Azzalure

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Azzalure, 125 Speywood units, powder for solution for injection
Botulinum toxin (type A) for injection
Please read the information in this leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your 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 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.
Some people are concerned about facial wrinkles. Azzalure may be 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) and wrinkles in the lateral eye area (crow's feet).

2. Important information before using Azzalure

When not to use Azzalure injections:

• if the patient is allergic to Clostridium botulinum toxin type A or to any of the other components 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
Before receiving Azzalure injections, discuss the following with your doctor:

• 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 choking;
• if there is inflammation at the proposed injection site;
• if the muscles at the proposed injection site are weak;
• if the patient has bleeding disorders resulting in longer than usual clotting time, e.g. haemophilia (hereditary bleeding disorders caused by deficiency of clotting factors);
• if the patient has undergone facial surgery or if such surgery or other surgical procedures are planned in the near future;
• if the patient has previously received injections of another botulinum toxin;
• if there was no significant improvement in wrinkles after the last botulinum toxin treatment.

During treatment with Azzalure, dry eye may occur. Azzalure may cause reduced blink rate or decreased tear production, which may damage the surface of the eye.
This information will help the doctor make an appropriate decision regarding the risks and benefits of treatment.
Special warnings
Very rarely, botulinum toxin may cause muscle weakness in areas distant from the injection site.
When botulinum toxins are used more frequently than every 12 weeks or in higher doses for the treatment of other conditions, the formation of antibodies in patients has been rarely observed. The development of neutralizing antibodies may reduce the effectiveness of treatment.
Whenever visiting a doctor (regardless of the reason for the visit), inform the doctor about prior treatment with Azzalure.
Children and adolescents
Azzalure is not recommended for use in individuals under 18 years of age.
Azzalure and other medicines
Tell your doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to take, because Azzalure may interact with other medicines, particularly:

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

Taking Azzalure with food and drink
Azzalure injections may be administered before or after eating or drinking.
Pregnancy and breastfeeding
Azzalure should not be used during pregnancy.
Use of Azzalure is not recommended in breastfeeding women. If the patient is pregnant, planning to become pregnant, or breastfeeding, consult a doctor before using any medicine.
Driving and operating machinery
After Azzalure injection, transient blurred vision, muscle weakness or generalised weakness may occur. If such effects occur, the patient must not drive or operate machinery.

3. How to use Azzalure

Azzalure must be administered only by physicians who have appropriate
qualifications and experience in this type of treatment, as well as the required equipment.
The physician will prepare and administer the medicine to the patient. An Azzalure vial should be used for only one
patient during a single treatment session.
The recommended dose of Azzalure is:

• glabellar lines: 50 units, administered as 10 units at each of 5 injection sites in the forehead area above the nose and eyebrows;
• lateral canthal lines: 60 units, administered as 10 units at each of 6 injection sites, bilaterally, in the crow’s feet areas.

Units used for other botulinum toxin products are not equivalent. The Speywood units of Azzalure cannot be interchanged with units of other botulinum toxin products.
The effect of treatment should become apparent within a few days after injection.
The interval between subsequent Azzalure injections will be determined by the physician. 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.
Use of a higher than recommended Azzalure dose
Administration of a higher than recommended dose of Azzalure may cause weakening of certain muscles
located outside the injection site. This may occur after some delay. If such a situation occurs, the physician should be notified immediately.

4. Possible adverse reactions

Like all medicines, Azzalure may cause adverse reactions, although not everyone experiences them.

Seek immediate medical attention if the following occur:

• Difficulty breathing, swallowing, or speaking;
• Swelling of the face, skin redness, or itchy, bumpy rash. These symptoms may indicate an allergic reaction to Azzalure.

Inform the doctor if the patient experiences any of the following adverse reactions:

Glabellar 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 of the upper eyelid, eyelid swelling, watery eyes, dry eye syndrome, muscle twitching around the eye
• Transient facial paralysis

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

• Impaired, blurred, or double vision
• Dizziness
• Itching, rash
• Allergic reactions

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

• Itchy, bumpy rash
• Disorders of eye movements

Unknown (frequency cannot be estimated from available data)

• Numbness
• Decreased muscle mass
• Generalized weakness
• Fatigue
• Influenza-like symptoms

Periorbital (crow's feet) wrinkles:

Common (occurring in 1 to 10 in 100 patients)

• Headache
• Eyelid swelling
• Bruising, itching, and swelling around the eyes
• Drooping of the upper eyelid
• Transient facial paralysis

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

• Dry eye

Unknown (frequency cannot be estimated from available data)

• Allergic reactions
• Numbness
• Decreased muscle mass
• Generalized weakness
• Fatigue
• Influenza-like symptoms

These adverse reactions usually occurred within the first week after injections and resolved quickly. They were generally mild or moderate in severity.

Very rarely, adverse effects affecting muscles other than those injected with botulinum toxin have been reported. These include increased muscle weakness, difficulty swallowing, coughing, and choking during swallowing (when food or liquid enters the airways during swallowing, respiratory disturbances such as lung infections may occur). If any of these effects occur, contact a doctor immediately.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Azzalure

Keep out of the 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 stated month.
Store Azzalure 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 standpoint, the solution should be used immediately unless the method of
reconstitution excludes the risk of microbiological contamination. If the medicinal product is not used
immediately, the user is responsible for the storage conditions and duration prior to use.

6. Contents of the pack and other information

What Azzalure contains

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

*Complex of Clostridium botulinum toxin (bacterium) (type A) with hemagglutinin
Speywood units of Azzalure are specific to this product and cannot be interchanged with
other preparations containing botulinum toxin.
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 further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Italy, the country of export: 039063019
Parallel Import Authorisation Number: 220/24

The following information is intended for professional medical personnel only:

Azzalure, 125 Speywood units, powder for solution for injection
Botulinum toxin (type A) for injection
Dosage and method of administration:
See section 3 of the Patient 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.
Reconstitution must be performed in accordance with good practice, particularly with regard to
aseptic technique.
The Azzalure medicinal product must be dissolved in 0.9% sodium chloride solution (9 mg/ml) for injection.
According to the reconstitution table below, the required volume of 0.9% sodium chloride solution (9 mg/ml) for injection should be drawn into a syringe to obtain a clear, colourless solution with the following concentration:

An accurate measurement of 0.63 ml or 1.25 ml can be achieved using syringes graduated in 0.1 ml and 0.01 ml increments.
RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and before disposal, unused reconstituted Azzalure (in 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, or materials. They should be discarded into appropriate containers and disposed of according to 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) for powder, or using dry absorbent material for reconstituted product.
• 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 the 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 abundant 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 should be taken depending on the injected dose.

Strict adherence to instructions regarding the use, preparation, and disposal of the medicinal product is required.