Vistabel 4 Units Allergan/0.1 ml powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VISTABEL 4 Allergan Units/0.1ml powder for solution for injection

botulinum toxin type A

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Vistabel is and what it is used for

Vistabel is a peripherally-acting muscle relaxant.

Vistabel works by blocking nerve impulses directed to all muscles into which it has been injected. This prevents the muscles from contracting, resulting in temporary and reversible paralysis.

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

• Vertical lines between the eyebrows caused by maximal frowning, and/or
• Crow's feet caused by maximal smiling, and/or
• Forehead lines caused by maximal raising of the eyebrows,

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

2. What you need to know before using 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 myasthenia gravis or Eaton-Lambert syndrome (chronic diseases affecting the muscles).
• If there is an infection at the sites where injection is intended.

Warnings and precautions

Talk to your doctor or pharmacist before using Vistabel.

Very rarely, adverse effects possibly related to the distant spread of the toxin away from the site of administration have been reported (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 exaggerated muscle weakness.

Seek immediate medical attention if you notice difficulty swallowing, speaking, or breathing after treatment.

• The use of Vistabel is not recommended in patients with a history of dysphagia (difficulty swallowing) or impaired swallowing.
• The use of Vistabel is not recommended in individuals 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 result in treatment resistance. This could reduce the effectiveness of future treatments with botulinum toxin type A, even for other indications. To minimize this risk, the interval between treatments should not be less than three months.
• Very rarely, an allergic reaction may occur following administration of botulinum toxin.
• Ptosis (drooping of the eyelid) may occur after treatment.

Please inform your doctor:

• If you have previously experienced problems with botulinum toxin injections
• If you do not observe significant improvement in expression lines one month after your first treatment
• If you suffer from any disease affecting the nervous system (such as amyotrophic lateral sclerosis or a peripheral neuromuscular disorder)
• If there is inflammation at the proposed injection site
• If the muscles to be injected are weak or damaged
• If you have had surgery or injury to the head, neck, or chest
• If you are scheduled to undergo surgery soon

Use of Vistabel with other medicines:

The use of botulinum toxin together with aminoglycoside antibiotics, spectinomycin, or other medicines that interfere with neuromuscular transmission is not recommended.

Inform your doctor if you have recently received an injection of a medicine containing botulinum toxin (the active substance in Vistabel), as this may excessively increase the effect of Vistabel.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

The use of Vistabel is not recommended in women who are 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

Patients who drive or operate machinery should be warned of the risk of muscle weakness and/or generalized weakness, dizziness, and visual disturbances associated with the use of this medicine, which could make driving or operating machinery dangerous. 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., essentially "sodium-free".

3. How to use Vistabel

Method and route of administration

Vistabel should only be administered by physicians with appropriate qualifications and experience in this treatment and in the use of suitable equipment.

Vertical lines between the eyebrows caused by maximum frowning:

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 ml (4 Units) of Vistabel at each of the 5 injection sites indicated.

Improvement in the severity of glabellar lines caused by maximum frowning generally occurs within the week following treatment, with maximum effect observed at 5 or 6 weeks after injection. The treatment effect has been shown to last up to 4 months after injection.

“Crow’s feet” lines caused by maximum smiling:

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

The usual dose is 24 Units. You will be injected with the recommended volume of 0.1 ml (4 Units) of Vistabel at each of the 6 injection sites indicated (3 injection sites on each side of the eye).

Improvement in the severity of “crow’s feet” lines caused by maximum smiling generally occurs within the week following treatment. The treatment effect has been shown to last an average of 4 months after injection.

Forehead lines caused by maximum raising of the eyebrows:

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

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

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

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

General information:

If you are receiving treatment simultaneously for “crow’s feet” lines caused by maximum smiling and vertical lines between the eyebrows caused by maximum frowning, you will receive a total dose of 44 Units.

