Nuceiva

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or healthcare practitioner.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you have any side effects, talk to your doctor, pharmacist, or healthcare practitioner. This includes any possible side effects not listed in this leaflet. See section 4.

1. What NUCEIVA is and what it is used for
2. What you need to know before NUCEIVA is used
3. How to use NUCEIVA
4. Possible side effects
5. How to store NUCEIVA
6. Contents of the pack and other information

• if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis or Eaton Lambert syndrome (chronic diseases affecting the muscles);
• if you have an infection or inflammation at the proposed injection sites between the eyebrows and over the brows (as seen in Figure 1).

Side effects possibly related to the spread of botulinum toxin from the site of injection can occur very rarely (e.g. muscle weakness, difficulty in swallowing or food or liquid entering the airways). Patients receiving recommended doses may have exaggerated muscle weakness.

Localised pain, inflammation/swelling, abnormal sensation (paraesthesia), decreased sensation (hypoaesthesia), tenderness, rash (erythema), localised infection, bleeding and/or bruising have been associated with the injection. Needle-related pain and/or anxiety has resulted in vasovagal responses such as paleness, nausea, sweating, blurred vision, a rapid heartbeat, lightheadedness, and/or a temporary drop in blood pressure causing dizziness or fainting.

Visit your doctor, pharmacist, or healthcare practitioner immediately if you find it difficult to swallow, to speak or to breathe after treatment.

• This medicine is not recommended in patients who have had problems swallowing (dysphagia) and breathing recently or in the past, which would preclude the safe administration of the product in the opinion of your doctor.
• Too frequent or excessive dosing may lead to antibody formation. Antibody formation can stop botulinum toxin type A from working even for other uses.
• Very rarely, an allergic reaction can occur after the injection of botulinum toxin. Symptoms may include skin reactions, including hives and itching and flushed or pale skin, swollen eyes, lips mouth or throat, a weak and rapid pulse, dizziness, and wheezing or breathlessness.
• Drooping of the eyelid may occur after treatment.

Please tell your doctor, pharmacist, or healthcare practitioner if:

• you had problems with previous botulinum toxin injections;
• you see no significant improvement of your lines one month after your first course of treatment;
• you suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy);
• you have inflammation at the proposed injection site(s);
• the muscles to be injected are weak or wasted;
• you have a bleeding disorder as injection may lead to bruising.

The use of this medicine is not recommended in individuals under 18 years.

Tell your doctor, pharmacist, or healthcare practitioner if you are taking, have recently taken or might take any other medicines.

The use of botulinum toxin is not recommended in association with aminoglycoside antibiotics, spectinomycin or other medicines that interfere with nerve impulses to the muscle.

Tell your doctor, pharmacist, or healthcare practitioner if you have recently been injected with a medicine containing botulinum toxin (the active substance of NUCEIVA), as this may increase the effect of this medicine excessively.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor, pharmacist, or healthcare practitioner for advice before you receive this medicine.

The use of this medicine is not recommended during pregnancy and in women able to have children who are not using contraception.

This medicine is not recommended in breast-feeding women.

Muscle weakness, dizziness, and visual disturbance with this medicine could make driving or the use of machines dangerous. Do not drive or use machinery until such effects have cleared.

This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free’.

If you get any side effects, talk to your doctor, pharmacist, or healthcare practitioner. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.

• The active substance is: 50 Units botulinum toxin type A.
• The other ingredients are human albumin and sodium chloride.

NUCEIVA is presented as a white powder for solution for injection in a transparent glass vial.

Each pack contains 1 vial.

For any information about this medicine, please contact the Marketing Authorisation Holder ([email protected]).