VISTABEL 4 vials ALLERGAN/0.1 ml POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

VISTABEL 4 Units Allergan /0.1ml 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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Vistabel and what is it used for

Vistabel is a peripheral muscle relaxant.

Vistabel acts by blocking nerve impulses to all muscles into which it has been injected. This prevents the muscles from contracting, producing a temporary and reversible paralysis.

Vistabel is indicated for the temporary improvement in the appearance of:

• Vertical lines between the eyebrows produced by frowning to the maximum and/or,
• Crow's feet produced by smiling to the maximum and/or,
• Forehead lines produced by raising the eyebrows to the maximum,

when the severity of these facial lines in adult patients has a significant psychological impact.

2. What you need to know before you use Vistabel

Do not use Vistabel:

• If you are allergic to botulinum toxin type A or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe myasthenia gravis or Lambert-Eaton syndrome (chronic diseases that affect the muscles).
• If you have an infection at the sites where you plan to inject.

Warnings and precautions

Very rarely, adverse reactions possibly related to the spread of the toxin far from the site of administration (e.g. muscle weakness, difficulty swallowing or involuntary and improper passage of food or liquids into the airways) have been reported. Patients receiving the recommended doses may experience excessive muscle weakness.

• Go to your doctor immediately
• • If you notice it is difficult to swallow, speak or breathe after treatment.

• Vistabel is not recommended for use in patients with a history of dysphagia (difficulty swallowing) and altered deglutition.

• Vistabel is not recommended for use in persons under 18 years of age.

• There is limited experience with the use of Vistabel in patients over 65 years of age.

• Too frequent or excessive dosing may lead to the formation of antibodies, which could create resistance to treatment. This could reduce the effectiveness of subsequent treatments with botulinum toxin type A, even for other indications. To limit this risk, the interval between two treatments should not be less than three months.

• Very rarely, an allergic reaction may occur after administration of botulinum toxin.

• After treatment, eyelid drooping may occur.

• Please inform your doctor:
• • If you had problems with botulinum toxin injections in the past
  • If you do not observe significant improvement in facial lines after one month after your first treatment
  • If you suffer from any disease that affects the nervous system (such as amyotrophic lateral sclerosis or a peripheral neuromuscular disorder
  • If you have inflammation of the proposed injection site
  • If the muscles where you will be injected are weak or damaged
  • If you have had surgery or injury to the head, neck, or chest
  • If you are going to undergo surgery soon

Using Vistabel with other medicines:

It is not recommended to use botulinum toxin with aminoglycoside antibiotics, spectinomycin, or other medicines that interfere with neuromuscular transmission.

Tell your doctor if you have recently been injected with a medicine that contains botulinum toxin (the active ingredient of Vistabel), as this may increase the effect of Vistabel too much.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

Vistabel is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods.

Vistabel is not recommended during breastfeeding.

If you are pregnant, think you may be pregnant, or plan to become pregnant while being treated, contact your doctor. Your doctor will advise you whether you should continue treatment.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Drivers and machine operators are warned of the risk of muscle weakness and/or generalized, dizziness, and visual disturbances associated with the use of this medicine, which may make driving vehicles or operating machinery hazardous. Do not drive or operate machinery until symptoms have resolved.

Vistabel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How to use Vistabel

Form and route of administration

Vistabel should only be administered by doctors with the appropriate qualification and experience in this treatment and in the use of the appropriate equipment.

Vertical lines between the eyebrows produced by frowning to the maximum:

Vistabel is injected into the muscles (intramuscularly), directly into the affected area between the eyebrows.

The usual dose is 20 Units. You will be injected with the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel at each of the 5 points indicated for injection.

Improvement in the severity of the lines between the eyebrows produced by frowning to the maximum usually occurs within a week after treatment, with the maximum effect observed at 5 or 6 weeks after injection. The effect of the treatment has been shown to last up to 4 months after injection.

Crow's feet produced by smiling to the maximum:

Vistabel is injected directly into the affected area next to each eye.

