AZZALURE 10 SPEYWOOD UNITS/0.05ML POWDER FOR SOLUTION FOR INJECTION

Active substance: CLOSTRIDIUM BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX

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10 Speywood Units/0.05 ml,
powder for solution for injection
(botulinum toxin type A)

1501016002

1501016002

The following information is intended for
healthcare professionals only:

• If the product comes into contact with the skin,
wash the affected area with a solution of
sodium hypochlorite (bleach) then rinse
abundantly with water.
• If product enters into contact with the eyes, rinse
thoroughly with plenty of water or with an
ophthalmic eyewash solution.
• If product enters into contact with a wound, cut or
broken skin, rinse thoroughly with plenty of water
and take the appropriate medical steps according
to the dose injected.
These instructions for use handling and disposal
should be strictly followed.

10 Speywood Units/0.05 ml,
powder for solution for injection
(botulinum toxin type A)

Posology and method of administration:

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Please refer to section 3 of the Patient Information
Leaflet.
Special precautions for disposal and other
handling:

In this leaflet:
• What Azzalure is and what it is used for
• Before you use Azzalure
• How to use Azzalure
• Possible side effects
• How to store Azzalure
• Further information

1. WHAT AZZALURE IS AND WHAT IT IS
USED FOR
Azzalure contains a substance, botulinum toxin A,
which causes muscles to relax. Azzalure acts at the
junction between the nerves and muscle to prevent the
release of a chemical messenger called acetylcholine
from the nerve endings. This prevents muscles from
contracting. The muscle relaxation is temporary and
gradually wears off.
Some people are distressed when lines appear on
their face. Azzalure can be used in adults under 65
years to temporarily improve the appearance of any
moderate to severe glabellar lines. These are the
vertical frown lines between the eyebrows.

2. BEFORE YOU USE AZZALURE

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The instructions for use, handling and disposal should
be strictly followed.
Reconstitution should be performed in accordance with
good practice rules, particularly in the respect of asepsis.
Azzalure should be reconstituted using 0.63 ml of sodium
chloride 9 mg/ml (0.9%) solution for injection. This will
provide a clear solution containing 125 Speywood Units
of active substance at a concentration of 10U per 0.05ml
of reconstituted solution.
The accurate measurement of 0.63ml can be achieved
using 1ml insulin type syringes. These are graduated
to 1 ml in 0.1 ml and 0.01 ml increments.
RECOMMENDATIONS FOR THE DISPOSAL OF
CONTAMINATED MATERIALS
Immediately after use and prior to disposal, unused
reconstituted Azzalure (in the vial or in the syringe)
should be inactivated with 2ml of dilute sodium
hypochlorite solution at 0.55 or 1% (Dakin’s solution).
Used vials, syringes and materials should not be
emptied and must be discarded into appropriate
containers and disposed of in accordance with
local requirements.
RECOMMENDATIONS SHOULD ANY INCIDENT
OCCUR DURING THE HANDLING OF BOTULINUM
TOXIN
• Any spills of the product must be wiped up: either
using absorbent material impregnated with a
solution of sodium hypochlorite (bleach) in case of
the powder, or with dry, absorbent material in case
of reconstituted product.
• The contaminated surfaces should be cleaned using
absorbent material impregnated with a solution of
sodium hypochlorite (bleach), then dried.
• If a vial is broken, proceed as mentioned above by
carefully collecting the pieces of broken glass and
wiping up the product, avoiding any cuts to the skin.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Do not have an Azzalure injection if:
• you are aware you are allergic (hypersensitive) to
Clostridium botulinum toxin A or to any of the
ingredients of Azzalure
• you have an infection at the proposed site of
injection
• you have myasthenia gravis, Eaton Lambert
syndrome or amyotrophic lateral sclerosis

Take special care and tell your doctor before you
have the Azzalure injection if:
• you have any neuromuscular disorders
• you often have difficulty swallowing food (dysphagia)
• you find that you often have problems with food or
drink getting into your airways causing you to cough
or choke
• you have inflammation at the proposed site of
injection
• the muscles at the proposed site of injection are weak
• you suffer from a bleeding disorder which means
that you continue to bleed for longer than normal,
such as haemophilia
• you have had surgery on your face, or are likely to
undergo facial or other types of surgery soon
• you have already had other botulinum toxin injections
• you had no significant improvement of your lines
after your last treatment with botulinum toxin
This information will help your doctor to make an
informed decision about the risk and benefit of your
treatment.
Special warnings:
Very rarely, the effect of botulinum toxin may result in
muscle weakness away from the site of injection.
When botulinum toxins are used in higher doses to
treat other conditions, antibody formation has been
noted rarely in patients. The formation of neutralising
antibodies may reduce the effectiveness of treatment.
If you are seeing a doctor for any reason, make sure that
you tell them that you have been treated with Azzalure.
Taking other medicines
Azzalure may affect other medicines you are taking, or
have recently taken, especially
• antibiotics for an infection (e.g. aminoglycosides
such as gentamicin or amikacin), or
• other muscle relaxant drugs.
Always tell your doctor about all the medicines you are
taking. This means medicines you have bought
yourself as well as medicines on prescription from your
doctor.
Using Azzalure with food and drink
You can have Azzalure injections either before or after
eating or drinking.
Pregnancy and breast-feeding
You should not get Azzalure during pregnancy unless
clearly necessary. Treatment with Azzalure is not
recommended if you are breast-feeding. Tell your
doctor if you are pregnant or planning to become
pregnant or if you are breast-feeding. Ask your doctor
or pharmacist for advice before taking any medicine.

