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BACLOFEN 0.05 MG/1 ML SOLUTION FOR INJECTION

Active substance(s): BACLOFEN

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Experience so far does not allow any predictions to be made about combination of Baclofen with other
medications.
No information is available on co-administration with other medicines that are also delivered into the spinal
cord.

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following medicines may interact with Baclofen or Baclofen may interact with them:
- Medicines to relieve severe muscle spasms (antispastics).
- Medicines that have depressant effects on the functions of the central nervous system.
- Medicines to treat depression (tricyclic antidepressants).
- Medicines used to treat high blood pressure.

Baclofen 0.05mg/1ml solution for injection
Baclofen
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 or pharmacist.
In this leaflet:
1. What Baclofen is and what it is used for
2. Before you use Baclofen
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Further information

It may be necessary for the doctor to adjust the dose of Baclofen or one of your other medicines.
Using Baclofen with food and drink
Drinking alcohol while using Baclofen should be avoided as this may lead to an undesirable intensification
or unpredictable change in the effect of the medicine.
Pregnancy and breast-feeding
There is no experience on the use of Baclofen during pregnancy or while breast-feeding. Baclofen should
not be used during pregnancy or while breast-feeding unless the potential benefit to the mother outweighs
the potential risk to the child. Baclofen passes into breast milk. As so far there are no adequate studies
available the concentration cannot be predicted.
Driving and using machines
During treatment with Baclofen your ability to drive or operate machines may be considerably impaired.
Do not drive, operate machines or participate in any other hazardous activities.
In particular it should be noted that drinking alcohol at the same time further intensifies this decreased
alertness.

1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR
Baclofen is a medicine to relieve severe muscle spasms (antispastic).
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.

Important information about some of the ingredients of Baclofen
Baclofen 0.05 mg/1 ml solution for injection contains less than 1 mmol sodium (23 mg) per maximum
dose of 2 ml (corresponding to 100 microgram baclofen).
3. HOW TO USE BACLOFEN
Always use Baclofen exactly as your doctor has told you.

For this purpose the doctor will inject single injections (bolus injections) of Baclofen 0.05mg/1ml into your
spinal cord to test whether this will result in an improvement in your symptoms.

At a first stage the doctor will find out by single injections of Baclofen 0.05mg/l ml if this improves your
muscular spasms. If this is the case a special pump will be implanted under your skin, which permits
continuous delivery of small quantities of Baclofen.

2. BEFORE YOU USE BACLOFEN
Do not use Baclofen
- if you are allergic (hypersensitive) to baclofen or any of the other ingredients of Baclofen.
- if you have epilepsy that is untreatable.

It may take several days to find out the optimal dose for you. Once the optimum treatment is established,
your doctor must check your progress and functioning of the pump at regular intervals.

Take special care with Baclofen
- if you have abnormal flow of cerebral spinal fluid (liquor) as a result of obstructed passage,
- epilepsy or other cerebral seizures,
- bulbar paralytic symptoms or partial paralysis (pareses) of the respiratory muscles (neurological
syndromes caused by damage to the motor cranial nerves in the elongated spine),
- acute or chronic confusional states,
- psychotic disorders, schizophrenia or Parkinson's disease,
- history of abnormal autonomic nervous system reflexes,
- inadequate blood flow in the brain and difficulty breathing (cerebrovascular and respiratory
insufficiency),
- pre-existing overactivity of the bladder sphincter muscle,
- cardiac problems,
- impaired renal function,
- stomach and intestinal ulcers (peptic ulcers),
- severely impaired hepatic function.

Baclofen can be administered only by qualified specialist doctors by direct injection or infusion in the back
(spinal cord), for which special medical equipment is needed. For this reason hospitalisation will be
necessary at the beginning of therapy.

Intrathecal use.

The signs of overdose are:
- muscle weakness (too little muscle tone)
- sleepiness
- dizziness or light-headedness
- excessive salivation (hypersalivation)
- nausea or vomiting

Baclofen 0.05 mg/1 ml, solution for injection
Screening trial (under hospital conditions)
Prior to initiation of chronic infusion of Baclofen, patients must demonstrate
a response to baclofen in a screening trial. For this purpose a test dose of
Baclofen 0.05 mg/l is usually administered undiluted via a lumbar puncture
or an intrathecal catheter. The usual initial test dose is 25 µg or 50 µg
baclofen equivalent to ½-1 ampoule of Baclofen 0.05 mg/1 ml. The dose
should be given by adding to cerebral spinal fluid (barbotage) over one
minute (or longer). This can be stepped up by 25 µg increments at least
24 hours apart to the maximum test dose of 100 µg as follows:

This is necessary because of the great variability between patients in the
therapeutic dose that is effective. During long-term treatment baclofen can
be delivered continuously into the cerebral spinal fluid using an implantable
pump and Baclofen 10 mg/20 ml or Baclofen 10 mg/5 ml.

