BOTOX® is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines); moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile; moderate to severe crow’s feet lines seen at maximum smile and glabellar lines seen at maximum frown when treated simultaneously in adults, when the severity of these lines has an important psychological impact for the patient.
Like all medicines, BOTOX® can have side effects, although not everybody gets them. In general, side effects occur within the first few days following injection. They usually last only for a short time, but they may last for several months and in rare cases, longer. These adverse reactions may be related to treatment, injection technique or both.
Diffusion of botulinum toxin into nearby muscles is possible when high doses are injected, particularly in the neck area.
As expected for any injection procedure, pain/burning/stinging, swelling and/or bruising may be associated with the injection. Speak to your doctor if you are worried about this.
Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (e.g. muscle weakness, constipation, difficulty in swallowing, food or liquid accidentally going into the lungs which in some cases may lead to pneumonia). Injection of BOTOX® is not recommended in patients with a history of dysphagia (difficulty to swallow) and impaired swallowing.
The chance of having a side effect is described by the following categories:
Common - More than 1 out of 100 persons and less than 1 out of 10 persons.
Uncommon - More than 1 out of 1,000 persons and less than 1 out of 100 persons. Injections in the forehead for vertical lines Common side effects are: Headaches, drooping eye lid, skin redness, localised muscle weakness, face pain.
Uncommon side effects are: Infection, anxiety, numbness, dizziness, inflammation of the eyelid, eye pain, visual disturbance, nausea (feeling sick), dry mouth, skin tightness, swelling (face, eyelid, around the eyes), sensitivity to light, itching, dry skin, muscle twitching, flu syndrome, lack of strength, fever. Injections in the fan-shaped lines from the corner of the eyes Common side effects are: Swelling of the eyelid, injection site bleeding and/or bruising. Uncommon side effects are: Injection site pain and/or tingling or numbness.
Injections in the fan-shaped lines from the corner of the eyes, when treated at the same time as injections in the forehead for vertical lines
Common side effects are: Injection site bruising.
Uncommon side effects are: Injection site bleeding and/or pain.
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The following additional side effects have been reported for BOTOX® since it has been marketed: allergic reactions, which can be serious (swelling of the face and airways, difficulty in breathing), loss of nerve supply to/shrinkage of injected muscle, respiratory depression and/or respiratory failure, aspiration pneumonia (lung inflammation caused by accidentally breathing in food, drink, saliva or vomit), chronic disease affecting the muscles (myasthenia gravis), blurred vision, difficulties in seeing clearly, slurred speech, strabismus (squint), numbness, tingling and pain in hands and feet, fainting, pain/numbness/ or weakness starting from the spine, drooping of the muscles on one side of the face, weakness of the face muscles, difficulty moving the arm and shoulder, decreased skin sensation, muscle pain, abdominal pain, diarrhoea, vomiting, loss of appetite, dry mouth, feeling sick, fever, different types of red blotchy skin rashes, feeling generally unwell, speech problems, itching, excessive sweating, hair loss, loss of eyebrows, decreased hearing, noises in the ear, feeling of dizziness or “spinning” (vertigo).
Allergic reactions, difficulties to swallow, speak or breathe, have been reported rarely when botulinum toxin type A has been used for other uses. Visit your doctor immediately if such signs develop after BOTOX® treatment.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. BOTOX® should only be administered by medically qualified physicians with appropriate qualifications and expertise in this treatment and having the required equipment.
Too frequent or excessive dosing of BOTOX® may increase the risk of antibodies in the blood which may lead to failure of treatment with botulinum toxin when used for this and other conditions.
The aesthetic effects of BOTOX® last for an average of 3-4 months but will vary depending on the condition of the skin, area treated, amount of product injected, injection technique and lifestyle factors such as sun exposure and smoking.
After treatment, please avoid extreme facial expressions, alcohol consumption and applying make up for 12 hours.
Please avoid extreme sun exposure, UV light, freezing temperatures and saunas for 2 weeks after treatmen
