Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Botulinum toxin type a may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
E 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) ____________________________________________________________________________________________________________
Page 1 of 7
Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
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.
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: ____________________________________________________________________________________________________________
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Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
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 ____________________________________________________________________________________________________________
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Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
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
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.
5.
AZZALURE
Keep Azzalure out of the sight and reach of children. Your doctor should not use Azzalure after the expiry date which is stated on the label. The expiry date refers to the last day of that month. ____________________________________________________________________________________________________________
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Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
Store Azzalure in a refrigerator (2 ̊C – 8 ̊C). Unopened vials of Azzalure can be used following a single exposure to temperatures up to 25°C for up to 72 hours, after which time the unopened vial should be stored in a refrigerator (2°C – 8°C) for the duration of shelf-life. Do not freeze. Your doctor will dissolve Azzalure into a liquid solution for injection. Chemical and physical in-use stability has been demonstrated for 24 hours between 2 – 8°C. From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. 6.
What Azzalure contains
Clostridium botulinum (a bacteria) toxin A haemagglutinin 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: Ipsen Limited, 5th Floor, The Point, 37 North Wharf Road, Paddington, London, W2 1AF, United Kingdom.
Manufacturer: Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham, LL13 9UF, UK.
This leaflet was last revised in August 2025. If you would like any more information, or would like the leaflet in a different format, please contact Galderma (UK) Limited, tel. +44 (0) 300 3035674. Distributed by: Galderma (U.K.) Limited Evergreen House North Grafton Place London NW1 2DX
United Kingdom
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Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
————————————————————————————————————-The following information is intended for healthcare professionals only: Posology and method of administration: Please refer to section 3 of the Patient Information Leaflet. Special precautions for disposal and other handling: The instructions for use, handling and disposal should be strictly followed. Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis. Azzalure has to be reconstituted with a sodium chloride 9 mg/ml (0.9 %) solution for injection. As per the dilution table below, the requested amount of sodium chloride 9 mg/ml (0.9 %) solution for injection has to be drawn up into a syringe in order to obtain a reconstituted clear and colourless solution at the following concentration: Amount of solvent added (0.9 % sodium chloride solution) to a 125 U vial 0.63 ml 1.25 ml
Resulting dose
10 U per 0.05 ml 10 U per 0.1 ml
The accurate measurement of 0.63 ml or 1.25 ml can be achieved using syringes graduated in 0.1 ml and 0.01 ml increments. RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS Immediately after use and prior to disposal, unused reconstituted Azzalure (in the vial or in the syringe) should be inactivated with 2 ml 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. RECOMMENDATIONS SHOULD ANY INCIDENT OCCUR DURING THE HANDLING OF BOTULINUM TOXIN
Any spills of the product must be wiped up: either using absorbent material impregnated with a solution of sodium hypochlorite (bleach) in case of the powder, or with dry, absorbent material in case of reconstituted product. The contaminated surfaces should be cleaned using absorbent material impregnated with a solution of sodium hypochlorite (bleach), then dried. If a vial is broken, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin. If the product comes into contact with the skin, wash the affected area with a solution of sodium hypochlorite (bleach) then rinse abundantly with water. If product enters into contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution.
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Azzalure, 125 Speywood units, powder for solution for injection – approved UK PIL – 22Dec2025
If product enters into contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.
These instructions for use handling and disposal should be strictly followed.
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Azzalure, 125 Speywood units, powder for solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Azzalure, 125 Speywood units, powder for solution for injection is botulinum toxin type a.
Medicines with the same active substance, strength and form include: Alluzience, 200 Speywood units/ml, solution for injection, BOTOX 100 Allergan Units Powder for solution for injection, BOTOX 200 Allergan Units Powder for solution for injection. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Azzalure, 125 Speywood units, powder for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Azzalure is indicated for the temporary improvement in the appearance of moderate to severe
• Glabellar lines (vertical lines between the eyebrows) seen at maximum frown and/or
• Lateral canthal lines (crow's feet lines) seen at maximum smile
in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.
Posology:
Botulinum toxin units are different depending on the medicinal products. The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
Paediatric population
The safety and efficacy of Azzalure in individuals aged up to 18 years have not been established. The use of Azzalure is not recommended in subjects under 18 years.
Method of administration:
Azzalure should only be administered by a healthcare practitioner with appropriate qualifications and expertise in this treatment and having the required equipment, in accordance with national guidelines.
Once reconstituted, Azzalure should only be used to treat a single patient, during a single session.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Remove any make-up and disinfect the skin with a local antiseptic.
Intramuscular injections should be performed using a sterile suitable gauge needle.
The treatment interval depends on the individual patient's response after assessment. Treatment interval with Azzalure should not be more frequent than every three months.
The recommended injection points for glabellar lines and lateral canthal lines are described below:
Glabellar lines
The recommended dose is 50 Speywood units of Azzalure to be divided into 5 injection sites, 10 Speywood units are to be administered intramuscularly, at right angles to the skin, into each of the 5 sites: 2 injections into each corrugator muscle and one into the procerus muscle near the nasofrontal angle as shown above.
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.
In clinical studies, an optimal effect in glabellar lines was demonstrated for up to 4 months after injection. Some patients were still responders at 5 months (see section 5.1).
Lateral Canthal lines
The recommended dose per side is 30 Speywood units of Azzalure, to be divided into 3 injection sites; 10 Speywood units are to be administered intramuscularly into each injection point. Injection should be lateral (20 - 30° angle) to the skin and very superficial. All injection points should be at the external part of the orbicularis oculi muscle and sufficiently far from the orbital rim (approximately 1-2 cm) as shown above.
