VISTABEL 4 U Allergan/0.1 ml Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. VISTABEL, 4 units Allergan/0.1 ml, powder for solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is VISTABEL and what is it used for
4. Important information before using VISTABEL
   1. When not to use VISTABEL:
   2. Warnings and precautions
   3. VISTABEL and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Vistabel contains sodium
5. How to use VISTABEL
   1. Method and route of administration
   2. Vertical wrinkles between the eyebrows visible at maximum frown
   3. Crow's feet wrinkles visible at full smile
   4. Horizontal forehead wrinkles visible at maximum eyebrow elevation:
   5. General notes
6. Possible side effects
   1. IF THE PATIENT EXPERIENCES ANY DIFFICULTY BREATHING, SWALLOWING, OR SPEAKING AFTER RECEIVING VISTABEL, THEY SHOULD
   2. CONTACT THEIR DOCTOR IMMEDIATELY.
   3. Use for temporary improvement of the appearance of vertical wrinkles between the eyebrows
   4. Use for temporary improvement of the appearance of crow's feet wrinkles on the sides of the eyes at full smile, with or without simultaneous treatment of vertical wrinkles between the eyebrows
   5. Injection for temporary improvement of the appearance of horizontal forehead wrinkles visible at maximum eyebrow elevation and vertical wrinkles between the eyebrows visible at maximum frown, with or without simultaneous treatment of crow's feet wrinkles on the sides of the eyes
   6. Reporting side effects
7. How to store VISTABEL
8. Contents of the packaging and other information
   1. What VISTABEL contains
   2. What VISTABEL looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of revision of the leaflet: 02/2023
   7. The following information is intended for healthcare professionals only
   8. Procedure for safe disposal of used vials, syringes, and materials:
   9. Recommendations in case of an accident when handling botulinum toxin
   10. Product identification

Leaflet accompanying the packaging: information for the user

VISTABEL, 4 units Allergan/0.1 ml, powder for solution for injection

Botulinum toxin type A

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is VISTABEL and what is it used for
• 2. Important information before using VISTABEL
• 3. How to use VISTABEL
• 4. Possible side effects
• 5. How to store VISTABEL
• 6. Contents of the packaging and other information

1. What is VISTABEL and what is it used for

VISTABEL is a muscle relaxant with a peripheral effect.
VISTABEL works by blocking nerve impulses to all muscles into which it is injected, thus preventing muscle contraction and leading to their temporary and reversible paralysis.
VISTABEL is indicated for the temporary improvement of the appearance of the following wrinkles:

• vertical wrinkles between the eyebrows visible at maximum frown and/or
• crow's feet wrinkles visible at full smile and/or
• horizontal forehead wrinkles visible at maximum eyebrow elevation

when the severity of the wrinkles has a significant psychological impact on adult patients.

2. Important information before using VISTABEL

When not to use VISTABEL:

• if the patient is allergic (hypersensitive) to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with muscle weakness or Eaton-Lambert syndrome (chronic muscle diseases);
• if the patient has an infection at the proposed injection sites.

Warnings and precautions

Very rarely, side effects have been reported after using botulinum toxin, probably related to the spread of the toxin to distant sites from the injection site (e.g., muscle weakness, swallowing difficulties, or pneumonia caused by food or liquid entering the airways). In patients receiving recommended doses, increased muscle weakness may occur.
You should see a doctor immediately:

• If the patient experiences difficulty swallowing, speaking, or breathing after treatment.
• VISTABEL is not recommended for patients with a history of dysphagia (swallowing difficulties) and other swallowing disorders.
• VISTABEL is not recommended for patients under 18 years of age.
• Data on the use of VISTABEL in patients over 65 years of age are limited.
• Too frequent administration or too high doses may increase the risk of antibody formation. The formation of antibodies can lead to the failure of botulinum toxin type A treatment, even in other indications. To limit this risk, the interval between therapeutic treatments should not be less than three months.
• Very rarely, an allergic reaction may occur after injection of botulinum toxin.
• After injection, eyelid ptosis may occur.
• You should inform your doctor:
• if the patient has had problems with previous botulinum toxin injections,
• if there is no significant improvement in the appearance of forehead wrinkles after one month from the first treatment cycle,
• if the patient has various neurological diseases (such as amyotrophic lateral sclerosis or peripheral neuromuscular disorders),
• if the patient has an inflammatory condition at the proposed injection sites,
• if the muscles to be injected are weakened or damaged,
• if the patient has had surgery or injury to the head, neck, or chest,
• if the patient is about to undergo surgery.

