NeuroBloc Botulinum Toxin Type B (5000 U)

You must not be given NeuroBloc:

• if you are allergic (hypersensitive) to Botulinum Toxin Type B or any of the other ingredients ofNeuroBloc (listed in section 6 ?Further information?)
• if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis(Lou Gehrig’s disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain)

You must not be given NeuroBloc if any of the above applies to you. If you are not sure talk to your doctor or pharmacist.

Check with your doctor or pharmacist before you are given NeuroBloc:

• if you have a bleeding problem such as haemophilia
• if you have lung problems
• if you have difficulty swallowing. This is because swallowing problems could make you breathefood or liquids into your lungs, which could then cause very serious pneumonia

Use in children

NeuroBloc is not to be used in children aged 0-18 years.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• aminoglycoside antibiotics for an infection
• medicines to stop blood clotting, such as warfarin

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.

Before having an operatio

If you are going to have an operation, please tell your doctor that you have been given NeuroBloc. This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.

Pregnancy and breast feeding

• you will not normally be given NeuroBloc if you are pregnant or breast-feeding. This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother?s breast milk
• ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding

Driving and using machines

You may have muscle weakness or eye problems such as blurred vision or eyelid drooping after being given NeuroBloc. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of NeuroBloc

NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc. This means it is essentially ?sodium free?.

NeuroBloc will be given to you by a doctorwith specialist experience in the treatment of cervical dystonia and in the use of botulinum toxins.

How much will be given

• your doctor will decide how much NeuroBloc to give you
• the usual dose is 10,000 units, however, it can be higher or lower
• if you have had NeuroBloc injections before, your doctor will take into account how well itworked the other times

How NeuroBloc is given

• NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones arecausing the problem
• your doctor may inject part of the dose into different places in your muscles

Having more injections of NeuroBloc

• the effects of NeuroBloc will usually last about 12 to 16 weeks
• your doctor will decide if you need another injection and how much to give you

If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.

If you are given too much NeuroBloc

• if you have been given more NeuroBloc than you need, some of your muscles that were not injected may feel weak or you may develop symptoms away from the injected muscles, like difficulty in swallowing or breathing. This may occur when higher doses of up to 15,000 units are given
• if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately. If he/she is unavailable seek emergency assistance. You may need urgent medical treatment

A serious condition called ?botulism? which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body. If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored. Recovery usually takes place over a period of time.