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BACLOFEN AGUETTANT 0.05 MG/ML SOLUTION FOR INJECTION

Active substance(s): BACLOFEN

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Baclofen is intended for adults and children of
4 years and above and is used to reduce and
relieve the excessive tension in your muscles
(spasms) occurring in various illnesses such as
cerebral palsy, multiple sclerosis, spinal cord
diseases, cerebrovascular accidents, and other
nervous system disorders.
This injection is used in people who haven’t
responded to oral medicines or who get
unacceptable side effects when they take
baclofen by mouth.

Baclofen Aguettant
0.05 mg/ml

00000 00

solution for injection
00000 00

Baclofen Aguettant
0.05 mg/ml

2. WHAT YOU NEED TO KNOW BEFORE
BACLOFEN IS GIVEN TO YOU

solution for injection

Children and adolescents:
Baclofen formulation is intended for children of
4 years and above.
You must not be given Baclofen
• if you are allergic to baclofen or any of the other
ingredients of this medicine. (listed in section 6)
• if you suffer from epilepsy refractory to therapy
• Baclofen should not be administered by any
route other than intrathecal (into the spinal canal).

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Baclofen Aguettant 0.05 mg/ml solution for injection
{baclofen}
Read all of this leaflet carefully before you
start using this medicine because 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 nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
The name of this medicinal product is Baclofen
Aguettant 0.05 mg/ml solution for injection, but
will be referred as Baclofen throughout the whole
leaflet.

Warnings and precautions
Talk to your doctor or pharmacist before using
Baclofen
• if you are having any other injections into the
spine
• if you are suffering from any infection
• if you had a head injury within the last year
• if you ever had a crisis caused by a condition
called autonomic dysreflexia (Your doctor will be
able to explain this to you.)
• if you have had a stroke
• if you have epilepsy
• if you have a stomach ulcer or any other
problem with your digestion
• if you suffer from any mental illness
• if you are being treated for high blood pressure
• if you have Parkinson’s disease
• if you suffer from any liver, kidney or lung
disease
• if you have diabetes
• if you have difficulties in urinating
If the answer to any of this list of questions is
YES, tell your doctor or nurse because Baclofen
may not be the right medicine for you.
• If you are going to have an operation of any
kind, make sure that the doctor knows that you
are being treated with Baclofen.

What is in this leaflet:
1. What Baclofen is and what it is used for
2. What you need to know before Baclofen is
given to you
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Contents of the pack and other information
1. WHAT BACLOFEN IS AND WHAT IT IS USED
FOR
Your doctor has decided that you or your child
needs this medicine to help treat your condition.

Code : xxxxxx
PRODUIT :
NOT ABT BACLOFENE 0,05 mg/ml
PAYS : GB
Dimensions : mm = 419 x 269
Textes corps 12 interligné 13

VERSION

N° projet : 15_064_01
VERSION

INITIALES : C. WITTENBERG - PICTURAL AN
VERSIONS - DATE :
1 - 24/06/15 - 16h15
2 - 26/06/15 - 15h10
3 - 09/07/15 - 9h50
ANNULE ET REMPLACE :

N/A

NOIR

DECOUPE

•T
 he presence of a PEG tube increase the
incidence of infections in children.
• If you have a slowed cerebrospinal fluid
circulation the effect of Baclofen may be
reduced.
•C
 ontact your doctor immediately if you think
that Baclofen is not working as well as usual.
It is important to make sure that there are no
problems with the pump.
• Treatment with Baclofen must not stop suddenly
because of the risk of withdrawal effects. You
must make sure that you do not miss those
hospital visits when the pump reservoir is being
refilled.
•Y
 our doctor may want to give you a check up
from time to time while you are being treated
with Baclofen.
Precautions in paediatric patients:
Children should be of sufficient body mass
to accommodate the implantable pump for
chronic infusion. There is very limited clinical
data regarding the safety and efficacy of the
use of Baclofen in children under the age of
4 years.
Other medicines and Baclofen
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Some medicines can interfere with your
treatment. Remind your doctor or nurse if you are
taking any of the following:
• Other medicines for your spastic condition
• Antidepressants
• Medicines for high blood pressure
• Other drugs which also affect the kidney, e.g.
ibuprofen
• Medicines for Parkinson’s disease
• Medicines for epilepsy
• Opiates for pain relief
• Medicines which slow down the nervous
system, e.g. anti-histamines and sedatives.
(Some of these can be bought over-thecounter.)
Baclofen with food and drink
• Be careful when drinking alcohol - it may affect
you more than usual.
Pregnancy, breast-feeding and fertility
Ask your doctor or nurse for advice before taking
any medicine.
There are no adequate and sufficiently controlled
studies in pregnant women. Baclofen crosses