VISTABEL and other medicines

It is not recommended to use botulinum toxin in combination with aminoglycoside antibiotics, spectinomycin, or other medicines that affect neuromuscular transmission.
You should tell your doctor if you have recently been injected with a medicine containing botulinum toxin (the active substance of VISTABEL), as this may enhance the effect of VISTABEL to a significant degree.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

The use of VISTABEL is not recommended during pregnancy and in women of childbearing age who do not use contraception.
VISTABEL is not recommended for breastfeeding women.
You should contact your doctor if you become pregnant, plan to become pregnant, or become pregnant during treatment. Your doctor will discuss with you whether to continue treatment.
Before using any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Drivers and machine operators should be aware of the risk of generalized weakness and/or muscle weakness, dizziness, and vision disturbances associated with the use of this medicine, which may pose a risk when driving or operating mechanical equipment. You should not drive or operate machines until these symptoms have resolved.

Vistabel contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., the medicine is considered "sodium-free".

3. How to use VISTABEL

Method and route of administration

VISTABEL should only be administered by doctors with the appropriate qualifications and experience in using this type of treatment and the required equipment.

Vertical wrinkles between the eyebrows visible at maximum frown

VISTABEL is administered by injection into the muscle (intramuscularly), directly into the affected area between the eyebrows.
The standard dose is 20 units. The patient will be injected with the recommended volume of 0.1 milliliters (ml) (4 units) of VISTABEL into each of the 5 injection sites.
Improvement in the appearance of wrinkles between the eyebrows usually occurs within a week of treatment, and the maximum effect is observed 5-6 weeks after injection. The therapeutic effect lasts for up to 4 months after injection.

Crow's feet wrinkles visible at full smile

The doctor will inject VISTABEL directly into the affected areas on the sides of each eye.
The recommended dose is 24 units. 0.1 ml (4 units) of VISTABEL is administered at each of the 6 injection sites (3 injection sites on the sides of each eye).
Improvement in the appearance of crow's feet wrinkles usually occurs within a week of treatment. The therapeutic effect lasts for up to 4 months after injection.

Horizontal forehead wrinkles visible at maximum eyebrow elevation:

VISTABEL is administered by intramuscular injection, directly into the affected area of the forehead.
The standard dose is 20 units. The patient will be injected with the recommended volume of 0.1 milliliters (ml) (4 units) of VISTABEL into each of the 5 injection sites.
The total dose for the treatment of horizontal forehead wrinkles (20 units) in combination with vertical wrinkles between the eyebrows (20 units) is 40 units.
Improvement in the severity of horizontal forehead wrinkles visible at maximum eyebrow elevation usually occurs within a week of treatment. The therapeutic effect lasts for up to 4 months after injection.

General notes

If the glabellar lines are also treated, the total dose of the medicine is 44 units.
If three types of wrinkles are treated simultaneously (crow's feet wrinkles on the sides of the eyes visible at full smile, vertical wrinkles between the eyebrows visible at maximum frown, and horizontal forehead wrinkles visible at maximum eyebrow elevation), the total dose of the medicine is 64 units.
The interval between two treatment cycles should not be less than three months. The safety and efficacy of VISTABEL administered in repeated injections over a period longer than 12 months have not been studied.
In case of doubts about the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, VISTABEL can cause side effects, although not everybody gets them.
Usually, side effects occur within the first few days of injection and are temporary. Most reported adverse events were mild to moderate in severity.
About 1 in 4 patients may experience side effects after injection of VISTABEL for the treatment of vertical wrinkles between the eyebrows. Side effects after injection of VISTABEL for the treatment of crow's feet wrinkles or simultaneous treatment of crow's feet wrinkles and glabellar lines occurred in about 8% of patients. About 20% of patients may experience side effects after injection of VISTABEL for the simultaneous treatment of horizontal forehead wrinkles and vertical wrinkles between the eyebrows. About 14% of patients may experience side effects when the treatment of horizontal forehead wrinkles is combined with the treatment of crow's feet wrinkles on the sides of the eyes visible at full smile. Side effects may be related to the treatment, the injection technique, or both. Eyelid ptosis, which may be related to the injection technique, is a result of the local effect of VISTABEL relaxing the muscles.
Very rarely, side effects have been reported after using botulinum toxin, probably related to the spread of the toxin to distant sites from the injection site (e.g., muscle weakness, swallowing difficulties, constipation, or pneumonia caused by food or liquid entering the airways, which can be fatal). VISTABEL is not recommended for patients with a history of dysphagia (swallowing difficulties) and other swallowing disorders.

IF THE PATIENT EXPERIENCES ANY DIFFICULTY BREATHING, SWALLOWING, OR SPEAKING AFTER RECEIVING VISTABEL, THEY SHOULD

CONTACT THEIR DOCTOR IMMEDIATELY.

If the patient experiences hives, swelling, including swelling of the face or throat, wheezing, fainting, and shortness of breath, they should contact their doctor immediately.

