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LEVETIRACETAM MEDSOLUTIONS 100MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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!
Take the syringe and put it in the adaptor
Uncommon: (may affect 1 to 10 users

opening (figure 4). Turn the bottle upside down
(figure 5).

in 1000)

!
suicide attempt and suicidal ideation,

mental disorder, abnormal behaviour,
hallucination, anger, confusion, panic
attack, emotional instability/mood
Levetiracetam Medsolutions 100mg/ml
swings, agitation;
!
amnesia (loss of memory), memory
Oral solution
impairment (forgetfulness), abnormal
coordination/ataxia (impaired
Levetiracetam
coordinated movements),
Read all of this leaflet carefully before you start
Driving and using machines
paraesthesia (tingling), disturbance in attention
taking this medicine because it contains
Levetiracetam may make you feel sleepy, which
(loss of concentration);
!
Fill the syringe with a small amount of solution
!
decreased number of blood platelets,
important information for you.
may affect your ability to drive or operate any tools
by pulling the piston down (figure 5A), then
decreased number of white blood cells;
!
Keep this leaflet. You may need to read it
or machinery. This is more likely at the beginning
push the piston upward in order to remove any
!
weight decrease, weight increase;
again.
of your treatment or after an increase in the dose.
possible bubble (figure 5B). Pull the piston
!
diplopia (double vision), vision blurred;
!
If you have any further questions, ask your
You should not drive or use machines until it is
down to the graduation mark corresponding to
!
injury
doctor or pharmacist.
established that your ability to perform such
the quantity in milliliters (ml) prescribed by your
!
muscle weakness, myalgia (muscle pain);
!
This medicine has been prescribed for you. Do
activities is not affected.
doctor (figure 5C).
!
elevated/abnormal values in a liver function
not pass it onto others. It may harm them, even
test;
if their signs of illness are the same as yours.
Levetiracetam Oral Solution contains
!
hair loss, eczema, pruritus;
!
If you get any side effects, talk to your doctor or
Levetiracetam oral solution includes methyl
pharmacist. This includes any possible side
parahydroxybenzoate (E218) and propyl
Rare: (may affect 1 to 10 users in 10,000)
effects not listed in this leaflet (See section 4).
parahydroxybenzoate (E216) which may cause
!
severe allergic reactions (DRESS,
allergic reactions (possibly delayed).
anaphylactic reaction [severe and important
What is in this leaflet:
Levetiracetam oral solution also contains maltitol. If
allergic reaction], Quincke's oedema [swelling
1. What Levetiracetam Oral Solution is and what it
you have been told by your doctor that you have
of the face, lips, tongue and throat]);
is used for
an intolerance to some sugars, contact your doctor
!
infection;
!
decreased number of all blood cell types;
2. What you need to know before you take
before taking this medicinal product.
!
Turn the bottle the right way up (figure 6A).
!
decreased blood sodium concentration;
Levetiracetam Oral Solution
Remove the syringe from the adaptor (figure
!
suicide, personality disorders (behavioural
3. How to take Levetiracetam Oral Solution
3. How to take Levetiracetam Oral Solution
6B).
problems), thinking abnormal (slow thinking,
4. Possible side effects
unable to concentrate);
5. How to store Levetiracetam Oral Solution
Always take this medicine exactly as your doctor
!
uncontrollable muscle spasms affecting the
6. Contents of the pack and other information
has told you. Check with your doctor or pharmacist
head, torso and limbs, difficulty in controlling
if you are not sure.
movements, hyperkinesia (hyperactivity);
1. What Levetiracetam Oral Solution is and
!
pancreatitis;
what it is used for
Levetiracetam Oral Solution must be taken twice a
!
hepatic failure, hepatitis;
Levetiracetam 100 mg/ml oral solution is an
day, once in the morning and once in the evening,
!
skin rash, which may form blisters and looks
antiepileptic medicine (a medicine used to treat
at about same time each day.
like small targets (central dark spots
seizures in epilepsy).
surrounded by a paler area, with a dark ring
!
Empty the contents of the syringe in a glass of
Take Levetiracetam Oral Solution following your
around the edge) (erythema multiforme), a
water or baby's bottle by pushing the piston to
Levetiracetam is used:
doctor's instructions.
widespread rash with blisters and peeling skin,
the bottom of the syringe (figure 7).
particularly around the mouth, nose, eyes and
!
on its own in adults and adolescents from 16
genitals (Stevens-Johnson syndrome), and a
years of age with newly diagnosed epilepsy, to
Monotherapy
more severe form causing skin peeling in more
treat a certain form of epilepsy. Epilepsy is a
than 30% of the body surface (toxic epidermal
condition where the patients have repeated fits
Dose in adults and adolescents (from 16 years
necrolysis).
(seizures). Levetiracetam is used for the
of age):
epilepsy form in which the fits initially affect
