Product Information for the User

Dysport500 U Powder for Injectable Solution

Complex of Type A Toxin fromClostridium botulinum

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms and signs of illness as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Dysport and how is it used

2. What you need to know before starting to use Dysport

3. How to use Dysport

4. Possible adverse effects

5. Storage of Dysport

6. Contents of the package and additional information

Dysport is presented in the form of a powder for injectable solution. Each vial contains 500 units of botulinum toxin type A.

Dysport belongs to a group of medications known as: other peripheral acting muscle relaxants. It is a toxin produced by a bacterium, Clostridium botulinum that acts by blocking nerve impulses to the injected muscles, which causes the muscle to stop contracting.

Dysport will be administered by the doctor. In adults, it will be administered to control muscle spasms of the eyelids, face, neck, and shoulders, as well as the arm and leg in people who have suffered a cerebral embolism. In children two years of age or older with cerebral palsy, it will be administered to control spasticity in the muscles of the legs associated with deformity and to control spasticity in the muscles of the arms.

Dysport is also used in adults for the treatment of urinary incontinence due to bladder problems associated with spinal cord injury or multiple sclerosis in patients who regularly perform intermittent clean catheterization.

Do not use Dysport:

• If you are allergic (hypersensitive) to botulinum toxin or any of the other components of Dysport (listed in section 6).
• If you have a urinary tract infection at the time of receiving treatment for urinary incontinence.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before using Dysport and especially in the following situations:

- If you notice problems swallowing, speaking, or breathing, contact your doctor immediately, or go to the emergency room. In a small number of cases, these adverse effects could be severe or even fatal.

- If you have had an adverse reaction to a medication containing botulinum toxin.

- If you have a neuromuscular transmission disorder (e.g. myasthenia gravis); this may make you more sensitive to the effect of Dysport, which can result in excessive muscle weakness.

- If you have weakness or atrophy of the muscles in which your doctor intends to inject the product.

- If you have prolonged bleeding or an infection or inflammation in the muscles in which your doctor needs to inject Dysport.

- Be especially careful if you receive treatment for leg spasms due to a higher risk of falls in adults, especially in older people.

- If the muscles at the proposed injection sites show signs of wear.

When using Dysport in the muscles around the eye, your eyes may dry out (see section 4) which could damage the surface of your eyes. To prevent this, you may need treatment with protective drops, ointments, or a protective patch that closes the eye. Your doctor will advise on its use if necessary.

At the time of injection in the bladder for treating urinary incontinence, due to the procedure by which the injection is administered, you may experience an uncontrolled reflex reaction of your body (autonomic dysreflexia, for example, profuse sweating, stabbing headache, increased blood pressure, or pulse).

Children and adolescents:

Dysport will only be used in children aged two years or more for the treatment of spasticity of the legs in children. The safety and efficacy of the product have not been demonstrated for treatment in children in other indications.

Use of other medications:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

You should be especially careful in the case of concurrent administration with antibiotics to treat an infection or muscle relaxants. Some of these medications may increase the effect of Dysport.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Dysport during pregnancy unless it is clearly necessary and its effects justify any possible risk to the fetus.

The treatment with Dysport is not recommended if you are breastfeeding, as it is unknown whether Dysport passes into breast milk.

Driving and operating machinery:

You may experience blurred vision or transient muscle weakness after treatment with Dysport. If this occurs, do not drive or operate machinery.

Important information about some of the components of Dysport:

This medication contains human albumin in very small quantities. It meets all current quality and safety requirements, however, the risk of transmission of viral infections cannot be completely ruled out.

Only the vial of Dysport will be used for you and only for one treatment session.

This medication will always be administered by your doctor, so you will never self-administer it. Your doctor will determine the dose you need, the muscles that should be injected, and the number and frequency of injections.

Treatment of neck and shoulder muscle spasms

The recommended dose will be a total of 500 units, which your doctor will divide among the most affected muscles that should be injected. Injections will be given approximately every 12 weeks, depending on the relaxation obtained with previous administrations. The maximum dose should not exceed 1000 units.

Treatment of muscle spasms in the eyelids and face

For eyelid spasms, if it affects both eyelids, approximately 40 units will be injected per eye. Injections will be given approximately every 12 weeks, when the relaxing effect begins to fade. In subsequent visits, the dose may be increased to a maximum of 120 units per eye. The medication will be injected under the skin in different points around the eye.

If you present a facial spasm, it will be treated as if you had a spasm of a single eyelid.