If you are receiving treatment simultaneously for all three types of facial lines (“crow’s feet” caused by maximum smiling, vertical lines between the eyebrows caused by maximum frowning, and forehead lines caused by maximum raising of the eyebrows), 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 Vistabel injections over more than 12 months have not been evaluated.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In general, adverse effects occur in the first few days after injection and are temporary. Most reported adverse effects were mild to moderate in intensity. Approximately 1 in 4 patients may experience adverse effects after injection of Vistabel for glabellar lines caused by maximum frowning. Approximately 8% of patients may experience adverse effects after injection of Vistabel for crow’s feet caused by maximum smiling, when treated only for this indication or simultaneously with treatment for glabellar lines caused by maximum frowning. Approximately 20% of patients may experience adverse effects after injection of Vistabel for forehead lines caused by maximum eyebrow raising, when treated at the same time as glabellar lines caused by maximum frowning. Approximately 14% of patients may experience adverse effects when treatment for forehead lines combined with glabellar lines is also combined with treatment for crow’s feet caused by maximum smiling.

These adverse effects may be related to the treatment, the injection technique, or both. Ptosis (drooping eyelid), which may be related to the technique, is also associated with the local muscle-relaxing action of Vistabel.

Very rarely, adverse effects possibly related to distant spread of the botulinum toxin away from the site of administration have been reported with botulinum toxin (e.g., muscle weakness, difficulty swallowing, constipation, or aspiration pneumonia caused by the entry of food or liquids into the airways, which may be fatal). Injection of Vistabel is not recommended in patients with a history of dysphagia (difficulty swallowing) or impaired swallowing.

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

If you experience hives, swelling including swelling of the face or throat, wheezing, dizziness, or shortness of breath, contact your doctor immediately.

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/itching, swelling, and/or bruising.

If you are concerned about this, consult your doctor.

The likelihood of experiencing an adverse 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 caused by frowning

*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 caused by frowning, treated with or without crow's feet

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

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

The following is a list of additional adverse effects reported 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)
• Urticaria
• Loss of appetite
• Nerve damage
• Difficulty moving the arm and shoulder
• Voice and speech problems
• Weakness of facial muscles
• Decreased skin sensation
• Muscle weakness
• Chronic disease affecting muscles (myasthenia gravis)
• Numbness
• Pain and/or weakness starting from the spine
• Fainting
• Drooping of the muscles on one side of the face
• Increased intraocular pressure
• Eyelid ptosis
• Difficulty completely closing the eye
• Strabismus
• Blurred vision, difficulty seeing clearly
• Hearing loss
• Ringing in the ear
• Dizziness or spinning sensation (vertigo)
• Aspiration pneumonia (lung inflammation caused by accidental aspiration of food, drink, saliva, or vomit)
• Breathing difficulty
• Respiratory problems, respiratory depression and/or respiratory failure
• Abdominal pain
• Diarrhea
• Dry mouth
• Difficulty swallowing
• Nausea
• Vomiting
• Hair loss
• Eyebrow ptosis
• Psoriasis-like skin lesions (red, thickened, dry, scaly patches)
• Various types of skin rashes with red spots
• Excessive sweating
• Loss of eyebrows
• Itching
• Rash
• Loss of muscle mass
• Muscle pain
• Nerve conduction problems to the muscle / retraction of the injected muscle
• Malaise
• General malaise
• Fever
• Dry eye
• Localized muscle spasms / involuntary muscle contractions
• Swelling of the eyelid

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the vial and carton after EXP: The expiry date refers to the last day of the month indicated.

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

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

Do not dispose of any medicine via wastewater or household waste. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Vistabel

• The active substance is: botulinum toxin type A from Clostridium botulinum (0.1 ml of reconstituted solution for injection contains 4 Allergan Units).

• The other components are human albumin and sodium chloride.

Appearance of the product and contents of the container

Vistabel powder for injectable solution is presented as a fine white powder for injection solution, which may be difficult to see at the bottom of a clear glass vial. Before injection, the product must be dissolved in sterile preservative-free normal saline (sodium chloride 0.9% injectable solution). Each vial contains 50 or 100 Allergan Units of botulinum toxin type A.

Each pack contains 1 or 2 vials. Only certain pack 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 summary of product characteristics was reviewed in December 2025

The detailed and up-to-date 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 healthcare professionals:

Botulinum toxin units are not interchangeable between products. Recommended doses in Allergan Units differ from those of other botulinum toxin preparations.

