Label: Information for the User

VISTABEL 4 Units Allergan /0.1ml Powder for Injectable Solution

Botulinum Toxin Type A

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Vistabel and how is it used

2. What you need to know before starting to use Vistabel

3. How to use Vistabel

4. Possible adverse effects

5. Storage of Vistabel

6. Contents of the package and additional information

Vistabelis a peripheral muscle relaxant.

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

Vistabelis indicated for temporary improvement in the appearance of:

•Vertical lines between the eyebrows produced by maximum frowning and/or,

•Worry lines produced by maximum smiling and/or,

•Lines on the forehead produced by maximum raising of the eyebrows,

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

Do not use Vistabel:

• If you are allergic to botulinum toxin type A or any of the other components of this medication (listed in section 6).
• If you have myasthenia gravis or Eaton-Lambert syndrome (chronic diseases that affect the muscles).
• If you have an infection at the sites where the injection is to be administered.

Warnings and precautions

There have been rare reports of adverse reactions possibly related to the distant spread of the toxin from the administration site (e.g., muscle weakness, difficulty swallowing, or involuntary and inappropriate passage of food or liquids into the airways). Patients receiving the recommended doses may experience excessive muscle weakness.

• Seek medical attention immediately
• • If you notice that it is difficult to swallow, speak, or breathe after treatment.

• Do not recommend the use ofVistabelin patients with a history of dysphagia (difficulty swallowing) and altered deglutition.

• Do not recommend the use ofVistabelin individuals under 18 years old.

• There is limited experience with the use ofVistabelin patients over 65 years old.

• 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 treatments should not be less than three months.

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

• After treatment, a drooping eyelid may occur.

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

Use of Vistabel with other medications:

Do not recommend the use of botulinum toxin with aminoglycoside antibiotics, spectinomycin, or other medications that interfere with neuromuscular transmission.

Inform your doctor if you have recently been injected with a medication containing botulinum toxin (the active ingredient in Vistabel), as this may increase the effect of Vistabel too much.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Do not recommend usingVistabelduring pregnancyor in women of childbearing age who are not using contraceptive methods.

Do not recommend usingVistabelin breastfeeding women.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Caution is advised to drivers or individuals operating machinery due to the risk of muscle weakness and/or generalization, dizziness, and visual disturbances associated with the use of this medication, which could make driving or operating machinery hazardous. Do not drive or operate machinery until symptoms have subsided.

Vistabel contains Sodium

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

Administration Form and Route

Vistabelshould only be administered by doctors with the necessary qualifications and experience in this treatment and in the use of appropriate equipment.

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

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

The usual dose is 20 Units. They will inject the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel in each of the 5 points indicated for injection.

Improvement in the severity of the lines located between the eyebrows produced by raising the eyebrows to the maximum generally occurs during the week following treatment, with the maximum effect observed at 5 or 6 weeks after injection. It has been demonstrated that the effect of the treatment lasts up to 4 months after injection.

Wrinkles produced by smiling to the maximum:

Vistabel is injected directly into the affected area on the side of each eye.

The usual dose is 24 Units. They will inject the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel in each of the 6 points indicated for injection (3 injection points on the side of each eye).

Improvement in the severity of the wrinkles produced by smiling to the maximum generally occurs during the week following treatment. It has been demonstrated that the effect of the treatment lasts an average of 4 months after injection.

Lines on the forehead 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. They will inject the recommended volume of 0.1 milliliters (ml) (4 Units) of Vistabel in each of the 5 points indicated for injection.

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

Improvement in the intensity of the lines on the forehead produced by raising the eyebrows to the maximum generally occurs during the week following treatment. It has been demonstrated that the effect of the treatment lasts approximately 4 months after injection.

General Information:

If you are to receive treatment simultaneously for wrinkles produced by smiling to the maximum and vertical lines between the eyebrows produced by raising the eyebrows to the maximum, you will receive a total dose of 44 Units.

If you are to receive treatment simultaneously for the 3 types of facial lines (wrinkles produced by smiling to the maximum, vertical lines between the eyebrows produced by raising the eyebrows to the maximum, and lines on the forehead 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 have not been evaluated for more than 12 months.

