PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Levetiracetam 250 mg Film-coated Tablets

Levetiracetam

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

What Levetiracetam is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine

used to treat seizures in epilepsy).

This medicine 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:

-    partial onset seizures with or without generalisation in adults, adolescents, children and infants from 1 month age.

-    myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

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

child cannot be completely excluded. This medicine 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 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.

3 How to take Levetiracetam

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:

•    have kidney problems, follow your doctor's instructions, your dose may need to be adjusted.

•    notice any slow down in the growth of your child or unexpected puberty development, please contact your doctor.

•    notice an increase in seizure severity (e.g. increased number), please contact your doctor.

•    have any symptoms of depression and / or suicidal ideation, please contact your doctor. A small number of people being treated with antiepileptics such as Levetiracetam have had thoughts of harming or killing themselves.

Other medicines and Levetiracetam

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Levetiracetam with food, drink and alcohol

You can take Levetiracetam with or without food. As a safety precaution, do not take 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

Always take this medicine exactly as your doctor or pharmacist has told you. 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 and 3,000 mg each day. When you first start taking Levetiracetam, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg 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 and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg 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 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 might give your 25 kg child 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the ^evening.    Continued on the next page >>

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 treatment:

•    Levetiracetam is used as a chronic treatment. You should continue the 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. If your doctor decides to stop your treatment, he/she will instruct you to gradually withdraw the treatment.

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 have taken 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 you are stopping treatment, as with other antiepileptic medicines, Levetiracetam should be discontinued gradually to avoid an increase in seizures.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 the Yellow Card Scheme: 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

4 Possible side effects

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

Do not use this medicine after the expiry date stated on the carton box and blister after EXP.

The expiry date refers to the last day of the month. The shelf life after first opening of the bottle is 100 days.

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.

Store in the original package in order to protect from moisture.

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

Some side effects such as 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 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, 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;

•    liver function test abnormal;

•    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 hypersensitivity reactions (DRESS);

•    decreased blood sodium concentration;

•    suicide, personality disorders (behavioural problems),

Contents of the pack and other information

What Levetiracetam Film-coated Tablets contain

The active substance is called levetiracetam.

The other ingredients are:

Tablet core: povidone K25, cellulose microcrystalline, croscarmellose sodium, crospovidone (type A), silica colloidal anhydrous, talc, magnesium stearate.

Film-coating: hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E171), talc, indigo carmine (E132).

Levetiracetam 250 mg Film-coated Tablets are packaged in OPA/Al/PVC - Al blisters placed into cardboard boxes containing 10, 20, 28, 30, 50, 50 x 1, 60, 100, 120 and 200 film-coated tablets or HDPE bottles with polypropylene screw cap and silicagel capsule placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Each film-coated tablet contains 250 mg levetiracetam.

What Levetiracetam looks like and contents of the pack

Light blue, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 250 on one side.

The tablet can be divided into equal halves.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d.Verovskova 57, 1526,

Ljubljana, Slovenia or LEK S.A., ul. Podlipie 16, 95-010 Strykow, Poland or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany or S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania.

This leaflet was last revised in 01/2016.

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