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

• Moderate to severe vertical lines between the eyebrows resulting from maximal frowning (glabellar lines) and/or,
• Moderate to severe crow's feet lines resulting from maximal smiling and/or,
• Moderate to severe forehead lines resulting from maximal raising of the eyebrows,

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

Reconstitution must be performed in accordance with good practice standards, particularly with regard to aseptic technique. Vistabel must be reconstituted with sterile 0.9% sodium chloride injection solution (normal saline) without preservatives. When using a 50 Unit vial, 1.25 ml of sterile 0.9% sodium chloride injection solution without preservatives should be drawn 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 sterile 0.9% sodium chloride injection solution without preservatives should be drawn 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 denaturation of Vistabel, slowly inject the solvent into the vial and gently rotate the vial to avoid formation of bubbles. Discard the vial if the vacuum does not allow the solvent to enter. After reconstitution, visually inspect the solution for injection prior to use to ensure it is a clear, colorless to slightly yellow solution free of particles.

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

Prior to injection into glabellar lines (vertical lines produced at maximum frown of moderate to severe intensity), place the index finger or thumb firmly below the orbital rim to prevent extravasation below it. During injection, the needle should be oriented upward and medially. To reduce the risk of eyelid ptosis, the maximum dose of 4 Units per injection site and the number of injection sites must not be exceeded. In addition, injections close to the eyelid elevator muscle should be avoided, particularly in patients with larger depressor supercilii complexes. Injections into the corrugator muscle should be administered at the central portion of the muscle, at a distance of at least 1 cm above the eyebrow arch.

Injections for crow's feet (lateral canthal lines produced at maximum smile) should be performed with the needle bevel facing upward and oriented away from the eye. To reduce the risk of eyelid ptosis, the maximum dose of 4 Units per injection site and the number of injection sites must not be exceeded. In addition, injections should be administered laterally to the orbital rim, thereby maintaining a safe distance from the muscle controlling eyelid elevation.

The total dose for treatment of forehead lines (20 Units) together with glabellar lines (20 Units) is 40 Units/1 ml. When identifying the appropriate injection sites in the frontalis muscle, consider the overall relationship between the patient's forehead size and the distribution of frontalis muscle activity.

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

Immediately after use, any remaining reconstituted Vistabel injection solution in the vial and/or syringe must be inactivated prior to disposal by adding 2 ml of 0.5% sodium hypochlorite solution or 1% bleach, and then disposed of according to established local procedures.

Used vials, syringes, and materials must not be emptied but should be placed directly into appropriate containers and disposed of in accordance with established local regulations.

Recommendations in case of an accident during handling of botulinum toxin:

In the event of an accident during handling of the product, whether in lyophilized powder form or reconstituted solution, appropriate immediate measures as described below should be taken:

? Clean up any spill using an absorbent material soaked in sodium hypochlorite solution (bleach solution) if the product is in lyophilized powder form, or using a dry absorbent material if the product is reconstituted.

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

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

? If the product splashes onto the skin, wash thoroughly with sodium hypochlorite solution (bleach solution), then rinse meticulously with abundant water.

? If the product splashes into the eyes, carefully rinse with abundant water or with an eye cleaning solution.

? If the operator sustains an injury (cut or needlestick), proceed as described above and take appropriate medical measures based on the injected dose.

Product identification

To ensure the product is authentic Vistabel from AbbVie, check for tamper-evident features on the Vistabel cartons and a holographic film on the vial label. To view this film, examine the vial under the light of a table lamp or fluorescent light source. Rotate the vial back and forth between your fingers and look for rainbow-colored horizontal lines on the label, confirming that the word “abbvie” appears within the rainbow lines.

Do not use the product and contact your local AbbVie office if the rainbow-colored horizontal lines or the word “abbvie” are not present on the vial label.

Additionally, removable labels have been added to the Vistabel vial label, which include the product batch number and expiration date. These labels can be removed and affixed to the patient's record for traceability purposes. Once the labels are removed from the Vistabel vial label, the word “USED” will appear, thereby confirming that the product is authentic Vistabel.