• 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.

1. What Levetiracetam granules are and what they are used for
2. What you need to know before you take Levetiracetam granules
3. How to take Levetiracetam granules
4. Possible side effects
5. How to store Levetiracetam granules
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 taking Levetiracetam granules

• 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.
• Tell 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 granules, see a doctor as soon as possible.

• Levetiracetam granules are 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.

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 loss 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 granules 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sucrose may be harmful to the teeth.

Empty the entire contents of the sachet into a glass of water. Stir well until the granules have dissolved, then drink the solution immediately.

After drinking the solution, you may experience the bitter taste of levetiracetam.

You may take this medicine with or without food.

• Levetiracetam is used as a chronic treatment. You should continue Levetiracetam granules treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor’s advice as this could increase your seizures.

The possible side effects of an overdose of Levetiracetam granules are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more Levetiracetam granules than you should. Your doctor will establish the best possible treatment of overdose.

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

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

• 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 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), vision blurred
• elevated/abnormal values in a liver function test
• hair loss, eczema, pruritus
• 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 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

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: 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.

The active substance is levetiracetam.

Levetiracetam Neuraxpharm 250 mg granules for oral solution: each sachet contains 250 mg of levetiracetam

Levetiracetam Neuraxpharm 500 mg granules for oral solution: each sachet contains 500 mg of levetiracetam

Levetiracetam Neuraxpharm 750 mg granules for oral solution: each sachet contains 750 mg of levetiracetam

Levetiracetam Neuraxpharm 1000 mg granules for oral solution: each sachet contains 1000 mg of levetiracetam

Levetiracetam Neuraxpharm 1500 mg granules for oral solution: each sachet contains 1500 mg of levetiracetam

The other ingredients are: isomalt, acesulfame potassium, fantasy flavour (contains sucrose and propylene glycol (E 1520), masking flavour, ammonium glycyrrhizate.

Levetiracetam Neuraxpharm granules for oral solution is a white to slight brownish powder contained in a sachet.

Levetiracetam Neuraxpharm 250 mg granules for oral solution: each sachet contains 1 g of granules

Levetiracetam Neuraxpharm 500 mg granules for oral solution: each sachet contains 2 g of granules

Levetiracetam Neuraxpharm 750 mg granules for oral solution: each sachet contains 3 g of granules

Levetiracetam Neuraxpharm 1000 mg granules for oral solution: each sachet contains 4 g of granules

Levetiracetam Neuraxpharm 1500 mg granules for oral solution: each sachet contains 6 g of granules

The sachets are supplied in cardboard cartons.

Each carton contains 60 sachets.