IMPORTANT SAFETY INFORMATION (Continued)
There has not been a confi rmed serious case of spread of toxin eff ect
away from the injection site when BOTOX® (onabotulinumtoxinA) has
been used at the recommended dose to treat chronic migraine.
BOTOX® may cause loss of strength or general muscle weakness,
vision problems, or dizziness within hours to weeks of taking BOTOX®.
If this happens, do not drive a car, operate machinery, or do other
dangerous activities.
Do not take BOTOX® if you: are allergic to any of the ingredients in
BOTOX® (see Medication Guide for ingredients); had an allergic
reaction to any other botulinum toxin product such as Myobloc®
(rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin®
(incobotulinumtoxinA); have a skin infection at the planned injection site.
The dose of BOTOX® is not the same as, or comparable to, another
botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. They
include itching, rash, red itchy welts, wheezing, asthma symptoms, or
dizziness or feeling faint. Get medical help right away if you experience
symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as
ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk of serious side eff ects
including diffi culty swallowing and diffi culty breathing from typical
doses of BOTOX®.
Tell your doctor about all your medical conditions, including if you:
have or have had bleeding problems; have plans to have surgery; had
surgery on your face; weakness of forehead muscles; trouble raising
your eyebrows; drooping eyelids; any other abnormal facial change;
are pregnant or plan to become pregnant (it is not known if BOTOX®
can harm your unborn baby); are breastfeeding or plan to (it is not
known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including
prescription and nonprescription medicines, vitamins, and herbal
products. Using BOTOX® with certain other medicines may cause
serious side eff ects. Do not start any new medicines until you have
told your doctor that you have received BOTOX® in the past.
Tell your doctor if you have received any other botulinum toxin product
in the last 4 months; have received injections of botulinum toxin such
as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly
which product you received); have recently received an antibiotic by
injection; take muscle relaxants; take an allergy or cold medicine; take a
sleep medicine; take aspirin-like products or blood thinners.
Other side eff ects of BOTOX® include: dry mouth, discomfort or pain
at the injection site, tiredness, headache, neck pain, and eye problems:
double vision, blurred vision, decreased eyesight, drooping eyelids,
swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with
your doctor.
You are encouraged to report negative side eff ects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please refer to the Summary of Information
about BOTOX® on the following page.
www.headaches.org
|
National Headache Foundation
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