Azzalure

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. 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 contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 IS AZZALURE AND WHAT IS IT 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 to temporarily improve the appearance of moderate or 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, the following should be discussed with the doctor:

During treatment with Azzalure, dry eye may occur. Azzalure may cause reduced blinking or reduced tear production, which can damage the eye surface.
Such information will help the doctor make an informed decision regarding the risks and benefits of treatment.
Special warnings
Very rarely, the effect 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 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 the event of a visit to the doctor (for any reason), the doctor should be informed about previous treatment with Azzalure.

Children and adolescents

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

Azzalure and other medicines

The doctor should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take, as Azzalure may affect the action of other medicines, particularly:

• 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.
Azzalure is not recommended for use 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. If such effects occur, the patient 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 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 injection site, 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. If such a situation occurs, the doctor should be informed immediately.

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. These 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 dryness 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 injection and soon subsided. 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, the doctor should be informed immediately.

Reporting side effects

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

5. HOW TO STORE AZZALURE

Store in a place out of sight and reach of children.
Azzalure should not be used 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 dissolve 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 before use.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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 are human albumin 200 g/l and lactose monohydrate.

*Clostridium botulinum (bacteria) type A toxin complex 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 vial are available.
Azzalure is a white powder.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 63/120/10-C

Parallel import authorization number: 62/25

Date of leaflet approval: 13.02.2025

[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

Instructions for use, preparation, and disposal of the medicine should be strictly followed.
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:
Volume of diluent (0.9% sodium chloride solution) added to the vial containing 125 units
Resulting dose
0.63 ml
10 units per 0.05 ml
1.25 ml
10 units per 0.1 ml
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 product should be inactivated using 2 ml of diluted sodium hypochlorite solution at a concentration of 0.55 or 1% (Dakin's solution).
Used vials, syringes, and materials should not be emptied. 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 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, the affected area should be rinsed with sodium hypochlorite solution (bleach) and then thoroughly flushed with water.
• If the product comes into contact with the eyes, they should be thoroughly flushed with plenty of water or an ophthalmic irrigation solution.
• If the product comes into contact with a wound, cut, or damaged skin, the affected area should be thoroughly flushed 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.