ALLUZIENCE 200 U Speywood/ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: information for the user
3. Alluzience, 200 units Speywood/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Alluzience and what is it used for
5. Important information before using Alluzience
   1. When not to administer Alluzience:
   2. Warnings and precautions
   3. Special warnings
   4. Children and adolescents
   5. Alluzience and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alluzience contains sodium
6. How to use Alluzience
   1. Use in children and adolescents
   2. Use of a higher than recommended dose of Alluzience
7. Possible side effects
   1. Seek immediate medical attention if:
   2. If the patient experiences any of the following side effects, consult a doctor:
   3. Very common (may occur in more than 1 in 10 people):
   4. Common (may occur in up to 1 in 10 people):
   5. Uncommon (may occur in up to 1 in 100 people):
   6. Frequency not known (frequency cannot be estimated from the available data)
   7. Reporting side effects
8. How to store Alluzience
9. Contents of the packaging and other information
   1. What Alluzience contains
   2. What Alluzience looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Importer:
   6. Alluzience, 200 units of Speywood/ml, solution for injection
   7. Dosage and administration:
   8. Special precautions for disposal and preparation of the medicinal product:

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Alluzience, 200 units Speywood/ml, solution for injection

Botulinum toxin (type A) for injection

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the doctor. See section 4.

Table of contents of the leaflet

• 1. What is Alluzience and what is it 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 packaging and other information

1. What is Alluzience and what is it used for

Alluzience contains the active substance botulinum toxin type A, which causes muscle relaxation. Alluzience acts on the connection between nerves and muscles, preventing the release of the chemical transmitter acetylcholine from nerve endings. This prevents muscle contraction. Muscle relaxation is temporary and gradually subsides. Wrinkles on the face can negatively affect the well-being of some people. Alluzience is used in adults under 65 years of age to temporarily improve the appearance of moderate or severe forehead lines (vertical lines between the eyebrows).

2. Important information before using Alluzience

When not to administer Alluzience:

• if the patient is allergic to botulinum toxin type A or 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-Eaton syndrome, or amyotrophic lateral sclerosis.

Warnings and precautions

Inform the doctor before administering Alluzience:

• if the patient has neuromuscular disorders,
• if the patient frequently experiences difficulty swallowing food (dysphagia),
• if the patient frequently experiences choking on food or drink, causing coughing or choking,
• 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, indicating a longer than usual bleeding time, e.g., hemophilia (inherited blood clotting disorders caused by a lack of clotting factor),
• if the patient has had facial surgery or such surgery or other surgical procedures are planned in the near future,
• if there was no significant improvement in wrinkles after the last treatment with botulinum toxin.

This information will help the doctor make an informed decision regarding the risks and benefits of treatment.

Special warnings

Very rarely, side effects have been reported that are possibly related to the action of botulinum toxin at sites distant from the injection site (e.g., muscle weakness, difficulty swallowing, or food or fluid entering the airways). In case of difficulty swallowing, speaking, or breathing, contact the doctor immediately. If Alluzience is administered to the muscles around the eyes, dry eye may occur, which can cause damage to the eye surface. To prevent this, protective drops, ointment, or a protective shield covering the eye may be necessary. The doctor will inform the patient if this is required. When using botulinum toxins more frequently than once every 3 months or in higher doses to treat other conditions, rare cases of antibody formation have been observed in patients. The formation of neutralizing antibodies to the toxin may reduce the effectiveness of treatment. In case of a visit to the doctor (for any reason), 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

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 infections (e.g., aminoglycoside antibiotics such as gentamicin or amikacin) or
• other muscle relaxants.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. Alluzience should not be used during pregnancy or breastfeeding.

Driving and using machines

After treatment with Alluzience, temporary vision disturbances or muscle weakness may occur. In case of such effects, do not drive or operate machines.

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 should only be administered by a doctor with the appropriate qualifications and experience in such treatment and the necessary equipment. The doctor will administer the medicine to the patient by injection. One vial of Alluzience should only be used for one patient during one treatment session. The recommended dose for the treatment of forehead lines is 50 units of Speywood, administered as 10 units of Speywood in each of 5 injection sites on the forehead, in the area above the nose and eyebrows. The doses recommended in Speywood units differ from the doses of other botulinum toxin-containing medicines. The effect of treatment should be visible within a few days of injection and may last up to 6 months. The time interval between subsequent injections of Alluzience will be determined by the doctor. The medicine 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 higher than recommended dose of Alluzience may cause muscle weakness outside the injection site. Administration of excessive doses may cause respiratory muscle paralysis. This may occur after some time. In case of such symptoms, inform the doctor immediately. In case of any further doubts about the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely (may occur in up to 1 in 10,000 people) when using botulinum toxin, side effects have been reported that affect other muscles than those into which the medicine was injected. These included excessive muscle weakness, difficulty swallowing, coughing, and choking during swallowing (if food or fluid enters the airways during swallowing, respiratory disorders, e.g., pneumonia, may occur). Inform the doctor immediately about such symptoms.

