Dysport

Dysport

Clostridium botulinum type A
toxin-haemagglutinin complex

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have further questions, ask your doctor.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

• 1. What Dysport is and what it is used for


• 2. Before you use Dysport


• 3. How Dysport is given


• 4. Possible side effects


• 5. How to store Dysport


• 6. Further information

What Dysport Is And What It Is Used For

Dysport is a toxin produced by Clostridium botulinum bacteria. The toxin works by stopping muscles contracting. It does this by preventing the release of a chemical in between the nerves and muscles which would normally make the muscles contract. This helps to reduce some of the abnormal muscle contractions known as spasms.

Dysport is used in adults to treat muscle spasms

• around the eyes


• in the face


• in the neck and shoulders


• in the arm

Dysport is also used to treat spasms in legs of children (aged two years or older) with cerebral palsy, to improve their walking.

You may also have physiotherapy

Before You Use Dysport

Do not use Dysport:

If you are allergic to botulinum toxin or any of the ingredients (See section 6. for a list of ingredients).

Take special care with Dysport

There are increased risks of having Dysport injections under any of these circumstances.

Tell your doctor if:

• you have problems swallowing.


• you have any history of bronchitis, pneumonia or problems with breathing


• you have had an allergic reaction to a botulinum toxin in the past


• you have other problems or diseases that affect your muscles e.g. myasthenia gravis


• you bleed easily


• you have an infection where the injection will be given or if that area is swollen

Important information about one of the ingredients of Dysport

Dysport contains a small amount of albumin which has been obtained from human blood. The risk of passing on infections from blood cannot be eliminated completely when using human blood or products made from human blood.

Taking other medicines:

Please tell your doctor if you are taking any antibiotics for an infection (e.g. aminoglycosides such as gentamicin or amikacin) or muscle relaxant drugs.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding you should ask your doctor for advice before taking any medicine.

Dysport should not normally be used.

Use in children

Dysport should not be used in children younger than 2 years of age.

Driving and using machines

Dysport may cause muscle weakness or problems with your vision.

If you experience any of these effects, do not drive or use any machines.

How Dysport Is Given

Your doctor will give you your injection and decide how often you need treatment. This will depend on what you are being treated for.

A vial of Dysport should be used only for you and only for a single treatment session.

For treatment of muscle spasms in your arm:

The dose of Dysport will normally be 1000 units. The doctor may divide the amount between the affected arm muscles. Your muscle spasms should normally improve within 2 weeks.

For treatment of muscle spasms in your neck and shoulder:

The first dose of Dysport will normally be 500 units. The doctor will divide this amount into a number of places in the neck, probably into 2 or 3 of the neck muscles most affected by the condition. A smaller amount may be given to very underweight or elderly patients. Your muscle spasms should improve within 1 week. Further injections (250-1000 units) will be given about every 12 weeks depending on how long the effect lasts.

For treatment of muscle spasm around your eyes:

The first injection may be about 120 units per eye.

The medicine will be injected just under the skin at various sites around the eye. If only one eye is affected the doctor will only give injections of Dysport around this eye. Injections will be given about every 12 weeks depending on how long the effects last. On the next visits the amount of Dysport given may be reduced to 80 or 60 units per eye.

For treatment of muscle spasm in your face:

The doctor will give you injections on the side of your face that is affected. The first injection may be about 120 units. Injections will be given about every 12 weeks depending on how long the effects last. Your next injections of Dysport may be reduced to 80 or 60 units.

For treatment of a child with cerebral palsy with muscle spasms in their legs:

The first dose of Dysport will be 20 units for each kg of the child’s body weight. The doctor will divide the amount between both lower leg muscles. If only one leg is affected by spasms, the doctor will only give injections of 10 units per kg in this leg. Injections will be given about every 12 to 16 weeks. The dose your doctor gives the child could change depending on how they respond. The maximum dose is 1000 Units per patient each time.

