Package leaflet: Information for the patient Levetiracetam Wockhardt 250mg, 500mg, 750mg and 1,000mg Film-Coated Tablets

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.

The name of your medicine is Levetiracetam Wockhardt 250mg, 500mg, 750mg and 1,000mg Film-Coated Tablets.

In the rest of the leaflet it is called Levetiracetam Tablets.

What is in this leaflet:

1.    What Levetiracetam Tablets are and what they are used for

2.    What you need to know before you take Levetiracetam Tablets

3.    How to take Levetiracetam Tablets

4.    Possible side effects

5.    How to store Levetiracetam Tablets

6.    Contents of the pack and other information

Do not take Levetiracetam Tablets

•    If you are allergic to levetiracetam, pyrrolidone derivatives 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.

•    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.

Children and adolescents

•    Levetiracetam Tablets are not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam Tablets

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 a laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.

Pregnancy and breast-feeding

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

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.

Levetiracetam 750mg Film-Coated Tablets contain sunset yellow FCF aluminium lake (E110)

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

3. How to take Levetiracetam Tablets

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.

Levetiracetam Tablets 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 1,000mg and 3,000mg 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.

Example: if your daily dose is 1000mg, your reduced starting dose is two tablets of250mg in the morning and two tablets of250mg in the evening.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50kg or more:

General dose: between 1,000mg and 3,000mg each day.

Example: if your daily dose is 1000mg, you might take two tablets of250mg in the morning and two tablets of250mg 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 50kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the weight and dose.

Levetiracetam oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from six to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.

Method of administration

Swallow Levetiracetam Tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam Tablets with or without food.

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.

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, Levetiracetam Tablets should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Tablets treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Tablets.

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

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4. Possible side effects

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

The most frequent reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at a 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)

•    dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), 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 people)

•    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

•    elevated/abnormal values in a liver function test

•    weight decrease, weight increase

•    hair loss, eczema, pruritus

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

•    diplopia (double vision), vision blurred

•    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

•    liver 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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

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

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

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

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

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

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

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

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Levetiracetam Wockhardt 1,000mg Tablets are white, film-coated, oval shaped, debossed with “W535" on one side and a score line on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Levetiracetam Tablets are supplied in a blister pack of 60 tablets within an outer carton.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name	Reference number
Levetiracetam Wockhardt 250mg Film-Coated Tablets	PL 29831/0360
Levetiracetam Wockhardt 500mg Film-Coated Tablets	PL 29831/0361
Levetiracetam Wockhardt 750mg Film-Coated Tablets	PL 29831/0362
Levetiracetam Wockhardt 1,000mg Film-Coated Tablets	PL 29831/0363

This is a service provided by the Royal National Institute of Blind People.

These medicinal products are authorised in the Member States of the EEA under the following names: UK: Levetiracetam Wockhardt 250mg, 500mg, 750mg or 1,000mg Film-Coated Tablets Malta: Levetiracetam Wockhardt 250mg, 500mg, 750mg or 1,000mg Film-Coated Tablets

This leaflet was last revised in 02/2016.

^WOCKHARDT