Signataire AR

Signataire MKT

Signataire DI

NOM COMPLET :
Clio WITTENBERG

NOM COMPLET :

NOM COMPLET :
CLAUDE GUILHOT

the placental barrier. Baclofen must not be used
during pregnancy, unless the potential benefits
outweigh the possible risks to the foetus.
Breast-feeding
It is not known whether measurable levels of
the product can be detected in the maternal
milk of lactating mothers treated with Baclofen.
At oral therapeutic doses, the active substance
passes into breast milk, but in amounts so small
that the infant will probably not experience any
undesirable effects.
Driving and using machines
Some people may feel drowsy and/or dizzy or
have problems with their eyes while they are
being treated with Baclofen. If this happens, you
should not drive or do anything that requires you
to be alert (such as operate tools or machinery)
until these effects have worn off.
Important information about some of the
ingredients of Baclofen
This medicinal product contains less than 1 mmol
sodium (23 mg) per maximum daily dose, so it is
essentially “sodium-free”.

3. HOW TO USE BACLOFEN
Baclofen is administered by intrathecal injection.
This means that the medicine is injected directly
into the spinal fluid. The dose needed varies from
person to person depending on their condition,
and the doctor will decide what dose you need
after he/she has tested your response to the drug.
First of all the doctor will find out, by giving you
single doses of Baclofen, whether it is suitable
for you. Usually, this test dose is administered via
lumbar puncture or an intrathecal (spinal) catheter,
in order to provoke a response. During this period
your heart and lung functions will be closely
monitored. If your symptoms improve, a special
pump which can deliver the drug continuously,
will be implanted into your chest or abdominal
wall. The doctor will give you all of the information
you need to use the pump and to get the
correct dosage. Make sure that you understand
everything.
The final dose of Baclofen depends on how
each person responds to the drug. You will be
started on a low dose, and this will be increased
gradually over a few days, under the supervision
of the doctor, until you are having the dose which
is right for you. If the starting dose is too high, or
if the dose is increased too quickly, you are more
likely to experience side effects.

