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BACLOFEN AGUETTANT 0.5 MG/ML SOLUTION FOR INFUSION

Active substance(s): BACLOFEN

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00000 00

solution for infusion

Baclofen Aguettant
0.5 mg/ml
solution for infusion

00000 00

Baclofen Aguettant
0.5 mg/ml

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Baclofen Aguettant 0.5 mg/ml
solution for infusion
{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 pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
The name of this medicinal product
is Baclofen Aguettant 0.5 mg/ml
solution for infusion, but will be
referred as Baclofen throughout the
whole leaflet.
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.
Baclofen is intended for adults and
children of 4 years and above and

Code : xxxxxx
PRODUIT :
NOT ABT BACLOFENE 0,5 mg/ml
PAYS : GB
Dimensions : mm = 240 x 240
Textes corps 8,5 pts interligné 10,2 pts

VERSION

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.

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

N° projet : 15_064_04
VERSION

INITIALES : C. WITTENBERG - PICTURAL PP
VERSIONS - DATE :
1 - 01/07/15 - 10h45 4 - 06/07/15 - 13h50
2 - 03/07/15 - 9h50 5 - 09/07/15 - 9h55
3 - 03/07/15 - 13h35
ANNULE ET REMPLACE :

N/A

NOIR

DECOUPE

treated with Baclofen.
• The 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.
• Contact 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.
• Your 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-the-counter.)
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 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

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NOM COMPLET :
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NOM COMPLET :
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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 lightheadedness
• 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 0.5 mg/ml solution
for infusion
1 ampoule with 20 ml of solution
contains 10 mg of baclofen.
1 ml of solution for infusion contains
0.5 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 infusion
Clear and colourless solution in
ampoules.
Baclofen Aguettant 0.5 mg/ml solution
for infusion
Type I clear colourless glass 20 ml
ampoules with score-break and red
coloured ring marker.
Box of 1 ampoule containing 20 ml of
solution.
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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