The spread of botulinum toxin to nearby muscles is possible when injecting large doses, particularly in the neck area.
As with any injection, the injection may cause pain, stinging, burning pain, swelling, and/or bruising.
If these symptoms are disturbing, you should talk to your doctor.
The likelihood of a side effect occurring is defined in the following categories:

Use for temporary improvement of the appearance of vertical wrinkles between the eyebrows

Use for temporary improvement of the appearance of crow's feet wrinkles on the sides of the eyes at full smile, with or without simultaneous treatment of vertical wrinkles between the eyebrows

*side effects related to the injection procedure.

Injection for temporary improvement of the appearance of horizontal forehead wrinkles visible at maximum eyebrow elevation and vertical wrinkles between the eyebrows visible at maximum frown, with or without simultaneous treatment of crow's feet wrinkles on the sides of the eyes

1 Median time to onset of eyelid ptosis was 9 days after treatment.
2 Median time to onset of eyebrow ptosis was 5 days after treatment.
*side effects related to the injection procedure.
The following side effects have been reported after the marketing authorization of VISTABEL for the treatment of glabellar lines, crow's feet wrinkles, and other clinical indications:

• severe allergic reactions (angioedema, difficulty breathing),
• hives,
• loss of appetite,
• nerve damage,
• difficulty moving the arm and shoulder,
• voice and speech problems,
• facial muscle weakness,
• decreased skin sensation,
• muscle weakness,
• myasthenia gravis (a chronic disease affecting the muscles),
• numbness,
• pain or weakness starting from the spine,
• fainting,
• drooping of the muscles on one side of the face,
• increased eye pressure,
• eyelid ptosis,
• difficulty closing the eye completely,
• strabismus,
• vision disturbances, decreased visual acuity
• hearing loss,
• tinnitus,
• feeling of dizziness or "spinning",

• aspiration pneumonia (pneumonia caused by accidental inhalation of food, drink, saliva, or vomit),
• shortness of breath,
• breathing difficulties, including respiratory depression and/or respiratory failure,
• abdominal pain,
• diarrhea,
• dry mouth,
• swallowing difficulties,
• nausea,
• vomiting,
• hair loss,
• eyebrow drooping,
• skin changes similar to eczema, rashes on the skin (red, thick, and dry scales),
• various types of red, pinpoint skin rashes,
• excessive sweating,
• eyebrow loss,
• itching,
• rash,
• muscle atrophy,
• muscle pain,
• loss of muscle innervation/contraction of the injected muscles,
• lethargy,
• general malaise,
• fever,
• eye dryness,
• local muscle twitching/involuntary muscle contractions,
• eyelid swelling.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VISTABEL

Keep out of sight and reach of children.
Do not use VISTABEL after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C).
After reconstitution, the solution should be used immediately. However, the product has been shown to maintain its chemical and physical stability for 24 hours at 2°C - 8°C.

6. Contents of the packaging and other information

What VISTABEL contains

• The active substance of VISTABEL is: botulinum toxin type A (0.1 ml of the reconstituted solution for injection contains 4 Allergan units). Clostridium botulinum
• The other ingredients of VISTABEL are: human albumin and sodium chloride.

What VISTABEL looks like and contents of the pack

VISTABEL is a white powder for solution for injection, which may be almost invisible at the bottom of a clear glass vial. Before injection, the product must be reconstituted with sterile sodium chloride solution without preservatives (0.9% sodium chloride injection solution). Each vial contains either 50 or 100 Allergan units of botulinum toxin type A.
Each pack contains 1 or 2 vials.
NOT ALL PACK SIZES MAY BE MARKETED.

Marketing authorization holder

AbbVie Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer

Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, County Mayo
Ireland

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

Date of revision of the leaflet: 02/2023

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The following information is intended for healthcare professionals only

Units of botulinum toxin are different depending on the medicinal product and cannot be compared. The recommended Allergan units are not equivalent to the units of other botulinum toxin products.
VISTABEL is indicated for the temporary improvement of the appearance of the following wrinkles:

• vertical wrinkles between the eyebrows of moderate or severe severity visible at maximum frown (glabellar lines) and/or
• wrinkles in the area of the lateral canthus of the eye of moderate or severe severity visible at full smile (crow's feet wrinkles) and/or
• horizontal forehead wrinkles of moderate or severe severity visible at maximum eyebrow elevation, when the severity of the wrinkles has a significant psychological impact on adult patients.

