Azzalure®

An active ingredient called botulinum toxin type A, is derived from Clostridium botulinum, a type of bacteria. The toxins role is to stop nerves from carrying out their normal function. By preventing the release of significant chemicals, muscle contraction is also inhibited. The positive effect is to make muscles between the eyebrows relaxed, diminishing the appearance of vertical frown lines. The effect is only temporary and further treatments can be given every three months.

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 (the vertical frown lines between the eyebrows) and lateral canthal lines (crow’s feet lines).

Do not have an Azzalure injection if:

You are allergic to Clostridium botulinum toxin A or any of the other ingredients of this medicine
(listed in section 6)
You have an infection at the proposed site of injection
You have myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.

Warnings and precautions

Talk to your doctor, pharmacist or other healthcare practitioner 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 (hereditary bleeding disorders caused by deficiencies of clotting factor)
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.

HOW TO USE AZZALURE

Azzalure should only be administered by a doctor or other healthcare practitioner with appropriate
qualifications and expertise in this treatment and having the required equipment.
Your doctor or other healthcare practitioner 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:

For glabellar lines: 50 units, injected as 10 units at each of 5 injection sites in your forehead in the
area above your nose and eyebrows.
For lateral canthal lines: 60 units, injected as 10 units at each of 6 injection sites in both crow’s feet
regions.

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.