Package leaflet: Information for the user

Levetiracetam Hetero 1000 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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Levetiracetam 1000 mg is and what it is used for

2. What you need to know before you take Levetiracetam 1000 mg

3. How to take Levetiracetam 1000 mg

4. Possible side effects

5. How to store Levetiracetam 1000 mg

6. Contents of the pack and other information

1.    What Levetiracetam 1000 mg is and what it is

used for

Levetiracetam Hetero 1000 mg Film-Coated Tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam 1000 mg 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 1000 mg

Do not take Levetiracetam 1000 mg :

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Levetiracetam 1000 mg.

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.

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

A small number of people being treated with antiepileptics such as Levetiracetam 1000 mg 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 1000 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Levetiracetam 1000 mg with food and drink

You may take Levetiracetam 1000 mg with or without food. As a safety precaution, do not take Levetiracetam 1000 mg with alcohol.

Pregnancy and breast-feeding

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

Levetiracetam 1000 mg 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 1000 mg may impair your ability to drive or operate any tools or machinery, as Levetiracetam 1000 mg 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 1000 mg

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

Levetiracetam 1000 mg 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 will first start taking Levetiracetam 1000 mg, you doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose. Example: if your daily dose is 2,000 mg, you must take 1 tablet in the morning and 1 tablet 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 2,000 mg, you must take 1 tablet in the morning and 1 tablet 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:

You 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.

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 1000 mg tablets with a sufficient quantity of liquid (e.g. a glass of water).

The tablet can be divided into equal doses.

Duration of treatment:

•    Levetiracetam 1000 mg is used as a chronic treatment. You should continue Levetiracetam 1000 mg 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 1000 mg treatment, _he/she will instruct you about the gradual withdrawal of _Levetiracetam 1000 mg.

If you take more Levetiracetam 1000 mg than you should

The possible side effects of an overdose of Levetiracetam 1000 mg 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 1000 mg

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 1000 mg

If stopping treatment, as with other antiepileptic medicines, Levetiracetam 1000 mg 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 pharmacist or nurse.

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.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

Not known (frequency cannot be estimated from the available data)

Very common:

•    nasopharyngitis;

•    somnolence (sleepiness), headache.

Common:

•    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:

•    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, 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:

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.How to store Levetiracetam 1000 mg

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions.

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.

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 1000 mg contains

The active substance is levetiracetam. Each Film-coated tablet contains 1000 mg of levetiracetam.

The other ingredients are:

Tablet core:

Maize starch, Croscarmellose sodium, Povidone (K 30), Silica colloidal anhydrous, Talc and Magnesium Stearate.

Tablet coating:

Polyvinyl alcohol, Titanium dioxide (E171).Macrogol 3350 and Talc.

What Levetiracetam 1000 mg looks like and contents of the pack

Levetiracetam Hetero 1000 mg Film-Coated Tablets are white coloured, oblong shaped, scored on one side, film-coated tablets debossed with “H” on one side and “91” on the other side.

Levetiracetam 1000 mg are available in blister packs containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Hetero Europe S.L.

Viladecans Business Park Edificio Brasil

Catalunya 83-85

08840 Viladecans (Barcelona)

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000 Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Levetiracetam Hetero 1000 mg comprimido revestido por pehcula Levetiracetam Hetero 1000 mg comprimidos recubiertos con pehcula EFG

Levetiracetam Hetero 1000 mg, filmomhulde tabletten

Levetiracetam Hetero 1000 mg Filmtabletten

United Kingdom : Levetiracetam Hetero 1000 mg Film-coated tablets

This leaflet was last revised in 07/2014.