Reconstitution of the medicine should be performed in accordance with good practice, with particular attention to aseptic principles. VISTABEL should be reconstituted with sterile sodium chloride solution without preservatives (0.9% sodium chloride injection solution). When using a vial containing 50 units, 1.25 ml of 0.9% sodium chloride injection solution should be drawn into a syringe to prepare a reconstituted solution for injection with a concentration of 4 units/0.1 ml. When using a vial containing 100 units, 2.5 ml of sterile sodium chloride solution (0.9% sodium chloride injection solution) should be drawn into a syringe to prepare a reconstituted solution for injection with a concentration of 4 units/0.1 ml.

The middle part of the rubber stopper should be cleaned with alcohol.
To avoid denaturing VISTABEL, the diluent should be slowly injected into the vial and the vial should be gently rotated to avoid the formation of air bubbles. The vial should be discarded if the vacuum does not cause the diluent to be drawn into the vial. After reconstitution, the solution for injection should be visually inspected before use, checking that it is clear, colorless, or slightly yellowish and free from particulate matter.
VISTABEL should be used exclusively for the treatment of a single patient during a single procedure.
In the treatment of glabellar lines (vertical wrinkles visible at maximum frown of moderate or severe severity), to prevent ectropion, the thumb or index finger should be firmly pressed below the orbital rim before injection. During injection, the needle should be directed upwards and medially. To minimize the risk of eyelid ptosis, the maximum recommended dose of 4 units per injection site should not be exceeded, nor should the recommended number of injection sites. Additionally, injections should be avoided in the area of the levator palpebrae superioris muscle. This is particularly relevant for patients with well-developed muscles that depress the eyebrows (depressor supercilii). Injections into the frown lines should be performed in the middle part of these muscles, at a distance of at least 1 cm above the eyebrow arch.
In the treatment of crow's feet wrinkles (wrinkles in the area of the lateral canthus of the eye of moderate or severe severity visible at full smile), during injection, the needle should be directed upwards and away from the eye.
To minimize the risk of eyelid ptosis, the maximum recommended dose of 4 units per injection site should not be exceeded, nor should the recommended number of injection sites. Additionally, injections should be performed laterally in relation to the orbital rim, maintaining a safe distance to the muscles responsible for elevating the eyelid.
The total dose for the treatment of horizontal forehead wrinkles (20 units) in combination with vertical wrinkles between the eyebrows (20 units) is 40 units/1.0 ml. To identify the appropriate injection sites in the forehead muscle, the overall relationship between the size of the patient's forehead and the distribution of forehead muscle activity should be assessed.

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

Immediately after use and before disposal of the unused reconstituted VISTABEL solution for injection in the vial and/or syringe, the solution should be inactivated by adding 2 ml of diluted sodium hypochlorite solution (0.5% or 1% active chlorine) and disposed of in accordance with local requirements.
Used vials, syringes, and materials should not be emptied but should be disposed of in appropriate containers and then disposed of in accordance with local regulations.

Recommendations in case of an accident when handling botulinum toxin

In the event of an accident when handling the product, whether in the dried or reconstituted state, the following appropriate actions should be taken immediately.

• Spilled solution should be wiped up: with absorbent material moistened with sodium hypochlorite solution (Javel's solution) in the case of the product in the dried state, or with dry absorbent material, in the case of the reconstituted product.
• Contaminated surfaces should be cleaned with absorbent material moistened with sodium hypochlorite solution (Javel's solution) and then dried.
• If the vial is broken, the glass fragments should be carefully collected and the product should be wiped up in the manner described above, without risking skin cuts.
• If the solution spills onto the skin, it should be rinsed with sodium hypochlorite solution (Javel's solution) and then thoroughly rinsed with a large amount of water.
• If the solution gets into the eyes, they should be rinsed thoroughly with a large amount of water or ophthalmic rinsing solution.
• In the event of injury (cuts, punctures) to the person handling the product, the above actions should be taken and appropriate medical action should be taken, depending on the dose injected.

Product identification

To verify that you have received authentic VISTABEL product, manufactured and distributed by Allergan, check the security feature in the form of a semi-transparent silver Allergan logo on the cap and bottom of the carton, as well as the presence of a hologram on the vial label. The hologram on the vial should be checked by looking at the vial under the light of a desk lamp or fluorescent light. By rotating the vial, look for horizontal lines in rainbow colors containing the word "Allergan" on the label.
You should not use the product and should contact the local Allergan office for further information if:

• the rainbow-colored lines with the word "Allergan" are not present on the label
• the protective foil is damaged or missing from the cap or bottom of the carton
• the semi-transparent, silver Allergan logo on the protective foil is unclear or has a black circle with a diagonal line (e.g., a prohibition sign).

Additionally, the label contains stickers with the product name, expiry date, and batch number. The stickers can be peeled off and placed in the patient's card for identification purposes. After peeling off the sticker from the label, the word "USED" will be visible, further confirming the authenticity of the VISTABEL product, manufactured and distributed by Allergan.