Alluzience

PACKAGE LEAFLET

Package leaflet: information for the user

Alluzience, 200 units Speywood/ml, solution for injection

Botulinum toxin complex type A from Clostridium botulinum - hemagglutinin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4. Contents of this leaflet
  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 side 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 the active substance botulinum toxin A, which causes relaxation of
muscles. Alluzience acts at the neuromuscular junction to prevent the release of a chemical messenger
called acetylcholine from nerve endings. This prevents muscles from contracting. The
muscle relaxation is temporary and gradually wears off.
The well-being of some individuals may be affected by the appearance of facial wrinkles. Alluzience is used in
adults under 65 years of age to temporarily improve the appearance of moderate to severe glabellar lines (vertical wrinkles between the eyebrows).

2. What you should know before using Alluzience

Do not inject Alluzience if:

• you are allergic to botulinum toxin A or to any of the other ingredients of this medicine (listed in section 6);
• you have an infection at the proposed injection site;
• you suffer from myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.

Warnings and precautions

Talk to your doctor before receiving an injection of Alluzience if:

• you suffer from any neuromuscular disorder;
• you frequently have difficulty swallowing food (dysphagia);
• you often experience problems caused by food or drinks entering your airways, leading to coughing or choking;
• you have inflammation at the proposed injection site;
• the muscles at the proposed injection site are weak or show signs of wasting;
• you suffer from a bleeding disorder – that is, you continue bleeding for longer than normal,
  • such as haemophilia (inherited bleeding disorders caused by deficiencies in clotting factors);
• you have recently undergone facial surgery or are planning to have facial surgery or other types of surgery soon;
• you did not experience significant improvement in your wrinkles after your last treatment with botulinum toxin.

These details will help your doctor make an informed decision about the risks and benefits of your treatment.

Special warnings:

Very rare cases of side effects possibly related to the spread of the toxin effect away from the injection site have been reported with botulinum toxin (e.g. muscle weakness, difficulty swallowing, or involuntary passage of food or liquids into the airways).
Seek immediate medical attention if you experience difficulty swallowing, speaking, or breathing.
When Alluzience is used in muscles around the eye, dry eyes may occur, which could damage the surface of the eyes. To prevent this, treatment with protective eye drops, ointments, or a protective covering that closes the eye may be necessary. Your doctor will advise you if this is needed.
When botulinum toxins are used more than once every 3 months or at higher doses to treat other conditions, the formation of antibodies has been observed rarely in patients. The development of neutralizing antibodies may reduce the effectiveness of treatment.
If you consult any doctor for any reason, make sure to inform them that you have been treated with Alluzience.

Children and adolescents

Alluzience is not recommended for use in patients under 18 years of age.

Other medicines and Alluzience

Inform your doctor if you are currently using, have recently used, or might use any other medicines. This is important because some of these medicines may increase the effect of Alluzience:

• antibiotics for infection (e.g. aminoglycosides such as gentamicin or amikacin); or
• other muscle relaxants.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Alluzience must not be used during pregnancy or while breastfeeding.

Driving and using machines

Temporary visual disturbances or muscle weakness may occur following treatment with Alluzience. If you experience these, do not drive or operate machinery.

Alluzience contains sodium

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

3. How to use Alluzience

Alluzience must be administered only by physicians who have appropriate qualifications and experience in this treatment and who have access to the required equipment.
The physician will perform the injections. A vial of Alluzience must be used only for you and only for a single treatment session.
The recommended dose for glabellar lines is 50 Speywood units, injected as 10 Speywood units at each of the 5 injection sites in the forehead, in the area above the nose and between the eyebrows.
The recommended doses in Speywood units differ from other botulinum toxin preparations.
The effect of treatment should become evident within a few days after injection and may last up to 6 months.
The interval between Alluzience treatments will be determined by the physician. At least three months must elapse between treatments.
Use in children and adolescents
Alluzience is not recommended for use in patients under 18 years of age.
If you receive more Alluzience than you should
If you are given more Alluzience than required, muscles other than those injected may begin to weaken. Excessive doses may cause paralysis of respiratory muscles. This may not occur immediately. If this happens, contact your doctor immediately.
If you have any further 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 everybody gets them.

Very rarely (may affect up to 1 in 10,000 people), adverse effects with botulinum toxin have been reported in muscles different from those that received the injection. These effects include excessive muscle weakness, difficulty swallowing, coughing and choking while swallowing (if food or liquid enters the airways while you are swallowing, respiratory problems such as lung infections may occur). If this occurs, contact your doctor immediately.

Seek urgent medical help if:

• you have difficulty breathing, swallowing or speaking;
• your face swells or your skin becomes red, itchy or develops a lumpy rash. This may mean you are having a severe allergic reaction to Alluzience.

Contact your doctor if you notice any of the following 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, prickling sensation), 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, drooping eyebrow, tired eyes or reduced vision, dry eyes, muscle contractions around the eye, watery eyes.

Uncommon (may affect up to 1 in 100 people)

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

Not known (frequency cannot be estimated from the available data):

• Numbness
• Muscle wasting

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, please inform your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store 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 the refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer packaging to protect it from light.
After removing the vial from the refrigerator, 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 of removal from the refrigerator.
Once the vial has been opened, the product must be used immediately.

6. Package contents and other information

What Alluzience contains
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 excipients are: L-histidine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid, water for injections.
*Botulinum toxin from Clostridium botulinum (a bacterium), type A – haemagglutinin complex.
Botulinum toxin units are not interchangeable between products. The recommended doses in Speywood units differ from those of other botulinum toxin-containing preparations.

Description of the appearance of Alluzience and contents of the pack
Alluzience is an injectable solution. It is available in single packs containing 1 or 2 vials, or in a multiple pack containing 6 single packs, each with 2 vials. Not all pack sizes may be marketed.
Alluzience is a clear, colourless solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Pharma
70 rue Balard
75015 Paris
France

Marketing Authorisation Holder (Sales Licensee):
Galderma Italia S.p.A.
Via Manara Luciano, 15
20122 Milan
Italy

Manufacturer:
Ipsen Manufacturing Ireland Limited
Blanchardstown Industrial Park
Blanchardstown
Dublin 15
Ireland

The following information is intended exclusively for physicians or healthcare professionals:
Dosage and method of administration:
Refer to section 3 of the Patient Leaflet.

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

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and prior to disposal, unused Alluzience (which may remain in the vial or syringe) must be inactivated with a diluted sodium hypochlorite solution (bleach) (1% available chlorine).
Any spillage of Alluzience must be cleaned up using an absorbent cloth soaked in a diluted sodium hypochlorite solution.
Vials, syringes, and used materials must not be emptied and must be placed in appropriate containers and disposed of in accordance with local regulations.

RECOMMENDATIONS IN CASE OF INCIDENTS DURING HANDLING OF BOTULINUM TOXIN

• Any product spillage should be absorbed using dry, absorbent material.
• Contaminated surfaces should be cleaned using absorbent material soaked in a sodium hypochlorite solution (bleach), then dried.
• If a vial breaks, follow the procedure described above, carefully collecting glass fragments and drying up the product, taking care to avoid injury.
• If the product comes into contact with the skin, wash the affected area with a sodium hypochlorite solution (bleach), then rinse thoroughly with water.
• If the product comes into contact with the eyes, rinse thoroughly with plenty of water or an ophthalmic irrigation solution.
• If the product comes into contact with a skin lesion, rinse thoroughly with plenty of water and take appropriate medical measures depending on the injected dose.
  These instructions for use, handling, and disposal must be strictly followed.