Package leaflet: Information for the patient Levetiracetam-Lupin 250 mg Film-coated Tablets Levetiracetam-Lupin 500 mg Film-coated Tablets Levetiracetam-Lupin 750 mg Film-coated Tablets Levetiracetam-Lupin 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 Levetiracetam-Lupin is and what it is used for

2.    What you need to know before you take Levetiracetam-Lupin

3.    How to take Levetiracetam-Lupin

4.    Possible side effects

5.    How to store Levetiracetam-Lupin

6.    Contents of the pack and other information

1.    What Levetiracetam-Lupin is and what it is used for

Levetiracetam-Lupin contains the active substance levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam-Lupin is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could then extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    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 (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 Levetiracetam-Lupin Do not take Levetiracetam-Lupin:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levetiracetam-Lupin:

•    if you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose should be adjusted.

A small number of people being treated with anti-epileptics such as levetiracetam 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

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

Levetiracetam is not intended for use on its own (monotherapy) in children and adolescents below 16 years.

Other medicines and Levetiracetam-Lupin

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

It is especially important to inform your doctor if you are taking:

•    methotrexate (a medicine used to treat psoriasis, rheumatoid arthritis and some cancers)

•    macragol (a medicine for constipation). You should not take macrogol for one hour before and one hour after taking levetiracetam, as this may decrease its effect

•    probenecid (a medicine for gout).

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 should not be used during pregnancy unless clearly necessary, as there is a risk of harm to your unborn child.

Breast-feeding is not recommended during treatment as levetiracetam passes into breast milk.

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.

Levetiracetam-Lupin 750mg tablets contains Sunset yellow (E110)

Sunset yellow (E110) colouring agent may cause allergic reactions.

3.    How to take Levetiracetam-Lupin

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. The tablets can be divided into equal doses.

Swallow levetiracetam tablets with a sufficient quantity of liquid (e.g a glass of water). You may take this medicine with or without food.

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 (500 mg each day) during 2 weeks before, giving you the lowest general dose of 1000 mg.

Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of250 mg in the morning and 2 tablets of250 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 of250 mg in the morning and 2 tablets of250 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.

Levetiracetam 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets do not allow accurate dosage).

Duration of treatment:

•    Levetiracetam is 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-Lupin 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 took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam-Lupin:

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-Lupin:

If stopping treatment levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your treatment with this medicine, he/she will instruct you about a gradual withdrawal.

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 a sore nose or throat (nasopharyngitis), sleepiness (somnolence), headache, fatigue and dizziness. At the beginning of treatment or at dose increase, side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

If you notice any of the following serious side effects, stop taking this medicine and contact your doctor or go to your nearest hospital emergency department immediately Uncommon (may affect up to 1 in 100 people):

•    thinking about suicide or attempting suicide

•    Rare (may affect up to 1 in 1,000 people):severe immediate allergic reaction causing a rash, swelling of the face, lips, tongue and throat

•    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)

•    severe abdominal pain that spreads to the back, which may be signs of a swollen pancreas

Tell your doctor straight away if you notice any of the following, as you may need medical attention

Uncommon (may affect up to 1 in 100 people):

•    increased signs of infection such as fever, sore throat, mouth ulcers, which may be caused by a reduction in white blood cells

Rare (may affect up to 1 in 1,000 people):

•    delayed allergic reaction causing rash with fever and possibly swollen or tender lymph glands

•    signs of liver problems such as abdominal pain, fever, pale stools or dark urine, yellowing of the skin and eyes

Other possible side effects

Very common (may affect more than 1 in 10 people):

•    nasopharyngitis (common cold)

•    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 (lack of energy and enthusiasm), tremor (involuntary trembling)

•    vertigo (sensation of rotation)

•    cough

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea

•    rash

•    asthenia/fatigue (weakness/tiredness)

Uncommon (may affect up to 1 in 100 people):

•    decreased number of blood platelets, causing you to bruise or bleed more easily or for longer than usual

•    weight decrease, weight increase

•    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):

•    decreased number of all blood cell types

•    decreased blood sodium concentration

•    infection

•    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)

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

5.    How to store Levetiracetam Tablets

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

Do not use this medicine after the expiry date which is stated on the carton 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-Lupin Tablets contains

The active substance is levetiracetam. Each tablet contains 250 mg, 500 mg, 750 mg or 1000 mg levetiracetam.

The other ingredients are:

Common Tablet Core:

Maize starch, colloidal anhydrous silica, croscarmellose sodium, povidone K30, microcrystalline cellulose, talc and magnesium stearate.

Levetiracetam 250 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide (E171), macrogol 3350, macrogol 6000, talc and Indigo carmine (E132). Levetiracetam 500 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide (E171), macrogol 3350, macrogol 6000, talc and iron oxide yellow (E172). Levetiracetam 750 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide (E171), macrogol 3350, macrogol 6000, talc, iron oxide yellow (E172), iron oxide red (E172) and Sunset yellow (E110).

Levetiracetam 1000 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide (E171), macrogol 3350, macrogol 6000 and talc.

What Levetiracetam-Lupin Tablets look like and contents of the pack:

•    Levetiracetam 250 mg tablets are blue, oblong shaped, biconvex film coated tablets marked with “250” on one side and a score line on the other side.

•    Levetiracetam 500 mg tablets are yellow, oblong shaped, biconvex film coated tablet marked with “500” on one side and a score line on the other side.

•    Levetiracetam 750 mg tablets are peach coloured, oblong shaped, biconvex film coated tablet marked with “750” on one side and a score line on the other side.

•    Levetiracetam 1000 mg tablets are white to off white, oblong shaped, biconvex film coated tablet marked with “1000” on one side and a score line on one side.

Levetiracetam tablets are available in blister packs containing 10, 20, 30, 50, 60, 100, 120 and 200 tablets packaged in cartons.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Ltd.

Victoria Court Bexton Road Knutsford

Cheshire, WA16 0PF UK

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

Portugal Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Comprimidos revestidos por pelfcula

Hungary Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Filmtabletta Germany Levetiracetam-Hormosan 250mg, 500mg, 750mg & 1000mg Filmtabletten UK Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Film-coated tablets Italy Levetiracetam Mylan Generics 250mg, 500mg, 750mg & 1000mg Compresse rivestite con film

The leaflet was last revised in 08/2016

Manufacturer Code No. GO/DRUGS/654

ID#: 248335

LULU 0917