The anatomical landmarks can be more readily identified if observed and palpated at maximal smile. Care must be taken to avoid injecting the zygomaticus major/minor muscles to avoid lateral mouth drop and asymmetrical smile.
General information
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, inappropriate injection technique, and formation of toxin-neutralising antibodies
• Re-evaluation of the relevance of treatment with botulinum toxin A.
The efficacy and safety of repeat injections of Azzalure has been evaluated in Glabellar lines up to 24 months and up to 8 repeat treatment cycles and for Lateral Canthal lines up to 12 months and up to 5 repeat treatment cycles.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Presence of infection at the proposed injection sites
- Presence of myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.
Care should be taken to ensure that Azzalure is not injected into a blood vessel.
Pre-existing Neuromuscular Disorders
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.
Injection of Azzalure is not recommended in patients with a history of dysphagia and aspiration.
Local and distant spread of toxin effect
Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin. Patients treated with therapeutic doses may experience exaggerated muscle weakness. Swallowing and breathing difficulties are serious and can result in death.
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.
Dry eye has been reported with the use of Azzalure in the treatment of glabellar lines and lateral canthal lines (see section 4.8). Reduced tear production, reduced blinking, and corneal disorders, may occur with the use of botulinum toxins, including Azzalure.
Antibody formation
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.
Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Speywood units are different from other botulinum toxin preparations.
It is mandatory that Azzalure is used for one single patient treatment only during a single session. The excess of unused product must be disposed of as detailed in section 6.6. Particular precautions should be taken for product preparation and administration as well as for the inactivation and disposal of the remaining unused solution (see section 6.6).
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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
Azzalure should not be used during pregnancy. 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.
Breast-feeding
There is no information on whether Azzalure is excreted in human milk. The use of Azzalure during lactation cannot be recommended.
Fertility
There are no clinical data from the use of Azzalure on fertility. There is no evidence of direct effect of Azzalure on fertility in animal studies (see section 5.3).
Azzalure has a minor or moderate influence on the ability to drive and use machines. There is a potential risk of localised muscle weakness, visual disturbances or asthenia linked with the use of this medicinal product which may temporarily impair the ability to drive or operate machinery.
Approximately 3800 patients were exposed to Azzalure in the different clinical trials.
Based on placebo-controlled clinical trials, the observed rates of adverse reactions after the first injection of Azzalure were 22.3 % for the treatment of glabellar lines (16.6 % for placebo) and 6.2 % for the treatment of lateral canthal lines (2.9 % for placebo). Most of these events were of mild to moderate severity and reversible.
The most frequent undesirable reactions were headache and injection site reactions for glabellar lines and headache, injection site reactions and eyelid oedema for lateral canthal lines. In general, treatment/injection technique related reactions occurred within the first week following injection and were transient. The incidence of treatment/injection technique related reactions decreased over repeat cycles. Undesirable effects may be related to the active substance, the injection procedure, or a combination of both.
The safety profile of Azzalure for concomitant treatment of glabellar lines and lateral canthal lines was evaluated in the open label part of the phase III study; the nature and frequency of adverse reactions were comparable to what was observed when patients were treated for the individual indications.
The frequency of undesirable reactions is classified as follows:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
For glabellar lines:
System Organ Class
Adverse Reactions
Nervous system disorders
Very Common
Headache
Common
Temporary facial paresis (due to temporary paresis of facial muscles proximal to injection sites, predominantly describes brow paresis)
Uncommon
Dizziness
Eye disorders
Common
Asthenopia, Eyelid ptosis, Eyelid oedema, Lacrimation increased, Dry eye, Muscle twitching (twitching of muscles around the eyes)
Uncommon
Visual impairment, Vision blurred, Diplopia
Rare
Eye movement disorder
Skin and subcutaneous tissue disorders
Uncommon
Pruritus, Rash
Rare
Urticaria
General disorders and administration site conditions
Very Common
Injection site reactions (e.g. erythema, oedema, irritation, rash, pruritus, paraesthesia, pain, discomfort, stinging and haematoma)
Immune system disorders
Uncommon
Hypersensitivity
For lateral canthal lines:
System Organ Class
Adverse Reactions
Nervous system disorders
Common
Headache
Temporary facial paresis (temporary paresis of facial muscles proximal to injection sites)
Eye disorders
Common
Eyelid oedema
Eyelid ptosis
Uncommon
Dry eye
General disorders and administration site conditions
Common
Injection site reactions (e.g. haematoma, pruritus and oedema)
Adverse reactions 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).
Post-marketing experience
System Organ Class
Adverse Drug Reaction
Frequency
General disorders and administration site conditions
Asthenia, fatigue, influenza-like illness
Not known
Immune system disorders
Hypersensitivity
Not known
Nervous system disorders
Hypoaesthesia
Not known
Musculoskeletal and connective tissue disorders
Muscle atrophy
Not known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
Excessive doses of botulinum toxin may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment should be instigated if necessary.
Symptoms of overdose may not present immediately following injection.
Admission to hospital should be considered in patients presenting symptoms of botulinum toxin A poisoning (e.g. a combination of muscle weakness, ptosis, diplopia, swallowing and speech disorders, or paresis of the respiratory muscles).
Ask anything about Azzalure, 125 Speywood units, powder for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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