PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Levetiracetam Manx 100mg/ml

Oral Solution

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

i Keep this leaflet. You may need to read it again i If you have any further questions, ask your doctor or pharmacist i 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

In this leaflet

1.    What Levetiracetam is and what it is used for

2.    What you need to know before you take Levetiracetam

3.    How to take Levetiracetam

4.    Possible side effects

5.    How to store Levetiracetam

6.    Contents of the pack and other information

1.    What Levetiracetam is and what is it used for

Levetiracetam Manx 100mg/ml Oral Solution (hereinafter referred to as Levetiracetam) is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam 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 the 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 thereafter 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

i 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

Do not take Levetiracetam

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

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 i 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

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

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are taking or 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 reduction 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.

Levetiracetam 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 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 contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Levetiracetam oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Levetiracetam oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take Levetiracetam

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 must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the oral solution following your doctor's instructions.

Monotherapy

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

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

When you first start taking Levetiracetam, your doctor will prescribe you a lower dose (500mg each day) during 2 weeks before giving you the lowest gereral dose of 1000mg.

Add-on therapy

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

General dose: between 10ml (1,000mg) and 30ml (3,000mg) each day, divided in 2 intakes per day.

Dose in infants (6 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 age, weight and dose.

General dose: between 0.2ml (20mg) and 0.6ml (60mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Method of administration

Levetiracetam oral solution may be diluted in a glass of water or baby's bottle. You may take Levetiracetam with or without food.

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Separate the adaptor from the syringe (figure 2). Insert the i adaptor into the bottle neck (figure 3). Ensure it is well fixed.

Take the syringe and put it in the adaptor opening (figure 4). ■ Turn the bottle upside down (figure 5).

Fill the syringe with a small amount of solution by pulling the ■ piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

(continued overleaf)

WIP URN	v/	300516-GLET001-PIL-04
APPROVED URN
Job		Levetiracetam PIL - Side 1
Size		650 x 280mm
Date		30 May 2016
BOH Approval Date
Saved as		14136/04 PIL- Side 1.ai M1X
Prints		1 Colour - Black

Drink the whole contents of the glass/baby's bottle Close the bottle with the plastic screw cap Wash the syringe with water only (figure 8).

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 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 Levetiracetam than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam

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

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 adverse reactions were 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 i anorexia (loss of appetite)

depression, hostility or aggression, insomnia, nervousness or irritability

convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling) i vertigo (sensation of rotation) cough

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea i rash

asthenia/fatigue (tiredness)

Uncommon: may affect 1 to 10 users in 1000 people i decreased number of blood platelets, decreased number of white blood cells

i weight decrease, weight increase

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation

i 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 i 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 i infection

i 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)) i 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

i 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Levetiracetam

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

Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP.

The expiry date refers to the last day of the month.

Do not use after 4 months of first opening the bottle.

Store in the original bottle, in order to protect from light.

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 oral solution contains

The active substance is called levetiracetam. Each ml contains 100mg of levetiracetam.

The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water. What Levetiracetam looks like and contents of the pack Levetiracetam 100mg/ml oral solution is a clear liquid.

The 300ml glass bottle of Levetiracetam (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10ml oral syringe (graduated every 0.25ml) and an adaptor for the syringe.

The 200ml glass bottle (containing 150ml oral solution) of Levetiracetam (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3ml oral syringe (graduated every 0.1ml) and an adaptor for the syringe.

The 200ml glass bottle (containing 150ml oral solution) of Levetiracetam (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1ml oral syringe (graduated every 0.05ml) and an adaptor for the syringe.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK

Manufacturer

Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

Other formats

To request a copy of this leaflet in braille, large print or audio please call 01926 482511

This leaflet was last revised in May 2016

WIP URN: 300516-GLET001-PIL-04

WIP URN	✓	300516-GLET001-PIL-04
APPROVED URN
Job		Levetiracetam PIL - Side 2
Size		650 x 280mm
Date		30 May 2016
BOH Approval Date
Saved as		14136/04 PIL- Side 2.ai M1X

Prints 1 Colour - Black