Product Information for the Patient User

Azzalure, 125 Units Speywood, Powder for Injectable Solution

(Botulinum Toxin Type A)

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this product information.See Section 4.

1. What is Azzalure and how is it used

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

3. How to use Azzalure

4. Possible adverse effects

5. Storage of Azzalure

6.Contents of the package and additional information

Azzalure contains a substance, botulinum toxin A, which causes muscles to relax. Azzalure acts on the connection between nerves and muscles, blocking the release of a chemical messenger called acetylcholine at the nerve endings. This phenomenon prevents muscle contraction. Muscle relaxation is temporary and recovers gradually.

Some people feel unwell when wrinkles appear on their face. Azzalure can be used in adults under 65 years old for the temporary improvement of the appearance of moderate or severe glabellar lines (vertical expression lines between the eyebrows) and lateral canthal lines (crow's feet).

Do not use Azzalure:

• if you are allergic tobotulinum toxin Aor to any of the other components of this medication (listed in section 6).
• if you have an infection at the sites where the injection is to be administered.
• if you have myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis.

Warnings and precautions

Consult your doctor before starting to use Azzalure:

• if you have any neuromuscular disorder.
• if you frequently have difficulty swallowing (dysphagia).
• if you frequently have problems with food or drink because it enters your airways and causes choking or coughing.
• if you have any inflammation at the proposed injection site.
• if the muscles where the injection is to be administered are weak.
• if you have any bleeding disorder, which means you may bleed more than normal, such as hemophilia (a hereditary bleeding disorder caused by deficiencies in the coagulation factor).
• if you have undergone or will undergo facial surgery or other type of operation in the near future.
• if you have already been injected with other botulinum toxin injections.
• if after your last treatment with botulinum toxin, you have not experienced any improvement in your glabellar lines.

This information will help your doctor make a decision about the risks and benefits of your treatment.

When you receive treatment with Azzalure, your eyes may dry. Azzalure may cause your eyes to blink less frequently or produce fewer tears, which could damage the surface of your eyes.

Special precautions:

Very rarely, botulinum toxin produces muscle weakness in areas of the body away from the injection site.

When botulinum toxin is used at intervals more frequently than 12 weeks or at higher doses to treat other conditions, it has been observed very rarely that antibodies are produced. The formation of neutralizing antibodies may reduce the effectiveness of the treatment.

If you visit your doctor for any reason, make sure to inform him that you are being treated with Azzalure.

Children and adolescents

Azzalure is not indicated in subjects under 18 years of age.

Use of Azzalure with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication since Azzalure may affect other medications, especially

• antibiotics to treat an infection (e.g. aminoglycosides such as gentamicin or amikacin) or,
• other muscle relaxants.

Use of Azzalure with food and drinks

Azzalure injections can be administered before or after eating or drinking.

Pregnancy and breastfeeding

You should not use Azzalure during pregnancy. Treatment with Azzalure is not recommended if you are breastfeeding. If you are pregnant or think you may be pregnant or if you are breastfeeding, consult your doctor before using any medication.

Driving and operating machinery

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

Azzalure can only be administered by doctors with the necessary qualifications and experience in this treatment and who have the appropriate equipment.

Your doctor will prepare and apply the injections. A vial of Azzalure must be used for a single patient and a single treatment session.

The recommended dose of Azzalure is:

• For glabellar lines: 50 units; 10 units will be administered at each of the 5 injection sites on the forehead, the top of the nose, and the eyebrows.

• For lateral canthal lines: 60 units administered as 10 units at each of the 6 injection sites for both sides.

The units used in different botulinum toxin products are not equal. The Speywood units of Azzalure are not interchangeable with other botulinum toxin products.

The effect of the treatment should be noticeable a few days after the injection.

Your doctor will decide on the appropriate interval between each Azzalure treatment. This interval must not be less than 12 weeks.

Azzalure is not indicated for patients under 18 years of age.

If you use more Azzalure than you should

If you receive more Azzalure than necessary, other muscles treated may begin to weaken. This may not occur immediately. If you experience these symptoms, inform your doctor as soon as possible.

In case of overdose or accidental administration, call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount administered).

Like all medicines, Azzalure may cause side effects, although not everyone will experience them.

Seek medical attention if:

• You experience difficulty breathing, swallowing, or speaking.
• Your face swells or your skin becomes red, or you develop a rough, itchy rash. You may be experiencing an allergic reaction to Azzalure.