3. HOW TO USE AZZALURE
Azzalure should only be administered by physicians
with appropriate qualifications and expertise in this
treatment and having the required equipment.
Your doctor will prepare and give the injections. A vial
of Azzalure should be used only for you and only for a
single treatment session.
The recommended dose of Azzalure is 50 units,
injected as 10 units at each of 5 injection sites in your
forehead in the area above your nose and eyebrows.
The units used for different botulinum toxin products
are not the same. Azzalure Speywood units are not
interchangeable with other botulinum toxin products.
The effect of the treatment on the severity of your
glabellar lines should be noticeable in 2 to 3 days.
The interval between treatments with Azzalure will be
decided by your doctor. You should not have treatment
more often than every 12 weeks.
Azzalure is not suitable for patients under the age of 18.
If you receive more Azzalure than you should
If you are given more Azzalure than you need then
muscles other than the ones that were injected may
begin to feel weak. This may not happen straightaway.
If this happens, speak to your doctor immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Azzalure can cause side effects,
although not everybody gets them.
Seek urgent medical help if:
• You have difficulties breathing, swallowing or
speaking
• Your face swells or skin goes red or you get an itchy
lumpy rash. This may mean you are having an
allergic reaction to Azzalure
Tell your doctor if you notice any of the following
side effects:
Very Common (affects more than 1 user in 10)
• Redness, swelling, irritation, rash, itching, tingling,
pain, discomfort, stinging or bruising at the site of
the injection
• Headache
Common (affects 1 to 10 users in 100)
• Tired eyes or dim vision, drooping of the upper
eyelid, swelling of the eyelid, watering eyes, dry
eye, twitching of muscles around the eye
• Facial paralysis

Driving and using machines

Uncommon (affects 1 to 10 users in 1,000)
• Disturbed, blurred or double vision
• Dizziness
• Itching, rash
• Allergic reactions, see above

You may experience temporary blurred vision or
muscle weakness following treatment with Azzalure.
If affected, do not drive or use machinery.

Rare (affects 1 to 10 users in 10,000)
• Itchy and lumpy rash
• Eye movement disorder

Very rarely, side effects experienced in muscles other
than the ones that were injected have been reported
with botulinum toxin. These include excessive muscle
weakness, difficulty swallowing, due to coughing and
choking when swallowing (if food or liquid enters your
airway as you attempt to swallow, respiratory problems
can occur, such as lung infections). If this happens,
speak to your doctor immediately.
Usually these side effects have occurred within the
first week following injections and did not last long.
They were usually mild to moderate in severity.
If any of the side effects become serious, or if you
notice side effects not listed in this leaflet, please tell
your doctor or pharmacist.

This leaflet was last approved in July 2010.
If you would like any more information, or would like
the leaflet in a different format, please contact
Galderma (UK) Ltd, tel. 01923 208950.
Distributed by:
Galderma (UK) Ltd
Meridien House
69-71 Clarenden Road
Watford
Herts.
WD17 1DS
UK

5. HOW TO STORE AZZALURE
Keep Azzalure out of the reach and sight 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.
Your doctor will dissolve Azzalure into a liquid solution
for injection. It is recommended that the reconstituted
solution is used immediately, however it can be stored
for up to 4 hours in a refrigerator (2˚C - 8˚C).

6. FURTHER INFORMATION
What Azzalure contains
• The active substance is botulinum toxin type A*,
10 Speywood units/ 0.05ml. One vial contains
125 Speywood units.
• The other ingredients are human albumin 200g/L
and lactose monohydrate.
* Clostridium botulinum (a bacteria) toxin A
haemagglutin complex.
The Speywood units of Azzalure are specific to the
product and are not interchangeable with other
treatments containing botulinum toxin.
What Azzalure looks like and contents of the pack
Azzalure is a powder for solution for injection. It comes
in a pack size of 1 or 2 vials.
Azzalure is a white powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
For UK: Ipsen Limited, 190 Bath Road, Slough,
Berkshire, SL1 3XE, United Kingdom
For Ireland: Ipsen Biopharm Limited, Ash Road,
Wrexham Industrial Estate, Wrexham, LL13 9UF,
United Kingdom
Ipsen Biopharm Limited
Ash Road, Wrexham Industrial Estate,
Wrexham, LL13 9UF

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Manufacturer:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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