Azzalure 125 Units Speywood powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient user

Azzalure, 125 Speywood Units, powder for solution for injection

( Botulinum toxin type A )

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Azzalure is and what it is used for
2. What you need to know before using Azzalure
3. How to use Azzalure
4. Possible adverse effects
5. How to store Azzalure
6. Contents of the pack and other information

1. What Azzalure is and what it is used for

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

Some people are distressed by the appearance of facial wrinkles. Azzalure can be used in adults under 65 years of age for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) and lateral canthal lines (crow's feet).

2. What you need to know before using Azzalure

Do not use Azzalure:

• if you are allergic to Clostridium botulinum toxin type A or to any of the other components of this medicine (listed in section 6).
• if you have an infection at the sites where injection is intended.
• if you have myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.

Warnings and precautions

Talk to your doctor before starting treatment with Azzalure:

• if you have any neuromuscular disorder or defect.
• if you frequently have difficulty swallowing (dysphagia).
• if you often have problems with food or drink entering your airways, causing choking or coughing.
• if there is any inflammation at the proposed injection site.
• if the muscles to be injected are weak.
• if you have a coagulation disorder, meaning you may bleed more than normal, such as haemophilia (an inherited bleeding disorder caused by deficiencies in clotting factor).
• if you have undergone or will soon undergo facial surgery or any other type of surgery.
• if you have previously received other botulinum toxin injections.
• if, after your last treatment with botulinum toxin, you did not experience any improvement in your glabellar lines.

This information will help your doctor decide on the risks and benefits of your treatment.

When being treated with Azzalure, your eyes may become 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 may cause muscle weakness in areas of the body distant from the injection site.

When botulinum toxin has been used at intervals shorter than 12 weeks or at higher doses to treat other conditions, antibody formation has been observed infrequently. The development of neutralizing antibodies may reduce treatment effectiveness.

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

Children and adolescents

Azzalure is not indicated for use in individuals under 18 years of age.

Use of Azzalure with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, as Azzalure may interact with other medicines, especially:

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

Use of Azzalure with food and drink

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

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use Azzalure

Azzalure must only be administered by physicians with appropriate qualifications and experience in this treatment and who have access to suitable equipment.

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

The recommended dose of Azzalure is:

• For glabellar lines: 50 units; 10 units will be administered at each of the 5 injection sites in the forehead, upper nose, and eyebrow area.

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

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

The effect of treatment should become apparent within a few days after injection.

Your doctor will determine 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 required, other muscles different from those treated may begin to weaken. This may not occur immediately. If these symptoms appear, inform your doctor as soon as possible.

In case of overdose or accidental administration, contact the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medication and the amount administered).

4. Possible adverse effects

Like all medicines, Azzalure may produce adverse effects, although not everyone experiences them.

Seek medical help if:

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

Tell your doctor if you experience any of the following adverse effects:

For glabellar 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 of the upper eyelids, eyelid swelling, watery eyes, dry eyes, muscle contractions around the eye
• 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 disturbance

Frequency not known (cannot be estimated from the available data)

• Numbness
• Loss of muscle mass
• Generalized weakness
• Fatigue
• Flu-like symptoms

For lateral canthal lines:

Common (may affect up to 1 in 10 people)

• Headache
• Eyelid swelling
• Bruising, itching, and swelling around the eyes
• Drooping of the upper eyelid
• Temporary facial paralysis

Uncommon (may affect up to 1 in 100 people)

• Dry eye

Frequency not known (cannot be estimated from the available data)

• Allergic reactions
• Numbness
• Loss of muscle mass
• Generalized weakness
• Fatigue
• Flu-like symptoms

These adverse effects usually occur during the first week after injections and are usually short-lived. They are typically mild to moderate in intensity.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azzalure

Keep Azzalure out of the sight and reach of children.

Your doctor should not use Azzalure after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.

Store Azzalure in a refrigerator (2°C - 8°C). Unopened vials of Azzalure may be exposed to temperatures up to 25°C for a maximum of 72 hours. After this period, unopened vials must be stored in a refrigerator (between 2°C and 8°C) for the entire remaining shelf life. Do not freeze.

Your doctor will dissolve Azzalure in a liquid solution for injection.

After reconstitution, chemical and physical stability has been demonstrated for 24 hours at 2-8°C. From a microbiological standpoint, unless the reconstitution method excludes the risk of microbial contamination, the medicinal product should be used immediately. If not used immediately, the duration and conditions of storage after reconstitution are the responsibility of the user.

6. Additional Information

Composition of Azzalure

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

*Botulinum toxin type A from Clostridium botulinum (a bacterium) – hemagglutinin complex.

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

Appearance of the product and contents of the container

Azzalure is a powder for solution for injection. The pack contains 1 or 2 vials.

Azzalure is a white powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

Ipsen Manufacturing Ireland Limited

Blanchardstown Industrial Park

Blanchardstown, Dublin 15, Ireland

This leaflet was approved in December 2025.

If you would like further information, or are interested in the leaflet in a different format, please contact Laboratorios Galderma SA, tel. 902 02 75 95.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Dosage and method of administration:

Refer to section 3 of the Patient Information Leaflet.

Special precautions for disposal and other handling

Instructions for use, handling, and disposal must be strictly followed.

Reconstitution must be performed in accordance with good practice guidelines, particularly maintaining aseptic conditions.

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

The dilution table below indicates the required volume of 9 mg/ml (0.9%) sodium chloride injectable solution to be drawn into a syringe to obtain a reconstituted solution that is clear and colourless, with the following concentrations:

To measure accurately 0.63 ml or 1.25 ml, a syringe graduated in increments of 0.1 ml and 0.01 ml should be used.

RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS

Immediately after use and prior to disposal, unused reconstituted Azzalure solution (in the vial or in the syringe) must be inactivated with 2 ml of diluted sodium hypochlorite solution at 0.55% or 1% (Dakin's solution).

Vials, syringes, and materials used must not be emptied but should be placed in appropriate containers and disposed of according to established local procedures.

RECOMMENDATIONS IN CASE OF ACCIDENT DURING BOTULINUM TOXIN HANDLING

• Any residual product must be cleaned up, using an absorbent material soaked in sodium hypochlorite solution (bleach), if dealing with the powder, or using dry absorbent material, if dealing with the reconstituted product.
• Contaminated surfaces must be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach), then dried.
• If a vial breaks, proceed as described above, carefully collecting glass fragments and cleaning the product while avoiding cuts from broken glass.
• If the product comes into contact with the skin, wash the affected area with sodium hypochlorite solution (bleach) and rinse thoroughly with abundant water.
• If the product comes into contact with the eyes, carefully rinse with abundant water or with an ophthalmic cleaning solution.
• If the product comes into contact with a wound, cut, or abraded skin, carefully clean with abundant water and take appropriate medical measures according to the injected dose.

These instructions for use, handling, and disposal must be strictly followed.