The usual dose is 24 Units. You will be injected with the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel at each of the 6 points indicated for injection (3 injection points next to each eye).

Improvement in the severity of crow's feet produced by smiling to the maximum usually occurs within a week after treatment. The effect of the treatment has been shown to last an average of 4 months after injection.

Forehead lines produced by raising the eyebrows to the maximum:

Vistabel is injected directly into the muscle of the affected area on the forehead.

The usual dose is 20 Units. You will be injected with the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel at each of the 5 points indicated for injection.

The total dose for the treatment of forehead lines (20 Units) together with the glabellar lines (20 Units) is 40 Units.

Improvement in the severity of forehead lines produced by raising the eyebrows to the maximum usually occurs within a week after treatment. The effect of the treatment has been shown to last approximately 4 months after injection.

General information:

If you are going to receive treatment simultaneously for crow's feet produced by smiling to the maximum and vertical lines between the eyebrows produced by frowning to the maximum, you will receive a total dose of 44 Units.

If you are going to receive treatment simultaneously for the 3 types of facial lines (crow's feet produced by smiling to the maximum, vertical lines between the eyebrows produced by frowning to the maximum, and forehead lines produced by raising the eyebrows to the maximum), you will receive a total dose of 64 Units.

The interval between two treatments should not be less than three months.

The efficacy and safety of repeated injections of Vistabel for more than 12 months have not been evaluated.

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

4. Possible side effects

Like all medicines, Vistabel can cause side effects, although not everybody gets them.

In general, adverse reactions appear in the first days after injection and are temporary. Most reported adverse effects were of mild to moderate intensity. Approximately 1 in 4 patients may experience side effects after injection of Vistabel for vertical lines between the eyebrows produced by frowning to the maximum. Approximately 8% of patients may experience side effects after injection of Vistabel for crow's feet produced by smiling to the maximum when treated only for this or at the same time as for vertical lines between the eyebrows produced by frowning to the maximum. Approximately 20% of patients may experience side effects after injection of Vistabel for forehead lines produced by raising the eyebrows to the maximum when treated together with the treatment for vertical lines between the eyebrows produced by frowning to the maximum. Approximately 14% of patients may experience side effects when treatment for forehead lines together with glabellar lines is combined with treatment for crow's feet produced by smiling to the maximum.

These side effects may be related to the treatment, the injection technique, or both. Eyelid drooping, which may be related to the technique, is also associated with the local muscle-relaxing action of Vistabel.

Very rarely, adverse reactions possibly related to the spread of the toxin far from the site of administration (e.g. muscle weakness, difficulty swallowing, or pneumonia caused by the presence of unwanted food or liquids in the airways, which can be fatal) have been reported with botulinum toxin. Vistabel is not recommended for injection in patients with a history of dysphagia (difficulty swallowing) and altered deglutition.

IF YOU EXPERIENCE DIFFICULTYBREATHING, SWALLOWINGORSPEAKINGAFTERRECEIVINGTREATMENTWITHVISTABEL, CONTACTYOURDOCTORIMMEDIATELY.

If you experiencehives, inflammationincludinginflammationofthefaceorthroat, wheezing, feelingoffaintingorshortnessofbreath, contactyourdoctorimmediately.

The botulinum toxin may spread to nearby muscles if high doses are injected, particularly in the neck area.

As with any injection procedure, the injection may cause pain/burning/stinging, swelling, and/or bruising.

If you are concerned about this, consult your doctor.

The likelihood of having a side effect is described by the following categories:

Injections for the temporary improvement of vertical lines between the eyebrows

Injections for the temporary improvement of crow's feet, treated with or without vertical lines between the eyebrows produced by frowning to the maximum

*Some of these adverse reactions may be related to the injection procedure.

Injections for the temporary improvement of forehead lines and vertical lines between the eyebrows produced by frowning to the maximum, treated with or without crow's feet

1. The median time to onset of eyelid drooping was 9 days after treatment.
2. The median time to onset of eyebrow drooping was 5 days after treatment.

