Alluzience

Patient Information Leaflet

Alluzience, 200 Speywood units/ml, solution for injection
Botulinum toxin (type A) for injection
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Leaflet Contents

1. What Alluzience is and what it is used for
2. Important information 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 botulinum toxin type A as the active substance, which causes muscle relaxation. Alluzience acts at the nerve-muscle junction, preventing the release of the chemical messenger acetylcholine from nerve endings. This prevents muscle contraction. Muscle relaxation is temporary and gradually wears off. Facial wrinkles may negatively affect the well-being of some individuals. Alluzience is used in adults under 65 years of age for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical wrinkles between the eyebrows).

2. Important information before using Alluzience

When not to administer Alluzience injection:

• if the patient is allergic to botulinum toxin type A or to any of the other ingredients of this medicine (listed in section 6),
• in case of infection at the proposed injection site,
• in case of myasthenia gravis, Lambert-Eatonsyndrome, or amyotrophic lateral sclerosis.

Warnings and precautions
You should inform the doctor before receiving an Alluzience injection:

• if the patient has neuromuscular disorders,
• if the patient frequently experiences difficulty swallowing (dysphagia),
• if the patient frequently chokes on food or drink, causing coughing or gagging,
• if there is inflammation at the proposed injection site,
• if the muscles at the proposed injection site are weak or show signs of atrophy,
• if the patient has bleeding disorders resulting in longer than normal clotting time, e.g. haemophilia (inherited blood coagulation disorders caused by deficiency of clotting factor),
• if the patient has undergone facial surgery or if such surgery or other surgical procedures are planned in the near future,
• if, after the last botulinum toxin treatment, no significant improvement in wrinkles was observed.

This information will help the doctor make an appropriate decision regarding the risks and benefits of treatment.
Special warnings
Very rarely, adverse reactions probably related to the effect of botulinum toxin at sites distant from the injection site have been reported (e.g. muscle weakness, difficulty swallowing, or aspiration of food or fluid into the respiratory tract).
If difficulty in swallowing, speaking, or breathing occurs, contact a doctor immediately.
When Alluzience is injected into muscles around the eyes, dry eye may occur, which could lead to damage of the eye surface. To prevent this, protective eye drops, ointment, or an eye shield covering the eye may be necessary. The doctor will inform the patient whether this is required.
With more frequent than every 3 months or higher-dose use of botulinum toxins in the treatment of other diseases, formation of antibodies in patients has been observed rarely.
The development of neutralizing antibodies against the toxin may reduce the effectiveness of treatment.
Whenever visiting a doctor (regardless of the reason for the visit), the patient should inform the doctor about previous treatment with Alluzience.
Children and adolescents
Alluzience is not recommended for use in patients under 18 years of age.
Alluzience and other medicines
You should tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is important because some of these medicines may enhance the effect of Alluzience:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Alluzience must not be used during pregnancy or while breastfeeding.
Driving and operating machinery
After treatment with Alluzience, transient visual disturbances or muscle weakness may occur.
If such effects occur, the patient must not drive or operate machinery.
Alluzience contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Alluzience

Alluzience must be administered only by a physician qualified and experienced in this type of treatment and equipped with the necessary equipment.
The physician will administer the medication to the patient by injection. One vial of Alluzience should be used for only one patient during a single treatment session.
The recommended dose for the treatment of glabellar forehead lines is 50 Speywood units, administered as 10 Speywood units at each of 5 injection sites in the forehead area, above the nose and eyebrows.
Doses expressed in Speywood units differ from doses of other botulinum toxin-containing medications. The treatment effect should become visible within a few days after injection and may last up to 6 months.
The interval between subsequent injections of Alluzience will be determined by the physician.
Alluzience should not be used more frequently than every 3 months.
Use in children and adolescents
Alluzience is not recommended for use in patients under 18 years of age.
Use of a higher than recommended dose of Alluzience
Administration of a dose higher than recommended may cause weakening of muscles located outside the injection site. Excessive doses may lead to paralysis of respiratory muscles. This may occur after a delay. If such symptoms occur, the physician should be informed immediately.
If you have any further doubts regarding the use of this medication, consult your physician.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rarely (may occur in up to 1 in 10,000 people), when using botulinum toxin, adverse effects have been reported affecting muscles other than those into which the medicine was injected. These included excessive muscle weakness, difficulty swallowing, coughing and choking while swallowing (if food or liquid enters the airways during swallowing, respiratory disturbances may occur, e.g. lung infection). If such symptoms occur, a doctor should be informed immediately.