General dose: between 10 ml (1,000 mg) and 30
Reporting of side effects
only one side of the brain, but could thereafter
ml (3,000 mg) each day, divided in 2 intakes per
If you get any side effects, talk to your doctor or
extend to larger areas on both sides of the
day.
pharmacist. This includes any possible side
brain (partial onset seizure with or without
When you will first start taking Levetiracetam, your
!
Drink the whole contents of the glass/baby's
effects not listed in this leaflet. You can also report
secondary generalisation.) Levetiracetam has
doctor will prescribe you a lower dose during 2
bottle.
side effects directly via
been given to you by your doctor to reduce the
weeks before giving you the lowest general dose.
!
Drink the whole contents of the glass/baby's
www.mhra.gov.uk/yellowcard. By reporting side
bottle
number of fits.
effects, you can help provide more
!
Close the bottle with the plastic screw cap.
!
as an add-on to other antiepileptic medicines to
Add-on therapy
information on the safety of this medicine.
!
Wash the syringe with water only (figure 8).
treat:
,
Myoclonic seizures (short, shock-like jerks
Dose in adults and adolescents (12 to 17 years)
5. How to store Levetiracetam Oral Solution
of a muscle or group of muscles) in adults
weighing 50 kg or more:
and adolescents from 12 years of age with
General dose: between 10 ml (1,000 mg) and 30
Keep this medicine out of the sight and reach of
children.
juvenile myoclonic epilepsy
ml (3,000 mg) each day, divided in 2 intakes per
,
primary generalised tonic-clonic seizures
day.
Do not use this medicine after the expiry date
(major fits, including loss of consciousness)
stated on the cardboard box and bottle after EXP:.
in adults and adolescents from 12 years
Dose in infants (6 to 23 months), children (2 to
The expiry date refers to the last day of the month.
of age with idiopathic generalised epilepsy
11 years) and adolescents (12 to 17 years)
Duration of Treatment:
Do not use after 7 months of first opening the
(the type of epilepsy that is thought to have
weighing less than 50 kg:
!
Levetiracetam is used as a chronic treatment.
bottle.
a genetic cause).
Your doctor will prescribe the most appropriate
You should continue Levetiracetam treatment
,
partial onset seizures with or without
pharmaceutical form of Levetiracetam according to
for as long as your doctor has told you.
Store in the original container in order to protect
!
Do not stop your treatment without your
generalisation in adults, adolescents,
your age, weight and dose.
from light.
doctor's
advice
as
this
could
increase
your
children and infants from one month of age
General dose: between 0.2 ml (20 mg) and 0.6 ml
seizures.
(60 mg) per kg bodyweight each day, divided in 2
Do not throw away any medicines via wastewater
2. What you need to know before you take
intakes per day. The exact quantity of oral solution
or household waste. Ask your pharmacist how to
If you take more Levetiracetam than you should
Levetiracetam Oral Solution
formulation should be delivered using the syringe
throw away medicines you no longer use. These
The
possible
side
effects
of
Levetiracetam
provided in the cardboard box.
measures will help protect the environment.
overdose are agitation, aggression, sleepiness,
Do not take Levetiracetam Oral Solution:
decrease of alertness, inhibition of breathing and
!
if you are allergic (hypersensitive) to
Weight Starting dose:
Maximum dose:
6. Contents of the pack and other information
coma.
Levetiracetam or any of the other ingredients of
0.1 ml/kg twice daily 0.3 ml/kg twice daily
You should contact your doctor if you took more
What Levetiracetam Oral Solution contains
this medicine (see section 6).
6 kg
0.6 ml twice daily
1.8 ml twice daily
Levetiracetam than you should. Your doctor will
The active substance is Levetiracetam. Each 1 ml
8 kg
0.8 ml twice daily
2.4 ml twice daily
establish the best possible treatment of overdose.
of solution contains 100 mg of the active
10 kg 1 ml twice daily
3 ml twice daily
Warnings and Precautions
ingredient.
15 kg 1.5 ml twice daily
4.5 ml twice daily
Talk to your doctor or pharmacist before taking
If you forget to take Levetiracetam
The other ingredients are sodium citrate, citric acid
20 kg 2 ml twice daily
6 ml twice daily
Levetiracetam Oral Solution:
If you forget to take one or more doses then
anhydrous, methyl parahydroxybenzoate (E218),
contact your doctor.
25 kg 2.5 ml twice daily
7.5 ml twice daily
!
if you notice any slow down in the growth or
propyl parahydroxybenzoate (E216), ammonium
Do
not
take
a
double
dose
to
make
up
for
a
unexpected puberty development of your child
From 5 ml twice daily
15 ml twice daily
glycyrrhizate, acesulfame potassium (E950),
forgotten dose.
50 kg
!
if you suffer from kidney problems, follow your
glycerol (E422), Liquid maltitol (E965), grape
doctor's instructions. Doctor may decide if your
flavour, sucralose and purified water.
If
you
stop
taking
Levetiracetam
Dose in infants (1 month to less than 6
dose should be adjusted.
If
stopping
treatment,
Levetiracetam
should
be
