VISTABEL 4 Allergan units/0.1 ml, Botulinum Toxin type A Powder for Solution for Injection.
What Is Vistabel And What Is Vistabel Used For?
VISTABEL is a muscle relaxant. VISTABEL works by blocking nerve impulses to any muscle that has been injected. This prevents muscle contractions leading to temporary and recurrent muscle paralysis. VISTABEL is used for the temporary improvement of:
- Vertical wrinkles between the eyebrows that appear when you frown maximally (glabella folds)
- Laugh lines (crow’s kicks) at the edges of the eyes that appear when you smile maximally
- Forehead wrinkles appear when the eyebrows are raised to the maximum
The extent of facial wrinkles has a significant psychological impact on adult patients.
What Did You Need To Know Before Using VISTABEL?
Do Not Use VISTABEL
- 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 at the planned injection site.
Warnings And Precautions:
Side effects possibly related to the spread of toxin from the injection site have been reported in rare cases with botulinum toxin (e.g., muscle weakness, difficulty swallowing, or getting food or liquid into the airways). Patients treated with recommended doses may experience excessive muscle weakness.
See a doctor immediately if:
- You have difficulty swallowing, speaking, or breathing after treatment.
- VISTABEL is not recommended for patients with dysphagia (difficulty swallowing) and impaired swallowing ability.
- VISTABEL is not recommended for people under 18 years of age.
- Experience with the use of VISTABEL in patients over 65 years of age is limited.
- Too frequent or high dosage can increase the risk of forming antibodies.
Antibody formation can cause botulinum toxin type A treatment to fail for other uses. The period between the two treatments must not be shorter than three months to reduce this risk. - In very rare cases, an allergic reaction can occur after botulinum toxin injection.
- Drooping eyelids may occur after treatment.
Inform your doctor about the following:
- You have previously had problems with injecting yourself with botulinum toxin
- You do not experience a significant improvement in your wrinkles one month after the injection
- If you have certain diseases that affect your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy )
- You have inflammation at the planned injection site(s)
- The muscles to be injected are weak or have decreased in size
- You have had surgery or an injury to your head, neck, or chest
- You will soon undergo an operation.
Other Medicines And VISTABEL:
The use of botulinum toxin is not recommended in conjunction with the use of aminoglycoside antibiotics, spectinomycin, or other drugs that affect muscle nerve signals.
Tell your doctor if you have recently been injected with a medicine containing botulinum toxin (the active substance in VISTABEL), as this may increase the effect of VISTABEL too much.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
Pregnancy And Breastfeeding:
VISTABEL is not recommended during pregnancy or for women of childbearing age who are not using contraception. VISTABEL is not recommended for breastfeeding women.
Contact your doctor if you are pregnant, planning to become pregnant, or if you become pregnant during treatment. Your doctor will discuss with you whether you should continue treatment. Ask your doctor or pharmacist for advice before taking any medicine.
Driving Ability And Use Of Machinery:
Drive a car or use machines. You should be especially aware of the risk of general and muscle weakness, dizziness, and visual disturbances associated with this medicine, which may make driving or using machines dangerous. Do not drive or use machines until these symptoms have disappeared.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
VISTABEL Contains Excipients:
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is almost “sodium-free.”
How To Use VISTABEL?
Method of administration and route of administration
- VISTABEL should only be given by doctors who have special skills and knowledge of the treatment and use of the required equipment.
- Vertical wrinkles between the eyebrows that appear when you furrow your forehead to the maximum:
- VISTABEL is injected into your muscles ( intramuscularly ), directly in 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 injection sites.
- Improvement of the wrinkles between the eyebrows that appear when frowning maximally generally occurs within a week of treatment. The maximum effect is achieved 5 to 6 weeks after injection. The treatment effect has been shown to persist up to 4 months after injection.
- Laughter lines at the edges of the eyes that appear when you smile maximally:
- VISTABEL is injected directly into the affected area at the side of 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 injection sites (3 injection sites at the side of each eye).
