Skip to Content

LEVETIRACETAM ACCORD 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Levetiracetam Oral Solution

Market

UK

Language

English

Size

400 x 650 mm

Min. Font Size 10
Version No.

6 (Page 1 of 2)

Date

19_12_16 (Levetiracetam Solution(ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

• Wash the syringe with water only (figure 8).

Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more
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.

Measure the appropriate dosage using the 10 ml syringe included in the package
for patients of 4 years and above.
General dose:
Levetiracetam oral solution is taken twice daily, in two equally divided doses,
each individual dose being measured
between 5 ml (500mg) and 15 ml (1500mg).
Dose in children 6 months and older
Your doctor will prescribe the most appropriate pharmaceutical form of
Levetiracetam oral solution according to the age, weight and dose.
For children 6 months to 4 years, measure the appropriate dosage using the 3
ml syringe included in the package.
For children above 4 years, measure the appropriate dosage using the 10 ml
syringe included in the package.
General dose: Levetiracetam oral solution is taken twice daily, in two equally divided
doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml
(30mg), per kg bodyweight of the child. (see table below for dose examples).

Duration of treatment:
• 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.

What is in this leaflet
Weight
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

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

Do not take Levetiracetam oral solution
• If you are allergic to levetiracetam or any of the other ingredients of this
medicine (listed in section 6).

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

After measuring the correct dose with an appropriate syringe, 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)

Contact your doctor if you took more Levetiracetam oral solution than you
should. Your doctor will establish the best possible treatment of overdose.

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

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

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.

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.

The possible side effects of an overdose of Levetiracetam oral solution are
sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing
and coma.

If you forget to take Levetiracetam oral solution
Dose in infants (1 month to less than 6 months)
For infants 1 month to less than 6 months, measure the appropriate dosage
using the 1 ml syringe included in the package.
General dose: Levetiracetam oral solution is taken twice daily, in two equally divided
doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml
(21mg), per kg bodyweight of the infant. (see table below for dose examples).

Method of administration:

2. What you need to know before you take
Levetiracetam oral solution

If you take more Levetiracetam oral solution than you should

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.

• 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

Other medicines and Levetiracetam oral solution
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 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.

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

Pregnancy and breast-feeding
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.

• 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

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.
Breast-feeding is not recommended during treatment.
Driving and using machines

• 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).

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.
Levetiracetam oral solution contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol
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.

• 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).
Reporting of side effects

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

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.

5. How to store Levetiracetam oral solution

3. How to take Levetiracetam 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 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.

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

Monotherapy

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

Dose in adults and adolescents from 16 years of age

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 4 months of first opening the bottle.

• 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).

Measure the appropriate dosage using the 10 ml syringe included in the package
for patients 4 years and above.
General dose:
Levetiracetam oral solution is taken twice daily, in two equally divided doses,
each individual dose being measured between 5 ml (500mg) and 15 ml
(1500mg). 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.

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
What Levetiracetam oral solution contains
• Drink the whole contents of the glass/baby’s bottle.
• Close the bottle with the plastic screw cap.

- The active substance is levetiracetam. Each ml contains 100 mg of
levetiracetam.
- The other ingredients are sodium citrate, citric acid monohydrate, methyl

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Levetiracetam Oral Solution

Market

UK

Language

English

Size

400 x 650 mm

Min. Font Size 10
Version No.

6 (Page 2 of 2)

Date

19_12_16 (Levetiracetam Solution(ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

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
This leaflet was last revised in 12/2016.

Checked By
Regulatory Affairs

Approved By
Quality Assurance

+ Expand Transcript

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.

Hide