Eflornithine

WHY is this medicine prescribed?

Eflornithine is used to slow the growth of unwanted hair on the face in women, usually around the lips or under the chin. Eflornithine works by blocking a natural substance that is needed for hair to grow and is located in your hair follicle (the sac where each hair grows).

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Eflornithine comes as a cream to apply to the skin. It is usually applied twice a day. To help you remember to apply eflornithine cream, apply it around the same times every day, such as in the morning and in the evening. You should wait at least 8 hours between applications of eflornithine. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply eflornithine cream exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

Eflornithine cream slows hair growth but does not prevent it. You should continue to use your current method of hair removal (e.g., shaving, plucking, cutting) or treatment while using eflornithine cream. It may take four weeks or longer before you see the full benefit of eflornithine cream. Do not stop applying eflornithine without talking to your doctor. Stopping use of eflornithine will cause hair to grow as it did before treatment. You should notice improvement (less time spent using your current method of hair removal) within 6 months of beginning treatment with eflornithine. If no improvement is seen, your doctor will likely ask you to stop using eflornithine.

To use eflornithine cream, follow these steps:

1. Wash and dry the affected area(s).
2. Apply a thin layer to affected area(s) and rub in until absorbed.
3. Apply eflornithine cream only to affected skin areas. Do not allow the cream to get into your eyes, mouth, or vagina.
4. You should wait at least 4 hours after applying eflornithine cream before washing the area where it was applied.
5. You should wait at least 5 minutes after using your current method of hair removal before applying eflornithine.

You may apply cosmetics or sunscreen after an application of eflornithine cream has dried.

You may feel temporary stinging or burning if you apply eflornithine to broken skin.

What SPECIAL PRECAUTIONS should I follow?

Before using eflornithine,

• tell your doctor and pharmacist if you are allergic to eflornithine or any other medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.

• tell your doctor if you have or have ever had severe acne.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using eflornithine, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it, if at least 8 hours has passed since your previous application. However, if it is almost time for the next application, skip the missed dose and continue your regular application schedule. Do not apply extra cream to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Eflornithine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stinging, burning, or tingling of the skin
• redness of the skin
• skin rash
• acne
• swollen patches of skin that are reddened and contain a buried hair

Some side effects can be serious. The following symptom is uncommon, but if you experience it, stop using eflornithine and call your doctor immediately:

• severe irritation of the skin

Eflornithine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze eflornithine.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

You should not swallow eflornithine. If you apply extremely high doses (several tubes daily) of eflornithine to your skin you also may experience an overdose. If you swallow adapalene or apply extremely large amounts to your skin, call your local poison control center at 1-800-222-1222.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.