How does it work?

Dysport injections contain botulinum toxin type A, which is a toxin produced by the bacteria Clostridium botulinum.

Botulinum toxin type A is a bacterial toxin that prevents nerves from functioning normally (a neurotoxin). It prevents nerves from releasing a chemical called acetylcholine, which is essential for the nerves to communicate with muscle cells. This toxin therefore prevents muscles from receiving nerve stimulation.

Preventing nerve stimulation of muscles causes the muscles to become paralysed. Botulinum toxin type A causes muscle paralysis until such time as the nerve develops new endings to communicate with the muscles. It is useful for treating conditions where excessive nerve stimulation to muscles is causing abnormal muscle functioning, contractions or spasms. It is injected into the muscle for this purpose.

Dysport injections are either given into the muscle (intramuscularly) or under the skin (subcutaneous injection).

What is it used for?

• Uncontrolled blinking or continuous closure of the eyelid in adults (blepharospasm).
• Muscle spasm affecting one side of the face in adults (hemifacial spasm).
• Spasmodic rotation of the head to one side in adults (spasmodic torticollis/idiopathic cervical dystonia).
• Wrist and hand disability in adults due to spasm of the muscle in the upper arm as a result of a stroke.
• Foot deformity due to spasm of leg muscles in children with cerebral palsy aged two years and over (dynamic equinus foot deformity).

Warning!

• If you or someone you are caring for develops any swallowing, speech or breathing problems after having treatment with this medicine, you should consult your doctor immediately.
• If your symptoms start to improve on this medicine, make sure you resume your normal activities gradually. Try not to do too much too quickly as you may risk injury.
• Too frequent or excessive use of this medicine can cause the body to produce antibodies against the medicine, which could make it less effective.
• This medicine contains albumin, which is obtained from human blood. There is a small risk of viral infection associated with the use of this medicine, because the risk of transmitting infectious agents cannot be eliminated fully when using human blood products.

Use with caution in

• People with inflammation or infection at the proposed injection site.
• People at risk of bleeding after an injection into a muscle, for example due to blood clotting disorders such as haemophilia, or treatment with anticoagulant medicines.
• People with excessive weakness or wasting in the muscle to be injected.
• People with a history of swallowing difficulties (dysphagia), or food or liquid accidentally going into the lungs (aspiration).
• People with chronic breathing problems.
• Diseases or conditions affecting the nervous system (neurological conditions) for example motor neuropathy or amyotrophic lateral sclerosis.
• Other muscle problems or chronic disease affecting the muscles, for example myasthenia gravis.
• People who have recently had surgery or are due to have surgery in the near future.
• People at risk of closed angle glaucoma (applicable only to those being treated for blepharospasm).
• People who have had previous eye surgery (applicable only to those being treated for blepharospasm).

Not to be used in

• People who have previously had an allergic reaction to botulinum toxin type A injections.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It should not be used during pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It is not recommended for the treatment of women who are breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

General side effects:

• Pain, soreness or bruising around the injection site.
• Burning sensation when injection is administered.
• A temporary change in the muscle near where the injection given.
• Misplaced injections may paralyse nearby muscles and excessive doses may paralyse muscles that are not near the injection site.
• Weakness.
• Fatigue.
• Flu-like symptoms.
• Difficulty or pain when swallowing (dysphagia).
• Food or liquid accidentally going into the lungs (aspiration).
• Rash or itching.

Specific side effects when treating arm spasticity in stroke patients:

• Arm muscle weakness.
• Difficulty or pain when swallowing (dysphagia).
• Increased risk of injury through accidental falls.

Specific side effects when treating cerebral palsy:

• Weakness of the leg muscles.
• Change in walking pattern.
• Increased risk of falls.
• Urinary incontinence.
• Diarrhoea.
• Vomiting.

Specific side effects when treating spasmodic torticollis:

• Difficulty in swallowing certain foods.
• Change in voice.
• Weakness of the neck.
• Dry mouth.
• Headache.
• Double vision or blurred vision.
• Difficulty breathing.

Specific side effects when treating blepharospasm/hemifacial spasm:

• The soft eyelid tissues bruise easily. Your doctor will try to reduce this by applying gentle pressure after giving the injection.
• Drooping of the upper eyelid.
• Double vision.
• Dry eyes.
• Watering eyes.
• Facial muscle weakness.
• Eyelid swelling.
• Facial paralysis.
• Paralysis of the eye muscles.
• Turning inwards of the eyelid.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while being treated with this one, to make sure that the combination is safe.

Tell your doctor if you have recently had any other botulinum toxin injections, because if this injection is given too close to a previous injection it could cause excessive muscle weakness.

The muscle paralysing effect of botulinum toxin type A may be increased by the following medicines:

• aminoglycoside antibiotics, eg neomycin, gentamicin, tobramycin
• spectinomycin
• muscle relaxants, particularly those used in anaesthesia
• antibiotics such as polymixins, tetracyclines or lincomycin.

Other medicines containing the same active ingredient