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KEVESY (UK), Leaflet 210 x 500 mm

Kevesy

solution for infusion

Package leaflet: information for the user

Kevesy 5 mg/ml solution for infusion Kevesy 10 mg/ml solution for infusion Kevesy 15 mg/ml solution for infusion

Levetiracetam

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

•    If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet:

1.    What Kevesy is and what it is used for

2.    What you need to know before you are given Kevesy

3.    How to use Kevesy

4.    Possible side effects

5.    How to store Kevesy

6.    Contents of the pack and other information

WHAT KEVESY IS AND WHAT IT IS USED FOR

Kevesy is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Kevesy is used:

•    on its own in patients from 16 years of age with newly diagnosed epilepsy,

to treat partial onset seizures with or without secondary generalization

•    as an add-on to other antiepileptic medicines to treat:

-    partial onset seizures with or without generalisation in patients from 4 years of age

-    myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy

-    primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy

Kevesy is an alternative for patients when administration of antiepileptic oral medicine is temporarily not feasible.

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KEVESY

Kevesy must not be used

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

Warnings and precautions

Talk to your doctor or nurse before you are given Kevesy

•    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 (for example increased number), please contact your doctor.

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

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

medicines.

Kevesy with food, drink and alchohol

Kevesy may be used with or without food. As a safety precaution, do not use Kevesy with alcohol.

Pregnancy, breast-feeding and fertility

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 you are given this medicine.

Kevesy should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Kevesy 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

Kevesy may impair your ability to drive or operate any tools or machinery, as Kevesy 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.

Kevesy contains sodium

Kevesy 5 mg/ml contains 9.84 mg sodium per ml.

Kevesy 10 mg/ml contains 9.14 mg sodium per ml.

Kevesy 15 mg/ml contains 7.04 mg sodium per ml.

To be taken into consideration by patients on a controlled sodium diet.

Should your doctor decide to stop your Kevesy treatment, he/she will instruct you about the gradual withdrawal of Kevesy.

• There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Kevesy

If stopping treatment, as with other antiepileptic medicines, Kevesy 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, pharmacist or nurse.

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 side effects (may affect more than 1 in 10 people):

•    nasopharyngitis (nose and throat inflammation);

•    somnolence (sleepiness), headache.

Common side effects (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), tremor (involuntary trembling);

•    vertigo (sensation of rotation);

•    cough;

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

•    rash;

•    asthenia/fatigue (tiredness).

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

•    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 side effects (may affect up to 1 in 1,000 people):

•    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 (pancreas inflammation);

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

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

HOW TO STORE KEVESY

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 overwrap, bag and carton after EXP:.

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

This medicinal product does not require any special storage conditions.

This medicinal product is for single use only, any unused solution should be discarded.

Medicinal product with particulate matter or discoloration should not be used.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

Kevesy is administered by a doctor or nurse as an intravenous infusion, in one of your veins.

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

The intravenous formulation is an alternative to oral administration (as film-coated tablets or oral solution). Your doctor may decide to switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.

Monotherapy

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

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

When you will first start taking Kevesy, 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 1000 mg and 3000 mg each day.

•    Dose in children (4 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.

Method and route of administration:

Kevesy is for intravenous use. The solution for infusion should be administered over 15-minutes.

Duration of treatment:

•    Kevesy is used as a chronic treatment. You should continue Kevesy 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.

What Kevesy contains

The active substance is levetiracetam.

■    Each ml contains 5 mg of levetiracetam.

Each 100 ml bag contains 500 mg of levetiracetam.

■    Each ml contains 10 mg of levetiracetam.

Each 100 ml bag contains 1000 mg of levetiracetam.

■    Each ml contains 15 mg of levetiracetam.

Each 100 ml bag contains 1500 mg of levetiracetam.

The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.

What Kevesy looks like and contents of the pack

Kevesy is a clear, colourless to light yellow solution for infusion that is available in a single-use, ready-to-use 100 ml dual port bag with an aluminum over wrap. It is available in three different concentrations in cartons of 10 bags

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

STRAGEN UK Ltd Castle Court 41 London Road Reigate Surrey RH29RJ

Phone: +44 (0)870 351 87 44 Email: info@stragenuk.com

Manufacturer

Facta Farmaceutici S.A

Nucleo Industriale S. atto (loc. S. Nicolo' A Tordino)

64020 Teramo (TE), Italy

This leaflet was last revised in 04/2014.

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