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LEVETIRACETAM LIQMEDS 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM

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Artwork No.

090317/1

Colours Used

Customer

Liqmeds

Black

Description

Levetiracetam 100mg/ml Oral solutions Leaflet

Keyline (Cutting Edge)

Market

UK

Language

English

Size

210 x 500 mm

Min. Font Size

Arial, 9 pt

Page No.

1 of 1

Version No.

2

Date

09-05-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

Uncommon: (may affect 1 to 10 users in 1000 people)
!
Turn the bottle the right way up (figure 6A). Remove the
syringe from the adaptor (figure 6B).
Package Leaflet: Information for the User

Levetiracetam Liqmeds 100mg/ml Oral solution
Levetiracetam
Read all of this leaflet carefully before you start taking this
Monotherapy
medicine because it contains important information for you.
!
Keep this leaflet. You may need to read it again.
Dose in adults and adolescents from 16 years of age:
!
If you have any further questions, ask your doctor or
Measure the appropriate dosage using the 10 ml syringe
pharmacist.
included in the package for patients 4 years and above.
!
This medicine has been prescribed for you. Do not pass it
General dose: Levetiracetam is taken twice daily, in two equally
divided doses, each individual dose being measured between 5
onto others. It may harm them, even if their signs of illness
ml (500mg) and 15 ml (1500mg).
are the same as yours.
!
If you get any side effects, talk to your doctor or pharmacist.
When you will first start taking Levetiracetam, your doctor will
This includes any possible side effects not listed in this
prescribe you a lower dose during 2 weeks before giving you the
leaflet (See section 4).
lowest general dose.
What is in this leaflet:
Add-on therapy
1. What Levetiracetam Oral Solution is and what it is used for
2. What you need to know before you take Levetiracetam Oral
Dose in adults and adolescents (12 to 17 years) weighing 50
Solution
kg or more:
3. How to take Levetiracetam Oral Solution
Measure the appropriate dosage using the 10 ml syringe
4. Possible side effects
included in the package for patients of 4 years and above.
5. How to store Levetiracetam Oral Solution
General dose: Levetiracetam is taken twice daily, in two equally
6. Contents of the pack and other information
divided doses, each individual dose being measured between 5
ml (500mg) and 15 ml (1500mg).
1. What Levetiracetam Oral Solution is and what it is used
for
Dose in children 6 months and older
Your doctor will prescribe the most appropriate pharmaceutical
form of Levetiracetam 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.
Levetiracetam is used:
For children above 4 years, measure the appropriate dosage
!
on its own in adults and adolescents from 16 years of age
using the 10 ml syringe included in the package.
with newly diagnosed epilepsy, to treat a certain form of
General dose: Levetiracetam is taken twice daily, in two equally
epilepsy. Epilepsy is a condition where the patients have
divided doses, each individual dose being measured between
0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the
repeated fits (seizures). Levetiracetam is used for the
child. (see table below for dose examples).
epilepsy form in which the fits initially affect only one side of
Dose in children 6 months and older:
the brain, but could thereafter extend to larger areas on both
sides of the brain (partial onset seizure with or without
Weight
Starting dose:
Maximum dose:
secondary generalisation.) Levetiracetam has been given to
0.1 ml/kg twice daily 0.3 ml/kg twice daily
you by your doctor to reduce the number of fits.
6 kg
0.6 ml twice daily
1.8 ml twice daily
!
as an add-on to other antiepileptic medicines to treat:
8 kg
0.8 ml twice daily
2.4 ml twice daily
,
Myoclonic seizures (short, shock-like jerks of a muscle or
10 kg
1 ml twice daily
3 ml twice daily
group of muscles) in adults and adolescents from 12
15 kg
1.5 ml twice daily
4.5 ml twice daily
years of age with juvenile myoclonic epilepsy
20 kg
2 ml twice daily
6 ml twice daily
,
primary generalised tonic-clonic seizures (major fits,
25 kg
2.5 ml twice daily
7.5 ml twice daily
including loss of consciousness) in adults and
From 50 kg 5 ml twice daily
15 ml twice daily
adolescents from 12 years of age with idiopathic
generalised epilepsy (the type of epilepsy that is thought
Dose in infants (1 month to less than 6 months);
to have a genetic cause).
For infants 1 month to less than 6 months, measure the
,
partial onset seizures with or without generalisation in
appropriate dosage using the 1 ml syringe included in the
adults, adolescents, children and infants from one month
package.
of age
General dose: Levetiracetam is taken twice daily, in two equally
divided doses, each individual dose being measured between
2. What you need to know before you take Levetiracetam
0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the
Oral Solution
infant. (see table below for dose examples).
Levetiracetam oral solution is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).

