PACKAGE LEAFLET: INFORMATION FOR THE USER

Levetiracetam Synthon 250 mg film-coated tablets

Levetiracetam

In this leaflet:

1.    What Levetiracetam Synthon is and what it is used for

2.    What you need to know before you take Levetiracetam Synthon

3.    How to take Levetiracetam Synthon

4.    Possible side effects

5.    How to store Levetiracetam Synthon

6.    Contents of the pack and other information

1.    WHAT LEvETIRAcETAM SYNTHoN 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 1 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

Do not take Levetiracetam:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levetiracetam

•    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 (e.g. 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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Levetiracetam with food and drink

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

Pregnancy, breast-feeding

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.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

3. HOW TO TAkE LEVETIRACETAM SYNTHON

Always take Levetiracetam exactly as your doctor has told you. You should check with your doctor or pharmacist 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 number of tablets following your doctor's instructions.

Monotherapy

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

• General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) 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. Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) each day.

Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

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.

Levetiracetam 100 mg/ml oral solution is a presentation more appropriate to infants and children under the age of 6 years.

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

Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet in the morning and 1 tablet in the evening.

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

Levetiracetam 100 mg/ml oral solution is a presentation more appropriate to infants.

Method of administration:

Swallow levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).

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 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 tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam

Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten tablet.

If you stop taking 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.

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 decreased, weight increase • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, 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 red blood cells and/or white blood cells

•    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

•    blistering of the skin, mouth, eyes and genital area, skin eruption.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    how to store levetiracetam synthon

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 blister after EXP:. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 contains

The active substance is levetiracetam.

Each tablet contains 250 mg of levetiracetam.

•    The other ingredients are:

Tablet core: colloidal anhydrous silica, hydroxypropyl cellulose, low substituted microcrystalline cellulose, magnesium stearate

Film-coating of the 250 mg tablets: Opadry II Blue 85F20694 (polyvinyl alcohol, macrogol (PEG 3350), talc, titanium dioxide (E171), indigo carmine aluminium (E132)).

What Levetiracetam looks like and contents of the pack

Levetiracetam 250 mg film-coated tablets are blue, oblong, biconvex coated tablets, scored on both sides and debossed with L9TT and 250 on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The cardboard boxes contain 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. Not all pack sizes may be marketed.

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 December 2013