Levetiracetam Wockhardt 250 mg Filmomhulde Tabletten

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

Levetiracetam Tablets are used:

• on their 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 one month of 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.

Do not take Levetiracetam Tablets

• 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 Tablets

• 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 anti-epileptics such as Levetiracetam Tablets 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 Tablets

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

Levetiracetam Tablets with food, drink and alcohol

You may take Levetiracetam Tablets with or without food. As a safety precaution, do not take Levetiracetam Tablets 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 Tablets should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Levetiracetam Tablets have 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 Tablets may impair your ability to drive or operate any tools or machinery, as they 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.

Important information about some of the ingredients of Levetiracetam Tablets

Levetiracetam 750mg Tablets contain sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.

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 Tablets 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 Tablets, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

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:

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day. The dose should preferably be administered as the oral solution formulation.

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the weight and dose. Levetiracetam oral solution is a presentation more appropriate to infants and children under the age of 6 years.

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

Levetiracetam 100mg/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 Tablets are 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 Tablets than you should:

The possible side effects of an overdose of Levetiracetam Tablets 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 Tablets:

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 Tablets:

If stopping treatment, as with other antiepileptic medicines, Levetiracetam Tablets 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.

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)

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

• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting
• anorexia (loss of appetite)
• vertigo (sensation of rotation)
• cough
• rash
• asthenia/fatigue (tiredness).

Uncommon (may affect 1 to 10 users in 1000)

• paraesthesia (tingling) , amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), disturbance in attention (loss of concentration)

• abnormal behaviour, anger, confusion, panic attack, hallucination, mental disorder, suicide attempt and suicidal ideation, emotional instability/mood swings, agitation
• liver function test abnormal
• weight decrease, weight increase
• hair loss, eczema, pruritus
• decreased number of blood platelets , decreased number of blood cells

• diplopia (double vision), vision blurred
• muscle weakness, myalgia (muscle pain)
• injury.

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

• infection
• decreased number of all blood cell types
• 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).

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

Keep out of the reach and sight 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 that 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 longeruse. These measures will help protect the environment.

What Levetiracetam Tablets contain

The active substance is levetiracetam. The tablets are available in four strengths: 250mg, 500mg, 750mg and 1,000mg.

The other ingredients of the tablet core are:

Maize starch, croscarmellose sodium, povidone (K-30), colloidal anhydrous silica, purified talc and magnesium stearate.

The tablets are film-coated as follows:

Levetiracetam 250mg Tablets – opadry® II blue 85F20694 (polyvinyl alcohol-part. hydrolysed, titanium dioxide E171, macrogol 4000, talc E553b and indigo carmine aluminium lake E132).

Levetiracetam 500mg Tablets - opadry® II yellow 85F32004 (polyvinyl alcohol-part. hydrolysed, titanium dioxide E171, macrogol 4000, talc E553b and iron oxide yellow E172).

Levetiracetam 750mg Tablets - opadry® II orange 85F23452 (polyvinyl alcohol-part. hydrolysed, titanium dioxide E171, macrogol 4000, talc E553b, sunset yellow FCF aluminium lake E110 and iron oxide red E172).

Levetiracetam 1,000mg Tablets - opadry® II white 85F18422 (polyvinyl alcohol-part. hydrolysed, titanium dioxide E171, macrogol 4000 and talc E553b).

What Levetiracetam Tablets look like and contents of the pack

Levetiracetam 250mg Tablets are blue, film-coated, oval shaped, debossed with “W532” on one side and a score line on the other side.

Levetiracetam 500mg Tablets are yellow, film-coated, oval shaped, debossed with “W533” on one side and a score line on the other side.

Levetiracetam 750mg Tablets are orange, film-coated, oval shaped, debossed with “W534” on one side and a score line on the other side.

Levetiracetam 1000mg Tablets are white, film-coated, oval shaped, debossed with “W535” on one side and a score line on the other side.

Levetiracetam Tablets are supplied in a blister pack of 60 tablets within an outer carton.

Houder van de vergunning voor het in de handel brengen en fabrikant

Houder van der vergunning voor het in de handel brengen

Wockhardt UK Ltd,

Ash Road North

Wrexham LL13 9UF

Verenigd Koninkrijk

Fabrikant:

CP Pharmaceuticals Ltd

Ash Road North

Wrexham LL13 9UF

Verenigd Koninkrijk

In het register ingeschreven onder nummer:

Levetiracetam Wockhardt 250mg: RVG 109453

Levetiracetam Wockhardt 500mg: RVG 109454

Levetiracetam Wockhardt 750mg: RVG 109455

Levetiracetam Wockhardt 1000mg: RVG 109456

In lidstaten van de EEA ingeschreven onder de volgende namen:

Verenigd Koninkrijk: Levetiracetam 250mg, 500mg, 750mg of 1,000mg Film-Coated Tablets Duitsland: Levetiracetam Wockhardt 250mg, 500mg, 750mg of 1000mg Filmtabletten Malta: Levetiracetam 250mg, 500mg, 750mg of 1,000mg Film-Coated Tablets

Nederland: Levetiracetam Wockhardt 250mg, 500mg, 750mg of 1000mg Filmomhulde Tabletten

Deze bijsluiter is voor het laatst goedgekeurd in juli 2012.