Document: leaflet MAH GENERIC_PL 29831-0620 change

• leaflet MAH BRAND_PL 29831-0620
• leaflet MAH GENERIC_PL 29831-0620

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PACKAGE LEAFLET: INFORMATION FOR THE USER LEVETIRACETAM 100 mg/ml ORAL SOLUTION

Read all of this leaflet carefully before you start taking this medicine.

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. 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 please tell your doctor or pharmacist. This includes possible side effects noflisted in this leaflet.

What is in this leaflet:

What Levetiracetam is and what it is used for What you need to know before you take Levetiracetam How to take Levetiracetam Possible side effects How to store Levetiracetam Contents of the pack and other information

1.    WHAT LEVETIRACETAM IS AND WHAT IT IS USED FOR

_evetiracetam 100 mg/ml Oral Solution 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 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 Do not take Levetiracetam

If you are allergic (hypersensitive) to Levetiracetam or any of the other ingredients of this medicine (listed in section 6).

Warning 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.

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 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:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Levetiracetam with food and drink:

You may take Levetiracetam with or without food. As a safety precaution, do not take Levetiracetam 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 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 Levetiracetam 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 includes Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Levetiracetam 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 Levetiracetam exactly as your doctor has told you. You should 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 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day. When you will first start taking Levetiracetam, 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 10 ml (1,000 mg) and 30 ml (3,000 mg) 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 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose. General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) 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.

Weight	Starting dose: 0.1 ml/kg twice daily	Maximum dose: 0.3 ml/kg twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

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

General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) 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.

Weight	Starting dose: 0.07 ml/kg twice daily		Maximum dose: 0.21 ml/kg twice daily
4 kg	0.3 ml twice daily		0.85 ml twice daily
5 kg	0.35 m	l twice daily	1.05 ml twice daily
6 kg	0.45 m	l twice daily	1.25 ml twice daily
7 kg	0.5 ml Y.	twice daily	1.5 ml twice daily

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Levetiracetam 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 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, emotional instability/mood swings, agitation;

amnesia (toss 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 cells, 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 ana genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis). If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.

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 carton and bottle after EXP:. The expiry date refers to the last day of the month.

Do not use after 1 month of first opening the bottle. Store below 25°C. Due to sensitivity to light, store in the original container. Do not throw medicines via wastewater or householawaste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Levetiracetam contains

The active substance is called Levetiracetam. Each 1 ml contains 100 mg of levetiracetam.

The other ingredients are: Sodium citrate Citric acid, Methyl parahydroxybenzoate (E218), Propvl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), Acesulfame potassium (E950), Grape flavour, Purified water.

What Levetiracetam looks like and contents of the pack

Levetiracetam 100 mg/ml Oral Solution is a clear liquid.

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

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

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

Marketing Authorisation Holder and Manufacturer

PinewoodLaboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL Number: 04917/0097

This leaflet was last updated on 02/2014

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