion:

•    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 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 concentrate for solution for infusion 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 concentrate for solution for infusion is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam concentrate for solution for infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

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 loss of its effect.

Pregnancy and breastfeeding

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 concentrate for solution for infusion should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Levetiracetam concentrate for solution for infusion 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 concentrate for solution for infusion 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 concentrate for solution for infusion contains sodium

Other ingredients include sodium chloride, sodium acetate trihydrate, acetic acid solution and

water for injections.

One maximum single dose of Levetiracetam concentrate for solution for infusion contains 2.5mmol (or 57mg) of sodium (0.8mmol (or 19mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3. How Levetiracetam concentrate for solution for infusion is given

A doctor or a nurse will administer your 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 the film-coated tablets or from the 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 1000mg and 3000mg each day.

When you will first start taking 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 50kg or more:

General dose: between 1000mg and 3000mg each day.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50kg:

General dose: between 20mg per kg bodyweight and 60mg per kg bodyweight each day.

Method and route of administration:

Levetiracetam concentrate for solution for infusion is for intravenous use.

The recommended dose must be diluted in at least 100ml 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.

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The following information is intended for healthcare professionals only:

Directions for the proper use of Levetiracetam 100mg/ml concentrate for solution for infusion is provided in Section 3.

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

Table 1. Preparation and administration of Levetiracetam 100mg/ml concentrate for solution for infusion

Dose	Withdrawal volume	Volume of diluent	Infusion Time	Frequency of Administration	Total Daily Dose
250mg	2 5ml (half 5ml vial)	100ml	15 minutes	Twice Daily	500mg/day
500mg	5ml (one 5ml vial)	100ml	15 minutes	Twice Daily	1000mg/day
1000mg	10ml (two 5ml vials)	100ml	15 minutes	Twice Daily	2000mg/day
1500mg	15ml (three 5ml vials)	100ml	15 minutes	Twice Daily	3000mg/day

If you stop using Levetiracetam:

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 medicine, ask your doctor or pharmacist. Should your doctor decide to stop your Levetiracetam concentrate for solution for intravenous use treatment, he/she will instruct you about the gradual withdrawal.

■. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 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), blurred vision

•    Elevated/abnormal values in a liver function test

•    Hair loss, eczema, pruritis

•    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 abnormally (slow thinking, unable to concentrate)

•    Uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesias (hyperactivity)

•    Pancreatitis

•    Liver failure, hepatitis

•    Skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a 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 peeling in more than 30% of the body surface (toxic epidermal necrolysis)

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:

United Kingdom:

Yellow Card Scheme

Website: http://www.mhra.gov.uk/yellowcard Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: mailto:medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam concentrate for solution for infusion

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.

Store below 25°C. Chemical and physical in-use stability has been demonstrated for 7 days at 5°C to 22°C when diluted with 0.9% sodium chloride, 5% dextrose or Hartmann's Solution to 2mg/ ml. From a microbiological point of view, in-use storage time and conditions prior to use are the responsibility of the user.

Do not use if the product shows signs of deterioration such as discolouration.

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

•    The active substance is levetiracetam. Each ml of concentrate for solution for infusion contains 100 mg of levetiracetam. Each 5ml vial contains 500mg levetiracetam.

•    The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid solution and water for injection.

Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion is a clear, colourless, sterile concentrate. Presented in packs of five or ten, 5ml clear, neutral glass (Type I) vials. The vials are sealed with 13mm grey chlorobutyl PTFE (Teflon) faced rubber closures, secured with magenta aluminium Flip-Off caps.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF.

This Medicinal Product is authorised in the Member States under the following names:

UK and Ireland:

Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion

Cyprus: Levetiracetam Wockhardt 100mg/ml nuKvo SiaAupa yia napaoKEug SiaAupaioq npoq eyxuori France: LEVETIRACETAM WOCKARDT 100mg/ml, solution a diluer pour perfusion Other formats :

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge : 0800 198 5000 (UK only)

Please be ready to give the following information:

Product name	Reference number
Levetiracetam Wockhardt 100mg/ml concentrate for solution for infusion	29831/0526

This is s service provided by the Royal National Institute of Blind People.

For the Republic of Ireland please call +353 52 61 8000 This leaflet was last revised in 04/2016

107193/2

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This medicinal product is for single use only; any unused solution should be discarded.

Chemical and physical in-use stability has been demonstrated for 7 days at 5°C to 22°C when diluted with 0.9% sodium chloride, 5% dextrose or Hartmann's Solution to 2mg/ml. From a microbiological point of view, in-use storage time and conditions prior to use are the responsibility of the user.

Do not use if the product shows signs of deterioration such as discolouration.

Levetiracetam 100mg/ml concentrate for solution for infusion was found to be physically compatible and chemically stable when diluted to 2mg/ml and mixed with the following diluents for seven days when stored in infusion bags and stored at room temperature (5°C - 22°C).

Diluents:

•    0.9% sodium chloride

•    5% dextrose

•    Hartmanns Solution to 2mg/ml

PWOCKHARDT