To avoid unpleasant side effects which may be
serious and even life-threatening, it is important
that your pump does not run out. The pump must
always be filled by a doctor or nurse, and you
must make sure that you do not miss your clinic
appointments.
During long-term treatment some patients find
that Baclofen becomes less effective. You may
require occasional breaks in treatment. Your
doctor will advise you what to do.
Baclofen is not suitable for all children. The doctor
will decide.
Efficacy of baclofen intrathecal has been
demonstrated in controlled randomised studies
with infusion systems. EU certified pumps can
be used as implantable administration system: a
refillable reservoir is implanted beneath the skin,
mostly into the abdominal wall. This system is
connected to an intrathecal (spinal) catheter that
passes subcutaneously into the subarachnoid
space. Other pumps, known to be suitable for
intrathecal baclofen administration based on
experience, may be used.
If you have been given too much Baclofen
It is very important that you, and anyone caring for
you, can recognise the signs of overdose. These
may appear if the pump is not working properly,
and you must tell the doctor straight away.
Signs of overdose are:
• Unusual muscle weakness (too little muscle
tone)
• Sleepiness
• Dizziness or light-headedness
• Excessive salivation
• Nausea or vomiting
• Difficulty in breathing Convulsions
• Loss of consciousness
• Abnormally low body temperature
If you stop using Baclofen
You should not stop treatment suddenly. If the
doctor decides to stop your treatment, the dose
will be reduced gradually to prevent withdrawal
symptoms such as muscle spasms and
increased muscle rigidity, fast heart rate, fever,
confusion, hallucinations, changes in mood and
emotion, mental disorders, feeling persecuted
or convulsions (fits). On rare occasions these
symptoms could be life-threatening. If you or your
carers notice any of these symptoms, contact
your doctor immediately just in case something
has gone wrong with the pump or delivery
system.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen can cause side
effects, although not everybody gets them.
The side effects listed below have been reported:
Very common: may affect more than 1 in
10 people
• Feeling tired, drowsy or weak.
Common: may affect up to 1 in 10 people
• Feeling lethargic (having no energy)
• Headache, dizziness or light-headedness
• Pain, fever or chills
• Seizures
• Tingling hands or feet
• Problems with eyesight
• Slurred speech
• Insomnia
• Breathing difficulties, pneumonia
• Feeling confused, anxious, agitated or
depressed
• Low blood pressure (fainting)
• Feeling or being sick, constipation and
diarrhoea
• Loss of appetite, dry mouth or excessive saliva
• Rash and itching, swelling of the face or hands
and feet
• Urinary incontinence, or problems when
urinating
• Cramps
• Sexual problems in men, e.g. impotence.
Uncommon: may affect up to 1 in 100 people
• Feeling abnormally cold
• Memory loss
• Mood swings and hallucinations, feeling suicidal
• Stomach ache, difficulty in swallowing, loss of
taste, dehydration
• Loss of muscle control
• Raised blood pressure
• Slow heart beat
• Deep vein thrombosis
• Flushed or pale skin, excessive sweating
• Hair loss.
Other side effects (how often they happen is
not known)
• Restlessness
• Abnormally slow breathing rate.

There have been rare reports of problems
associated with the pump and delivery system.
There are sometimes adverse events associated
with the delivery system e.g. infections, a
collection of immune cells at the tip of delivery
tube or meningitis, in particular the presence
of a PEG tube increased the incidence of deep
infections in children.
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 national
reporting system:
Yellow Card Scheme
Website:http://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 BACLOFEN
Keep this medicine out of the sight and reach of
children.
Do not use Baclofen after the expiry date {month/
year} which is stated on the outer carton and on
the ampoule.The expiry date refers to the last day
of that month.
Do not refrigerate or freeze.
Store in the original package in order to protect
from light.
From a microbiological point of view, unless the
method of opening and dilution precludes the risk
of microbial contamination, the product should
be used immediately. If not used immediately,
in-use storage times and conditions are the
responsibility of the user.
Do not use Baclofen if you notice that the solution
is not clear and free from particles.
As it is limited to hospital use the waste
drug elimination is carried out directly by the
hospital. These measures will help to protect the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Baclofen contains
The active substance is baclofen
Baclofen Aguettant 0.05 mg solution for injection
1 ampoule with 1 ml of solution contains 0.05 mg
of baclofen.
1 ml of solution for injection contains 0.05 mg of
baclofen.

The other ingredients are sodium chloride
(3.5 mg/ml sodium) and water for injections.
What Baclofen looks like and contents of the
pack
Solution for injection
Clear and colourless solution in ampoules.
Baclofen Aguettant 0.05 mg solution for injection
Type I clear colourless glass 2 ml ampoules with
score-break and blue coloured ring marker.
Box of 5 and 10 ampoules containing 1 ml of
solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 LYON
France
Manufactured by:
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 LYON
France
Distributed by:
AGUETTANT LTD
N°1, Farleigh House
Flax Bourton
BRISTOL – BS48 1UR
United Kingdom
This leaflet was last revised in 06/2015.

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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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