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Package leaflet: Information for the patient

Levetiracetam Zentiva 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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.

What is in this leaflet:

1.    What Levetiracetam is and what it is used for

2.    What you need to know before you take Levetiracetam

3.    How to take Levetiracetam

4.    Possible side effects

5 How to store Levetiracetam

6. Contents of the pack and other information

1. WHAT LEVETIRACETAM 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 adults and adolescents 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:

o partial onset seizures with or without generalisation in adults, adolescents,

levetiracetam with alcohol.

Pregnancy and breast-feeding:

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

If you are pregnant or if you think you may be pregnant, please inform your doctor. Levetiracetam 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:

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

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

Levetiracetam must be taken twice a day, half of the daily dose in the morning and half of the daily dose 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 and 3,000 mg each day.

When you first start taking levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

children and infants from one month of age.

o myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy o primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy

Oral solution is a presentation more appropriate to infants and children under the age of 6 years.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM

Do not take Levetiracetam:

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

Warnings and precautions

Talk to your doctor 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, have recently taken or might take any other medicines.

Taking Levetiracetam with food, drink and alcohol

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

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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 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.

The dose should be administered as an oral solution formulation for children under 25 kg. General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

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

An 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 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.

The score line is not intended for breaking the tablet.

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

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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. 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 (may affect more than 1 user in 10):

•    nasopharyngitis

•    somnolence (sleepiness), headache

Common (may affect 1 to 10 users in 100):

•    anorexia (loss of appetite)

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability

•    convulsions, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling)

•    vertigo (sensation of rotation)

•    cough

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea

•    rash

•    asthenia/fatigue (tiredness)

Uncommon (may affect 1 to 10 users in 1,000):

•    decreased number of blood platelets, decreased number of white blood cells

•    weight decrease, weight increase

help provide more information on the safety of this medicine.

5. HOW TO STORE LEVETIRACETAM

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 the 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. Levetiracetam Zentiva 250 mg: each film-coated tablet contains 250 mg levetiracetam. Levetiracetam Zentiva 500 mg: each film-coated tablet contains 500 mg levetiracetam. Levetiracetam Zentiva 750 mg: each film-coated tablet contains 750 mg levetiracetam. Levetiracetam Zentiva 1000 mg: each film-coated tablet contains 1000 mg levetiracetam.

The other ingredients are:

Tablet core:

Povidone 30, Croscarmellose sodium, Silica, colloidal anhydrous, Sodium stearyl fumarate Tablet coating:

Hypromellose 2910/5, Macrogol 6000, Talc, Titanium dioxide (E-171), Simeticone emulsion (water, purified 67.4 %, simeticone 30.0 %, methylcellulose 2.5 %, sorbic acid 0.1 %) Levetiracetam Zentiva 250 mg also contains Indigo carmine aluminium lake (E-132) Levetiracetam Zentiva 500 mg also contains Iron oxide yellow (E-172)

Levetiracetam Zentiva 750 mg also contains

•    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

•    liver function test abnormal

•    hair loss, eczema, pruritus

•    muscle weakness, myalgia (muscle pain)

•    injury

Rare (may affect 1 to 10 users in 10,000):

•    infection

•    decreased number of all blood cells types

•    severe hypersensitivity reactions (DRESS)

•    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)

•    decreased blood sodium concentration.

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 the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can

Iron oxide red (E-172), Iron oxide yellow (E-172) What Levetiracetam looks like and contents of the pack

Film-coated tablet.

Levetiracetam Zentiva 250 mg: Blue oblong film-coated tablet, scored on both sides. Levetiracetam Zentiva 500 mg: Yellow oblong film-coated tablet, scored on both sides. Levetiracetam Zentiva 750 mg: Orange oblong film-coated tablet, scored on both sides. Levetiracetam Zentiva 1000 mg: White to off-white oblong, film-coated tablet, scored on both sides.

Levetiracetam Zentiva 250, 500, 750, 1000 mg is packed in PVC/Al blisters with 20, 30, 60, 100, 200 tablets.

It means 2, 3, 6, 10, 20 blisters, each containing 10 tablets in one folding box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey,

GU1 4YS, UK.

Manufacturer

Zentiva, k.s., Praha, Ceska republika This leaflet was updated in July 2014.

ZV/532 77

Master for leaflet print UNIVERSAL 160x400 mm - prekladany

Size:    160/400 mm

Bible paper 45 g/m²

Optical code: design and location according artwork text on the both sides of the leaflet

backside without optical and look codes