If you are given more Dysport than you should

If you are given more Dysport than you need muscles other than the ones that were injected may begin to feel weak. This may not happen straightaway. If this happens, speak to your doctor immediately. Seek urgent medical help if you have difficulty breathing, swallowing or speaking.

If you forget an injection of Dysport

Nothing will happen if an injection is missed other than some of the spasm or muscle stiffness may return. Tell your doctor and he will decide when the next injection is needed.

If you stop taking Dysport

Your muscle movements will return to the way they were before treatment.

Dysport Side Effects

Like all medicines, Dysport can cause side effects, although not everybody gets them.

Tell your doctor immediately if:

• you have any problems swallowing, breathing or with your speech


• you develop difficulty in breathing with or without swelling of the face, lips, tongue and /or throat, redness of the skin or an itchy lumpy rash (urticaria). This may mean you are having an allergic reaction to Dysport.

The chance of having a side effect is described by the following groups:

How often it occurs


Very Common: Occurs in more than 1 in 10 patients treated

Common: in less than 1 in 10 patients treated

Uncommon: in less than 1 in 100 patients treated

Rare: in less than 1 in 1000 patients treated

Some side effects may occur in any patient treated with Dysport whilst other side effects may depend on the condition treated. Make sure you read all the sections that apply to you.

Treatment of any condition (all patients)

Side effects that have occurred include:

Common:

• Bruising, or pain around the site where the injection was given or a burning sensation at the time the injection is given


• Generalised weakness


• Tiredness


• Flu-like symptoms

Uncommon:

• Itching

Rare:

• Skin rashes and muscle weakness

Other side effects related to the spread of Dysport away from the site of administration have also been reported (worsened muscle weakness, difficulty with swallowing or inhalation of foreign material which in very rare cases have been fatal).

Treatment of muscle spasms in the arm:

Side effects that have occurred include:

Common:

• Arm muscle weakness


• Accidental injury/falls


• Difficulty in swallowing

Treatment of muscle spasms in the eyes or face

Side effects that have occurred include:

Very common:

• Drooping eyelids

Common:

• Dry eyes


• Double vision


• More tears than usual


• Swelling of the eyelid


• Facial muscle weakness

Uncommon:

• Facial nerves may become paralysed

Rare:

• Difficulty in moving the eye


• The edge of the eyelid may turn in towards the eyeball and the eye muscles may become paralysed

Tell your doctor immediately if you notice very dry eyes.

Treatment of muscle spasms in the neck or shoulders:

Side effects that have occurred include:

Very common:

• Difficulty in swallowing. This side effect may be expected to resolve within 2 to 4 weeks.

Common:

• Neck muscle weakness


• A change to the tone of the voice

Uncommon:

• Dry mouth


• Double or blurred vision


• Headache

Rare:

• Dysport may cause breathing difficulties

Treatment of children with muscle spasms in the leg:

Side effects that have occurred include:

Common:

• The muscles of the lower leg may be weakened too much. This may change the way you walk or make you fall over more


• Urinary incontinence


• Diarrhoea


• Vomiting

If any of the side effects becomes serious or if you notice any side effects not listed in this leaflet, please tell your doctor.

How To Store Dysport

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the box.

Dysport will be stored in a refrigerator (2°C-8°C) at the place where the injections are carried out. This medicine should not be given to patients to store.

Further Information

What Dysport contains

The active constituent of Dysport is Clostridium botulinum complex (500 units). Dysport also contains human albumin and lactose. Before it is injected Dysport will be dissolved in sodium chloride for injection (a solution of salt).

What Dysport looks like and contents of the pack

Dysport is a white powder in a glass container called a vial. Each pack contains 2 vials of Dysport

Marketing Authorisation Holder and manufacturer

The marketing authorization holder is:

Ipsen Limited

190 Bath Road

Slough

Berkshire

SL1 3XE

UK

Dysport is manufactured by:

Ipsen Biopharm Limited

Ash Road

Wrexham Industrial Estate

Wrexham

LL13 9UF

This leaflet was last approved in

February 2009

Product licence number

PL 06958/0005