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Vaniqa Information
The problem
of unwanted facial hair extends beyond the normal need for bleaching, tweezing, hot waxing or the use of other
depilatory
applications.
Many women with excess facial hair suffer from low self-confidence and/or
feel less feminine secondary to the facial hair.
Vaniqa works
by actively inhibiting an enzyme located in the root of the hair follicle,
ornithine decarboxylase, which is necessary for cellular division and
subsequently hair growth. Vaniqa does not interfere with the female hormones.
The medication works actively on growing hair cells. These hair cells
are in staggered growth patterns, therefore, Vaniqa may take 4-8 weeks
to become fully effective. Women should continue to use their normal depilatory
applications until Vaniqa becomes fully affective.
Women may
continue to use their daily moisturizer, sunscreens, skin rejuvenation
medications, cosmetics etc. in conjunction with Vaniqa. Individuals should
wait approximately five minutes following the application of Vaniqa, and
then apply their products in a normal fashion. (please consult your dermatologist
prior to applying other prescription medications such as cortisone, etc.)
It is important
to note that Vaniqa did not show to increase sensitivity to the sun in
clinical studies. Potential side effects of Vaniqa include but are not
limited to the following such as stinging, burning or itching sensations
and redness (more likely if immediately applied after shaving), folliculitis
and acne. These are unusual and affect less than 1% of all users.
Vaniqa is
not recommended in children under the age of 12 or in pregnant or nursing
women. If you are in your child-bearing years you should consult with
your gynecologist/obstetrician prior to using the medication.
Individuals
should apply Vaniqa twice a day to areas where excessive hair is prevalent.
The use of Vaniqa should be limited to the area surrounding the lips and
under the chin. Following application the treated area should not be washed
for at least 4 hours. The medication should not be reapplied within an
eight-hour period. Clinical studies have shown that unwanted facial hair
will return to before treatment values approximately eight weeks following
the discontinued use of the medication.
Individuals
will realize that Vaniqa is working usually within the first eight weeks
of treatment. Most women notice that they are using their depilatory applications
agents less frequently during this time period. Clinical studies have
shown significant results in more than 60% of those individuals treated.
While Caucasian women have had a slightly better rate of response than
African American women, Vaniqa has still been successful for all races
involved in clinical studies. Studies were conducted with Caucasians and
African Americans, Hispanics, Asians, and Native Americans.
Additional Information
This section contains more
information concerning VANIQA that you should read prior to
beginning treatment. This section does not list all the benefits and risks
of VANIQA and does not take the place of discussions with your physician
or healthcare professional about your condition or your treatment. If
you have questions, talk with your healthcare professional.
What is
VANlQA?
VANIQA (pronounced “VAN-i-ka”)
is a prescription medication applied to the skin for the reduction
of unwanted facial hair in women. The active ingredient in
VANIQA is eflornithine hydrochloride. VANIQA also contains ceteareth-20,
cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben,
mineral oil, PEG-100 stearate, phe-noxyethanol, propylparaben, stearyl
alcohol and water.
How does
VANIQA work?
VANIQA interferes with an
enzyme found in the hair follicle of the skin needed for hair growth. This
results in slower hair growth and improved appearance where VANIQA is
applied.
VANIQA does not permanently
remove hair or “cure” unwanted facial hair. It is not a depilatory.
Your treatment program should include con-tinuation of any hair removal
technique you are currently using. VANIQA will help you manage your condition
and improve your appearance. Improvement in the condition occurs gradually.
Don’t be discouraged if you see no immediate improvement. Be patient.
Improvement may be seen as early as 4 to 8 weeks of treatment. Improvement
may take longer in some individuals. If no improvement is seen after 6
months of use, discontinue use. Clinical studies show that in about 8
weeks after stopping treatment with VANIQA, the hair will return to the
same condition as before beginning treatment.
Who should
not use VANIQA?
You should not use VANIQA
if you are allergic to any of the ingredients in the cream. All ingredients
are listed on the tube and at the beginning of this leaflet. You should
not use VANIQA if you are less than 12 years of age.
What should
you tell your physician before using VANIQA?
If you are allergic to any
of the ingredients, tell your physician. If you are pregnant or plan
to become pregnant, discuss with your physician whether you should use
VANIQA during pregnancy. No clinical studies have been performed in pregnant
women. If you are breast-feeding, consult your physician before using
VANIQA. It is not known if VANIQA is passed to infants through breast
milk. If you are taking any prescription medicines, non-prescription medicines
or using any facial or skin creams, check with your physician before use
of VANIQA.
How should I use VANIQA?
Use VANIQA only for the condition
for which it was prescribed by your physician. Do not give it
to other people or allow other people to use it. You will need to continue
your normal procedures for hair removal until desired results have been
achieved. You may then be less bothered by the time spent in removing
hair or the frequency of hair removal. VANIQA is to be used twice daily,
at least eight hours apart, or asdirected by your physician. VANIQA is
for external use only.
Follow the instructions for
application of VANIQA carefully. Apply a thin layer of VANIQA to the affected
areas of the face and adjacent involved areas under the chin and rub in
thoroughly. You should not wash the treatment areas for at least 4 hours
after application of VANIQA (eflornithine hydrochloride) Cream, 13.9%.
VANIQA may cause temporary
redness, rash, burning, stinging or tingling, especially when the skin
is damaged. If irritation continues, stop use of VANIQA and contact your
physician. Avoid getting the medication in your eyes or inside your nose
or mouth. If the product gets in your eyes, rinse thoroughly with water
and contact your physician. If you forget or miss a dose of VANIQA do
not try to “make it up”. Return to your normal application schedule as
soon as you can.
You may use your normal cosmetics
or sunscreen after applying
VANIQA, but you should wait
a few minutes to allow the treatment to
be absorbed before applying
them. If your condition gets worse with treatment, stop use of VANIQA
and contact your physician.
What are
the possible side effects of VANIQA?
VANIQA may cause temporary
redness, stinging, burning, tingling or rash on areas of the skin
where it is applied. Folliculitis (hair bumps) may also occur. If these
persist, consult your physician.
How should
VANIQA be stored?
VANIQA (eflornithine hydrochloride)
Cream, 13.9%, should be stored at 15°C-30°C (59°F-86°F). Do not freeze.
Keep this and all medicines out of the reach of children. This medicine
was prescribed for your particular condition. Do not use it for another
condition or give it to anyone else. This
summary does not include everything there is to know about VANIQA.
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