1. What Vales is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Vales 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).
Vales concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Vales medicine is temporarily not feasible.

2. Before you are given Vales
Do not use Vales
- If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine.
Warnings and precautions
Talk to your doctor before you are given Vales
- 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 Vales 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
- Vales is not indicated in children and adolescents below 16 years on it’s own (monotherapy).
Taking other medicines
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 result in a reduction of its effect.
Pregnancy and breast-feeding
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.
Vales 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
Vales 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.
Important information about some of the ingredients of Vales
Vales contains sodium
One maximum single dose of Vales concentrate contains 2.5 mmol of sodium (0.8 mmol of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3. How Vales is given 
A doctor or a nurse will administer you Vales as an intravenous infusion.
Vales 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 1000 mg and 3,000 mg each day.
When you will first start taking Vales, 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:
Vales is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
Duration of treatment:
There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
If you stop using Vales
If stopping treatment, as with other antiepileptic medicines, Vales should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Vales treatment, he/she will instruct you about the gradual withdrawal of Vales.
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.
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, diarrhea, 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 edema [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.
- 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).
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Vales 
Keep out of reach of children.
Store below 30°C. 
Vales vials are for single use only, any unused solution must be discarded.
After Dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8°C. 
Do not use beyond the expiry date or if the product shows any sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.