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Package Leaflet: Information for the patient

Levetiracetam Milpharm 250 mg film-coated tablets Levetiracetam Milpharm 500 mg film-coated tablets Levetiracetam Milpharm 750 mg film-coated tablets Levetiracetam Milpharm 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 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.

What is in this leaflet:

1.    What Levetiracetam Milpharm is and what it is used for

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

3.    How to take Levetiracetam Milpharm

4.    Possible side effects

5.    How to store Levetiracetam Milpharm

6.    Contents of the pack and other information

1. What Levetiracetam Milpharm is and what it is used for

Levetiracetam Milpharm film-coated tablet are an antiepileptic

medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Milpharm is used

•    on its 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.

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

Do not take Levetiracetam Milpharm:

•    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 Milpharm

•    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.

•    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 Milpharm 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 Milpharm

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

Levetiracetam Milpharm with food, drink and alcohol

You may take Levetiracetam Milpharm with or without food. As a safety precaution, do not take Levetiracetam Milpharm 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 Milpharm should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. 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 Milpharm may impair your ability to drive or operate any tools or machinery, as Levetiracetam Milpharm 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 Milpharm:

Levetiracetam Milpharm 750 mg contains Sunset Yellow FCF (E110). Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

3. How to take Levetiracetam Milpharm

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 Milpharm 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 1000 mg and 3,000 mg each day.

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

250 mg

Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

500 mg

Example: if your daily dose is 2,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

750 mg

Example: if your daily dose is 3,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

1000 mg

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.

250 mg

Example: if your daily dose is 1,000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

500 mg

Example: if your daily dose is 1,000 mg, you must take one tablet in the morning and one tablet in the evening.

750 mg

Example: if your daily dose is 1,500 mg, you must take one tablet in the morning and one tablet in the evening.

1000 mg

Example: if your daily dose is 2,000 mg, you must take one tablet in the morning and one 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:

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

An 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.

250 mg

Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet in the morning and 1 tablet in the evening.

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

An Levetiracetam 100 mg/ml oral solution is a presentation more appropriate to infants.

Method of administration:

Swallow Levetiracetam Milpharm tablets with a sufficient quantity of liquid (e.g. a glass of water).

Duration of treatment:

•    Levetiracetam Milpharm is used as a chronic treatment. You should continue Levetiracetam Milpharm 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 Milpharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Milpharm.

If you take more Levetiracetam Milpharm than you should:

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

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 Milpharm:

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

4. Possible side effects

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

•    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: may affect 1 to 10 users in 1000

•    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;

•    liver function test abnormal;

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

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

•    infection;

•    decreased number of all blood cell types;

•    severe hypersensitivity reactions (DRESS);

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

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store Levetiracetam Milpharm

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, blister & bottle label 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 Milpharm contains

The active substance is called levetiracetam. Each film-coated tablet contains 250 mg/ 500 mg/ 750 mg/ 1000 mg levetiracetam.

The other ingredients are:

Tablet core: Maize starch, silica colloidal anhydrous (E551), povidone (K-30) (E1201), talc (E553b), magnesium stearate (E470b).

Film-coating:

250 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132).

500 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171), macrogol 4000, iron oxide yellow (E172).

750 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132), sunset yellow aluminium lake (E110), iron oxide red. (E172).

1000 mg: Hypromellose 5 cp (E464), titanium dioxide (E 171), macrogol 400.

What Levetiracetam Milpharm looks like and contents of the pack

Film-coated tablet.

Levetiracetam Milpharm 250 mg film-coated tablets Blue oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘10’ on one side and plain on the other side. The tablet can be divided into equal halves.

Levetiracetam Milpharm 500 mg film-coated tablets Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘11’ on one side and plain on the other side. The tablet can be divided into equal halves.

Levetiracetam Milpharm 750 mg film-coated tablets Orange oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘12’ on one side and plain on the other side. The tablet can be divided into equal halves.

Levetiracetam Milpharm 1000 mg film-coated tablets White modified oval shaped, biconvex film-coated tablets debossed with break line separating ‘E’ and ‘13’ on one side and plain on the other side. The tablet can be divided into equal halves.

Levetiracetam Milpharm film-coated tablets are packaged in PVC/PE/PVdC - Aluminium foil blister pack or HDPE bottle with polypropylene cap pack.

Pack size:

Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets Bottle pack: 30, 100, 200 and 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

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

Levetiracetam Arrow Lab 250mg/ 500mg/ 1000mg, comprime pellicule secable Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/ 1000mg Filmtabletten

Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/

1000mg film-coated tablets

Levetiracetam Aurobindo 500mg/ 1000mg

compresse rivestite con film

Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/

1000mg, filmomhulde tabletten

Levetiracetam Aurobindo

Levetiracetam Aurobindo 250mg/ 500mg/

1000mg comprimat filmate Levetiracetam Aurobindo 250mg/ 500mg/

1000mg comprimidos recubiertos con pelfcula Levetiracetam Milpharm 250mg/ 500mg/ 750mg/ 1000mg film-coated tablets

This leaflet was last revised in 08/2014.