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

Like all medications, Vistabel can cause side effects, although not everyone will experience them.

Generally, side effects appear in the first few days after injection and are temporary. Most reported side effects had a 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 maximum frowning. Approximately 8% of patients may experience side effects after injection of Vistabel for crow's feet produced by maximum smiling when receiving treatment only for this or at the same time as for vertical lines between the eyebrows produced by maximum frowning.Approximately 20% of patients may experience side effects after injection of Vistabel for forehead lines produced by maximum eyebrow raising when receiving treatment along with treatment for vertical lines between the eyebrows produced by maximum frowning. Approximately 14% of patients may experience side effects when treatment for forehead lines along with vertical lines is combined with treatment for crow's feet produced by maximum smiling.

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

Very rarely, with botulinum toxin, side effects have been reported that may be related to the distant spread of the toxin from the injection site (e.g., muscle weakness, difficulty swallowing, constipation, or pneumonia caused by the presence of food or liquids in the airways, which can be fatal). It is not recommended to inject Vistabel in patients with a history of dysphagia (difficulty swallowing) and altered deglutition.

IF YOU EXPERIENCE ANY DIFFICULTY BREATHING, SWALLOWING, OR SPEAKING AFTER RECEIVING TREATMENT WITH VISTABEL, CONTACT YOUR DOCTOR IMMEDIATELY.

If you experience urticaria, inflammation, including facial or throat inflammation, sneezing, sensation of dizziness, or lack of breath, contact your doctor immediately.

The botulinum toxin can 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/itching, swelling, and/or petechiae.

If you are concerned about this, consult your doctor.

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

Injectable treatments for temporary improvement of vertical lines between the eyebrows

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

*Some of these side effects may be related to the injection procedure.

Injectable treatments for temporary improvement of forehead lines and vertical lines between the eyebrows produced by frowning, 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 eyelid drooping was 5 days after treatment.

*Some of these side effects may be related to the injection procedure.

The following list includes additional side effects reported for Vistabel since its commercialization for the treatment of glabellar lines, crow's feet, and other clinical indications:

• Severe allergic reaction (hives under the skin, difficulty breathing)
• Urticaria
• Loss of appetite
• Nerve damage
• Difficulty moving the arm and shoulder
• Problems with voice and speech
• Weakness of facial muscles
• Decreased sensation of the skin
• Weakness
• Chronic disease affecting muscles (myasthenia gravis)
• Numbness
• Pain/weakness starting from the spine
• Blackouts
• Falling of facial muscles on one side
• Increased intraocular pressure
• Eyelid drooping
• Difficulty closing the eye completely
• Strabismus
• Blurred vision, difficulty seeing clearly
• Decreased hearing
• Noises in the ear
• Sensation of dizziness or "spinning" (vertigo)
• Aspiration pneumonia (inflammatory lung disease caused by accidental aspiration of food, drink, saliva, or vomit)
• Respiratory difficulty
• Respiratory problems, respiratory depression, and/or respiratory insufficiency
• Abdominal pain
• Dyspepsia
• Dry mouth
• Difficulty swallowing
• Nausea
• Vomiting
• Hair loss
• Eyelid drooping
• Psoriasiform skin lesions (red, thickened, dry, and scaly)
• Different types of skin eruptions with red spots
• Excessive sweating
• Hair loss
• Itching
• Eruption
• Muscle wasting
• Muscle pain
• Problems with nerve conduction to the muscle/muscle retraction
• Discomfort
• General malaise
• Fever
• Dry eye
• Muscle spasms/localized muscle contractions
• Swelling of the eyelid

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not useVistabelafter the expiration date that appears on the vial and the carton after EXP: The expiration date is the last day of the month indicated.

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

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

Composition of Vistabel

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

1unit of Clostridium botulinum

- The other components are human albumin and sodium chloride.