Baclofen is intended for administration in single bolus test doses (via spinal
catheter or lumbar puncture) and, for chronic use, in implantable pumps
suitable for continuous administration of intrathecal baclofen into the
intrathecal space (EU certified pumps). Establishment of the optimum dose
schedule requires that each patient undergoes an initial screening phase
with intrathecal bolus, followed by a very careful individual dose titration
prior to maintenance therapy. Intrathecal administration of baclofen through
an implanted delivery system should only be undertaken by physicians with
the necessary knowledge and experience. Specific instructions for
implantation, programming and/or refilling of the implantable pump are given
by the pump manufacturers, and must be strictly adhered to.

The screening, implantation and dose titration phases of the intrathecal
treatment are to be carried out in hospital with very careful monitoring by
appropriately qualified specialist doctors and in centres with specific
experience. In view of possible life-threatening events or severe adverse
reactions appropriate resuscitative equipment should be on stand-by.
(see also section 3 “How to Use Baclofen”).

How is Baclofen prepared and administered?

The following information is intended for medical or healthcare
professionals only:

Baclofen

Baclofen 0.05mg/1ml solution for injection

No specific studies have been carried out on interactions with other medicines.

If you use more Baclofen than you should
It is very important that you, and those caring for you, are able to recognise the signs of overdose. These
may appear suddenly or slowly for example because the pump is not working properly.

Each ampoule is for single use only. The solution it contains is stable,
isotonic, pyrogen and antioxidant free and has a pH-value of 5–7.

Using Baclofen with other medicines
Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other
medicines, including medicines obtained without a prescription.

If you have any of the above signs, tell your doctor straight away. These signs may be followed by more
serious side effects unless you are treated immediately.

Before using Baclofen each solution should be tested to make sure it is clear
and colourless; if particulate matter of discolorations are present, the
solution must not be used and should be discarded.

Elderly patients
Several patients over the age of 65 years have been treated with Baclofen during the clinical trials without
specific problems. Experience with Baclofen tablets shows however that this patient group may be more
susceptible to side effects. Elderly patients should therefore be carefully monitored for the occurrence of
side effects

The signs of withdrawal are:
increased spasticity, too much muscle tone
- difficulty with muscle movements
- increase in heart rate or pulse
- itching, tingling. burning sensation or numbness (paraesthesia) in your hands or feet
- palpitations
- anxiety
- high body temperature
- low blood pressure
- altered mental conditions for example agitation, confusion, hallucinations, abnormal thinking and
behaviour, convulsions

Before using Baclofen in patients with posttraumatic spasticity the
subarachnoid space should be investigated using myelography. If this
reveals signs of an arachnoiditis, treatment with Baclofen must not be
initiated.

Children and adolescents
Baclofen intrathecal formulation is intended for children of 4 years and above. Children should be of
sufficient body mass to accommodate the implantable pump. There is very limited clinical data in children
under the age of six.

If treatment with Baclofen is interrupted
It is very important that you, and those caring for you, are able to recognise signs of Baclofen withdrawal.
These may appear suddenly or slowly for example because the pump is not working properly due to
battery problems, catheter problems or alarm dysfunction.

Evidence demonstrating the efficacy of Baclofen was obtained in clinical
trials using the SynchroMed Infusion System. This is an implantable drug
delivery system with refillable reservoirs, which is implanted in a
subcutaneous pocket usually on the abdominal wall. The device is
connected to an intrathecal catheter that passes subcutaneously to the
subarachnoid space. Reliable experience with other implantable pump
systems is so far not available.

For patients with spasticity due to head injury, it is recommended not to proceed to long-term Baclofen
therapy until the symptoms of spasticity are stable and can be reliably assessed.

If your muscle spasticity is not improving or if you start having spasms again, either gradually or suddenly,
contact your doctor immediately.

-

difficulty in breathing (respiratory depression), respiratory arrest (apnoea)
convulsions
clouding or loss of consciousness (coma)
abnormal low body temperature

If you have any signs of an overdose of Baclofen, tell your doctor straight away.

For a description of the signs of withdrawal, see “If treatment with Baclofen is interrupted”.

If you stop using Baclofen
If this medicine must be stopped, this may only be done by your doctor who will reduce the dose gradually
to avoid side effects. Suddenly stopping Baclofen can cause withdrawal symptoms which in some cases
have proven fatal.

For a description of the signs of overdose, see “If you receive more Baclofen than you should”.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.

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

5. HOW TO STORE BACLOFEN
Keep out of the reach and sight of children.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen can cause side effects, although not everybody gets them. These occur more
often at the start of treatment during your hospital stay, but they may also occur later. Many of these side
effects are also known to be associated with the specific medical condition for which you are being
treated.

Do not use Baclofen after the expiry date which is stated on the ampoule and the folding box. The expiry
date refers to the last day of that month.

The following categories are used as the frequency convention for side effects:

The product should be used immediately after opening.
The solution must be clear and colourless. If particulate matter or discoloration are present the solution
must not be used and should be discarded.

