Alluzience 200 units Speywood/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient user

Alluzience, 200 Speywood units/ml, solution for injection

Clostridium botulinum type A botulinum toxin – hemagglutinin complex

Read all of this 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, ask your doctor.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Alluzience is and what it is used for

Alluzience contains a substance, botulinum toxin A, which causes muscles to relax. Alluzience acts on 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 reverses.

Some people are distressed by the appearance of wrinkles on their face. Alluzience 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).

2. What you need to know before using Alluzience

Do not use Alluzience:

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

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• if you have any neuromuscular disorders
• if you often have difficulty swallowing (dysphagia)
• if you frequently 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 or show signs of atrophy
• if you have a coagulation disorder, meaning you may bleed more than normal, such as hemophilia (an inherited bleeding disorder caused by deficiencies in clotting factors)
• if you have undergone or will soon undergo facial surgery or any other type of operation
• 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.

Special precautions:

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

Seek immediate medical attention if you have difficulty swallowing, speaking, or breathing.

When Alluzience is used in the muscles around the eye, your eyes may become dry, which can damage the surface of your eyes. To prevent this, you may need treatment with protective eye 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 intervals shorter than 3 months or at higher doses to treat other conditions, the development of antibodies has been observed infrequently. The formation of neutralizing antibodies may reduce the effectiveness of treatment.

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

Children and adolescents

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

Other medicines and Alluzience

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

• antibiotics used 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 must not be used during pregnancy or while 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 operate machinery.

Alluzience contains sodium

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

3. How to use Alluzience

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

Your doctor will administer the injections. One vial of Alluzience must be used for a single patient and for a single treatment session only.

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

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

The effect of treatment should become apparent within a few days after injection and may last up to 6 months.

Your doctor will determine the appropriate interval between each Alluzience treatment. 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 required, muscles other than those treated may begin to weaken. Excessive doses may cause paralysis of the respiratory muscles. This may not occur immediately. If these symptoms occur, inform your doctor as soon as possible.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Very rarely (may affect up to 1 in 10,000 people), adverse effects involving botulinum toxin in muscles other than those at the injection site have been reported. These effects include excessive muscle weakness, difficulty swallowing, coughing, and choking sensation when swallowing (if liquids or food enter the airways during swallowing, respiratory problems such as lung infections may occur). If this occurs, inform your doctor immediately.

Seek urgent medical assistance 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 having an allergic reaction to Alluzience.

Tell 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, 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, eyelid swelling, eyebrow ptosis, eye fatigue or reduced vision, dry eyes, muscle contraction around the eye, excessive tearing.

Uncommon (may affect up to 1 in 100 people)

• Eyelid twitching, visual disturbance, blurred or double vision
• Eye allergy, hypersensitivity, rash.

Frequency unknown (cannot be estimated from available data)

• Numbness
• Loss of muscle mass

Reporting of 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 leaflet. You may also report them directly via 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 Alluzience

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

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

Store Alluzience in a 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 allow the vial to reach room temperature before use. Alluzience may be stored at temperatures up to a maximum of 25°C for a single period of up to 12 hours, provided it remains unopened and protected from light. Alluzience must be discarded if not used within 12 hours after removal from refrigeration.

Once opened, the product should be used immediately.

6. Contents of the pack and other information

Composition of Alluzience

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

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

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

Botulinum toxin units are not interchangeable between different products. Recommended doses in Speywood units differ from those of other botulinum toxin preparations.

Appearance of the product and contents of the pack

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

Alluzience is a clear, colourless solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Ipsen Pharma
70 rue Balard
75015 Paris
France

Manufacturer:

Ipsen Manufacturing Ireland Limited
Blanchardstown Industrial Park
Blanchardstown
Dublin 15
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Local representative:

Laboratorios Galderma SA
Serrano Galvache, 56
28033 Madrid - Spain
Tel: 902 02 75 95

Date of the most recent review of this summary: November 2022

Other sources of information

Detailed and up-to-date information on this medicinal product 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:

Posology and method of administration:

Refer to section 3 of the Patient Information Leaflet.

Special precautions for disposal and other handling

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

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS

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

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

Used vials, syringes, and materials must 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 residual product should be cleaned up using a dry absorbent material.
• Contaminated surfaces should be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach), then dried.
• If a vial breaks, proceed as indicated above, carefully collecting glass fragments and cleaning up the product, taking care to avoid 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 rinse with abundant water and take appropriate medical measures according to the injected dose.

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