Botulinum Toxin (often called Botox ®) when injected into a muscle temporarily relaxes the muscle by blocking nerve impulses. As the nerve impulses are blocked the muscle is temporarily unable to contract so that dynamic wrinkles are not formed. This gives the overlying facial skin a softer, smoother and more youthful appearance.

Most people find that the injections cause only mild local pain and tenderness. Immediately after the injection there may be mild swelling at the injection site which usually subsides within 48 hours. Slight bruising is also possible.

Botox side effects are rare. Occasionally, the treatment may relax nearby muscle groups causing temporary drooping of the eyebrow or eyelids. This may last for a few weeks but will resolve with time.

As with any medicine an allergic reaction may occur, this is however quite rare. Conversely there may be some unintended benefits in some people such as easing of tension type headaches as the muscles in the forehead relax.

Botox has been used for over 20 years and does not appear to cause any negative long-term effects.

We use Azzalure by Galderma

AZZALURE - PACKAGE LEAFLET: INFORMATION FOR THE USER

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZZALURE

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.

This information will help your doctor or other healthcare practitioner to make an informed decision about
the risk and benefit of your treatment.

When you are treated with Azzalure, your eyes may become dry. Azzalure may make your eyes blink less
often or produce less tears, which could harm the surface of your eyes.

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 at more frequent intervals than 12 weeks or at 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.

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

Other medicines and Azzalure
Tell your doctor, pharmacist or other healthcare practitioner if you are using, have recently used or might use
any other medicines, as Azzalure may affect other medicines, especially:
• Antibiotics for an infection (e.g. aminoglycosides, such as gentamicin or amikacin), or
• Other muscle relaxant drugs.

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. Treatment with Azzalure is not recommended if you are
breast-feeding.
If you are pregnant or planning to become pregnant, or if you are breast-feeding, ask your doctor, pharmacist
or other healthcare practitioner for advice before taking any medicine.

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

3. 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.
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 should be noticeable within a few days after injection.
The interval between treatments with Azzalure will be decided by your doctor or other healthcare
practitioner. You should not have treatment more often than every 12 weeks.
Azzalure is not indicated 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 straight away. If this happens, speak to your doctor or other healthcare
practitioner 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 or other healthcare practitioner if you notice any of the following side effects:
For glabellar lines:

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
• Temporary facial paralysis

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

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

Not known (frequency cannot be estimated from the available data):
• Numbness
• Muscle wasting
• Generalised weakness
• Fatigue
• Flu-like symptoms

For lateral canthal lines:
Common (affects 1 to 10 users in 100)
• Headache
• Swelling of the eyelid
• Bruising, itching and swelling around the eyes
• Drooping of the upper eyelid
• Temporary facial paralysis

Uncommon (affects 1 to 10 users in 1,000)
• Dry eye

Not known (frequency cannot be estimated from the available data):
• Allergic reactions
• Numbness
• Muscle wasting
• Generalised weakness
• Fatigue
• Flu-like symptoms
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 or other healthcare
practitioner immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or other healthcare practitioner. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.

- People with infection at the proposed injection site.
- People who have previously had an allergic reaction to Botulinum toxin type A injections.
- People with muscle problems or chronic diseases affecting the muscles, such as Myasthenia Gravis, Eaton Lambert syndrome.
- Children under the age of 18 years.
- Women who are pregnant or breast feeding.

- People at risk of bleeding as there is an increased risk of bruising post procedure. These include people who have blood clotting disorders such as Haemophilia, those who are taking treatments with anticoagulant medicines such as Warfarin, Heparin, Aspirin and Anti-Inflammatory medicines. Certain herbal remedies such as Gingiko Bilboa, St John’s Wort and Vitamin E
- People with excessive weakness or wasting in the muscle to be injected, such as those patients with history of Strokes or Bell’s Palsy
- People with Chronic Breathing difficulties

Botox injections generally have an onset action of 5 to 10 days to fully develop, with the average longevity of roughly 3 to 4 months.