• 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.

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

• 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 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 have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, 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, pharmacist or nurse 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, see a doctor as soon as possible.
  In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills you may notice that the seizures remain present or are becoming worse during your treatment.

• Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

Tell your doctor, pharmacist or nurse 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 being given 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 it with your doctor.

A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.

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.

For 250mg & 500mg dose:

This medicine contains less than 1mmol sodium (23mg) per vial, that is to say essentially 'sodium-free'.

1000mg dose/10ml (two 5ml vials):

This medicine contains 38mg sodium per 10ml, equivalent to 1.9% of the WHO recommended maximum daily intake of 2g sodium for an adult.

1500mg dose/15ml (three 5ml vials):

This medicine contains 57mg sodium per 15ml, equivalent to 2.85% of the WHO recommended maximum daily intake of 2g sodium for an adult.

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.

• 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 should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your treatment with levetiracetam, he/she will instruct you about the gradual withdrawal.

• 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 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 (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 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), blurred vision
• Elevated/abnormal values in a liver function test
• Hair loss, eczema, pruritis
• Muscle weakness myalgia (muscle pain)
• Injury

Rare: may affect up to 1 in 1,000 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)
• 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.

Very rare: may affect up to 1 in 10,000 people

• repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).

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 Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

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Manufacturer:

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0800 198 5000 (UK only)

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Product name Reference number

Levetiracetam Wockhardt 100mg/ml concentrate for solution or infusion 29831/0526

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