LIORESAL Intrathecal Injection 50 micrograms/1 ml
LIORESAL Intrathecal Infusion 10 mg/5 ml
LIORESAL Intrathecal Infusion 10 mg/20 ml
(baclofen)
The product will be called Lioresal Intrathecal in this leaflet
What you need to know about Lioresal Intrathecal
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start treatment. It contains important information. Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or nurse.
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 Lioresal Intrathecal is and what it’s used for
- 2. Things to consider before you start Lioresal Intrathecal
- 3. Having Lioresal Intrathecal
- 4. Possible side effects
- 5. How to store Lioresal Intrathecal
- 6. Further information
What Lioresal Intrathecal is and what it’s used for
Lioresal Intrathecal contains the active ingredient, baclofen. It is administered by intrathecal injection directly into the spinal fluid. It is available in three different sizes and strengths containing either 50 micrograms in 1 ml, 10 mg in 5 ml or 10 mg in 20 ml of baclofen.
Baclofen is a muscle-relaxant drug. Lioresal Intrathecal is used to relieve muscle rigidity (spasticity) which may occur as a result of injury or illness affecting the spinal cord or the brain. 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.
Things to consider before you have a Lioresal Intrathecal injection
Some people MUST NOT have Lioresal Intrathecal. Talk to your doctor if:
- you think you may be allergic to baclofen or to any of the other ingredients of the injection. (These are listed at the end of the leaflet.)
You should also ask yourself these questions before having Lioresal Intrathecal:
- Have you understood everything the doctor or nurse has told you about the risks associated with Lioresal Intrathecal?
- Do you understand how to use the injection pump?
If you are at all confused about either of these points, please ask the doctor or nurse.
- Are you having any other injections into the spine?
- Are you suffering from any infection?
- Have you had a head injury within the last year?
- Have you ever had a crisis caused by a condition called autonomic dysreflexia? (Your doctor will be able to explain this to you.)
- Have you had a stroke?
- Do you have epilepsy?
- Do you have a stomach ulcer or any other problem with your digestion?
- Do you suffer from any mental illness?
- Are you being treated for high blood pressure?
- Do you have Parkinson’s disease?
- Do you suffer from any liver, kidney or lung disease?
- Do you have diabetes?
- Do you have difficulties in urinating?
- Are you pregnant or breast feeding?
If the answer to any of this second list of questions is YES, tell your doctor or nurse because Lioresal Intrathecal may not be the right medicine for you.
Are you taking 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.)
Always tell your doctor or nurse about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?
Some people may feel drowsy and/or dizzy or have problems with their eyes while they are being treated with Lioresal Intrathecal. 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.
Other special warnings
- Be careful when drinking alcohol - it may affect you more than usual.
- Contact your doctor immediately if you think that Lioresal Intrathecal is not working as well as usual. It is important to make sure that there are no problems with the pump.
- Treatment with Lioresal Intrathecal 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 Lioresal Intrathecal.
- If you are going to have an operation of any kind, make sure that the doctor knows that you are being treated with Lioresal Intrathecal.
Having a Lioresal Intrathecal injection
Lioresal Intrathecal 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 Lioresal Intrathecal, whether it is suitable for you. 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 Lioresal Intrathecal 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.
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.
During long-term treatment some patients find that Lioresal becomes less effective. You may require occasional breaks in treatment. Your doctor will advise you what to do.
Lioresal Intrathecal is not suitable for all children. The doctor will decide.
Overdose
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
Lioresal Intrathecal Side Effects
Lioresal Intrathecal is suitable for most people, but, like all medicines, it can sometimes cause side effects.
The side effects listed below have been reported:
More than 1 in 10 people have experienced:
Feeling tired, drowsy or weak.
Up to 1 in 10 people have experienced:
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.
Up to 1 in 100 people have experienced:
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.
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 or meningitis.
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.
How to store Lioresal Intrathecal
Keep all medicines out of the reach and sight of children.
Lioresal Intrathecal should be stored below 30ºC.
They should not be used after the expiry date which is printed on the outside of the pack.
Further information
Lioresal Intrathecal is available in three different sizes and strengths containing either 50 micrograms in 1 ml, 10 mg in 5 ml or 10 mg in 20 ml of the active ingredient, baclofen.
The ampoules also contain sodium chloride and water for injections.
The product licence holder is
Lioresal Intrathecal is released onto the market by
This leaflet was revised in April 2008.
If you would like any more information, or would like the leaflet in a different format,
please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
LIORESAL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited
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