- Improvement of the laugh lines at the edges of the eyes that appear when smiling maximally generally occurs within a week of treatment. The treatment effect has been shown to persist an average of 4 months after injection.
- Wrinkles that appear when eyebrows are raised to the maximum:
- VISTABEL is injected directly into the muscle in the affected forehead area.
- 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 injection sites.
- The total dose of treating forehead wrinkles (20 units) at the same time as glabella folds (20 units) is 40.
- Improvement of forehead wrinkles that appear when raising the eyebrows to the maximum generally occurs within a week of treatment. The treatment effect has persisted for approximately 4 months after injection.
- General information:
- If you are treated for laugh lines at the edges of the eyes that appear when you smile maximally, at the same time, you are treated for vertical wrinkles between the eyebrows that appear when you frown maximally; you will receive a total dose of 44 units.
- Suppose you are treated for all 3 types of facial wrinkles at the same time (laugh lines at the edges of the eyes that appear when you smile maximally, vertical wrinkles between the eyebrows that appear when you frown maximally, and forehead wrinkles that appear when the eyebrows are maximally raised). In that case, you will receive a total dose of 64 units.
- The period between the two treatments must not be shorter than 3 months.
- The efficacy and safety of repeated injections of VISTABEL after 12 months have not been evaluated.
- If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
Contact your doctor or pharmacist if you have further questions about this medicine.
Possible Vistabel Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Generally, side effects appear within the first few days after injection and are temporary. Most side effects that have been reported are of mild to moderate severity.
About 1 in 4 patients may experience side effects after injecting VISTABEL against the vertical wrinkles between the eyebrows that appear when you furrow your forehead maximally.
About 8% of patients may experience side effects after injection with VISTABEL for laugh lines at the edges of the eye that appear when smiling maximally when treated alone or at the same time as vertical wrinkles between the eyebrows that appear when frowning maximally.
About 20% of patients may experience side effects after injection with VISTABEL against forehead wrinkles that appear when the eyebrows are raised to the maximum at the same time as a treatment for vertical wrinkles between the eyebrows that occur when the forehead is furrowed to the maximum.
About 14% of patients may experience side effects when treating forehead wrinkles simultaneously as a treatment for vertical wrinkles in connection with treatment for laugh lines at the edges of the eyes that appear when you smile maximally.
Side effects can be related to the treatment, injection technique, or both. Drooping eyelids, which may be related to the injection technique, are consistent with the local muscle relaxant effect of VISTABEL.
Adverse reactions possibly related to the spread of toxin from the injection site have been reported very rarely with botulinum toxin (e.g., muscle weakness, difficulty swallowing, constipation, or pneumonia due to ingesting food or liquid in the airways, which can be fatal ).
VISTABEL is not recommended for patients with dysphagia (difficulty swallowing) and impaired swallowing ability.
IF YOU HAVE DIFFICULTY BREATHING, SWALLOWING, OR SPEAKING AFTER RECEIVING VISTABEL, CONTACT YOUR DOCTOR IMMEDIATELY.
If you develop hives, swelling of the face or neck, wheezing, fainting, and difficulty breathing, contact your doctor immediately.
The spread of botulinum toxin to nearby muscles is possible when high doses are injected, especially in the neck area.
In connection with an injection, as is usual with injections, the sting itself may cause:
- Pain
- Burning
- Stinging sensation
- Swelling
- Bruising
Talk to your doctor if this is something that worries you. The risk of getting a side effect is described in the following categories:
| Usual | may affect up to 1 in 10 people |
| Less common | may affect up to 1 in 100 people |
Injection for temporary improvement of vertical wrinkles between the eyebrows
| Usual | Headache, numbness, drooping eyelids, nausea, skin redness, skin tightening, local muscle weakness, facial pain, injection site swelling, subcutaneous bruising, injection site pain, injection site irritation |
| Less common | Infection, anxiety, dizziness, eyelid inflammation, eye pain, visual disturbances, blurred vision, dry mouth, swelling (face, eyelids, around the eyes), sensitivity to light, itching, dry skin, muscle twitching, flu symptoms, weakness, fever |
Injection for the temporary improvement of laugh lines at the edges of the eyes with or without simultaneous treatment of vertical wrinkles between the eyebrows that appear when frowning
| Usual | Hematoma (bleeding/bruising) at the injection site*. |
| Less common | Swelling of the eyelid, bleeding at the injection site*, pain at the injection site*, numbness or tingling at the injection site. |
* Some of these side effects may also be caused by the injection procedure.