Do not take Levetiracetam Oral Solution:
Dose in infants (1 month to less than 6 months)
!
if you are allergic (hypersensitive) to Levetiracetam or any of
the other ingredients of this medicine (see section 6).
Weight Starting dose:
Maximum dose:
0.07
ml/kg
twice
0.21
ml/kg twice
Warnings and Precautions
daily
daily
Talk to your doctor or pharmacist before taking Levetiracetam
4 kg
0.3 ml twice daily
0.85 ml twice daily
Oral Solution:
5
kg
0.35
ml
twice
daily
1.05 ml twice daily
!
if you notice any slow down in the growth or unexpected
6
kg
0.45
ml
twice
daily
1.25 ml twice daily
puberty development of your child
7 kg
0.5 ml twice daily
1.5 ml twice daily
!
if you suffer from kidney problems, follow your doctor's

!
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);
!
decreased number of blood platelets, decreased number of
white blood cells;
!
weight decrease, weight increase;
!
Empty the contents of the syringe in a glass of water or
!
diplopia (double vision), vision blurred;
baby's bottle by pushing the piston to the bottom of the
!
injury
syringe (figure 7).
!
muscle weakness, myalgia (muscle pain);
!
Drink the whole contents of the glass/baby's bottle.
!
elevated/abnormal values in a liver function test;
!
Close the bottle with the plastic screw cap.
!
hair loss, eczema, pruritus;
!
Wash the syringe with water only (figure 8).

Rare: (may affect 1 to 10 users in 10,000 people)
!
severe allergic reactions (DRESS, anaphylactic reaction
[severe and important allergic reaction], Quincke's oedema
[swelling of the face, lips, tongue and throat]);
!
infection;
!
decreased number of all blood cell types;
!
decreased blood sodium concentration;
!
suicide, personality disorders (behavioural problems),
Duration of Treatment:
thinking abnormal (slow thinking, unable to concentrate);
!
Levetiracetam is used as a chronic treatment. You should
!
uncontrollable muscle spasms affecting the head, torso and
continue Levetiracetam treatment for as long as your doctor
limbs, difficulty in controlling movements, hyperkinesia
has told you.
(hyperactivity);
!
Do not stop your treatment without your doctor's advice
!
pancreatitis;
as this could increase your seizures.
!
hepatic failure, hepatitis;
!
sudden decrease in kidney function
If you take more Levetiracetam than you should
!
skin rash, which may form blisters and looks like small
The possible side effects of Levetiracetam overdose are
targets (central dark spots surrounded by a paler area, with
agitation, aggression, sleepiness, decrease of alertness,
a dark ring around the edge) (erythema multiforme), a
inhibition of breathing and coma.
widespread rash with blisters and peeling skin, particularly
You should contact your doctor if you took more Levetiracetam
around the mouth, nose, eyes and genitals (Stevensthan you should. Your doctor will establish the best possible
Johnson syndrome), and a more severe form causing skin
peeling in more than 30% of the body surface (toxic
treatment of overdose.
epidermal necrolysis).
!
rhabdomyolysis (breakdown of muscle tissue) and
If you forget to take Levetiracetam
associated blood creatine phosphokinase increase.
If you forget to take one or more doses then contact your doctor.
Prevalence is significantly higher in Japanese patients when
Do not take a double dose to make up for a forgotten dose.
compared to non-Japanese patients.
If you stop taking Levetiracetam
If stopping treatment, Levetiracetam should be discontinued
gradually to avoid an increase of seizures. Should your doctor
decide to stop your Levetiracetam treatment, he/she will instruct
you about the gradual withdrawal of Levetiracetam. Ask your
doctor or pharmacist if you have any further questions on the
use of this product,
4. Possible Side Effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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

