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    What is the most important information I should know about Vaniqa?

• Vaniqa is for external use only.
• Continue to use Vaniqa even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with Vaniqa should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with Vaniqa.

    What is Vaniqa?

• Eflornithine interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where Vaniqa is applied.
• Vaniqa is used to reduce unwanted facial hair in women. Vaniqa does not permanently remove hair or "cure" unwanted facial hair. Vaniqa will help you manage your condition and improve your appearance.
• Vaniqa may also be used for purposes other than those listed in this medication guide.

    Who should not use Vaniqa?

• Do not use Vaniqa if you have had an allergic reaction to it in the past.
• Vaniqa is in the FDA pregnancy category C. This means that it is not known whether Vaniqa will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.
• It is also not known whether eflornithine passes into breast milk. Do not use Vaniqa without first talking to your doctor if you are breast-feeding a baby.
• Vaniqa has not been approved for use by children younger than 12 years of age.

    How should I use Vaniqa?

• Apply Vaniqa exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Vaniqa does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Vaniqa will help you manage your condition and improve your appearance.
• Vaniqa is for external use only.
• Vaniqa is usually applied twice daily, at least eight hours apart, or as directed by your doctor.
• Wash your hands before and after each application of Vaniqa.
• Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying Vaniqa. Apply a thin layer of Vaniqa to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.
• Cosmetics or sunscreen may be used after applying Vaniqa, but you should wait a few minutes to allow the treatment to be absorbed before applying them.
• Do not wash the treatment areas for at least 4 hours after application of Vaniqa.
• Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If Vaniqa gets in your eyes, rinse them thoroughly with water and contact your doctor.
• Vaniqa may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of Vaniqa to once a day. If irritation continues, stop using Vaniqa and contact your doctor.
• Continue to use Vaniqa even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with Vaniqa should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with Vaniqa.
• Store Vaniqa at room temperature away from moisture and heat. Do not allow the medication to freeze.

    What happens if I miss a dose?

• If you miss a dose of Vaniqa, skip the dose you missed and apply your next regularly scheduled dose as directed. Do not apply a double dose of this medication or try to "make up" a missed dose.

    What happens if I overdose?

• An overdose of Vaniqa is not likely to occur. If the cream has been ingested, or if you suspect an overdose has occurred, contact your doctor, hospital emergency room, or poison control center for advice.

    What should I avoid while using Vaniqa?

• Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If Vaniqa gets in your eyes, rinse thoroughly with water and contact your doctor.

    What are the possible side effects of Vaniqa?

• Vaniqa may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of Vaniqa to once a day. If irritation continues, stop using Vaniqa and contact your doctor.
• Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

    What other drugs will affect Vaniqa?

• Before using Vaniqa, talk to your doctor if you are taking any other prescription or over-the-counter medications, especially if you are using any other topical preparations. You may not be able to use Vaniqa, or you may require a dosage adjustment or special monitoring during treatment.
• Drugs other than those listed here may also interact with Vaniqa. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

    Where can I get more information?

• Your pharmacist has additional information about Vaniqa written for health professionals that you may read.