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LEVETIRACETAM STRIDES 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Package Leaflet: Information for the patient

Levetiracetam Strides 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 signs of illness 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







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

1. What Levetiracetam Strides oral solution is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Strides 100 mg/ml oral solution is used:
• on its own in adults and adolescents from 16 years of age with newly diagnosed
epilepsy, to treat certain form of epilepsy. Epilepsy is a condition where the patients
have repeated pits (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
generalization). 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:
οο partial onset seizures with or without generalisation in adults, adolescents, children
and infants from one month of age
οο 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
οο 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 Levetiracetam Strides oral solution
Do not take Levetiracetam Strides oral solution
• 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 before taking Levetiracetam Strides 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 slowdown 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 Levetiracetam
Strides 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.
Children and adolescents
• Levetiracetam Strides oral solution is not indicated in children and adolescents below
16 years on it’s own (monotherapy)
Other medicines and Levetiracetam Strides oral solution
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
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.

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Concomitant administration of levetiracetam and methotrexate has been reported to
decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate
concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels
should be carefully monitored in patients treated concomitantly with the two drugs.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think you may be pregnant, or planning to have a
baby ask your doctor for advice before you taking this medicine.
Levetiracetam Strides 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 Strides oral solution 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 Strides Oral solution may impair your ability to drive or operate any tools
or machinery, as it 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 Strides oral solution contains methyl parahydroxybenzoate and
maltitol

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 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Method of administration:
Levetiracetam Strides oral solution may be diluted in a glass of water or baby’s bottle. You
may take Levetiracetam Strides oral solution with or without food.
Instructions for use:
οο Open the bottle: press the cap and turn it anticlockwise (figure 1)

Levetiracetam Strides oral solution includes methyl parahydroxybenzoate (E218) which
may cause allergic reactions (possibly delayed).
Levetiracetam Strides oral solution 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 Strides oral solution
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 Strides 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.

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

Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1,000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam Strides oral solution, your doctor will
prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest
general dose of 1000 mg.
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

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

οο 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).

Front Side

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

Very common (may affect more than 1 users in 10 people):

6. Contents of the pack and other information

• nasopharyngitis;

What Levetiracetam Strides oral solution contains

• somnolence (sleepiness), headache.
Common (may affect 1 to 10 users in 100 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 and enthusiasm), tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
οο 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).

• rash;
• asthenia/fatigue (tiredness).
Uncommon (may affect 1 to 10 users in 1000 people):
• decreased number of blood platelets, decreased number of white blood cells;

− The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
− The other ingredients are: sodium citrate (E331), citric acid monohydrate (E330),
methyl parahydroxybenzoate (E218), ammonium glycyrrhizate (E958), glycerol
(E422), maltitol liquid (E965), acesulfame potassium (E950), flavour natural white
grape, purified water.
What Levetiracetam Strides oral solution looks like and contents of the pack
Levetiracetam Strides 100 mg/ml oral solution is a clear liquid.
The 300 ml glass bottle of Levetiracetam Strides 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 Strides oral solution (for infants and young
children aged from 6 months to less than 4 years) is packed in a cardboard box containing

• weight decrease, weight increase;

a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour,

The 150 ml glass bottle of Levetiracetam Strides oral solution (for infants aged 1 month to

hallucination, anger, confusion, panic attack, emotional instability/mood swings,

less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated

agitation;

every 0.05 ml) and an adaptor for the syringe.

• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/
οο Drink the whole contents of the glass/baby’s bottle.
οο Close the bottle with the plastic screw cap.
οο Wash the syringe with water only (figure 8).

ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in
attention (loss of concentration);
• diplopia (double vision), vision blurred;
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.
Rare (may affect 1 to 10 users in 10,000 people):
• infection;
• decreased number of all blood cell types;
• Severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic
reaction], Quincke’s oedema [swelling of face, lips, tongue and throat]);

Duration of treatment:
• Levetiracetam Strides oral solution is used as a chronic treatment. You should continue
Levetiracetam Strides 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.
If you take more Levetiracetam Strides oral solution than you should:
The possible side effects of an overdose of Levetiracetam Strides oral solution are
sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Levetiracetam Strides oral solution than you should.
Your doctor will establish the best possible treatment of overdose.
If you forget to take Levetiracetam Strides 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 Strides oral solution:
If stopping treatment, Levetiracetam Strides oral solution should be discontinued gradually
to avoid an increase of seizures.
Should your doctor decide to stop your Levetiracetam Strides oral solution treatment, he/
she will instruct you about the gradual withdrawal of Levetiracetam Strides oral solution.

• 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;
• liver 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

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WD18 9SS UNITED KINGDOM
Manufacturer
Beltapharm S.p.A
Via Stelvio 66
Cusano Milanino (MI) – 20095
ITALY
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge: 0800 198 5000
Please be ready to give the following information:
Product name

Reference number

Levetiracetam Strides 100mg/ml Oral Solution

PL 28176/0163

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 06/2016

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

Do not use this medicine after the expiry date stated on the cardboard box and bottle after

Dimension: 380 x 310 mm

Watford, Hertfordshire

You can also report side effects directly via the Yellow Card Scheme at: ww.mhra.gov.uk/

4. Possible side effects

effects should however decrease over time.

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side effects not listed in this leaflet.

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

increase side effects like sleepiness, tiredness and dizziness may be more common. These

Unit 4, Metro Centre

If you get any side effects talk to your doctor or pharmacist. This includes any possible

5. How to store Levetiracetam Strides oral solution

(sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose

Strides Arcolab International Limited

Reporting of side effects

pharmacist.

them. The most frequently reported adverse reactions were nasopharyngitis, somnolence

Marketing Authorisation Holder:

peeling in more than 30% of the body surface (toxic epidermal necrolysis).

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

Like all medicines, this medicine can cause side effects, although not everybody gets

Marketing Authorisation Holder and Manufacturer

EXP: The expiry date refers to the last day of the month.
Do not use after 7 months of first opening the bottle.
Store in the original bottle, 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
protect the environment.

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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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