PATIENT CONSENT FOR TREATMENT WITH AZZALURE PRODUCTS

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Azzalure* (Botulinum Toxin Type A) uses the toxin produced by the bacteria responsible for botulism in food poisoning. However, the amount of toxin used is minimal and generally well tolerated in clinical trials. The toxin temporarily weakens the muscles responsible for developing facial expression lines caused by muscle activity. Static facial lines, e.g. those due to sun damage. will not usually respond to treatment with botulinum toxin, as they are not caused by muscle activity.

Yes

Azzalure" (Botulinum Toxin Type A) is licensed for the temporary improvement of moderate to severe vertical lines between the eyebrows (glabellar lines) seen at maximum frown and/or lateral canthal lines (crow's feet lines) seen at maximum smile and is injected because the severity of your lines has had an important psychological impact on you.*

Yes

Treatment is not recommended if you are pregnant or breastfeeding.*

Yes

After treatment with Azzalure* for glabellar lines you should start to see an improvement within 2 to 3 days. However the full effect can take up to 30 days. The benefits of treatment usually lasts between 4 and 6 months for glabellar lines, but can vary depending on your individual response. For lateral canthal lines, the benefit of treatment usually last between 3 to 4 months.*

Yes

The most common side effects of Azzalure" in the glabellar lines are headache and injection site reactions (e.g. redness, swelling. irritation, rash, itching, numbness, pain, discomfort, stinging, brusing and bleeding) and for lateral canthal lines; headache, injection site reactions and cyclid oedema. Normally these reactions are mild to moderate, reversible and occur in the first week after treatment. There is also a small possibility of slight drooping of the eyelid or visual problems.*

Yes

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

Yes

Other side effects are listed in the Patient Information Leaflet (please ask if you have not been given this*

Yes

Azzalure* may cause temporary blurred vision or muscle weakness. If affected, you should not drive or use machinery.*

Yes

Azzalure* contains a very small amount of albumin, which comes from human blood It is very unlikely that this could pass on an infection, but it cannot be entirely ruled out.*

Yes

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Schemeat www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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