Treatment of arm muscle spasms after an embolism

The recommended dose and should not be exceeded will be 1000 units, but when also injecting the shoulder muscles, the dose may be increased to 1500 units. Your doctor may divide the total dose among the affected muscles of the arm and shoulder. Improvement of muscle spasms will usually be observed in 1 week after administration. Injections may be repeated at a frequency of 12 to 16 weeks.

Treatment of leg muscle spasms after an embolism

The recommended dose and should not be exceeded will be 1500 units. Your doctor may divide the dose among the affected muscles of the leg. Injections may be repeated at a frequency of 12 to 16 weeks.

Treatment of muscle spasms in the arm and leg

If you need to receive injections in the arm and leg in the same treatment session, your doctor may divide the dose between your arm and leg, but the total dose should not exceed 1500 units.

Treatment of muscle spasms in the legs in children with cerebral palsy

For children 2 years of age or older: your doctor will decide the dose. Dysport is injected into the affected muscles of the legs. The dose should not exceed 1000 units or 30 units/kg per treatment session, repeated every 16-22 weeks, or as needed, but never less than 12 weeks.

Treatment of muscle spasms in the arms in children with cerebral palsy

For children 2 years of age or older: your doctor will decide the dose. Dysport is injected into the affected muscles of the arms. If treatment is injected into one arm, the dose should not exceed 640 units or 16 units/kg per treatment session, whichever is less. If treatment is injected into both arms, the dose should not exceed 840 units or 21 units/kg per treatment session, whichever is less. Muscle spasms should improve in the weeks following treatment, and this improvement may last up to 34 weeks. Your doctor will repeat the treatment approximately every 16-28 weeks, or as needed, but never less than 16 weeks.

Treatment of muscle spasms in the arms and legs in children with cerebral palsy

If you need to receive injections in the arms and legs in the same treatment session, your doctor will decide the dose of Dysport to be injected in each limb, but the total dose should not exceed 1000 units per session or 30 units/kg, whichever is less. The repetition of treatment may be considered no earlier than 12-16 weeks after the previous treatment session.

Treatment of urinary incontinence

The first dose administered in the bladder muscle will be 600 units, but your doctor may decide to increase the dose to 800 units in subsequent injections.

Dysport will be administered through a procedure called cystoscopy. A lighted instrument will be inserted into the bladder through the opening by which urine is expelled (called the urethra). This allows your doctor to see the inside of the bladder and administer the Dysport injections in the bladder wall. Only Dysport will be administered if you are already performing a clean intermittent catheterization (CIC). CIC is a procedure in which a soft, hollow tube (catheter) is temporarily inserted into the bladder through the urethra to help empty the bladder of urine, and then removed once the bladder is empty. Ask your doctor to explain more details of the procedure.

You will need to take antibiotics to prevent a urinary tract infection. If you are taking anticoagulant medications, your doctor will adjust your treatment before and after the Dysport injections. You may be administered a local anesthetic or general anesthetic or a sedative before the injections. You will be observed for at least 30 minutes after the injections. Symptoms usually improve in 2 weeks, and improvement may last up to 48 weeks. Your doctor will repeat the treatment as needed, but not more frequently than every 12 weeks.

If you use more Dysport than you should:

If you receive more Dysport than you should, it is possible that other muscles different from those injected may begin to weaken. This may not occur immediately. If it does, inform your doctor as soon as possible. If you experience difficulty swallowing, breathing, or speaking, seek urgent medical attention.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20.

If Dysport was not administered:

If you forgot to go to the hospital to receive the next injection of Dysport, nothing will happen to you, except that you may notice that the muscle stiffness or spasms you had before treating with Dysport return. Consult your doctor, and he will decide when you need the next injection.

If you interrupt treatment with Dysport:

The relaxing effect may eventually fade, and muscle contractions may return to their pre-treatment state.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Dysport can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contact your doctor immediately or go to the emergency room if:

You experience respiratory difficulty with or without facial inflammation, lips, tongue, and/or throat, skin redness or itching (urticaria). You may be experiencing an allergic reaction to Dysport.

Of the patients treated with Dysport in clinical trials, approximately 25% experienced an adverse event.

The frequency of side effects is classified as follows:

Very frequent(may affect more than 1 in 10 people)

Frequent(may affect up to 1 in 10 people)

Infrequent(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

The general adverse reactions for all indications were as follows:

Frequent:

- Generalized weakness, fatigue, flu-like syndrome, pain, and/or hematoma at the injection site

Infrequent:

- Itching

Rare:

- Muscle mass and tone decrease

- Skin rash

The frequency of cases of numbness and muscle mass loss (could not be estimated with the available data) is unknown.

