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GENLEV 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Product:

Genlev 100 mg/ml
Oral Solution

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Activase

PL No.:

28444/0146

Pack Size:

150 ml and 300 ml

Dimensions:

210 x 315 mm

Livery:

Activase

Created By:

DTawde

Manufacturer:

-

Artwork Code:

A0146/O/PIL/A2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9 pt

Final Preparation Date For Submission: 30/06/2016

Packing Site Technical Approval:

Market:

UK

Component:

Leaflet

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
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00/00/0000

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

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.

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
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 17 years) 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.
Weight
6 kg
8 kg
10 kg
15 kg
20 kg
25 kg
From 50 kg

Starting dose:
0.1 ml/kg twice daily
0.6 ml twice daily
0.8 ml twice daily
1 ml twice daily
1.5 ml twice daily
2 ml twice daily
2.5 ml twice daily
5 ml twice daily

Maximum dose:
0.3 ml/kg twice daily
1.8 ml twice daily
2.4 ml twice daily
3 ml twice daily
4.5 ml twice daily
6 ml twice daily
7.5 ml twice daily
15 ml twice daily

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.
Weight
4 kg
5 kg
6 kg
7 kg

Starting dose:
0.07 ml/kg twice daily
0.3 ml twice daily
0.35 ml twice daily
0.45 ml twice daily
0.5 ml twice daily

Maximum dose:
0.21 ml/kg twice daily
0.85 ml twice daily
1.05 ml twice daily
1.25 ml twice daily
1.5 ml twice daily

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

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

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

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.
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]).

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
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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