*Some of these adverse reactions may be related to the injection procedure.

The following is a list of additional side effectsreported for Vistabel since its marketing for the treatment of glabellar lines, crow's feet, and other clinical indications:

• severe allergic reaction (swelling under the skin, difficulty breathing)
• hives
• loss of appetite
• nerve damage
• difficulty moving the arm and shoulder
• problems with voice and speech
• weakness of the facial muscles
• decreased skin sensation
• muscle weakness
• myasthenia gravis (a chronic disease that affects the muscles)
• numbness
• pain/weakness that starts in the spine
• fainting
• drooping of the muscles on one side of the face
• increased eye pressure
• eyelid drooping
• difficulty closing the eye completely
• strabismus
• blurred vision, difficulty seeing clearly
• decreased hearing
• ringing in the ears
• feeling of dizziness or "spinning" (vertigo)
• aspiration pneumonia (lung inflammation caused by accidental aspiration of food, drink, saliva, or vomit)
• breathing difficulties
• respiratory problems, respiratory depression, and/or respiratory failure
• abdominal pain
• diarrhea
• dry mouth
• difficulty swallowing
• nausea
• vomiting
• hair loss
• drooping of the eyebrow
• psoriasiform skin patches (red, thickened, dry, and scaly)
• different types of skin rashes with red spots
• excessive sweating
• loss of eyebrows
• itching
• rash
• loss of muscle mass
• muscle pain
• problems with nerve conduction to the muscle/injection site muscle contraction
• discomfort
• general discomfort
• fever
• dry eye
• localized muscle spasms/muscle contractions
• swelling of the eyelid

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vistabel

Keep out of the sight and reach of children.

Do not use Vistabel after the expiry date which is stated on the vial and carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between +2°C and +8°C).

After reconstitution, it is recommended to use the solution for injection immediately; however, it can be stored for up to 24 hours in a refrigerator (at +2°C to +8°C).

6. Container Contents and Additional Information

Vistabel Composition

The active principle is: botulinum toxin type A1 (0.1 ml of reconstituted solution for injection contains 4 Allergan Units).

1 of Clostridium botulinum

• The other components are human albumin and sodium chloride.

Product Appearance and Container Contents

Vistabel is presented as a fine white powder for solution for injection that can be difficult to see in the bottom of a transparent glass vial; before being injected, the product must be dissolved in a normal saline solution without preservatives (0.9% sodium chloride injectable solution). Each vial contains 50 or 100 Allergan Units of botulinum toxin type A.

Each container contains 1 or 2 vials. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid, Spain

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

or

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This leaflet was approved in February 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

INFORMATION INTENDED ONLY FOR THE MEDICAL PROFESSIONAL

Botulinum toxin units are not interchangeable from one product to another. The recommended doses in Allergan Units are different from other botulinum toxin-based preparations.

Vistabel is indicated for temporary improvement in the appearance of:

• Moderate to severe vertical lines between the eyebrows produced by maximum frowning (glabellar lines) and/or,
• Moderate to severe crow's feet produced by maximum smiling and/or,
• Moderate to severe forehead lines produced by maximum eyebrow lifting,

when the severity of these facial lines in adult patients has a significant psychological impact.

Reconstitution must be performed according to good practice standards, particularly with regard to asepsis. Vistabel should be reconstituted with a normal saline solution without preservatives (0.9% sodium chloride injectable solution). When using a 50-Unit vial, 1.25 ml of normal saline solution without preservatives (0.9% sodium chloride injectable solution) should be introduced into a syringe to obtain a reconstituted solution with a concentration of 4 Units/0.1 ml. When using a 100-Unit vial, 2.5 ml of normal saline solution without preservatives (0.9% sodium chloride injectable solution) should be introduced into a syringe to obtain a reconstituted solution with a concentration of 4 Units/0.1 ml.

The central part of the rubber stopper should be cleaned with alcohol.