Do not use this medicine after the expiry date stated on the
Tell your doctor immediately, or go to your nearest
cardboard box and bottle after EXP:.
emergency department, if you experience:
The expiry date refers to the last day of the month.
!
weakness, feel light-headed or dizzy or have difficulty
Do not use after 7 months of first opening the bottle.
breathing, as these may be signs of a serious allergic
Store in the original container in order to protect from light.
(anaphylactic) reaction
!
swelling of the face, lips, tongue and throat (Quincke's
Do not throw away any medicines via wastewater or household
oedema)
waste. Ask your pharmacist how to throw away medicines you
!
flu-like symptoms and a rash on the face followed by an
no longer use. These measures will help protect the
extended rash with a high temperature, increased levels of
environment.
liver enzymes seen in blood tests and an increase in a type

instructions. Doctor may decide if your dose should be
Method of administration:After measuring the correct dosage
adjusted.
with an appropriate syringe, Levetiracetam Oral Solution may be
!
A small number of people being treated with anti-epileptics
diluted in a glass of water or baby's bottle. You may take
such as Levetiracetam have had thoughts of harming or
Levetiracetam with or without food.
killing themselves. .If you have any symptoms of depression
of white blood cell (eosinophilia) and enlarged lymph nodes
and/or suicidal ideation, please contact your doctor.
6. Contents of the pack and other information
(Drug Reaction with Eosinophilia and Systemic Symptoms
Instructions for Use:
!
Open the bottle: press the cap and
[DRESS]),.
Children and adolescents
What Levetiracetam Oral Solution contains
turn
it
anticlockwise
(figure
1)
!
symptoms such as low urine volume, tiredness, nausea,
Levetiracetam Oral Solution is not indicated in children and
The active substance is Levetiracetam. Each 1 ml of solution
vomiting, confusion and swelling in the legs, ankles or feet,
adolescents below 16 years on it's own (monotherapy)
contains 100 mg of the active ingredient.
as this may be a sign of sudden decrease of kidney function
The other ingredients are sodium citrate, citric acid anhydrous,
Other medicines and Levetiracetam:
!
a skin rash which may form blisters and look like small
methyl parahydroxybenzoate (E218), propyl
Please tell your doctor or pharmacist if you are taking or have
targets (central dark spots surrounded by a paler area, with
parahydroxybenzoate (E216), ammonium glycyrrhizate,
recently taken any other medicines,
a dark ring around the edge) (erythema multiforme)
acesulfame potassium (E950), glycerol (E422), Liquid maltitol
!
a widespread rash with blisters and peeling skin, particularly
(E965), grape flavour, sucralose and purified water.
Do not take macrogol (a drug used as laxative) for one hour
around the mouth, nose, eyes and genitals (Stevensbefore and one hour after taking levetiracetam as this may
!
Separate the adaptor from the syringe (figure2). Insert the
Johnson syndrome)
results in a reduction of its effect.
What Levetiracetam Oral Solution looks like and contents of
adaptor into the bottle neck (figure 3). Ensure it is well fixed.
!
a more severe form of rash causing skin peeling in more
the pack
Pregnancy, breast-feeding and fertility
than 30% of the body surface (toxic epidermal necrolysis)
Levetiracetam Oral Solution is a clear, colourless to light yellow
If you are pregnant or breast-feeding, think you may be
!
signs of serious mental changes or if someone around you
colour liquid.
pregnant or are planning to have a baby, your doctor or
notices signs of confusion, somnolence (sleepiness),
The 300 ml glass bottle (for children aged 4 years and above,
pharmacist for advice before taking this medicine.
amnesia (loss of memory), memory impairment
adolescents and adults) is packed in a cardboard box containing
a 10 ml oral syringe (graduated every 0.25ml) and an adaptor
(forgetfulness), abnormal behaviour or other neurological