months);
!
A small number of people being treated with
What Levetiracetam Oral Solution looks like
discontinued gradually to avoid an increase of
General dose: between 0.14 ml (14 mg) and 0.42
anti-epileptics such as Levetiracetam have had
and contents of the pack
seizures. Should your doctor decide to stop your
ml (42 mg) per kg bodyweight each day, divided in
thoughts of harming or killing themselves. .If
Levetiracetam Oral Solution is a clear, colourless
Levetiracetam treatment, he/she will instruct you
2 intakes per day. The exact quantity of solution
you have any symptoms of depression and/or
to light yellow colour liquid.
about the gradual withdrawal of Levetiracetam.
should be delivered using the syringe provided in
suicidal ideation, please contact your doctor.
The 300 ml glass bottle (for children aged 4 years
the cardboard box.
and above, adolescents and adults) is packed in a
Ask your doctor or pharmacist if you have any
cardboard box containing a 10 ml oral syringe
Children and adolescents
further questions on the use of this product,
(graduated every 0.25ml) and an adaptor for the
Weight Starting dose:
Maximum dose:
Levetiracetam Oral Solution is not indicated in
syringe.
children and adolescents below 16 years on it's
0.07 ml/kg twice
0.21 ml/kg twice
4. Possible Side Effects
own (monotherapy)
daily
daily
The 150 ml glass bottle (for infants and young
Like all medicines, this medicine can cause side
4 kg
0.3 ml twice daily
0.85 ml twice daily
children aged from 6 months to less than 4 years)
effects, although not everybody gets them. The
5 kg
0.35 ml twice daily
1.05 ml twice daily
Other medicines and Levetiracetam:
is packed in a cardboard box containing a 3 ml
most
frequently
reported
adverse
reactions
were
Please tell your doctor or pharmacist if you are
6 kg
0.45 ml twice daily
1.25 ml twice daily
oral syringe (graduated every 0.1ml) and an
nasopharyngitis, somnolence (sleepiness),
taking or have recently taken any other medicines,
7 kg
0.5 ml twice daily
1.5 ml twice daily
adaptor for the syringe.
headache, fatigue and dizziness. Some of the side
effects like sleepiness, tiredness and dizziness
Method of administration:
Do not take macrogol (a drug used as laxative) for
The 150 ml glass bottle (for infants aged 1 month
may be more common at the beginning of the
Levetiracetam Oral Solution may be diluted in a
one hour before and one hour after taking
to less than 6 months) is packed in a cardboard
treatment or at dose increase. These effects
glass of water or baby's bottle. You may take
levetiracetam as this may results in a reduction of
box containing a 1 ml oral syringe (graduated
should however decrease over time.
Levetiracetam with or without food.
its effect.
every 0.05ml) and an adaptor for the syringe.
Tell your doctor if you notice any of the following
Instructions for Use:
Levetiracetam Oral solution with food, drink
Marketing Authorisation Holder and
side effects or notice any other effects not listed:
!
Open the bottle: press the cap and turn it
and alcohol
Manufacturer:
The Marketing Authorisation Holder for your
anticlockwise (figure 1)
This solution can be taken with or without food. Do
Very common (may affect more than 1 user in
solution are:
10):
not take Levetiracetam with alcohol, as a safety
Medsolutions (Europe) Limited,
!
somnolence (sleepiness), headache
precaution.
Cavendish House, 369 Burnt Oak Broadway,
!
nasopharyngitis
Edgware, HA8 5AW, United Kingdom
Pregnancy, breast-feeding and fertility
Common (may affect 1 to 10 users in 100):
If you are pregnant or breast-feeding, think you
!
convulsion, balance disorder (equilibrium
The manufacturers for your solution is:
may be pregnant or are planning to have a baby,
disorder), dizziness (sensation of
Wave Pharma Limited,
your doctor or pharmacist for advice before taking
unsteadiness), lethargy (lack of energy and
4th Floor Cavendish House,
this medicine.
enthusiasm), tremor, (involuntary trembling);
369 Burnt Oak Broadway,
!
depression, hostility or aggression, anxiety,
Edgware, HA8 5AW, United Kingdom
!
Separate the adaptor from the syringe
This solution should not be used in pregnancy
insomnia, nervousness or irritability;
(figure2). Insert the adaptor into the bottle neck
unless clearly necessary. A risk of birth defects for
!
vertigo (sensation of rotation);
If you would like this leaflet in different format
(figure 3). Ensure it is well fixed.
your unborn child cannot be completely excluded.
!
anorexia (loss of appetite);
information or want to report any side effects
Levetiracetam has shown unwanted reproductive
!
abdominal pain, diarrhoea, dyspepsia
please contact marketing authorisation holder
effects in animal studies at dose levels higher than
(indigestion), vomiting, nausea;
listed above.
!
cough;
you would need to control your seizures.
!
rash;
This leaflet was last revised in October 2016
!
asthenia/fatigue (tiredness).
Breast-feeding is not recommended during
treatment.
Package Leaflet: Information for the User

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.

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