Seek immediate medical attention if:

• Difficulty breathing, swallowing, or speaking occurs.
• Facial swelling or redness of the skin or an itchy, lumpy rash occurs. The appearance of such symptoms may indicate that the patient has developed a severe allergic reaction to Alluzience.

If the patient experiences any of the following side effects, consult a doctor:

Very common (may occur in 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 occur in up to 1 in 10 people):

• Transient facial paralysis,
• Upper eyelid ptosis, eyelid edema, eyebrow ptosis, feeling of eye fatigue or blurred vision, dry eye, eyelid twitching, eye irritation.

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

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

Frequency not known (frequency cannot be estimated from the available data)

• Numbness,
• Muscle atrophy.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Alluzience

Store the 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. Store the vials in the outer packaging to protect from light. After removing the vial from the refrigerator, it is recommended to wait until the vial reaches room temperature. Alluzience can be stored at a temperature up to 25°C for a maximum of 12 hours, provided the packaging is not opened and is protected from light. If Alluzience is not used within 12 hours of removal from the refrigerator, it should be discarded. The medicinal product should be used immediately after opening the vial.

6. Contents of the packaging and other information

What Alluzience contains

The active substance of Alluzience is botulinum toxin type A, 200 units of Speywood/ml. One vial contains: 125 units of Speywood in 0.625 ml of solution. The other ingredients are: L-histidine, sucrose, sodium chloride, polysorbate 80, hydrochloric acid, water for injections. The complex of Clostridium botulinum (bacteria) type A toxin with hemagglutinin. Units of botulinum toxin are not equivalent to units of other botulinum toxin-containing medicines. The recommended doses in Speywood units differ from the doses 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 bulk pack containing 6 single packs, each containing 2 vials. Not all pack sizes may be marketed. Alluzience is a clear, colorless solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ipsen Pharma 65 Quai Georges Gorse 92100 Boulogne-Billancourt France

Importer:

Ipsen Manufacturing Ireland Limited Blanchardstown Industrial Park Blanchardstown Dublin 15 Ireland Date of last revision of the leaflet:March 2023 Additional information or a leaflet in another format can be obtained by contacting: Galderma Polska Sp. z o.o. ul. Puławska 145 02-715 Warsaw, Poland tel. +48 22 331 21 80 Information intended for healthcare professionals only:

Alluzience, 200 units of Speywood/ml, solution for injection

Botulinum toxin (type A) for injection

Dosage and administration:

See section 3 of the leaflet accompanying the packaging.

Special precautions for disposal and preparation of the medicinal product:

Strictly follow the instructions for use, preparation, and disposal of the medicinal product. RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS Immediately after administration to the patient, any remaining Alluzience product in the vial or syringe should be inactivated using a diluted solution of sodium hypochlorite (1% free chlorine). Surfaces contaminated with Alluzience should be cleaned with an absorbent material soaked in a diluted solution of sodium hypochlorite. Do not empty used vials, syringes, and materials. Dispose of them in the appropriate containers and dispose of them in accordance with local requirements. RECOMMENDATIONS IN CASE OF AN INCIDENT DURING PREPARATION OF BOTULINUM TOXIN

• Spilled product should be wiped up with a dry, absorbent material.
• The contaminated surface should be cleaned with an absorbent material soaked in a sodium hypochlorite solution (bleach), and then dried.
• In case of a broken vial, follow the above instructions. Carefully collect the broken glass fragments and wipe up the product, taking care not to cut the skin.
• If the product comes into contact with the skin, wash the affected area with a sodium hypochlorite solution (bleach) and then rinse thoroughly with water.
• If the product comes into contact with the eyes, rinse them thoroughly with a large amount of water or an ophthalmic rinsing solution.
• If the product comes into contact with a wound, cut, or damaged skin, rinse the affected area thoroughly with a large amount of water and take appropriate medical action depending on the injected dose.

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