Appearance of the product and contents of the package

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

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid, Spain

Responsible for manufacturing:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

This leaflet was approved in February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

INFORMATION DIRECTED ONLY TO THE DOCTOR OR HEALTHCARE PROFESSIONAL

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

Vistabelis indicated for temporary improvement in the appearance of:

•Vertical lines of moderate to severe between the eyebrows produced by maximum frowning (glabellar lines) and/or,

•Wrinkles of the lateral canthus of moderate to severe produced by maximum smiling and/or,

•Forehead lines of moderate to severe produced by maximum raising of the eyebrows,

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

The reconstitution must be performed in accordance with good practices, particularly with regard to asepsis.Vistabelmust be reconstituted with asterile normal saline solution without preservatives (sodium chloride 0.9% injectable solution). When using a vial of 50 Units, 1.25 ml ofsterile normal saline solution without preservatives (sodium chloride 0.9% injectable solution)must be introduced into a syringe to obtain a reconstituted injection solution with a concentration of 4 Units/0.1 ml. When using a vial of 100 Units, 2.5 ml ofsterile normal saline solution without preservatives (sodium chloride 0.9% injectable solution)must be introduced into a syringe to obtain a reconstituted injection solution with a concentration of 4 Units/0.1 ml.

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

To avoid the denaturation ofVistabel, inject the solvent slowly into the vial and gently rotate the vial to avoid the formation of bubbles. Discard the vial if the vacuum does not allow the solvent to enter. Once reconstituted, the reconstituted injection solution must be visually inspected before use to ensure that it is a clear, colorless to slightly yellow solution without particles.

Vistabelmust be used for the treatment ofonepatient 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 the injection, the needle must be oriented superiorly and medially. To reduce the risk of ptosis, do not exceed the maximum dose of 4 Units per injection point or the number of injection points. In addition, injections near the levator palpebrae muscle must be avoided, particularly in patients with larger brow-depressor (superior tarsal) complexes. Injections into the corrugator muscle must be made in the central part of the muscle, at least1 cmabove the eyebrow arch.

Injections for the wrinkles of the lateral canthus must be performed with the bevel of the needle upwards and oriented away from the eye. To reduce the risk of ptosis, do not exceed the maximum dose of 4 Units per injection point or the number of injection points. In addition, injections must be performed towards the outside of the orbital rim, thus 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, evaluate the global relationship between the patient's forehead size and the distribution of frontal muscle activity.

Procedure to follow for safe disposal of vials, syringes, and used materials:

Immediately after use, all the reconstituted injection solution ofVistabelthat remains in the vial and/or syringe must be deactivated, before its disposal, with 2 ml of 0.5% hypochlorite solution or 1% bleach and must be disposed of in accordance with the local procedures established.

Vials, syringes, and used materials must not be emptied but must be deposited in suitable containers and disposed of in accordance with the local regulations established.

Recommendations in case of accident during manipulation of the botulinum toxin

In case of accident when handling the product, whether the dried powder under vacuum or reconstituted, the following measures must be taken immediately:

?Clean up any spill, whether with a material soaked in a sodium hypochlorite solution (bleach solution) if it is the dried powder under vacuum, or with a dry material if it is the reconstituted product.

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

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

?If it splashes on the skin, wash it with a sodium hypochlorite solution (bleach solution) and then thoroughly rinse with plenty of water.

?If it splashes in the eyes, clean it carefully with plenty of water, or with an eye cleaning solution.

?If the operator himself is injured (if he cuts or pricks himself), proceed as indicated above and take the necessary medical measures in accordance with the injected dose.

Product identification

To ensure that the product is the authenticVistabelfrom Allergan, please check two transparent guarantee seals containing the silver and translucent Allergan logo and located on the top and bottom flaps of theVistabelbox, and a holographic film on the vial label. To view this film, examine the vial under a desk lamp or a fluorescent light source. Rotating the vial back and forth between your fingers, look for the horizontal lines of the 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 the rainbow color or the word “Allergan” are not present on the vial label.
• The guarantee seals are not intact and present on both flaps of the box.
• The translucent Allergan logo on the seals is not clearly visible or has a black circle with a diagonal line (prohibition sign).

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