Product Information for the Patient User

Alluzience, 200 units Speywood/ml, injectable solution

Toxin type A fromClostridium botulinum– hemagglutinin complex

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 doubts, 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 Alluzience and for what it is used

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

3. How to use Alluzience

4. Possible adverse effects

5. Storage of Alluzience

6. Contents of the package and additional information

Alluziencecontains a substance, botulinum toxin A, which causes muscles to relax.Alluzience 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. Alluzience may be used in adults under 65 years old for the temporary improvement of the appearance of moderate to severe glabellar lines (vertical expression lines between the eyebrows).

No use Alluzience:

• if you are allergic to botulinum toxin A or 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 this medication:

• 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 or show signs of atrophy
• if you have any bleeding disorder, which means you may bleed more than normal, such as hemophilia (hereditary hemorrhagic disorder caused by deficiencies in coagulation factors)
• if you have been or will be undergoing facial surgery or other type of operation
• 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.

Special precautions:

Very rarely, side effects have been reported with botulinum toxin possibly related to the spread of the toxin's effect to distant locations from the injection site (e.g., muscle weakness, difficulty swallowing, or unwanted food or liquids in the airways).

Seek medical attention immediately if you experience difficulty swallowing, speaking, or breathing.

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

When botulinum toxin has been used at intervals more frequently than 3 months 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 them that you are being treated with Alluzience.

Children and adolescents

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

Other medications and Alluzience

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. This is important because some of these medications may 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, or think you may be pregnant, consult your doctor before using this medication.

Alluzience should not be used during pregnancy or while breastfeeding.

Driving and operating machinery

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

Alluzience contains sodium

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

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

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

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

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

The effect of the treatment should be appreciated a few days after the injection, and may last up to 6 months.

Your doctor will decide on the appropriate interval between each treatment with Alluzience. This interval must 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 may 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount administered).

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Very rarely (it may affect up to 1 in 10,000 people) adverse effects with botulinum toxin have been reported in muscles other than those at the injection site. These effects include excessive muscle weakness, difficulty swallowing, cough, 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, report it immediately to your doctor.

Seek urgent medical assistance if:

• You experience respiratory difficulty, swallowing difficulty, or speech difficulty
• Your face swells or your skin becomes red, or you experience a rough, itchy rash.You may be experiencing an allergic reaction to Alluzience.

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

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

• Headache
• Reactions at the injection site (such as pain, tingling, 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
• Eyelid drooping, eyelid swelling, eyebrow drooping, eye fatigue, or decreased vision, dry eyes, eye muscle contraction, tearing.

Uncommon (may affect up to 1 in 100 people)

• Eye twitching, vision changes, blurry or double vision
• Ocular allergy, hypersensitivity, rash.

Unknown frequency (cannot be estimated with available data)

• Numbness
• Muscle mass loss

Reporting Adverse Effects:

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

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

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

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

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

Once opened, the product must be used immediately.

Alluzience Composition

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

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

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

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

Product appearance and packaging contents

Alluzience is an injectable solution. It comes in an individual pack of 1 or 2 vials or in a multiple pack containing 6 individual packs, each containing 2 vials. Some packaging sizes may not be marketed.

Alluzience is a transparent and colourless 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

Last review date of this leaflet:November 2022

Other sources of information

The detailed and updated information about this medicine 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 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.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS

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

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

Used vials, syringes, and materials must not be emptied and must be disposed of in suitable containers and disposed of in accordance with local regulations.

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Clean any remaining product with a dry absorbent material.
• Contaminated surfaces must be cleaned with an absorbent material soaked in a sodium hypochlorite solution and then dried.
• If a vial is broken, proceed as indicated above, carefully collecting the broken glass fragments and cleaning the product, 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 and rinse with plenty of water.
• If the product comes into contact with the eyes, clean them carefully with plenty of water or 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.

Follow these usage, handling, and disposal instructions strictly.