PackageLeaflet:Informationforthe patient

Levetifi 250 mg film-coated tablets.

Levetifi 500 mg film-coated tablets.

Levetifi 750 mg film-coated tablets.

Levetifi 1000 mg film-coated tablets.

Levetiracetam

Read all of this leaflet carefully before you or your child 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 Levetifi is and what it is used for

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

Levetifi is used:

• partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;

• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;

• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Levetifi

Do not take Levetifi

Warnings and precautions

Talk to your doctor before taking Levetifi

• 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.

• A small number of people being treated with anti-epileptics such as Levetifi have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Other medicines and Levetifi

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

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking

levetiracetam as this may results in a loss of its effect.

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 for advice before taking this medicine.

Levetifi should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetifi 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

Levetifi 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.

Levetifi 750 mg tablets contain Sunset Yellow FCF (E110)

Sunset Yellow FCF (E110) coloring agent may cause allergic reactions.

3. How to take Levetifi

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

Take the number of tablets following your doctor’s instructions.Levetifi must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

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

General dose: between 1000 mg and 3000 mg each day.

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

Example: if your daily dose is 1000 mg, your reduced starting dose is2 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 1000 mg and 3000 mg each day.

Example: if your daily dose is 1000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month 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.

An oral solution is a formulation more appropriate to infants and children

under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than

50kg and when tablets don’t allow accurate dosage.Method of administration:

Swallow Levetifi tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take

Levetifi with or without food.

Duration of treatment:

• Levetifi is used as a chronic treatment. You should continue Levetifi 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 you take more Levetifi than you should:

The possible side effects of an overdose of Levetifi 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 Levetifi:

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 Levetifi:

If stopping treatment, Levetifi should be discontinued gradually to avoid an increase of seizures.

Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

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.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

• nasopharyngitis;

• somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

• anorexia (loss of appetite);

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

• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), 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 1000 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;

• elevated/abnormal values in a liver function test;

• hair loss, eczema, pruritus;

• muscle weakness, myalgia (muscle pain);

• injury.

Rare: may affect 1 to 10 users in 10,000 people

• infection;

• decreased number of all blood cell types;

• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

• 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 the national reporting system [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetifi

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 bottle/blister after EXP. The expiry date refers to the last day of the month.

This medicine 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 Levetifi contains

The active substance is called levetiracetam.

250 mg

Each tablet contains 250 mg levetiracetam.

The other ingredients are:

Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.

Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Indigo Carmine Aluminium Lake (E132)

500 mg

Each tablet contains 500 mg levetiracetam.

The other ingredients are:

Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.

Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Iron Oxide Yellow (E172)

750 mg

Each tablet contains 750 mg levetiracetam.

The other ingredients are:

Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.

Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b), Sunset Yellow FCF Aluminium Lake (E110), Iron Oxide Red (E172)

1000 mg

Each tablet contains 1000 mg levetiracetam.

The other ingredients are:

Tablet core: Maize Starch, Povidone (K30), Magnesium stearate, Colloidal anhydrous silica.

Film-coating: Polyvinyl Alcohol-Partially Hydrolyzed, Titanium Dioxide (E171), Macrogol 3350, Talc (E553b),

What Levetifi looks like and contents of the pack

250 mg: The film-coated tablets are blue coloured, capsule shaped tablets with deep notch on one side.

500 mg: The film-coated tablets are yellow coloured, capsule shaped tablets with deep notch on one side.

750 mg: The film-coated tablets are orange coloured, capsule shaped tablets with deep notch on one side.

1000 mg: The film-coated tablets are white coloured, capsule shaped tablets with deep notch on one side.

Levetifi film-coated tablets are supplied in blister packs and bottles.

Blister packs contain 10, 20, 30, 50, 60, 90, 100, 120 and 200 film-coated tablets.

Bottles contain 10, 20, 30, 50, 60, 90, 100, 120 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

[To be completed nationally.]

Manufacturer

[To be completed nationally.]

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

[To be completed nationally]

This leaflet was last revised in July 2016.

2016-08-15