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Nuceiva

Active Ingredient:
botulinum toxin type a
Company:  
EVOLUS INTERNATIONAL LTD See contact details
ATC code: 
M03AX01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 29 Oct 2024
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 55681/0002.

{printer} Print patient leaflet as text only

Nuceiva 50U

Package leaflet: Information for the user

NUCEIVA 50 Units powder for solution for injection

botulinum toxin type A

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • 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.

What is in this leaflet

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

1. What NUCEIVA is and what it is used for

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 below 65 years of age in whom those facial lines have an important psychological impact.

2. What you need to know before NUCEIVA is used
NUCEIVA must not be used:
  • 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).

Warnings and precautions

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.

Children and adolescents

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

Other medicines and NUCEIVA

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

NUCEIVA contains sodium

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

3. How to use NUCEIVA

Unit doses for NUCEIVA are not interchangeable with those used for other preparations of botulinum toxin.

This medicine 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 this medicine 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

This medicine is injected into your muscles (intramuscularly), directly into the affected area above and between the eyebrows.

Once reconstituted, NUCEIVA should only be used to treat a single patient, during a single session.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or healthcare practitioner.

4. Possible side effects

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 this medicine 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 as these can be symptoms of an allergic reaction.

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

Reporting of side effects

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.

5. How to store NUCEIVA

Store in a refrigerator (2°C to 8°C).

Keep out of the sight and reach of children.

Unopened vial

Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.

6. Contents of the pack and other information
What NUCEIVA contains
  • The active substance is: 50 Units botulinum toxin type A.
  • The other ingredients are human albumin and sodium chloride.

What NUCEIVA looks like and contents of the pack

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

Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer
Evolus Pharma B.V.
Apollolaan 151
1077 AR Amsterdam
The Netherlands

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

This leaflet was last revised in July 2024.

EVOLUS INTERNATIONAL LTD
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Address
First Floor West, Davidson House, Forbury Square, Reading, RG1 3EU, UK
WWW
https://www.evolus-europe.com
Medical Information Direct Line
0800 054 1302
Medical Information e-mail
[email protected]