In addition to the general, the specific adverse reactions for each indication were as follows:

Torticollis spasmodico

Very frequent:

- Difficulty swallowing, dry mouth

- Muscle weakness

Frequent:

- Headache, dizziness, mild facial nerve paralysis

- Blurred vision, difficulty seeing clearly

- Voice tone change, difficulty breathing

- Neck pain, muscle and bone pain, muscle pain, hand and finger pain, muscle spasm

Infrequent:

- Double vision, eyelid drooping

- Nausea

- Muscle tissue loss, jaw muscle disorder

Rare:

- Aspiration

Blepharospasm and hemifacial spasm

Very frequent:

- Eyelid drooping

Frequent:

- Facial muscle weakness

- Double vision, dry eyes, tearing

- Eyelid edema

Infrequent:

- Facial paralysis

Rare:

- Eye muscle paralysis

- Eyelid folded towards the eyeball

Arm spasticity in adults

Frequent:

- Reactions at the injection site (e.g., pain, redness, swelling, etc.), weakness, fatigue, flu-like illness

- Muscle weakness, musculoskeletal pain, limb pain

Infrequent:

- Difficulty swallowing

Leg spasticity in adults

Frequent:

- Fatigue, weakness, flu-like illness, reactions at the injection site (e.g., pain, hematomas, erythema, itching)

- Falls

- Leg muscle weakness, muscle pain

- Difficulty swallowing

Leg spasticity in children with cerebral palsy

Frequent:

- Leg muscle weakness, muscle pain

- Urinary incontinence

- Flu-like illness, pain, redness, and/or hematoma at the injection site, abnormal gait, fatigue

- Falls

Infrequent:

- Fatigue, weakness

Arm spasticity in children with cerebral palsy

Frequent:

- Muscle weakness, muscle pain

- Flu-like symptoms, fatigue, itching, hematomas, pain, swelling, or redness at the injection site

- Skin redness

Infrequent:

- Muscle weakness, weakness

Treatment of arms and legs in children with cerebral palsy

No specific findings were observed for the administration of Dysport in the same session of treatment in the arm and leg compared to what is expected when treating the arm or leg separately.

Excessive muscle weakness of the affected muscle and/or localized diffusion of Dysport to other muscles may lead to accidental injuries from falls and abnormal gait.

All these effects, if they occur, would be noticeable a few days after injection and would normally disappear in 2 to 4 weeks. If any of these side effects become bothersome or concern you, tell your doctor.

Treatment of urinary incontinence due to uncontrolled contractions of the bladder muscle

Frequent:

- Blood in the urine *

- Constipation

- Bacteria in the urine*.

- Erectile dysfunction, also known as impotence

- Urinary tract infection*

- Headache

- Fever

Infrequent:

- Numbness

- Muscle weakness

- Pain in the bladder*.

- Uncontrolled reflex reaction of your body (autonomic dysreflexia)*

- Inability to empty the bladder (urinary retention)

- Bleeding from the bladder or the tube that carries urine from the bladder to the outside of the body (urethra)

*This side effect may be related to the procedure

Experience after product commercialization

The profile of adverse reactions received by the Company during the use of the medicine after its market launch corresponds to that observed during the clinical trials. Sporadically, cases of hypersensitivity (allergy) have been reported.

Rarely, adverse reactions resulting from the appearance of the toxin's effects in distant locations from the injection site (excessive muscle weakness, difficulty swallowing, aspiration pneumonia that can be fatal) have been communicated.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Store in a refrigerator (between 2°C and 8°C), in the hospital where the injections will be administered. Do not freeze.

It is recommended that the reconstituted solution be used immediately, however it may be stored in a refrigerator (between 2°C and 8°C) for a maximum of 24 hours.

This medication should never be given to patients for use or storage.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Immediately after administering Dysport, all residue that may remain in the vial or syringe must be inactivated using diluted hypochlorite solution (1% available chlorine). Subsequently, all used material will be eliminated, according to standard hospital practices. Any amount of Dysport spilled must be rinsed with a absorbent cloth soaked in diluted hypochlorite solution.

DYSPORT Composition

The active ingredient is: complex of type A toxin fromClostridium botulinum,500 units.

The other components are lactose and human albumin.

Product appearance and packaging contents

In the Dysport packaging, there are two vials containing the white lyophilized powder in the form of a tablet, for reconstitution.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136. 08038 Barcelona - Spain.

Responsible manufacturer:

Ipsen Manufacturing Ireland Limited

Blanchardstown Industrial Park

Blanchardstown, Dublin 15, Ireland

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.