This solution should not be used in pregnancy unless clearly
for the syringe.
signs including involuntary or uncontrolled movements.
necessary. A risk of birth defects for your unborn child cannot be
completely excluded. Levetiracetam has shown unwanted
These could be symptoms of an encephalopathy.
reproductive effects in animal studies at dose levels higher than
The 150 ml glass bottle (for infants and young children aged
!
Take the syringe and put it in the adaptor opening (figure 4).
you would need to control your seizures.Breast-feeding is not
from 6 months to less than 4 years) is packed in a cardboard
The most frequently reported adverse reactions were
Turn the bottle upside down (figure 5).
recommended during treatment.
box containing a 3 ml oral syringe (graduated every 0.1ml) and
nasopharyngitis, somnolence (sleepiness), headache, fatigue
an adaptor for the syringe.
and dizziness. Some of the side effects like sleepiness,
Driving and using machines
tiredness and dizziness may be more common at the beginning
Levetiracetam may make you feel sleepy, which may affect your
The 150 ml glass bottle (for infants aged 1 month to less than 6
of the treatment or at dose increase. These effects should
ability to drive or operate any tools or machinery. This is more
months) is packed in a cardboard box containing a 1 ml oral
likely at the beginning of your treatment or after an increase in
however decrease over time.
syringe (graduated every 0.05ml) and an adaptor for the syringe.
the dose. You should not drive or use machines until it is
Tell your doctor if you notice any of the following side effects or
established that your ability to perform such activities is not
notice any other effects not listed:
Marketing Authorisation Holder and Manufacturer:
affected.
The Marketing Authorisation Holder for your solution are:
Very common (may affect more than 1 user in 10 people):
!
Fill the syringe with a small amount of solution by pulling the
Levetiracetam Oral Solution contains
Liqmeds Limited
!
somnolence (sleepiness), headache
piston down (figure 5A), then push the piston upward in
Levetiracetam oral solution includes methyl parahydroxyCavendish House,
!
nasopharyngitis
order to remove any possible bubble (figure 5B). Pull the
benzoate (E218) and propyl parahydroxybenzoate (E216) which
369 Burnt Oak Broadway,
piston down to the graduation mark corresponding to the
may cause allergic reactions (possibly delayed). Levetiracetam
Edgware HA8 5AW, United Kingdom
quantity
in
milliliters
(ml)
prescribed
by
your
doctor
(figure
Common (may affect 1 to 10 users in 100 people):
oral solution also contains maltitol. If you have been told by your
5C).
!
convulsion, balance disorder (equilibrium disorder),
doctor that you have an intolerance to some sugars, contact
The manufacturers for your solution is:
your doctor before taking this medicinal product.
dizziness (sensation of unsteadiness), lethargy (lack of
Wave Pharma Limited,
energy and enthusiasm), tremor, (involuntary trembling);
4th Floor Cavendish House,
3. How to take Levetiracetam Oral Solution
!
depression, hostility or aggression, anxiety, insomnia,
369 Burnt Oak Broadway,
nervousness or irritability;
Edgware, HA8 5AW, United Kingdom
Always take this medicine exactly as your doctor has told you.
!
vertigo (sensation of rotation);
Check with your doctor or pharmacist if you are not sure.
!
anorexia (loss of appetite);
Levetiracetam Oral Solution must be taken twice a day, once in
If you would like this leaflet in different format information or
!
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting,
the morning and once in the evening, at about same time each
want to report any side effects please contact marketing
day. Take Levetiracetam Oral Solution following your doctor's
nausea;
authorisation holder listed above.
instructions.
!
cough;
!
rash;
This leaflet was last revised in May 2017
!
asthenia/fatigue (tiredness).

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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