Contact a doctor urgently if:

• You experience difficulty breathing, swallowing, or speaking.
• You develop facial swelling or skin redness, or an itchy, bumpy rash. These symptoms may indicate that the patient has developed a severe allergic reaction to Alluzience.

If any of the following adverse effects occur, contact a doctor:

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), general weakness, fatigue, flu-like symptoms.

Common (may affect up to 1 in 10 people):

• Transient facial paralysis,
• Drooping of the upper eyelid, eyelid swelling, drooping of the eyebrow, feeling of eye fatigue or blurred vision, dry eye, muscle twitching around the eye, watery eyes.

Uncommon (may affect up to 1 in 100 people):

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

Frequency unknown (frequency cannot be estimated from available data):

• Numbness,
• Muscle atrophy.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Alluzience

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial in the outer packaging
to protect from light.
After removing the vial from the refrigerator, allow it to reach room temperature before use.
Alluzience may be stored at a temperature not exceeding 25°C for up to 12 hours, provided
that the container is not opened and is protected from light.
If Alluzience is not used within 12 hours after removal from the refrigerator, it must be discarded.
The medicinal product should be used immediately after opening the vial.

6. Contents of the pack 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 other ingredients are: L-histydine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid, water for injections.
Botulinum toxin complex from Clostridium botulinum (bacterium) type A with hemagglutinin.
Botulinum toxin units are not interchangeable with units of other botulinum toxin-containing medicinal products. Doses recommended in Speywood units differ from those of other botulinum toxin products.

What Alluzience looks like and contents of the pack
Alluzience is a solution for injection. It is available in a single pack containing 2 vials and a multipack containing 6 single packs, each containing 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

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

Additional information or the package leaflet in another format is available upon request from:
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warszawa, Poland
tel. +48 22 331 21 80

Information intended exclusively for healthcare professionals:
Alluzience, 200 Speywood units/ml, solution for injection
Botulinum toxin (type A) for injection

Dosage and method of administration:
See section 3 of the Package Leaflet.

Special precautions for disposal and preparation of the medicinal product for administration:
Strictly follow instructions regarding use, preparation and disposal of the medicinal product.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after administration to the patient, any residual Alluzience product remaining in the vial or syringe must be inactivated using diluted sodium hypochlorite solution (1% free chlorine).
Surfaces contaminated with Alluzience should be cleaned with an absorbent material soaked in diluted sodium hypochlorite solution.
Do not empty used vials, syringes or materials. They should be discarded into appropriate containers and disposed of in accordance with local requirements.

RECOMMENDATIONS IN CASE OF INCIDENT DURING PREPARATION OF BOTULINUM TOXIN

• Spilled product should be wiped up using a dry, absorbent material.
• Contaminated surfaces should be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach), then dried.
• In case of broken vial, follow the above instructions. Carefully collect fragments of broken glass and wipe up the product, taking care not to cut the skin.
• If the product has come into contact with the skin, wash the contaminated area with sodium hypochlorite solution (bleach), then rinse thoroughly with water.
• If the product has come into contact with the eyes, rinse the eyes thoroughly with a large amount of water or ophthalmic irrigation solution.
• If the product has come into contact with a wound, cut or damaged skin, the contaminated area should be thoroughly rinsed with abundant water and appropriate medical actions taken depending on the dose administered.

Strictly follow instructions regarding use, preparation and disposal of the medicinal product.