Azzalure, 125 Speywood units, powder for solution for injection

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See Section 4.

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

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 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 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 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 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 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.

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 immediately.

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:

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

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

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, listed below:

For UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Ireland: via

By reporting side effects, you can help provide more information on the safety of this medicine.

What Azzalure contains

• The active substance is botulinum toxin type A*. 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:

Manufacturer:

For UK:

For Ireland: