Azzalure

PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Azzalure, 125 units Speywood, powder for solution for injection

(botulinum toxin type A)

Read all of 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 further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Azzalure is and what it is used for
• 2. Before you use Azzalure
• 3. How to use Azzalure
• 4. Possible side effects
• 5. How to store Azzalure
• 6. Contents of the pack and other information

1. WHAT AZZALURE IS AND WHAT IT IS USED FOR

Azzalure contains botulinum toxin type A, which causes muscle relaxation. Azzalure acts on the connection between nerves and muscles, preventing the release of a chemical messenger, acetylcholine, from the nerve endings. This prevents muscle contraction. Muscle relaxation is temporary and gradually disappears.
Some people are concerned about facial wrinkles. Azzalure can be used in adults under 65 years of age for the temporary improvement of moderate to severe frown lines (vertical frown lines between the eyebrows) and crow's feet lines (at the side of the eyes).

2. BEFORE YOU USE AZZALURE

When not to use Azzalure injections

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

Warnings and precautions

Before having an Azzalure injection, you should discuss this with your doctor:

• if you have nerve or muscle disorders;
• if you often have difficulty swallowing food (dysphagia);
• if you often choke on food or liquid, causing coughing or choking;
• if there is inflammation at the proposed injection site;
• if the muscles at the proposed injection site are weak;
• if you have bleeding disorders, meaning a longer than usual bleeding time, e.g. haemophilia (inherited bleeding disorders due to a lack of clotting factor);
• if you have had facial surgery or plan to have facial surgery or other surgical procedures in the near future;
• if you have already received injections of another botulinum toxin;
• if you did not experience significant improvement in wrinkles after your last botulinum toxin treatment. During Azzalure treatment, dry eye may occur. Azzalure may cause decreased blinking or tear production, which may damage the eye surface. This information will help your doctor make a decision about the risks and benefits of treatment. Special warnings Very rarely, the effect of the botulinum toxin may cause weakness of muscles away from the injection site. When using botulinum toxins more frequently than every 12 weeks or in higher doses for the treatment of other conditions, rare cases of antibody production have been observed in patients. The production of antibodies that neutralize the toxin may reduce the effectiveness of treatment. If you visit a doctor (for any reason), you should inform them of your previous Azzalure treatment.

Children and adolescents

Azzalure should not be used in people under 18 years of age.

Azzalure and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, because Azzalure may affect the action of other medicines, in particular:

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

Using Azzalure with food and drink

Azzalure injections can be given before or after food or drink.

Pregnancy and breastfeeding

Azzalure should not be used during pregnancy.
Azzalure should not be used in breastfeeding women. If you are pregnant, plan to become pregnant, or are breastfeeding, you should consult your doctor before using any medicine.

Driving and using machines

After an Azzalure injection, you may experience temporary blurred vision, muscle weakness, or general weakness. If you experience such effects, you should not drive or operate machinery.

3. HOW TO USE AZZALURE

Azzalure should only be administered by doctors with the appropriate qualifications and experience in this treatment and the necessary equipment.
Your doctor will prepare the medicine and administer it to you. The Azzalure vial should only be used for one patient during one treatment session.
The recommended dose of Azzalure is:

• frown lines: 50 units, administered as 10 units at each of 5 injection sites on the forehead in the area above the nose and eyebrows;
• crow's feet lines: 60 units, administered as 10 units at each of 6 injection sites on both sides in the crow's feet area.

Units used for other botulinum toxin products are different. Speywood units of Azzalure cannot be exchanged with other botulinum toxin products.
The effect of the treatment should be visible within a few days after injection.
The time between repeated Azzalure injections will be determined by your doctor. The medicine should not be used more frequently than every 12 weeks.
Azzalure is not intended for use in patients under 18 years of age.

Using more Azzalure than recommended

Administering more Azzalure than recommended may cause weakness of some muscles away from the injection site. This may occur after some time. If such a situation occurs, you should contact your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Azzalure can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience:

• difficulty breathing, swallowing, or speaking;
• facial swelling or redness of the skin or itchy, lumpy rash. These symptoms may be a sign of an allergic reaction to Azzalure.

