PACKAGE LEAFLET: INFORMATION FOR THE USER

Levetiracetam Synthon 100 mg/ml oral solution

Levetiracetam

In this leaflet:

1.    What Levetiracetam Synthon 100 mg/ml is and what it is used for

2.    What you need to know before you take Levetiracetam Synthon 100 mg/ml

3.    How to take Levetiracetam Synthon 100 mg/ml

4.    Possible side effects

5.    How to store Levetiracetam Synthon 100 mg/ml

6.    Contents of the pack and other information

1.    WHAT LEvETIRAcETAM SYNTHoN

100 mg/ml is and what it is used for

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

Levetiracetam is used:

•    on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation.

•    as an add-on to other antiepileptic medicines to treat:

-    partial onset seizures with or without generalisation in patients from one month of age

-    myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy

-    primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy.

2.    WHAT YOU NEED TO Know BEFORE YOU

take levetiracetam synthon

100 MG/ML

Do not take Levetiracetam 100 mg/ml:

•    If you are allergic (hypersenstive) to levetiracetam or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Levetiracetam 100 mg/ml

•    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.

•    If you notice an increase in seizure severity (eg. increased number), 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.

Other medicines and Levetiracetam 100 mg/ml Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Levetiracetam 100 mg/ml with food, drink and alcohol

You may take levetiracetam with or without food. As a safety precaution, do not take levetiracetam with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. 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

Levetiracetam may impair your ability to drive or operate any tools or machinery, as levetiracetam 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 100 mg/ml contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and maltitol

Levetiracetam oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). This medicine also contains maltitol, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE LEvETIRACETAM SYNTHON 100 MG/ML

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the oral solution following your doctor's instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per 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 50 kg or more:

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe or pipette provided in the cardboard box.

Dose in infants (1 month to less than 6 months):

General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Method of administration:

Levetiracetam oral solution may be diluted in a glass of water

or baby's bottle.

Instruction for use of the 300 ml bottle:

•    Open the bottle: press the cap and turn it anticlockwise (figure 1)

•    Separate the adaptor from the pipette (figure 2)

•    Insert the pipette adaptor into the bottle neck (figure 3). Ensure it is well fixed.

•    Put the pipette in the bottle though the adaptor opening (figure 4)

•    Fill the pipette with solution by pulling the piston up (figure 5).

•    Pull the piston up to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 6). Remove the pipette from the adaptor.

•    Empty the contents of the pipette into a glass of water or baby's bottle by pushing the piston to the bottom (figure 7).

•    Drink the whole contents of the glass/ baby's bottle.

•    Close the bottle with the plastic screw cap. Wash the pipette with water only (figure 8).

Duration of the treatment:

•    Levetiracetam is used as a chronic treatment. You should continue levetiracetam 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. Should your doctor decide to stop your levetiracetam treatment, he/she will instruct you about the gradual withdrawal of levetiracetam.

If you take more Levetiracetam 100 mg/ml than you should

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

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

If you forget to take Levetiracetam 100 mg/ml

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 you stop taking Levetiracetam 100 mg/ml

I f 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 medicinal product, ask your doctor or pharmacist.

4. possible side effects

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

Tell your doctor if you have any of the following and they worry you.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

very common side effects (may affect more than 1 in 10 people)

Nasopharyngitis • somnolence (sleepiness) • headache. common side effects (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, tremor (involuntary trembling) • vertigo (sensation of rotation) • cough (increase of pre-existing cough)

•    abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting • rash • asthenia/fatigue (tiredness).

Uncommon side effects (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, 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 • liver function test abnormal • hair loss, eczema, pruritus • muscle weakness, myalgia (muscle pain) • injury.

Rare side effects (may affect up to 1 in 1,000 people)

Infection • decreased number of all blood cell types • severe hypersensitivity reactions (DRESS) • 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 • hepatic 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).

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 You can also report side effects directly via Yellow Card Scheme, Website: www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    how to store levetiracetam synthon

100 MG/ML

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton box and bottle after 'EXP'. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use after 4 months of first opening the bottle.

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

What Levetiracetam 100 mg/ml contains

•    The active substance(s) is levetiracetam. Each ml contains 100 mg of levetiracetam.

•    The other ingredient(s) are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.

Levetiracetam is packed in a 300 ml glass bottle in a cardboard box. Each ml contains 100 mg of levetiracetam.

What Levetiracetam 100 mg/ml looks like and contents of the pack

Levetiracetam 100 mg/ml oral solution is a clear liquid supplied in a glass bottle packed in a cardboard box together with an oral syringe or dosing pipette and adaptor:

300 ml supplied with a 10 ml dosing pipette for children aged 4 years and above, adolescents and adults (graduated every 0.25 ml)

Marketing Authorisation Holder:

Synthon BV, Microweg 22, 6545 CM Nijmegen,

The Netherlands

Manufacturer:

Synthon Hispania, S.L., C/Castello, 1 - Poligono Las Salinas, 08830 Sant Boi de Llobregat, Barcelona, Spain

Distributed by:

Consilient Health (UK) Ltd., 500 Chiswick High Road,

London, W4 5RG.

This leaflet was last revised in March 2014