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BACLOFEN 0.05 MG/ML SOLUTION FOR INJECTION

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2. BEFORE YOU TAKE BACLOFEN

solution for injection
{baclofen}

Baclofen Aguettant
0.05mg
solution for injection
{baclofen}

00000 00

Baclofen Aguettant
0.05mg

00000 00

Children and adolescents:
Baclofen formulation is intended for children of 4 years
and above.

Please read this product information carefully before
you or your child is given Baclofen since it contains
important information.
• 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. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.
The name of this medicinal product is Baclofen
Aguettant 0.05 mg solution for injection, but will be
referred as Baclofen throughout the whole leaflet.
In this leaflet:
1. What Baclofen is and what it is used for
2. Before you take Baclofen
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Further 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 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.

Do not use Baclofen
• if you are allergic to baclofen or to any of the other
ingredients of Baclofen. (These are listed at the end of
the leaflet.)
• if you suffer from epilepsy refractory to therapy.
Baclofen should not be administered by any route other
than intrathecal (into the spinal canal).
Take special care with 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.
• 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.
Taking other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Some medicines can interfere with your treatment.
Remind your doctor or nurse if you are taking any of the
following:
• Other medicines for your spasticity 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.)
Using Baclofen with food and drink
• Be careful when drinking alcohol - it may affect you
more than usual.
Fertility, pregnancy and breast-feeding
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.
Lactation
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 use more Baclofen than you should
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.
Stop taking the medicine and/or seek urgent medical advice
if you present any of the side effects below:
Common: may affect up to 1 in 10 people
Seizures
Pneumonia

Uncommon: may affect up to 1 in 100 people
Feeling suicidal
Deep vein thrombosis
The side effects listed below have also 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
Tingling hands or feet
Problems with eyesight
Slurred speech
Insomnia
Breathing difficulties
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
Stomach ache, difficulty in swallowing, loss of taste,
dehydration
Loss of muscle control
Raised blood pressure
Slow heart beat
Flushed or pale skin, excessive sweating
Hair loss.
There have been rare (may affect up to 1 in 1,000
people) reports of problems associated with the pump
and delivery system. There are sometimes (frequency
cannot be estimated from the available data) adverse
events associated with the delivery system e.g. infections
or meningitis, in particular the presence of a PEG tube
increased the incidence of deep infections in childre.
If any of the symptoms become troublesome, or if you
notice anything else not mentioned here, please go and
see your doctor. He/she may want to adjust the dose or
give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This included any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: http://yellowcard.mhra.gov.uk/
By reporting side effects you can help provide more information on the safety of this medicine

5. HOW TO STORE BACLOFEN

Keep all medicines out of the reach and sight 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. FURTHER INFORMATION

What Baclofen contains
The active substance is baclofen.
Baclofen Aguettant 0.05mg 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 0.05mg solution for injection
Type I clear colourless glass 2 ml ampoules with scorebreak and blue colour 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 approved in 11/2013

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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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