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BACLOFEN 0.05 MG/1 ML SOLUTION FOR INJECTION

Active substance(s): BACLOFEN

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Elderly
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

Package leaflet: Information for the user

Baclofen 0.05 mg/1 ml solution for injection
Baclofen
Read all of this leaflet carefully before you or your child is given this medicine because it contains
important information for you or your child.
- 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 or your child 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 or your child get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Baclofen is and what it is used for
2. What you need to know before you or your child are given Baclofen
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Contents of the pack and other information

Other medicines and Baclofen
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
No specific studies have been carried out on interactions with other medicines.
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.
The following medicines may interact with Baclofen or Baclofen may interact with them:
- medicines to treat your Parkinson's disease
- 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.
It may be necessary for the doctor to adjust the dose of Baclofen or one of your other medicines.
Baclofen with food and drink and alcohol
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.

1. What Baclofen is and what it is used for

Baclofen 0.05 mg/1 ml solution for injection is used to test the response to the use of baclofen in the
spinal cord in cases of severe chronic spasticity associated with multiple sclerosis, following spinal
injuries or those of cerebral origin that are unresponsive to standard medical treatment.

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 expected benefit for the mother
outweighs the potential risk for 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.

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

Baclofen contains sodium
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).

2. What you need to know before you or your child are given Baclofen

3. How to use Baclofen

Do not use Baclofen
- if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)
- if you have epilepsy that is untreatable.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

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

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

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

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

Establishment of the optimum dose schedule for Baclofen requires that each
patient undergoes an initial screening phase with a bolus injection of 0.05
mg/1 ml Baclofen via an intrathecal catheter or lumbar puncture, followed by
a very careful individual dose titration prior to maintenance therapy.
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.
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.
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.

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 healthcare professionals only

Baclofen

Baclofen 0.05 mg/1 ml solution for
injection

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. The safe use of Baclofen in the spinal cord of children under
the age of four has not yet been established.

Intrathecal use.

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 ml 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. In
children the recommended test dose is 25 µg. 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:

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

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.

Baclofen 0.05 mg/1 ml, solution for injection

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.

At a first stage the doctor will find out by single injections of Baclofen 0.05 mg/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.

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.
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.

Warnings and precautions
Talk to your doctor before you are given 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.

37.50 cm

The active substance in Baclofen 0.05 mg/1 ml solution for injection is baclofen, which belongs to a group
of medicines called muscle relaxants.
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.

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- low blood pressure
- altered mental conditions for example agitation, confusion, hallucinations, abnormal thinking and
behaviour, convulsions.
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.
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.
The signs of overdose are
- muscle weakness (too little muscle tone)
- sleepiness
- dizziness or light-headedness
- excessive salivation (hypersalivation)
- nausea or vomiting
- 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

5. How to store Baclofen
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
This medicinal product does not require any special storage conditions.
The product should be used immediately after opening.
The solution must be clear and colourless. If particulate matter or discolouration are present the solution
must not be used and should be discarded.
Any unrequired fraction must be destroyed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other 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.

4. Possible side effects
What Baclofen looks like and contents of the pack
Solution for injection.
Baclofen is a clear, colourless solution in a clear, colourless ampoule.

Very common side effects (may affect more than 1 in 10 people)
- drowsiness
- hypotonia.

Baclofen 0.05 mg/1 ml, solution for injection is available in a pack containing 1 or 5 ampoules.

Common side effects (may affect up to 1 in 10 people)
- decreased appetite
- depression, confusional state, disorientation, agitataion, anxiety
- 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
- accommodation disorders with vision blurred or double vision
- orthostatic hypotension
- respiratory depression, aspiration pneumonia, dyspnoea, bradypnoea
- vomiting, constipation, diarrhoea/bowl incontinence, nausea, dry mouth, increased salivationNausea
and vomiting occur more frequently in patients with cerebral spasticity.
- urticaria, pruritus
- hypertonia, muscular weakness
- urinary retention, urinary incontinence
Urinary retention occurs more frequently in patients with cerebral spasticity.
- sexual dysfunction
- oedema peripheral, face oedema, pain, fever, shivering.

Marketing Authorisation Holder and Manufacturer

Not all pack sizes may be marketed.

375 mm

Like all medicines, this medicine 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.

Sun Pharmaceutical 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:
Spain:
France:
IT:
UK:

Baclofen SUN 0,05 mg/1 ml Injektionslösung
Baclofeno SUN 0,05 mg/1 ml Solución inyectable
Baclofène SUN 0,05 mg/1 ml Solution injectable
Baclofene SUN 0,05 mg/1 ml Soluzione iniettabile
Baclofen 0.05 mg/1 ml Solution for Injection
044BP1633D

This leaflet was last revised in 07/2014.

SuppliersLOGO/IDhere

Uncommon side effects (may affect up to 1 in 100 people)
- dehydratation
- suicidal thoughts and attempt, paranoia, hallucinations, disturbed mood, feeling of extreme happiness
- impairment of muscle coordination (ataxia), hypothermia, difficulty swallowing (dysphagia), loss of
memory / forgetfulness, nystagmus
- bradycardia
- deep vein thrombosis, hypertension, reddening of the skin, pallor
- ileus, reduced taste perception
- alopecia, excessive sweating.
Rare (may affect up to 1 in 1,000 people)
- life-threatening withdrawal symptoms due to drug delivery failure.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

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 ml (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.

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

044BP1633D

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