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

Active substance: CLOSTRIDIUM BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX

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Draft ONE - 1040168 - TJ

1040168

The following information is intended for
healthcare professionals only:

RECOMMENDATIONS SHOULD ANY INCIDENT
OCCUR DURING THE HANDLING OF BOTULINUM
TOXIN

PACKAGE LEAFLET:
INFORMATION FOR THE USER

• you have myasthenia gravis, Eaton Lambert
syndrome or amyotrophic lateral sclerosis

• 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.

Warnings and precautions
Talk to your doctor before you have the Azzalure
injection if:
• you have any neuromuscular disorders

• The contaminated surfaces should be cleaned
using absorbent material impregnated with a
solution of sodium hypochlorite (bleach), then dried.

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

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

• 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.

Posology and method of administration:
Please refer to section 3 of the Patient Information
Leaflet
Special precautions for disposal and other
handling:
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 has to be reconstituted with a sodium chloride
9 mg/ml (0.9%) solution for injection.
As per the dilution table below, the requested amount
of sodium chloride 9 mg/ml (0.9%) solution for injection
has to be drawn up into a syringe in order to obtain a
reconstituted clear solution at a concentration of 10U
per 0.05 ml.

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.

• 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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.

• If product enters into contact with the eyes, rinse
thoroughly with plenty of water or with an
ophthalmic eyewash solution.

• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See Section 4.

• 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.

In 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



1040168 Document fonts:
Helvetica (family)
Azzalure 125U
OCRB
Pack insert
UK/IE
English Minimum font size:
8.5pt
Chesapeake
Preliminary Artwork Approval
Final Artwork Approval

Barcode type: Datamatrix (1040168)
Front
Perforation:
161.5 mm from LH edge when viewed from front.
Parallel to 210 mm dimension

Ipsen Biopharm Ltd
Ash Road, Wrexham Ind. Est.,
Wrexham, LL13 9UF, UK.
Tel: +44 (0) 1978 661181

• 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.

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.

Very rarely, the effect of botulinum toxin may result in
muscle weakness away from the site of injection.

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

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 seeing a doctor for any reason, make sure
that you tell them that you have been treated with
Azzalure.

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.

Other medicines and Azzalure

4. POSSIBLE SIDE EFFECTS

Azzalure may affect other medicines you are taking, or
have recently taken, especially

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

• antibiotics for an infection (e.g. aminoglycosides
such as gentamicin or amikacin), or

Seek urgent medical help if:

Do not have an Azzalure injection if:

Used vials, syringes and materials should not be
emptied and must be discarded into appropriate
containers and disposed of in accordance with local
requirements.

Black, P 320 U, P 2945 U

• you suffer from a bleeding disorder which means
that you continue to bleed for longer than normal,
such as haemophilia

Azzalure with food and drink

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE AZZALURE

Immediately after use and prior to disposal, unused
reconstituted Azzalure (in the vial or in the syringe)
should be inactivated with 2 ml of dilute sodium
hypochlorite solution at 0.55 or 1% (Dakin’s solution).

Colours:

• the muscles at the proposed site of injection are
weak

Special warnings:

• other muscle relaxant drugs.

• You have difficulties breathing, swallowing or
speaking

• you are allergic to Clostridium botulinum toxin A or
any of the other ingredients of this medicine (listed
in Section 6).

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.

• 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

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.

RECOMMENDATIONS FOR THE DISPOSAL OF
CONTAMINATED MATERIALS

402 x 210 mm Component code:
Leaflet-05 PS Presentation:
Component:
ICN:
00896D Territory:
Draft No.:
ONE Language:
Artwork Amend Date:
28/07/2014 Print supplier:

• you have inflammation at the proposed site of
injection

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.

The accurate measurement of 0.63 ml can be achieved
using 1 ml insulin type syringes. These are graduated
to 1 ml in 0.1 ml and 0.01 ml increments.

Dimensions:

• 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

1. WHAT AZZALURE IS AND WHAT IT IS
USED FOR

Amount of solvent added
Resulting dose
(0.9% sodium chloride solution) (Units per 0.05 ml)
to a 125 U vial
0.63 ml
10 U

Specification ref:

• you have an infection at the proposed site of
injection.

For confirmation of Final
Artwork Approval refer to
electronic signature
summary in PALM

Draft ONE - 1040168 - TJ
Tell your doctor if you notice any of the following
side effects:

5. HOW TO STORE AZZALURE

Very Common (affects more than 1 user in 10)

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.

• 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

Keep Azzalure out of the reach and sight of children.

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).

If you would like any more information, or would like the
leaflet in a different format, please contact Galderma
(UK) Ltd, tel. +44 (0) 1923 208950.
Distributed by:
Galderma (UK) Ltd
Meridien House
69-71 Clarenden Road
Watford
Herts.
WD17 1DS
UK

• Facial paralysis
• Disturbed, blurred or double vision

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

• Dizziness

What Azzalure contains

• Itching, rash

• The active substance is botulinum toxin type A*,
10 Speywood units/ 0.05 ml. One vial contains
125 Speywood units.

Uncommon (affects 1 to 10 users in 1,000)

• Allergic reactions, see above
• Eye movement disorder

• The other ingredients are human albumin 200g/L
and lactose monohydrate.

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.
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.
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.
For UK: If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
For Ireland: You can also report side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; e-mail: medsafety@hpra.ie. By
reporting side effects you can help provide more
information on the safety of this medicine.

402 x 210 mm Component code:
Leaflet-05 PS Presentation:
Component:
ICN:
00896D Territory:
Draft No.:
ONE Language:
Artwork Amend Date:
28/07/2014 Print supplier:
Dimensions:

Specification ref:

Colours:
Barcode type:

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
Manufacturer:
Ipsen Biopharm Limited
Ash Road
Wrexham Industrial Estate
Wrexham
LL13 9UF
This leaflet was last revised in July 2014.

1040168 Document fonts:
Helvetica (family)
Azzalure 125U
OCRB
Pack insert
UK/IE
English Minimum font size:
8.5pt
Chesapeake
Preliminary Artwork Approval

Black

Final Artwork Approval

see other side

Back



* Clostridium botulinum (a bacteria) toxin A
haemagglutin complex.

Perforation:
See other side

Ipsen Biopharm Ltd
Ash Road, Wrexham Ind. Est.,
Wrexham, LL13 9UF, UK.
Tel: +44 (0) 1978 661181

For confirmation of Final
Artwork Approval refer to
electronic signature
summary in PALM



• Itchy and lumpy rash

1040168

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

Expand view ⇕

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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