Tell your doctor if you notice any of the following side effects:

Frown lines:

Very common (affecting more than 1 in 10 people)

• redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging, or bruising at the injection site
• headache

Common (affecting 1 to 10 in 100 people)

• eye dryness or blurred vision, drooping eyelid, eyelid swelling, eye watering, dry eye syndrome, eyelid twitching
• temporary facial paralysis

Uncommon (affecting 1 to 10 in 1,000 people)

• distorted, blurred, or double vision
• dizziness
• itching, rash
• allergic reactions

Rare (affecting 1 to 10 in 10,000 people)

• itchy, lumpy rash
• eye movement disorders

Unknown (frequency cannot be estimated from the available data)

• numbness
• muscle mass loss
• general weakness
• fatigue
• flu-like symptoms

Crow's feet lines:

Common (affecting 1 to 10 in 100 people)

• headache
• eyelid swelling
• bruising, itching, and swelling around the eyes
• drooping eyelid
• temporary facial paralysis

Uncommon (affecting 1 to 10 in 1,000 people)

• dry eye

Unknown (frequency cannot be estimated from the available data)

• allergic reactions
• numbness
• muscle mass loss
• general weakness
• fatigue
• flu-like symptoms

These side effects usually occurred within the first week after injection and soon disappeared. They were usually mild or moderate in intensity.
Very rarely, side effects have been reported that affect muscles other than those into which the botulinum toxin was injected. These include increased muscle weakness, difficulty swallowing, and coughing or choking when swallowing (when food or liquids enter the airways while swallowing, breathing difficulties such as pneumonia may occur). If such effects occur, you should contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AZZALURE

Keep out of sight and reach of children.
Do not use Azzalure after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
Azzalure should be stored in a refrigerator (2°C-8°C). Do not freeze.
Your doctor will reconstitute Azzalure and prepare the solution for injection.
Chemical and physical stability of the solution has been demonstrated for 24 hours at 2°C-8°C.
From a microbiological point of view, the solution should be used immediately, unless the method of reconstitution precludes the risk of microbial contamination. If the product is not used immediately, the user is responsible for the storage time and conditions prior to use.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Azzalure contains

• The active substance is botulinum toxin type A. One vial contains 125 Speywood units.
• The other ingredients are human albumin and lactose monohydrate. The Clostridium botulinum toxin complex (bacteria) type A with hemagglutinin Speywood units of Azzalure are specific to this product and cannot be exchanged with other botulinum toxin products.

What Azzalure looks like and contents of the pack

Azzalure is a powder for solution for injection. Packs containing 1 or 2 vials are available.
Azzalure is a white powder.

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:July 2022
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

The following information is intended for healthcare professionals only:

Azzalure, 125 units Speywood, powder for solution for injection

(botulinum toxin type A)

Dosage and administration:

See section 3 of the Patient Information Leaflet.

Special precautions for disposal and handling of the product

Strictly follow the instructions for use, preparation, and disposal of the product.
Reconstitution should be performed in accordance with good practice, particularly with regard to aseptic technique.
Azzalure must be dissolved in 0.9% sodium chloride solution (9 mg/ml) for injection. According to the following table for dissolution, the required volume of 0.9% sodium chloride solution (9 mg/ml) for injection should be drawn into a syringe to obtain a clear and colorless solution with the following concentration:

Accurate measurement of 0.63 ml or 1.25 ml can be achieved using syringes calibrated in increments of 0.1 ml and 0.01 ml.
RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and before disposal, unused reconstituted Azzalure (in a vial or syringe) should be inactivated using 2 ml of diluted sodium hypochlorite solution at a concentration of 0.55 or 1% (Dakin's solution).
Do not empty used vials, syringes, and materials. They should be disposed of in 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 an absorbent material soaked in sodium hypochlorite solution (bleach) in the case of powder or using a dry, absorbent material in the case of the reconstituted product.
• Contaminated surfaces should be cleaned with an absorbent material soaked in sodium hypochlorite solution (bleach) and then dried.
• In the event 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 contaminated area with sodium hypochlorite solution (bleach) and then rinse thoroughly with water.
• If the product comes into contact with the eyes, rinse them thoroughly with plenty of water or an ophthalmic rinsing solution.
• If the product comes into contact with a wound, cut, or damaged skin, the contaminated area should be rinsed thoroughly with plenty of water and appropriate medical action should be taken, depending on the injected dose.

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