PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Genlev 100 mg/ml Oral Solution

(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 symptoms 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 Genlev is and what it is used for

2.    What you need to know before you take Genlev

3.    How to take Genlev

4.    Possible side effects

5.    How to store Genlev

6.    Contents of the pack and other information

Genlev contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Genlev contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). It 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 Genlev

1. What Genlev is and what it is used for

Genlev contains the active ingredient levetiracetam, is an antiepileptic medicine which is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).

Genlev can be 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.

•    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 Genlev

Do not take Genlev:

•    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 or pharmacist before taking Genlev

•    if you suffer kidney problems, as your doctor may need to adjust your dose

•    if you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor

•    A small number of people being treated with anti-epileptics such as Genlev have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, immediately contact your doctor.

Children and adolescents

Genlev is not indicated in children and adolescents below 16 years on it's own (monotherapy).

Other medicines and Genlev

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.

Genlev with food and drink

Genlev can be taken with or without food.

Fertility, pregnancy and breast-feeding

Genlev should not be taken during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Genlev 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 or while breast-feeding unless you are told otherwise by your doctor.

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.

Driving and using machines

Genlev may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. It may cause dizziness, drowsiness and tiredness. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machinery until it is established that your ability to perform such activities is not affected.

Always take Genlev exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you. If you have the impression that the effect of Genlev is too strong or too weak, talk to your doctor or pharmacist as dose changes need to be made gradually.

Genlev 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

Adults and adolescents from 16 years of age

General dose: between 10 ml (1000 mg) and 30 ml (3000 mg) each day, divided in two intakes per day.

When you will first start taking Genlev, your doctor will prescribe you a lower dose for two weeks before giving you the lowest general dose.

Children and adolescents under 16 years of age

Genlev is not recommended for use as a monotherapy in this age group.

Add-on therapy

Adults and adolescents (12 to 17years) weighing 50 kg or more

General dose: between 10 ml (1000 mg) and 30 ml (3000 mg) each day, divided in two 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 Genlev 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 two intakes per day. The exact quantity of oral solution should be delivered using the syringe provided in the pack.

Dose for 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 two intakes per day. The exact quantity of oral solution should be delivered using the syringe provided in the pack.

Method of administration:

Genlev may be diluted in a glass of water or baby's bottle.

Instructions for use:

Open the bottle, press the cap and turn it anticlockwise (figure 1).

Separate the adaptor from the syringe (figure 2).

Insert the adaptor into the bottle neck (figure 3).

Ensure it is well fixed.

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 bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7).

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).

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

•    common cold

•    sleepiness, headache

Common side effects (may affect up to 1 to 10 people)

•    loss of appetite

•    depression, hostility, agression, anxiety, difficulty sleeping, nervousness or irritability

•    convulsions, loss of balance, dizziness, lethargy (lack of energy and enthusiasm), tremor

•    vertigo

•    cough

•    stomach pain, diarrhoea, indigestion, vomiting (being sick), nausea (feeling sick)

•    rash

•    feeling tired or weak

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

•    increase or decrease in weight

•    attempts or thoughts of suicide, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attacks, fluctuation in mood, agitation

•    loss of memory, forgetfulness, difficulty with coordination, numbness and tingling ('pins and needles'), loss of concentration

•    double or blurred vision

•    elevated/abnormal values in a liver function test

•    hair loss, eczema, itching

•    muscle weakness, muscle pain

•    accidental injury

Rare side effects (may affect 1 to 1000 people)

•    infection

•    decreased number of all blood cell types

•    decreased blood sodium concentration

•    suicide, personality disorder, abnormal thinking

•    problems with abnormal or excessive movements such as writhing, jerking movements and stiffness

•    inflammation of the pancreas

•    liver failure or inflammation of the liver

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 Genlev

Duration of treatment:

•    Genlev is used as a chronic treatment. You should continue Genlev 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 Genlev than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take this leaflet and the remaining medicine with you so that the doctor knows what you have taken.

The symptoms of an overdose can include sleepiness, agitation, aggression, loss of consciousness, reduced alertness, breathing problems and coma.

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

This medicinal product does not require any special temperature storage conditions. Store in the original container in order to protect from light.

Do not use this medicine 7 months after you first opened the bottle.

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

If you forget to take Genlev

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Genlev

Do not stop taking Genlev unless your doctor tells you to. If your treatment is stopped it should be done gradually. If you stop taking Genlev suddenly or before your doctor tells you, there is an increased risk 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, Genlev can cause side effects, although not everybody gets them. The most frequently reported adverse reactions were common cold, 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.

If you get any of the following side effects, STOP TAKING this medicine and see a doctor or go to a hospital straight away:

•    an allergic reaction, the signs of which may include swelling of the face, lips, mouth or throat leading to difficulty in breathing or swallowing; skin rash, itching or hives

•    decreased platelets (blood clotting cells) and decrease in white blood cells

•    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) or severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin

•    severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]).

What Genlev contains

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

The other ingredients are maltitol liquid, glycerol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium citrate, ammonium glycyrrhizate, acesulfame potassium, grape flavouring, purified water.

What Genlev looks like and contents of the pack

Genlev 100 mg/ml Oral Solution is a clear, colourless, grape flavoured liquid. The 300 ml glass bottle of Genlev (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 ml) and an adaptor for the syringe.

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited,

11 Boumpoulinas, 3rd Floor, P.C. 1060 Nicosia, Cyprus

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2016.

A0146/O/PIL/A2