AZZALURE 125 UNITA SPEYWOOD Proszek do roztworu do wstrzykiwań

Treść ulotki

1. What is Azzalure and what is it used for
2. What you need to know before using Azzalure
3. How to use Azzalure
4. Azzalure must only be administered by appropriately qualified physicians with
   1. Possible side effects
   2. How to store Azzalure
   3. Contents of the pack and other information

Azzalure, 125 Units Speywood, powder for injectable solution
(botulinictoxin type A)

Read this leaflet carefully before you use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:
1 What Azzalure is and what it is used for
2 What you need to know 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 is Azzalure and what is it used for

Azzalure contains a substance, botulinum toxin type A, which causes muscle relaxation.
Azzalure works at the junction between nerves and muscles by inhibiting the release
from nerve endings of a chemical messenger called acetylcholine. This prevents
muscle contraction. Muscle relaxation is temporary and gradually wears off.
In some people, the appearance of wrinkles on the face can have a significant psychological impact.
Azzalure can be used in adults under 65 years of age to
temporarily improve the appearance of glabellar lines (vertical wrinkles that form between the eyebrows when frowning) and lateral canthal lines (crow's feet), of moderate to severe degree.

2. What you need to know before using Azzalure

Do not have an injection of Azzalure:

• if you are allergic to type A Clostridium botulinumtoxin or to any of the other ingredients of this medicine (listed in section 6)
• if you have an infection in the area chosen for the injection
• if you suffer from myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis.

Warnings and precautions
Talk to your doctor before having an injection of Azzalure if:

• you suffer from any neuromuscular disorder
• you often have difficulty swallowing food (dysphagia)
• you notice that you often have problems caused by food or beverages passing into your airways, causing you to cough or choke
• you have inflammation in the area chosen for the injection
• the muscles in the area chosen for the injection are weak
• you have a bleeding disorder, i.e. you continue to bleed for longer than normal, such as haemophilia (inherited bleeding disorders caused by coagulation factor deficiencies)
• you have had facial surgery, or are planning to have facial or any other surgery in the near future
• you have already had other injections of botulinum toxin
• you have not experienced any significant improvement in wrinkles after your last treatment with botulinum toxin

This information will help your doctor make an informed decision about the
benefits and risks of your treatment.
When you are treated with Azzalure, your eyes may become dry. Azzalure may
reduce blinking or tear production, and this can damage the surface of your
eyes.

Special warnings
Very rarely, the effect of botulinum toxin can result in muscle weakness in
an area distant from the injection site.
When botulinum toxins are used at more frequent intervals than 12 weeks or
with higher doses to treat other disorders, antibody formation has been observed in some patients in rare cases. The formation of neutralizing antibodies can
reduce the effectiveness of treatment.
If you see a doctor for any reason, be sure to tell them that you have been treated
with Azzalure.

Children and adolescents
Azzalure is not indicated for subjects under the age of 18 years.

Other medicines and Azzalure
Tell your doctor if you are taking, have recently taken or might take any other
medicines as Azzalure can interact with other medicines, especially

• antibiotics used to treat an infection (e.g. aminoglycosides such as gentamicin or amikacin), or
• other muscle relaxants.

Azzalure with food and drink
You can have an injection with Azzalure both before and after eating meals and
drinks.

Pregnancy and breastfeeding
You should not have treatment with Azzalure during pregnancy. Treatment with
Azzalure is not recommended during breastfeeding. If you are pregnant or are
planning a pregnancy or are breastfeeding, ask your doctor before
using any medicine.

Driving and operating machinery
After treatment with Azzalure, blurred vision, muscle weakness or generalised weakness may occur, which are transient. In such cases, do not drive vehicles or
operate machinery.

3. How to use Azzalure

Azzalure must only be administered by appropriately qualified physicians with

proven experience in this treatment and equipped with the necessary equipment.
The physician will prepare and perform the injections. A vial of Azzalure must be used
only for you and only for a single session.
The recommended dose of Azzalure is:

• For glabellar lines: 50 units to be administered in fractions of 10 units at each of the 5 injection sites on the forehead, in the area above the nose and eyebrows.
• For lateral canthal lines: 60 units to be administered in fractions of 10 units at each of the 6 injection sites in both areas of crow's feet wrinkles.

The units used for different botulinum toxin products are not the same. The
Speywood units of Azzalure are not interchangeable with those of other botulinum toxin-based
products.
The effect of the treatment should be visible within a few days of the injection.
The interval between sessions for treatment with Azzalure will be established by the physician. You should not
undergo treatments at intervals of less than 12 weeks.
Azzalure is not indicated for patients under the age of 18 years.

If you receive more Azzalure than you should
If you receive more Azzalure than necessary, you may begin to experience weakness of muscles other
than those injected. This may not happen immediately. If this occurs, contact your doctor immediately.

4. Possible side effects

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

Seek medical attention immediately if:

• you experience difficulty breathing, swallowing or speaking.
• you develop swelling of the face or the skin becomes red or presents with nodular erythema accompanied by itching. This may mean you are having an allergic reaction to Azzalure.

