ALLUZIENCE 200 Units/mL Injectable Solution

2. What you need to know before using Alluzience

Do not use Alluzience:

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

Warnings and precautions

Consult your doctor before starting to use this medicine:

• if you have any neuromuscular disorder
• if you often have difficulty swallowing (dysphagia)
• if you often have problems with food or drink entering your airways, causing choking or coughing
• if you have any inflammation at the proposed injection site
• if the muscles where you will be injected are weak or show signs of atrophy
• if you have any coagulation disorder, which means you may bleed more than normal, such as hemophilia (hereditary bleeding disorder caused by coagulation factor deficiencies)
• if you have undergone or will undergo facial surgery or other surgery
• if you did not experience any improvement in your glabellar lines after your last treatment with botulinum toxin

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

Special precautions:

Very rare side effects have been reported with botulinum toxin, possibly related to the spread of the toxin effect to areas away from the injection site (e.g., muscle weakness, difficulty swallowing, or unwanted food or liquids in the airways). Seek medical attention immediately if you have difficulty swallowing, speaking, or breathing.

When using Alluzience in the muscles around the eye, your eyes may become dry, which can damage the surface of your eyes. To avoid this, you may need treatment with protective drops, ointments, or a protective cover that closes the eye. Your doctor will tell you if this is necessary.

When botulinum toxin has been used at more frequent intervals of 3 months or at higher doses to treat other conditions, the production of antibodies has been observed infrequently. The formation of neutralizing antibodies can reduce the effectiveness of treatment.

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

Children and adolescents

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

Other medicines and Alluzience

Tell your doctor if you are taking, have recently taken, or may take any other medicine. This is important because some of these medicines can increase the effect of Alluzience:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Alluzience should not be used during pregnancy or breastfeeding.

Driving and using machines

You may experience blurred vision or temporary muscle weakness after treatment with Alluzience. If this occurs, do not drive or use machines.

Alluzience contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to use Alluzience

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

Your doctor will apply the injections. A vial of Alluzience should be used for a single patient and a single treatment session.

The recommended dose for glabellar lines is 50 units Speywood, administered as 10 units in each of the 5 injection sites on the forehead, at the top of the nose, and eyebrows.

The recommended doses in Speywood units are different from other botulinum toxin preparations.

The effect of the treatment should be noticeable a few days after the injection and can last up to 6 months.

Your doctor will decide on the appropriate interval between each treatment with Alluzience. This interval should not be less than 3 months.

Use in children and adolescents

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

If you use more Alluzience than you should

If you receive more Alluzience than necessary, other muscles different from those treated may begin to weaken. Excessive doses can cause paralysis of the respiratory muscles. This may not occur immediately. If these symptoms appear, inform your doctor as soon as possible.

In cases of overdose or accidental administration, call the Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount administered).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very rarely (may affect up to 1 in 10,000 people), side effects have been reported with botulinum toxin in muscles other than those at the injection site. These effects include excessive muscle weakness, difficulty swallowing, coughing, and a feeling of choking when swallowing (if liquids or food enter the airways when trying to swallow, respiratory problems such as pneumonia can occur). If this happens, inform your doctor immediately.

Seek urgent medical attention if:

• You experience difficulty breathing, swallowing, or speaking
• Your face swells or your skin turns red, or you have a rough rash with itching. You may be suffering an allergic reaction to Alluzience.

Tell your doctor if you experience any of these side effects:

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

• Headache
• Reactions at the injection site (such as pain, tingling, bruising, redness, swelling, itching, rash, irritation, discomfort, stinging), generalized weakness, fatigue, and flu-like symptoms.

Common (may affect up to 1 in 10 people)

• Temporary facial paralysis
• Drooping of the upper eyelid, swelling of the eyelid, drooping of the eyebrow, eye fatigue, or decreased vision, dry eye, contraction of the muscles around the eye, tearing.

Uncommon (may affect up to 1 in 100 people)

• Eyelid twitching, vision changes, blurred or double vision
• Ocular allergy, hypersensitivity, rash.

Frequency not known (cannot be estimated from available data)

• Numbness
• Muscle mass loss

Reporting side effects:

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

5. Storage of Alluzience

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

Do not use Alluzience after the expiration date stated on the label.

Store Alluzience in the refrigerator (2°C - 8°C). Do not freeze. Keep the vials in the original packaging to protect them from light.

After removing the vial from the refrigerator, it is recommended to let the vial reach room temperature. Alluzience can be stored at temperatures up to a maximum of 25°C for a single period of 12 hours without opening and protected from light. Alluzience should be discarded if not used within 12 hours after removal from refrigeration.

Once opened, the product must be used immediately.

6. Contents of the pack and further information

Composition of Alluzience

The active substance is botulinum toxin type A*, 200 units Speywood/ml. One vial contains 125 units Speywood in 0.625 ml of solution.

The other components are: L-histidine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid, water for injectable preparations

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

The units of botulinum toxin are not interchangeable from one product to another. The recommended doses in Speywood units are different from other botulinum toxin preparations.

Appearance of the product and pack contents

Alluzience is an injectable solution. It comes in a single pack of 1 or 2 vials or in a multipack containing 6 single packs, each containing 2 vials. Not all pack sizes may be marketed.

Alluzience is a clear and colorless solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

France

Manufacturer:

Ipsen Manufacturing Ireland Limited

Blanchardstown Industrial Park

Blanchardstown

Dublin 15

Ireland

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Local representative:

Laboratorios Galderma SA

Serrano Galvache, 56.

28033 Madrid - Spain

Phone: 902 02 75 95

Date of last revision of this leaflet:November 2022

Other sources of information

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

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This information is intended only for healthcare professionals:

Posology and method of administration:

See section 3 of the Patient Information Leaflet.

Special precautions for disposal and other handling

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

RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS

Immediately after patient treatment, any unused Alluzience (in the vial or syringe) should be inactivated with a diluted sodium hypochlorite solution (bleach) (1% available chlorine).

Any spilled Alluzience should be cleaned with an absorbent cloth soaked in a diluted sodium hypochlorite solution.

Used vials, syringes, and materials should not be emptied and should be disposed of in appropriate containers and eliminated according to local requirements.

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Any remaining product should be cleaned with a dry absorbent material.
• 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 indicated above, carefully collecting the glass fragments and cleaning the product, avoiding cuts 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, rinse carefully with plenty of water or an eye cleaning solution.
• If the product comes into contact with a wound, cut, or broken skin, rinse carefully with plenty of water and take appropriate medical measures according to the injected dose.

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