Lioresal Intrathecal

This leaflet answers some common questions about Lioresal Intrathecal.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you having Lioresal Intrathecal against the benefits they expect it will give you.

You may need to read it again.

Lioresal Intrathecal is used to reduce tension in your muscles which causes spasms. These spasms happen in various illnesses such as multiple sclerosis, cerebral palsy and other diseases or injuries of the spinal cord or brain.

Because this medicine reduces spasms and the pain that goes with them, it helps to make you more mobile. This helps you to manage your daily activities and makes physiotherapy easier.

Lioresal Intrathecal belongs to a group of medicines called muscle relaxants. It contains the active ingredient, baclofen, in the form of an ampoule for injection. It is used when medicines taken by mouth do not work well enough or when they cause too many side effects.

The solution in the ampoule is injected into your back (spinal cord) using a special pump. From the pump, a constant amount of baclofen goes into your spinal cord through a tiny tube.

This medicine can be used for adults and for children aged four years or older.

Your doctor may have prescribed it for another purpose.

This medicine is only available with a doctor's prescription.

Symptoms of an allergic reaction may include hives or an itchy skin rash, flushing of the face, swelling of the face, lips or tongue, faintness, tight feeling in the chest, wheezing or difficulty breathing.

In that case, return it to your pharmacist.

There is no information on use of this medicine in pregnancy or while breast-feeding.

Get urgent medical help if you observe that your implanted device is not working and you also notice withdrawal symptoms (see "If the medicine must be stopped").

Your doctor may not want to give you this medicine or may want to take special precautions if you have any of the above conditions.

Some medicines and Lioresal Intrathecal may interfere with each other. These include:

You may need to take different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are having Lioresal Intrathecal.

This medicine can only be given by experienced doctors using special medical equipment. You will need to stay in hospital, at least at the beginning of treatment.

Your doctor will inject a small amount of Lioresal Intrathecal into your spinal cord to see if it improves your muscle spasms.

If it does, then a special pump will be implanted under the skin of your abdomen. The pump will give you a small amount of medicine all the time.

You will be monitored closely in a fully equipped and staffed environment during the screening phase and dose-titration period immediately following pump implant. You will regularly be assessed for your dosage requirements, for possible side effects or evidence of infection. The functioning of the delivery system will also be checked.

You or the person caring for you will be shown how to look after the pump at home and how to keep the skin where it has been implanted free from infection.

It may take several days to find the amount of medicine that suits you best. Your doctor will keep a close watch on you during this time.

After that, your doctor will still want to see you regularly to check your progress and make sure your pump is working well.

Signs of overdose may happen suddenly or more slowly (for example, because the pump is not working properly).

If this medicine must be stopped for any reason, your doctor will reduce the dose gradually to avoid unwanted side effects. Suddenly stopping Lioresal Intrathecal or rapidly reducing the dose can cause serious side effects which in a few, rare cases have been fatal.

Stopping this medicine suddenly may bring on severe and uncontrolled muscle spasms and other unwanted symptoms, including difficulty in muscle movements, dizziness or light-headedness due to low blood pressure, severe itching and numbness or tingling in hands and feet, anxiety, high fever, altered mental conditions for example agitation, confusion, hallucination, abnormal thinking and behaviour or convulsions (seizures), persistent painful erection of the penis (priapism) and infection (sepsis).

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

If not, the pump may not work properly or you could get a serious skin infection.

If you don't have the pump refilled when you are supposed to, you may suddenly run out of medicine (see "If the medicine must be stopped" for more information).

Errors in changing the flow rate could make the dose of medicine too high and lead to serious side effects.

Your doctor may be able to change the dose of Lioresal Intrathecal to make it work better for you.

You doctor can discuss with you the risks of being given this medicine while you are pregnant.

See "If the medicine must be stopped" for more information.

This medicine may cause dizziness, sleepiness or blurred vision in some people.

You may feel more sleepy or dizzy than usual.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Some side effects could be associated with the delivery system.

The above side effects could be serious. You may need medical attention.

Some people may get other side effects of Lioresal Intrathecal.

Heat and dampness can destroy some medicines. Lioresal Intrathecal will keep well if it is cool and dry.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Lioresal Intrathecal is packaged in clear glass ampoules in packs of one ampoule. There are different sizes of ampoule available:

The smallest size is used to test your response to Lioresal Intrathecal. The two larger sizes are used to fill the pump, depending on the amount of medicine you need.

As well as baclofen, the active ingredient, the ampoules also contain sodium chloride and water for injection.