Other side effects related to the spread of Dysport® away from The information leaflet in the medicine pack tells you more the site of administration have also been reported (worsened about the possible side effects. muscle weakness, difficulty with swallowing or inhalation of If you think you have a side effect, including any not listed in foreign material which in very rare cases have been fatal). this leaflet, or if you have any questions or concerns, please talk to your healthcare professional. Side effects seen in people treated with for spasmodic : You can also report suspected adverse events directly to the Irish Medicines Board using the online form at www.imb.ie or by using • Dry mouth the freepost yellow card system. The IMB can also be contacted • Muscle weakness on 01-6764971. • Difficulty in swallowing • What should you do if you see a different • Dizziness • Neck pain healthcare professional? • Muscle pain If you see a different healthcare professional for another problem, • Stiff muscles make sure that you tell them that you are having treatment with • Shortness of breath botulinum toxin. • Musculoskeletal pain • Face muscle weakness Is there anything else you can do to help control • Neck muscle weakness or come to terms with the condition? • Pain in the hands and feet As with all forms of , a positive attitude is important. • A change to the tone of the voice Learning about torticollis and talking to other people who have it • Blurred vision or other problems in seeing clearly may help you to come to terms with your problem and enable you • Jaw problems to find ways of coping with your symptoms. A patient support • Double vision group can help you to talk to other people in your area who have • Loss of muscle tissue experience of similar conditions. Support from family and friends is • Drooping of the upper or lower eyelid important. They may also benefit from learning more about • Breathing difficulties torticollis, so that they can better understand your problems. If you experience any of these side effects, talk to your healthcare professional straight away. In a small number of cases these side effects could be serious or even fatal. If your usual healthcare professional is not available, seek urgent medical help.

Who is most at risk of serious side effects? The risk of these side effects may be higher in people who: For further information, please contact your healthcare professional • Already have swallowing problems • Already have breathing problems • Already have nerve or muscle problems • Are being treated with medicines which can increase the effect of botulinum toxin SPASMODIC Talk to your healthcare professional if you have, or have TORTICOLLIS Some of your had, any of these problems, or if you are taking any questions answered other medicines.

Date of preparation: September 2013 IEDYS130906 Creating your solution

CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX What is this guide for? What causes torticollis? How long does it take for botulinum toxin to start This guide provides you with some important As with other forms of dystonia, the causes of torticollis are not working after injection? facts about Dysport® that you need to be yet fully understood. It is thought that it may be linked Improvement should be seen within 2 weeks after injection. aware of. However, it does not replace the to a chemical imbalance in the part of your brain that controls advice given to you by your healthcare movement. The wrong signals are sent out and so the wrong For how long does botulinum toxin work? professional. Further very important muscles contract. This causes the unusual movements of your The effect is temporary: information about Dysport®, including special neck that you cannot control. • It usually lasts for 3 to 4 months. After this time the link warnings and side effects, is included in the between the nerve and the muscle starts to work again patient information leaflet which is supplied in each package of Will you always suffer from torticollis? •i Th s means that the muscle may start to get stiff again and Dysport®. If you have not received a patient information leaflet, Torticollis may get worse over a period of years before it settles further botulinum toxin injections may be needed please remember to ask your healthcare professional for one and down, but its progress is very unpredictable. For a while it can to read it very carefully. improve or disappear completely. This happens in 5 to 10 people rIt is ve y important that re-treatment is not performed more out of 100 for no apparent reason. However, in many cases the often than is recommended by the manufacturer. What is spasmodic torticollis? problem returns after a period of months or years. Spasmodic torticollis is also called ‘cervical dystonia’. This type When is surgery used? of illness is a focal (localised) dystonia. A dystonia is a type of Will torticollis spread to other parts of my body? In some cases, surgery is offered. It is rarely used, but it can unusual movement which you cannot control. It happens in a It is uncommon for torticollis to spread to other parts of your be used when the problem is very severe, or when all other variety of nerve (neurological) problems. In ‘focal dystonia’, body, but it can happen. It usually happens in your neck muscles. treatments have not worked. the illness affects a particular part of your body. However, some people can also have abnormal blinking () or other types of focal dystonia such as “writer’s What are the possible side effects of Spasmodic torticollis affects the muscles of your neck, making your cramp” of the hand or spasm of the vocal chords (laryngeal botulinum toxin? head tilt (laterocollis) or your neck twist to one side (rotational dystonia). torticollis), forward (anterocollis) or backward (retrocollis). Seek immediate medical help if at any time after treatment: • You have any problems breathing, swallowing or speaking, Is there a cure for torticollis? with or without swelling of the face, lips, tongue and/or throat All these forms are often just called ‘torticollis’. It is called ‘spasmodic’ There is no cure for torticollis. However, a number of different because you have a muscle spasm, which can vary in strength over • You get severe redness of the skin or an itchy lumpy rash treatments are available that can help to keep the problem • You get very dry eyes time. The spasm can also cause trembling in some people. under control. Side effects seen in people treated with botulinum toxin for Who is affected by torticollis? What treatments are available? any illness: Both men and women can be affected. It affects any age group, A variety of treatment options are available including but not • Br uising or pain around the site where the injection was given but is more common in middle-aged people. limited to injections of botulinum toxin. The choice of treatment or a burning sensation at the time the injection is given depends on what is best for you and your situation. Speak to • Generalised weakness What are the signs of torticollis? your doctor about all the treatment options. • Tiredness Torticollis usually develops gradually. In the beginning, you may • Flu-like symptoms notice that your head turns when you are talking, walking, driving Wha t is botulinum toxin and how does it work? • Itching or trying to write. You may also have some trembling (called Botulinum toxin is a protein that is produced naturally by a • Skin rashes and muscle weakness ‘’) of your head. This may happen particularly when you are particular type of bacterium which can be used as a medicine to trying to stop your head turning or jerking. Over time your head relax your muscles. may turn more or less all the time to one side, tilt towards your •n Ti y amounts are injected into your neck and shoulder muscles, shoulder or lean forwards or backwards. Torticollis can vary from reducing the nerve signals that cause the muscles to contract being mild to severe. The spasm you feel may be worse when you • I t can reduce the abnormal head and neck movements and are under stress and it can often cause pain. relieve pain