Injection for the temporary improvement of forehead wrinkles, vertical wrinkles between the eyebrows that appear when you frown with or without simultaneous treatment of laugh lines at the edges of the eyes
| Usual | Headache, drooping eyelids 1, tightening of the skin, drooping eyebrows 2, hematoma or bruising at the injection site*. |
| Less common | Pain at the injection site*. |
1. Droopy eyelids occurred a median of 9 days after treatment
2. Drooping eyebrows appeared at a median of 5 days after treatment
* Some of these side effects may also be caused by the injection procedure.
The following list describes additional adverse reactions reported for VISTABEL since the drug was first marketed for the treatment of glabella folds, 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 or shoulder
- Voice and speech difficulties
- Facial muscle weakness
- Decreased sensation in the skin
- Muscle weakness
- A chronic disease affecting the muscles ( myasthenia gravis )
- Numbness
- Pain or weakness radiating from the spine
- Fainting
- The muscles on one side of the face hang down
- Increased pressure in the eye
- Droopy eyelids
- Difficulty closing the eye completely
- Squint
- Blurred vision
- Difficulty seeing clearly
- Impaired hearing
- Tinnitus
- Dizziness or feeling that “everything is spinning” ( vertigo )
- Aspiration pneumonia ( pneumonia caused by accidental inhalation of food, drink, saliva, or vomit)
- Shortness of breath
- Breathing difficulties
- Respiratory depression
- Respiratory failure
- Abdominal pain
- Diarrhea
- Dry mouth
- Difficulty swallowing
- Nausea
- Vomiting
- Hair loss
- Drooping eyebrows
- Psoriasis-like skin rash (red, thick, dry, and scaly)
- Different types of red blotchy rashes
- Profuse sweating
- Loss of eyebrows
- Itching
- Rash
- Muscle loss
- Muscle pain
- Loss of nerve supply to/shrinkage of the injected muscle
- Malaise
- A general feeling of malaise
- Fever
- Dry eyes
- Local muscle twitching/involuntary muscle contractions
- Swelling of eyelids
How Should VISTABEL Be Stored?
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the bottle and the carton after Ex. data/EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 °C – 8 °C).
- After preparation, immediate use of the solution for injection is recommended. However, it has been shown that the solution for injection can be stored for up to 24 hours in a refrigerator (2°C – 8°C).
Contents Of The Packaging And Other Information:
Contents Declaration
- The active substance is: botulinum toxin type A 1 (0.1 ml of the ready-mixed solution contains 4 Allergan units).1 from Clostridium botulinum.
- Other ingredients are human albumin and sodium chloride.
Appearance And Package Sizes Of The Medicine:
- VISTABEL is supplied as a fine white powder for injection and may be difficult to see at the bottom of a clear glass vial. Before injection, the product must be dissolved in sterile normal saline without preservatives (0.9% sodium chloride solution for injection ). Each vial contains 50 or 100 Allergan units of botulinum toxin type A.
- Each pack contains 1 or 2 bottles.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This medicine is approved in the European Economic Area under the names:
| Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Holland, Ireland, Iceland, Croatia, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, Hungary, Austria. | VISTA TABLE |
| Germany | VISTABEL 4 Allergan-Einheiten/0.1 ml Pulver zur Herstellung einer Injektionslösung |
| Italy | VISTA BEX |