Vaniqa Topical

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of eflornithine in children under the age of 12 years with use in other age groups. However, this medicine is not expected to cause different side effects or problems in older children than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

This medicine comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use this medicine, be sure to ask your health care professional.

This medicine is usually used on the face and nearby involved areas under the chin only. Do not get the medicine in your eyes, nose, or mouth. Rinse thoroughly with water and contact your doctor if the medicine gets in the eyes

You need to continue your normal hair removal procedures while using this medicine, and the medicine should be applied at least five minutes after the unwanted hair has been removed. You should wait until the medicine dries before applying cosmetics or sunscreen.

Do not wash the treated areas for at least 4 hours after applying the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For reduced rate of facial hair growth in women.
    • Adults and children 12 years of age or older—Coat the problem areas on the face and nearby areas under the chin with the medicine two times a day with the second treatment coming at least eight hours after the first.
    • Children under 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If skin irritation occurs, reduce the frequency of treatments. If irritation continues, stop using the medicine and contact your doctor.

If no improvement is seen after six months of treatment, stop using the medicine and contact your doctor.

If condition gets worse while you use the medicine, stop the medicine and contact your doctor.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne
• stinging skin

• Burning or bleeding skin
• chapped, red lips
• chronic acne
• hair bumps
• numbness
• rash
• reddening of skin
• swelling of lips
• tingling skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Burning, stinging, tingling, and redness of the skin may occur. If these effects persist or worsen, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: acne, "hair bumps" (folliculitis).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.