To avoid denaturing Vistabel, inject the solvent slowly into the vial and gently rotate it to avoid bubble formation. Discard the vial if the vacuum does not allow the solvent to enter. Once reconstituted, a visual inspection of the solution for injection should be performed before use to check that it is a clear, colorless to slightly yellowish solution without particles.

Vistabel should be used for the treatment of a single patient during a single session.

Before injecting into the glabellar lines (vertical lines produced by maximum frowning of moderate to severe intensity), place the index finger or thumb firmly under the orbital rim to avoid extravasation below it. During injection, the needle should be oriented superiorly and medially. To reduce the risk of eyelid ptosis, do not exceed the maximum dose of 4 Units per injection point or the number of injection points. Additionally, injections near the levator palpebrae muscle should be avoided, particularly in patients with larger eyebrow-depressor complexes. Injections into the corrugator muscle should be performed in the central part of the muscle, at a distance of at least 1 cm above the eyebrow arch.

Injections for crow's feet (lateral canthal lines produced by maximum smiling) should be performed with the needle bevel up and oriented away from the eye. To reduce the risk of eyelid ptosis, do not exceed the maximum dose of 4 Units per injection point or the number of injection points. Additionally, injections should be performed outward from the orbital rim, maintaining a safe distance from the muscle that controls eyelid elevation.

The total dose for the treatment of forehead lines (20 Units) together with glabellar lines (20 Units) is 40 Units/1.0 ml. When identifying the location of the appropriate injection points in the frontal muscle, assess the overall relationship between the patient's forehead size and the distribution of frontal muscle activity.

Procedure for Safe Disposal of Vials, Syringes, and Used Materials:

Immediately after use, any remaining reconstituted Vistabel solution in the vial and/or syringe should be inactivated before disposal with 2 ml of 0.5% hypochlorite solution or 1% bleach and disposed of according to local procedures.

Vials, syringes, and used materials should not be emptied but should be placed in suitable containers and disposed of according to local regulations.

Recommendations in Case of Accident During Handling of Botulinum Toxin

In case of an accident when handling the product, either the dried powder or the reconstituted product, immediate measures should be taken, as described below:

? Any spill should be cleaned up with an absorbent material soaked in a sodium hypochlorite solution (bleach solution) if it is the dried powder product, or with a dry absorbent material if it is the reconstituted product.

? Contaminated surfaces should be cleaned with an absorbent material soaked in a sodium hypochlorite solution (bleach solution) and then dried.

? If a vial is broken, proceed as indicated above; carefully collect the glass fragments and clean up the product, avoiding skin cuts.

? If the product comes into contact with the skin, wash with a sodium hypochlorite solution (bleach solution) and then rinse thoroughly with plenty of water.

? If the product comes into contact with the eyes, rinse carefully with plenty of water or with an eye cleaning solution.

? If the operator is injured (cut or pricked), proceed as indicated above and take appropriate medical measures depending on the injected dose.

Product Identification

To ensure that the product is authentic Vistabel from Allergan, look for two transparent warranty seals containing the Allergan silver and translucent logo, located on the top and bottom of the Vistabel box flaps, and a holographic film on the vial label. To view this film, examine the vial under the light of a desk lamp or a fluorescent light source. Rotating the vial back and forth between your fingers, look for the horizontal lines of rainbow color on the label and confirm that the word "Allergan" appears within the rainbow lines.

Do not use the product and contact your local Abbvie office if:

• The horizontal lines of rainbow color or the word "Allergan" are not present on the vial label.
• The warranty seals are not intact and present on both flaps of the box.
• The Allergan translucent logo on the warranty seals is not clearly visible or has a black circle with a diagonal line (prohibited sign).

In addition, two removable stickers have been added to the label of the Vistabel vial, which include the batch number and expiration date of the product. These stickers can be removed and attached to the patient's medical history for traceability purposes. Once the stickers are removed from the label of the Vistabel vial, the word "used" will appear, ensuring that the product is authentic Vistabel manufactured by Allergan.