Inform your doctor if you experience any of the following side effects:

For frown lines:

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

• Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging, or bruising at the injection site
• Headache

Common (may affect up to 1 in 10 people)

• Eye fatigue or decreased vision, drooping eyelids, eyelid swelling, tearing, dry eyes, or eye muscle contraction
• Temporary facial paralysis

Uncommon (may affect up to 1 in 100 people)

• Altered vision, blurred vision, or double vision
• Dizziness
• Itching, rash
• Allergic reactions

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

• Itching and rough rash
• Eye movement disorder

Unknown frequency (cannot be estimated with available data)

• Numbness
• Muscle mass loss
• Generalized weakness
• Fatigue
• Symptoms like the flu

For lateral canthal lines:

Common (may affect up to 1 in 10 people)

• Headache
• Swollen eyelid
• Hematoma, itching, and swelling around the eyes
• Drooping eyelid
• Temporary facial paralysis

Uncommon (may affect up to 1 in 100 people)

• Dry eyes

Unknown frequency (cannot be estimated with available data)

• Allergic reactions
• Numbness
• Muscle mass loss
• Generalized weakness
• Fatigue
• Symptoms like the flu

These side effects usually occur within the first week after injections and do not last long. They are usually mild to moderate.

Very rarely, side effects with botulinum toxin in muscles other than those at the injection site have been reported. These include excessive muscle weakness, difficulty swallowing due to coughing and a sensation of choking when swallowing (if liquids or food enter the airways, respiratory problems such as pulmonary infections may occur). If this happens, inform your doctor immediately.

Reporting side effects:

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

Keep Azzalure out of sight and reach of children.

Your doctor should not use Azzalure after the expiration date indicated on the label. The expiration date is the last day of the month indicated.

Store Azzalure in a refrigerator (2°C - 8°C). Do not freeze.

Your doctor will dissolve Azzalure in a liquid injection solution.

Once reconstituted, chemical and physical stability has been demonstrated for 24 hours between 2-8°C. From a microbiological standpoint, unless the reconstitution method excludes the risk of microbial contamination, the medication should be used immediately. In the event that it is not used immediately, the time and storage conditions once reconstituted are the responsibility of the user.

Composition of Azzalure

• The active principle is botulinum toxin type A*.A vial contains 125 Speywood units.
• The other components are human albumin 200g/L and lactose monohydrate.

*Botulinum toxin type A fromClostridium botulinum(a bacterium)- hemagglutinin complex.

The Speywood units of Azzalure are specific to the product and are not interchangeable with other treatments containing botulinum toxin.

Appearance of the product and contents of the packaging

Azzalure is a powder for injectable solution. The packaging is 1 or 2 vials.

Azzalure is a white powder.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ipsen Pharma, S.A.U. Gran Via de les Corts Catalanes 130-136. 08038, Barcelona - Spain

Local representative:

Laboratorios Galderma SA

Serrano Galvache, 56. 28033 Madrid - Spain

Tel: 902 02 75 95

Responsible for manufacturing:

Ipsen Manufacturing Ireland Limited

Blanchardstown Industrial Park

Blanchardstown, Dublin 15, Ireland

This prospectus has been approved in February 2025.

If you want more information, or are interested in the prospectus in a different format, contactLaboratorios Galderma SA, tel. 902 02 75 95.

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

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This information is intended solely for doctors or healthcare professionals:

Dosage and administration:

See section 3 of the Patient Information Leaflet.

Special precautions for disposal and other handling

Follow the usage, handling, and disposal instructions strictly.

The reconstitution should be performed in accordance with good practices, especially respecting aseptic conditions.

Azzalure should be reconstituted with a 9 mg/ml (0.9%) sodium chloride injectable solution.

In the dilution table below, the amount of 9 mg/ml (0.9%) sodium chloride injectable solution to be added to a vial of 125 U is indicated to obtain a transparent and colorless reconstituted solution with the following concentrations:

To measure accurately the 0.63 ml or 1.25 ml, a graduated syringe with increments of 0.1 ml and 0.01 ml will be used.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS

Immediately after use and before disposal, the reconstituted Azzalure solution (in the vial or syringe) that has not been used should be inactivated with 2 ml of diluted sodium hypochlorite solution at 0.55% or 1% (Dakin solution).

The vials, syringes, and materials used should not be emptied, but should be deposited in suitable containers and disposed of according to local established procedures.

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Clean any remaining product, either with an absorbent material soaked in a sodium hypochlorite solution (bleach), if it is the powder, or with an absorbent material and dry, if it is the reconstituted product.
• Contaminated surfaces should be cleaned with an absorbent material soaked in a sodium hypochlorite solution (bleach) and then dried.
• If a vial is broken, proceed as mentioned above, carefully collecting the glass fragments and cleaning the product while avoiding cutting yourself with the broken glass.
• If the product comes into contact with the skin, wash the affected area with a sodium hypochlorite solution (bleach) and rinse with plenty of water.
• If the product comes into contact with the eyes, clean them carefully with plenty of water or with an eye cleaning solution.
• If the product comes into contact with a wound, cut, or raised skin, clean it carefully with plenty of water and take the necessary medical measures according to the injected dose.

These usage, handling, and disposal instructions should be followed strictly.