Azzalure

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Azzalure, 125 units Speywood, powder for solution for injection

Botulinum toxin (type A) for injection

You should read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Azzalure is and what it is used for
• 2. Important information before using 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 affects 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. Some people are concerned about wrinkles on their face. Azzalure can be used in adults under 65 years of age for the temporary improvement of moderate to severe frown lines (vertical lines between the eyebrows) and crow's feet lines (around the outer corner of the eyes).

2. Important information before using Azzalure

When not to use Azzalure injections:

Warnings and precautions

Before administering Azzalure, you should discuss it with your doctor:

During treatment with Azzalure, dry eyes may occur. Azzalure may cause reduced blinking or reduced tear production, which can damage the surface of the eye. Such information will help the doctor make a proper decision regarding the risks and benefits of treatment. Special warnings: Very rarely, the action of botulinum toxin may cause weakness of muscles distant from the injection site. When using botulinum toxins more frequently than every 12 weeks or in higher doses for the treatment of other diseases, 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), the patient should inform the doctor about previous treatment with Azzalure.

Children and adolescents

The use of Azzalure is not recommended in people under 18 years of age.

Azzalure and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as Azzalure may affect the action of other medicines, in particular:

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

Using Azzalure with food and drink

Azzalure injections can be administered before or after eating or drinking.

Pregnancy and breastfeeding

Azzalure should not be used during pregnancy. It is not recommended to use Azzalure in breastfeeding women. If the patient is pregnant, plans to become pregnant, or is breastfeeding, they should consult their doctor before using any medicine.

Driving and using machines

After Azzalure injection, temporary blurred vision, muscle weakness, or general weakness may occur. In case of such an effect, the patient should not drive or operate machines.

3. How to use Azzalure

Azzalure should only be administered by doctors with the appropriate qualifications and experience in such treatment and the necessary equipment. The doctor will prepare the medicine and administer it to the patient. 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, injected at 10 units per each of 6 injection sites bilaterally 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 treatment should be visible within a few days after injection. The time interval between subsequent Azzalure injections will be determined by the doctor. The medicine should not be used more frequently than every 12 weeks. Azzalure is not indicated for use in patients under 18 years of age.

Using a higher dose of Azzalure than recommended

Administering a higher dose of Azzalure than recommended may cause weakness of some muscles outside the injection site. This may occur after some time. In case of such a situation, the patient should immediately inform their doctor.

4. Possible side effects

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

You should urgently contact your doctor if:

• you experience difficulty breathing, swallowing, or speaking;
• you experience facial swelling or redness of the skin or an itchy, lumpy rash. Such symptoms may indicate an allergic reaction to Azzalure.

You should inform your doctor if you notice the following side effects:

Frown lines:

Very common (occurring in more than 1 in 10 patients)

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

Common (occurring in 1 to 10 in 100 patients)

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

Uncommon (occurring in 1 to 10 in 1,000 patients)

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

Rare (occurring in 1 to 10 in 10,000 patients)

• 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 (occurring in 1 to 10 in 100 patients)

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

Uncommon (occurring in 1 to 10 in 1,000 patients)

• 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 Azzalure injections and soon subsided. They were usually mild or moderate. Very rarely, reports of side effects affecting muscles other than those into which the botulinum toxin was injected have been received. These include increased muscle weakness, difficulty swallowing, and coughing or choking when swallowing (when food or liquids enter the airways during swallowing, respiratory disorders such as pneumonia may occur). If such effects occur, the patient should immediately contact their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Azzalure

Store out of sight and reach of children. Do not use Azzalure after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Azzalure should be stored in a refrigerator (2°C-8°C). Do not freeze. The 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 medicine is not used immediately, the user is responsible for the storage time and conditions before use.

6. Contents of the pack and other information

What Azzalure contains

• The active substance of Azzalure is botulinum toxin (type A) for injection*. One vial contains 125 Speywood units.
• The other ingredients of Azzalure are human albumin and lactose monohydrate.

*Botulinum toxin complex (bacterium) (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. For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne Billancourt, France

Manufacturer:

Ipsen Manufacturing Ireland Limited, Blanchardstown Industrial Park, Blanchardstown, Dublin 15, Ireland

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Marketing authorization number in Italy, the country of export:039063019, 039063021

Parallel import authorization number: 220/24

Date of leaflet approval: 29.05.2024

[Information about the trademark]

--------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Azzalure, 125 units Speywood, powder for solution for injection

Botulinum toxin (type A) for injection

Dosage and administration:

See section 3 of the Patient Information Leaflet.

Special precautions for disposal and preparation of the medicine for use

Instructions for use, preparation, and disposal of the medicine should be strictly followed. Reconstitution should be performed in accordance with the principles of 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 table below 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 0.1 ml and 0.01 ml increments. RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS: Immediately after use and before disposal of unused Azzalure after reconstitution (in the vial or syringe), the medicine 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 AN 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 product after reconstitution.
• Contaminated surfaces should be cleaned with an absorbent material soaked in 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 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.

Instructions for use, preparation, and disposal of the medicine should be strictly followed.