AZZALURE
10 Speywood Units/0.05 ml, powder for solution for injection
(botulinum toxin type A)
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.
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
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.
Before You Use Azzalure
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.
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.
Important information about some of the ingredients of Azzalure
Azzalure contains a very small amount of albumin which has come from human blood.
It is very unlikely that this could pass on an infection but it cannot be entirely ruled out.
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 straight away. If this happens, speak to your doctor immediately.
Azzalure PIL 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
Uncommon (affects 1 to 10 users in 1,000)
- Disturbed, blurred or double vision
- Dizziness
- Itching, rash
- Allergic reactions, see above
Rare (affects 1 to 10 users in 10,000)
- Itchy and lumpy rash
- Eye movement disorder
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.
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).
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.
*Clostriduium botulinum (a bacterium) 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 pack size of 1 or 2 vials.
Azzalure is a white powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last approved in January 2009.
If you would like any more information, or would like the leaflet in a different format, please contact Galderma (UK) Ltd, tel. 01923 208950.
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