See a doctor if you notice any of the following side effects:
For glabellar lines:
Very common (affects more than 1 in 10 users)

• Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, burning sensation or bruising at the injection site
• Headache

Common (affects up to 1 in 10 users)

• Tired eyes or decreased vision, drooping of the upper eyelid, swelling of the eyelid, tearing, dry eye, contractions of the muscles around the eye
• Temporary facial paralysis

Uncommon (affects up to 1 in 1,000 users)

• Visual disturbance, blurred or double vision
• Dizziness
• Itching, erythema
• Allergic reactions

Rare (affects up to 1 in 10,000 users)

• Erythema accompanied by itching and nodules
• Eye movement disorder

Not known (frequency cannot be estimated from the available data):

• Numbness
• Muscle loss
• Generalized weakness
• Fatigue
• Flu-like symptoms

For lateral canthal lines:
Common (affects up to 1 in 10 users)

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

Uncommon (affects up to 1 in 1,000 users)

• Dry eye

Not known (frequency cannot be estimated from the available data):

• Allergic reactions
• Numbness
• Muscle loss
• Generalized weakness
• Fatigue
• Flu-like symptoms

These side effects usually occur within the first week after injections,
are short-lived and of mild to moderate intensity.
Very rarely, side effects have been reported in muscles other than those into which the botulinum toxin was injected. These side effects include: excessive muscle weakness, difficulty swallowing due to coughing and choking when swallowing (if food
or liquids enter the airways while trying to swallow, respiratory problems such as lung infections may occur). If this happens, seek immediate medical attention.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Azzalure

Keep Azzalure out of the sight and reach of children.
Do not use Azzalure after the expiry date which is stated on the label. The
expiry date refers to the last day of that month.
Store Azzalure in a refrigerator (2˚C - 8˚C). Do not freeze.
The doctor will dissolve Azzalure in a liquid injectable solution. Chemical and physical
stability during use has been demonstrated for 24 hours between 2-8 ° C. From a
microbiological point of view, unless the reconstitution method excludes the risk of
microbial contamination, the product must be used immediately.
If not used immediately, the storage times and conditions are
the responsibility of the user.

6. Contents of the pack and other information

What Azzalure contains

• The active substance is type A botulinictoxin*. One vial contains 125 Speywood units.
• The other ingredients are human albumin 200 g/L and anhydrous lactose. * Toxin of Clostridium botulinum(a bacterium) type A - complex-hemagglutinin

The Speywood units of Azzalure are specific to this product and are not interchangeable
with those for other botulinum toxin-based products.

Description of the appearance of Azzalure and contents of the pack
Azzalure is a powder for injectable solution. It is available in packs of 1 or 2
vials.
Azzalure is a white powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Pharma
65 quai Georges Gorse, 92100
Boulogne Billancourt
France
Sales representative:
Galderma Italia S.p.A.
Via Dell’Annunciata, 21
20121 Milano

Manufacturer:
Ipsen Manufacturing Ireland Limited
Blanchardstown Industrial Park
Blanchardstown
Dublin 15
Ireland
otherwise, contact Galderma Italia S.p.A., tel. +39 – 039 – 634691
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The following information is intended exclusively for physicians:
Dosage and administration:
Special precautions for disposal and handling:
Instructions for use, handling and disposal must be followed
strictly.
Product reconstitution must be performed according to good practice guidelines,
especially regarding aseptic procedures.
Azzalure must be reconstituted with 9 mg/ml (0.9%) sodium chloride solution for
injection.
The dilution table below indicates the amount of 9 mg/ml (0.9%) sodium chloride
injection solution required to be withdrawn with a syringe in order to obtain a clear and
colorless reconstituted solution at the following concentration:

Accurate measurement of 0.63 ml or 1.25 ml can be obtained using graduated syringes
with 0.1 and 0.01 ml markings.
RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and before disposal, the reconstituted and unused Azzalure solution
(remaining in the vial or syringe) must be inactivated with 2 ml of
sodium hypochlorite solution diluted to 0.55 or 1% (Dakin's solution).
Vials, syringes and used materials must not be emptied and must be
collected in appropriate containers and disposed of in accordance with current local regulations.
RECOMMENDATIONS IN CASE OF AN ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Dry any spilled product using an absorbent material soaked with sodium hypochlorite solution (bleach) in case of powder or with dry absorbent material in case of reconstituted product.
• Contaminated surfaces must be cleaned using an absorbent material soaked with sodium hypochlorite solution (bleach) and then dried.
• In case of a vial breaking, proceed as indicated above, carefully collecting the glass fragments and drying the product, taking care not to injure yourself.
• 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 thoroughly with water or an ophthalmic solution for eye washing.
• If the product comes into contact with a wound, cut or skin lesion, rinse thoroughly with water and take appropriate measures based on the dose with which you have been contaminated.

These instructions for handling and disposal must be followed strictly.