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

Any unrequired fraction must be destroyed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

Metabolism and nutrition disorders
Common:
Decreased appetite.
Uncommon:
Dehydration.
Psychiatric disorders
Common:
Depression, Confusional state, Disorientation, Agitataion, Anxiety.
Uncommon:
Suicidal thoughts and attempt, Paranoia, Hallucinations, Disturbed
mood.
Nervous system disorders
Very common:
Drowsiness
Common:
Respiratory depression, Convulsion, Lethargy, Slurred quiet speech,
Headache, Numbness with tingling of the buttocks and feet,
Sleeplessness, Sedation, Dizziness.
Convulsion and headache occur more frequently in patients with
cerebral spasticity.
Uncommon:
Ataxia, Hypothermia, Dysphagia, Loss of memory / forgetfulness,
Nystagmus.
Eye disorders
Common:
Accommodation disorders with vision blurred or double vision.
Cardiac disorders
Uncommon:
Bradycardia.
Vascular disorders
Common:
Orthostatic hypotension.
Uncommon:
Deep vein thrombosis, Hypertension, Reddening of the skin, Pallor.
Respiratory, thoracic and mediastinal disorders
Common:
Aspiration pneumonia, Dyspnoea, Bradypnoea.
Gastrointestinal disorders
Common:
Vomiting, Constipation, Diarrhoea/bowl incontinence, Nausea, Dry mouth,
Increased salivation.
Nausea and vomiting occur more frequently in patients with cerebral spasticity.
Uncommon:
Ileus, Reduced taste perception.
Skin and subcutaneous tissue disorders
Common:
Urticaria, Pruritus.
Uncommon:
Alopecia, Excessive sweating.
Musculoskeletal and connective tissue disorders
Very common:
Hypotonia.
Common:
Hypertonia, Muscular weakness.
Renal and urinary disorders
Common:
Urinary retention, Urinary incontinence.
Urinary retention occurs more frequently in patients with cerebral spasticity.
Reproductive system and breast disorders
Common:
Sexual dysfunction.
General disorders and administration site conditions
Common:
Oedema peripheral, Face oedema, Pain, Fever, Shivering.

What Baclofen looks like and contents of the pack
Solution for injection,
Baclofen is a clear, colourless solution in a clear, colourless ampoule.
Baclofen 0.05mg/1ml, solution for injection is available in a pack containing 1 or 5 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceuticals Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Baclofen SUN 0,05 mg/1 ml Injektionslösung
Spain:
Baclofen SUN 0,05 mg/1 ml Solución inyectable
France:
Baclofène SUN 0,05 mg/1 ml Solution injectable
IT:
Baclofene SUN 0,05 mg/1 ml Soluzione iniettabile
UK:
Baclofen 0.05 mg/1 ml Solution for Injection
This leaflet was last approved in 03/2011.

Baclofen 0.05 mg/1 ml
Test dose [µg baclofen] ml solution equiv. to no. of ampoules
25 µg
0.5 ml =½ ampoule
50 µg
1.0 ml =1 ampoule
75 µg
1.5 ml =1½ ampoules
100 µg
2.0 ml =2 ampoules

After each bolus injection the patient must be monitored for 4–8 hours.
The onset of the effect of a single intrathecal dose is usually ½–1 hour after
administration. The maximum spasmolytic effect is approx. 4 hours after
administration and persists for 4–8 hours. The onset of activity, maximum
effect and duration of the effect differs from patient to patient and depends
on the dose, severity of the symptoms and type and rate of delivery.
Patients should demonstrate a clinically relevant decrease in muscle tone
and/or frequency or severity of spasms in order to be considered
responders to treatment. Patients who do not respond to a test dose of
2 ampoules Baclofen 0.05 mg/1(equivalent to 100 µg baclofen) should not
be given further increases of dose nor be considered for continuous
intrathecal infusion.

The tolerability of the test dose can vary in different individuals. As signs of
severe overdose (coma) have been observed in a patient after a single test
dose of 25 µg treatment should be initiated only under hospital conditions
and should be performed with resuscitative equipment on stand-by.

Paediatric population

Screening phase
The initial lumbar puncture test dose for patients 4 to <18 years of age
should be 25-50 μg/day based upon age and size of the child. Patients who
do not experience a response may receive a 25 μg/day dose escalation
every 24 hours. The maximum screening dose should not exceed
100 μg/day in paediatric patients.

Dose Titration phase
No proposed changes.

Incompatibilities
Baclofen 0.05 mg/1 ml solution for injection is used undiluted.

044BP1633B

6. FURTHER INFORMATION
What Baclofen contains
The active substance is: baclofen.
1 ampoule with 1 ml solution for injection contains 0.05 mg baclofen.
- The other ingredients are: sodium chloride and water for injections.

044BP1633B

Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

Storage conditions
This medicinal product does not require any special storage conditions.

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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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