Patient Leaflet Updated 12-Jul-2023 | EVOLUS INTERNATIONAL LTD
Nuceiva
NUCEIVA 50 Units powder for solution for injection
botulinum toxin type A
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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
NUCEIVA contains the active substance botulinum toxin type A.
It prevents muscles from contracting, leading to a temporary paralysis. It works by blocking the nerve impulses to the muscles in which it has been injected.
NUCEIVA is used for the temporary improvement in the appearance of vertical lines between the eyebrows. It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact.
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.
Visit your doctor, pharmacist, or healthcare practitioner immediately if you find it difficult to swallow, to speak or to breathe after treatment.
Please tell your doctor, pharmacist, or healthcare practitioner if:
The use of NUCEIVA 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 NUCEIVA 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 NUCEIVA is not recommended during pregnancy and in women able to have children who are not using contraception.
NUCEIVA 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’.
Unit doses for NUCEIVA are not interchangeable with those used for other preparations of botulinum toxin.
NUCEIVA should only be injected by doctors or other healthcare practitioners with appropriate qualifications and expertise in the treatment of glabellar lines at maximum frown.
The usual dose of NUCEIVA is 20 Units. You will be injected with the recommended volume of 0.1 millilitre (ml) (4 Units) of NUCEIVA into each of 5 injection sites.
Improvement of severity of the lines between the eyebrows generally occurs within a few days of treatment.
The interval between treatments will be decided by your doctor or healthcare practitioner.
How NUCEIVA is injected
NUCEIVA is injected into your muscles (intramuscularly), directly into the affected area above and between the eyebrows.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or healthcare practitioner.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, side effects occur within the first few days after injection and are temporary. Most side effects are of mild to moderate severity.
If you have any difficulty in breathing, swallowing or speaking after receiving NUCEIVA contact your doctor or healthcare practitioner immediately.
If you get hives, swelling, including swelling of the face or throat, wheezing, feeling faint or shortness of breath, contact your doctor or healthcare practitioner immediately.
The chance of having a side effect is described by the following categories:
Common (May affect up to 1 in 10 people)
Headache, muscle imbalance resulting in elevated or asymmetrical eyebrows, eyelid drooping, injection site bruise.
Uncommon (May affect up to 1 in 100 people)
Sensory disturbance, head discomfort, dry eye, eyelid swelling, eye swelling, muscle twitching, injection site: redness, pain, tingling.
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.
Keep out of the sight and reach of children.
Unopened vial
Do not use NUCEIVA after the expiry date which is stated on the vial and the carton after EXP.
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]).
This leaflet was last revised in June 2023.
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