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LEVETIRACETAM THAME 100MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Package leaflet: Information for the user
Levetiracetam Thame 100mg/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.
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.









The name of your medicine is Levetiracetam
Thame 100mg/ml Oral Solution but it will be
referred to as Levetiracetam throughout this
leaflet.
What is in this leaflet:
1. What Levetiracetam is and what it is
used for
2. What you need to know before you take
Levetiracetam
3. How to take Levetiracetam
4. Possible side effects
5. How to store Levetiracetam
6. Contents of the pack and other
information

1. What Levetiracetam is and what it is
used for
Levetiracetam is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).
Levetiracetam can be 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:
o Partial onset seizures with or without
generalisation in adults, adolescents,
children and infants from one month of
age
o Myoclonic seizures in adults and
adolescents from 12 years of age with
juvenile myoclonic epilepsy
o Primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of
age with idiopathic generalised epilepsy

Other medicines and Levetiracetam
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.

Dose in adults and adolescents (12 to 17
years) weighing 50 kg or more:
General dose: between 1000mg (10ml) and
3000mg (30ml) each day, divided in 2 intakes
per day.

Levetiracetam with food, drink and alcohol
You may take Levetiracetam with or without
food. As a safety precaution, do not take
Levetiracetam with alcohol.

Dose in infants (6 to 23 months), children
(2 to 11 years) and adolescents (12 to 17
years) weighing less than 50 kg:

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant or if you think you may be
pregnant, please inform your doctor.
Levetiracetam 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
Levetiracetam may impair your ability to drive
or operate any tools or machinery, as
Levetiracetam 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 contains:
Methyl parahydroxybenzoate (E218):
This may cause allergic reactions (possibly
delayed).
Liquid Maltitol (E965): If you have been told
by your doctor that you have intolerance to
some sugars, contact your doctor before taking
this medicinal product.
Sodium citrate (E331): This medicinal product
contains 3.58 mmol (or 82.2 mg) sodium per
maximum dose of 30ml. To be taken into
consideration by patients on a controlled sodium
diet.
This product also contains 9.61mg/ml propylene
glycol (E1520) as an ingredient necessary for
the medicine to work properly. Talk to your
doctor or pharmacist before giving this medicine
to your baby if she is less than 4 weeks old.

2. What you need to know before you

take Levetiracetam

3. How to take Levetiracetam


Do not take Levetiracetam:
If you are allergic (hypersensitive) to
levetiracetam or any of the other ingredients
of this medicine (listed in Section 6).

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

PIL/UK/MFG106/03/v1

Add-on therapy

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 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.

General dose: between 20mg (0.2ml) and 60mg
(0.6ml) 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:
0.1ml/kg twice
daily

6 kg

0.6ml twice daily

8 kg

0.8ml twice daily

10 kg
15 kg

1ml twice daily
1.5ml twice daily

20 kg
25 Kg

2ml twice daily
2.5ml twice daily

From 50
Kg

5ml twice daily

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

Dose in infants (1 month to less than 6
months):
General dose: between 14mg (0.14ml) and
42mg (0.42ml) 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:
0.07ml/kg twice
daily

4 kg

0.3ml twice daily

5 kg

0.35ml twice
daily
0.45ml twice
daily
0.5ml twice daily

6 kg
7 kg

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

Method of administration:
Levetiracetam oral solution may be diluted in a
glass of water or baby’s bottle. If this is done,
take the solution immediately after dilution.
Use the measuring syringe provided in the pack
to deliver the required dose.
Instructions for the use of syringe:
1. Open the bottle: press the cap and turn it
anticlockwise (figure 1)
2. Separate the adaptor from the syringe (figure
2). Insert the adaptor into the bottle neck
(figure 3).

Monotherapy
Dose in adults and adolescents (from 16
years of age)
General dose: between 1000mg (10ml) and
3000mg (30ml) each day, divided in 2 intakes
per day.

Ensure it is fixed well.
Take the syringe and put it in the adaptor
opening (figure 4). Turn the bottle upside
down (figure 5).

When you will first start taking Levetiracetam,
your doctor will prescribe you a lower dose
during 2 weeks before giving you the lowest
general dose.

TURN OVER

3. Fill the syringe with a small amount of
solution by pulling the piston down (figure
5A), then push the piston up in order to
remove any possible air bubbles (figure 5B).
Pull the piston down to the graduation mark
corresponding to the quantity in millilitres
(ml) prescribed by your doctor (figure 5C).

4. 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).
5. Drink the whole contents of the glass/baby’s
bottle immediately.
6. Close the bottle with the plastic screw cap.
Wash the syringe with water (figure 8) and
store in a clean place.

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

the beginning of the treatment or at dose
increase. These effects should however decrease
over time.
Very Common (may affect more than 1 in
10 users)
 Nasopharyngitis;
 Somnolence (sleepiness), headache.
Common (may affect 1 to 10 users in 100):
 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):
 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):
 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
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 yellowcard.
Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

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

5. How to store Levetiracetam


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

PIL/UK/MFG106/03/v1






Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
stated on the carton box and bottle after
‘EXP:,’the expiry date refers to the last day of
the month.
This medicinal product does not require any
special storage conditions.
Discard 7 months after first opening.



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 Levetiracetam contains
The active substance is levetiracetam.
Each ml of oral solution contains 100mg
levetiracetam.
The other ingredients are: sodium citrate (E331)
(for pH-adjustment), citric acid monohydrate
(for pH-adjustment), methyl
parahydroxybenzoate (E218), ammonium
glycyrrhizate, glycerol (E422), maltitol liquid
(E965), grape flavour (contains propylene glycol
(E1520)) and purified water.
What Levetiracetam looks like and contents
of the pack
Levetiracetam oral solution is a clear, colourless
solution with grape flavour supplied in amber
glass bottles with tamper evident child resistant
plastic cap.
The 300ml glass bottle is packed in a cardboard
box containing a 10ml oral syringe with 0.25 ml
graduation mark and an adaptor for the syringe.
The 150ml glass bottle is packed in a cardboard
box containing a 3 ml oral syringe with 0.1ml
graduation mark and an adaptor for the syringe.
The 150ml glass bottle is packed in a cardboard
box containing a 1ml oral syringe with 0.05 ml
graduation mark and an adaptor for the syringe.
Not all pack sizes may be marketed.
POM
Marketing Authorisation Holder and
Manufacturer:
Syri Limited t/a Thame Laboratories
Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
This leaflet was last revised in 07/2015
The medicinal product is authorised in the
Member states of the EEA under the
following names:
UK and IE: Levetiracetam Thame 100mg/ml
Oral Solution

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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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