LEVETIRACETAM ACCORD 100 MG/ML ORAL SOLUTION

Active substance: LEVETIRACETAM

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General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day,
divided in 2 intakes per day.
Package leaflet: Information for the user

Levetiracetam 100 mg/ml
oral solution
Levetiracetam
Read all of this leaflet carefully before you 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 or nurse.
- 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 or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Levetiracetam oral solution is and what it is used for
2. What you need to know before you take Levetiracetam oral solution
3. How to take Levetiracetam oral solution
4. Possible side effects
5. How to store Levetiracetam oral solution
6. Contents of the pack and other information

1. What Levetiracetam oral solution is and what
it is used for
Levetiracetam oral solution is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam oral solution 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

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 oral solution 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
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

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

If you take more Levetiracetam oral solution than you should
The possible side effects of an overdose of Levetiracetam oral solution are
sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing
and coma.
Contact your doctor if you took more Levetiracetam oral solution than you
should. Your doctor will establish the best possible treatment of overdose.
If you forget to take Levetiracetam oral solution
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 oral solution

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.

If stopping treatment, as with other antiepileptic medicines, Levetiracetam oral
solution should be discontinued gradually to avoid an increase of seizures.

Weight

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

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:
Levetiracetam oral solution 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)

4. 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: may affect more than 1 user in 10
• nasopharyngitis;
• somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100

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

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Levetiracetam oral
solution
• 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 oral solution have had thoughts of harming or killing themselves.
If you have any symptoms of depression and/or suicidal ideation, please
contact your doctor.

• Levetiracetam oral solution is used as a chronic treatment. You should continue
Levetiracetam oral solution 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. Should your doctor decide to stop your Levetiracetam oral
solution treatment, he/she will instruct you about the gradual withdrawal of
Levetiracetam oral solution.

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

2. What you need to know before you take
Levetiracetam oral solution
Do not take Levetiracetam oral solution

Duration of treatment:

• 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

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

Other medicines and Levetiracetam oral solution

• 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: may affect 1 to 10 users in 10,000

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

Levetiracetam oral solution 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.

• 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;
• 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).

Breast-feeding is not recommended during treatment.

Reporting of side effects

Levetiracetam oral solution with food, drink and alcohol
You may take Levetiracetam oral solution with or without food. As a safety
precaution, do not take Levetiracetam oral solution with alcohol.
Pregnancy and breast-feeding

• 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).

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
Levetiracetam oral solution may impair your ability to drive or operate any tools
or machinery, as Levetiracetam oral solution 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.

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

5. How to store Levetiracetam oral solution

Levetiracetam oral solution contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol

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 carton and
bottle after EXP. The expiry date refers to the last day of that month.
Do not use after 1 month of first opening the bottle.

Levetiracetam oral solution includes methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).
Levetiracetam oral solution also contains maltitol (E965). If you have been told
by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

• 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).

3. How to take Levetiracetam oral solution

Dose in adults and adolescents (from 16 years of age)
General dose: between 10 ml (1000 mg) and 30 ml (3,000 mg) each day, divided
in 2 intakes per day. When you will first start taking Levetiracetam oral solution,
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

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

6. Contents of the pack and other information

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 oral solution 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

If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly viaYellow Card Scheme
Website:www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

What Levetiracetam oral solution contains
• 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).

- The active substance is levetiracetam. Each ml contains 100 mg 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 containing propylene glycol, purified water.
What Levetiracetam oral solution looks like and contents of the pack
Levetiracetam oral solution is clear, colourless grape flavoured liquid.
The 300 ml glass bottle of Levetiracetam oral solution (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 Levetiracetam oral solution (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 Levetiracetam oral solution (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.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Wessling Hungary Kft.
Budapest, Fóti út 56, 1047,
Hungary
This leaflet was last revised in 01/2015.

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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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