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NAME OF THE MEDICINAL PRODUCT : Azzalure, 10 Speywood units/0.05ml, powder for solution for injection. QUALITATIVE AND QUANTITATIVE COMPOSITION : Botulinum toxin type A *10 Speywood units **/0.05ml of reconstituted solution. Vial of 125 units. *Clostridium botulinum toxin A haemagglutinin complex. **One Speywood unit (U) is defined as the median lethal peritoneal dose in mice (LD50). The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. Excipient : human albumin 200g/L, lactose monohydrate. CLINICAL INDICATIONS : Azzalure is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. POSOLOGY AND METHOD OF ADMINISTRATION : Prior to injection, the product should be reconstituted. Remove any make-up and disinfect the skin with a local antiseptic. Intramuscular injections should be performed at right angles to the skin using a sterile 29-30 gauge needle. The recommended dose is 50 Speywood units (0.25 ml of reconstituted solution) of Azzalure to be divided into 5 injection sites, 10 Speywood units (0.05 ml of reconstituted solution) are to be administered intramuscularly into each of the 5 sites: 2 injections into each corrugator muscle and one into the procerus muscle near the nasofrontal angle. The anatomical landmarks can be more readily identified if observed and palpated at maximal frown. Before injection, place the thumb or index finger firmly below the orbital rim in order to prevent extravasation below the orbital rim. The needle should be pointed upward and medially during the injection. In order to reduce the risk of ptosis, avoid injections near the levator palpebrae superioris muscle, particularly in patients with larger brow-depressor complexes (depressor supercilii). Injections in the corrugator muscle must be made into the central part of that muscle, at least 1 cm above the orbital rim. The treatment interval depends on the individual patient’s response after assessment. In clinical studies, an optimal effect was demonstrated for up to 4 months after injection. Some patients were still responders at 5 months (see section 5.1). Treatment interval should not be more frequent than every three months. In the event of treatment failure or diminished effect following repeat injections, alternative treatment methods should be employed. In case of treatment failure after the first treatment session, the following approaches may be considered: Analysis of the causes of failure, e.g. incorrect muscles injected, injection technique, and formation of toxin-neutralising antibodies; Re-evaluation of the relevance of treatment with botulinum toxin A. The safety and effectiveness of Azzalure in individuals under 18 years of age have not been demonstrated. CONTRAINDICATIONS : Azzalure is contraindicated, - In individuals with a known hypersensitivity to botulinum toxin A or to any of the excipients of the formulation; - In the presence of infection at the proposed injection sites; - In the presence of myasthenia gravis, Eaton Lambert Syndrome or Amyotrophic lateral sclerosis. SPECIAL WARNINGS AND PRECAUTIONS FOR USE : Azzalure should be used with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission. Such patients may have an increased sensitivity to agents such as Azzalure, which may result in excessive muscle weakness. Adverse reactions possibly related to the distribution of the effects of the toxin to sites remote from the site of administration have been reported very rarely with botulinum toxin. Patients treated with therapeutic doses may experience exaggerated muscle weakness. Injection of Azzalure is not recommended in patients with a history of dysphagia and aspiration. Patients or care-givers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties arise. The recommended dose and frequency of administration for Azzalure must not be exceeded. It is essential to study the patient’s facial anatomy prior to administering Azzalure. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to this anatomy, as a result of previous surgical interventions should be taken into consideration. Caution should be taken when Azzalure is used in the presence of inflammation at the proposed injection site(s) or when the targeted muscle shows excessive weakness or atrophy. As with all intramuscular injections, Azzalure treatment is not recommended in patients who have a prolonged bleeding time. Injections at more frequent intervals or at higher doses can increase the risk of antibody formation to botulinum toxin. Clinically, the formation of neutralising antibodies may reduce the effectiveness of subsequent treatment. The effect of administering different botulinum neurotoxins during the course of treatment with Azzalure is unknown and must be avoided. It is mandatory that Azzalure is used for one single patient treatment only during a single session. Particular precautions should be taken for product preparation and administration as well as for the inactivation and disposal of the remaining unused solution. Immediately after use and prior to disposal, unused reconstituted Azzalure (in the vial or in the syringe) should be inactivated with 2ml of dilute sodium hypochlorite solution at 0.55 or 1% (Dakin’s solution). Used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION : Concomitant treatment of Azzalure and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) should only be used with caution since the effect of botulinum toxin type A may be potentiated. No interaction studies have been performed. No other interactions of clinical significance have been reported. PREGNANCY AND LACTATION : Pregnancy : Azzalure should not be used during pregnancy unless clearly necessary. There are no adequate data from the use of botulinum toxin type A in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see Section 5.3). The potential risk for humans is unknown. Lactation : There is no information on whether Azzalure is excreted in human milk. The use of Azzalure during lactation cannot be recommended. UNDESIRABLE EFFECTS : The most frequently occurring related reactions are headache and injection site reactions. In general, treatment/injection technique related reactions occur within the first week following injection and are transient. Most of these reactions reported were of mild to moderate severity and were reversible. Very common ($ 1/10) : Headache, Injection site reactions (e.g. erythema, oedema, irritation, rash, pruritus, paraesthesia, pain, discomfort, stinging and bruising). Common ($ 1/100 to ,1/10): Facial paresis (predominantly describes brow paresis), Asthenopia, Ptosis, Eyelid oedema, Lacrimation increase, Dry eye, Muscle twitching (twitching of muscles around the eyes). Uncommon ($ 1/1,000 to ,1/100): Dizziness, Visual disturbances, Vision blurred, Diplopia, Pruritus, Rash, Hypersensitivity. Rare ($ 1/10,000 to ,1/1,000): Eye movement disorder, Urticaria. Adverse effects resulting from distribution of the effects of the toxin to sites remote from the site of injection have been very rarely reported with botulinum toxin (excessive muscle weakness, dysphagia, aspiration pneumonia with fatal outcomes in some cases). (see section 4.4). PHARMACODYNAMIC PROPERTIES : Other muscle relaxants, peripherally acting agents. ATC code: M03AX01. The primary pharmacodynamic effect of Clostridium botulinum toxin type A is due to chemical denervation of the treated muscle resulting in a measurable decrease of the compound muscle action potential, causing a localized reduction of, or paralysis in, muscle activity. SHELF LIFE : 2 years. Reconstituted solution: 4 hours at between 2°C and 8°C. SPECIAL PRECAUTIONS FOR STORAGE : Store in a refrigerator (2°C - 8°C). Do not freeze. MARKETING AUTHORISATION HOLDER: Ipsen. DATE OF REVISION OF THE TEXT : July 2010. For a complete information, you should consult the national published prescribing information.

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of AZZALURE® AZZALURE, with its well established safety profile, offers high level of patient satisfaction thanks to its rapid onset (2-3 days) and long duration of action (up to 5 months).1-4

AZZALURE is indicated for the treatment of glabellar lines*1

*AZZALURE is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psycho- logical impact on the patient. 1. AZZALURE Summary of Product Characteristics. 2. Moy et al. Arch Facial Plast Surg 2009. 3. Rzany B et al. Dermatol Surg 2007; 33:S18-25. 4. Ascher B et al. J Am Acad Dermatol 2004; 51:223-33. AZZ 09-2011. © Galderma. All rights reserved except where indicated. Photos: Laurence Monneret, Virginie Rol.

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