Ciclopirox Olamine Topical suspension

What is this medicine?

CICLOPIROX (sye kloe PEER ox) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections of the skin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• large areas of burned or damaged skin
• an unusual or allergic reaction to ciclopirox, mineral oil, benzyl alcohol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for use on the skin only. Do not take by mouth. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Follow the directions on the prescription label. Wash your hands before and after use. If treating infections on the hand, only wash hands before use. Shake well before using. Apply a thin layer to the affected area and rub in gently. Do not use an airtight bandage to cover the affected area unless your doctor or health care professional tells you to. Use at regular intervals. Do not use your medicine more often than directed. Finish the full course prescribed by your doctor or health care professional even if you think you are better. Do not stop using except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 10 years of age or older for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or take extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products without telling your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not improve within 2 to 4 weeks, or of they get worse.

Tell your doctor or health care professional if you develop sores or blisters that do not heal properly. If your skin infection returns after you stop using this medicine, contact your doctor or health care professional.

If you are using this medicine for jock itch, do not wear underwear that is tight-fitting or made from synthetic fibers such as rayon or nylon. Instead, wear loose-fitting, cotton underwear. Dry the area completely after bathing.

If you are using this medicine to treat athlete's foot, carefully dry the feet, especially between the toes, after bathing. Do not wear socks made from wool or synthetic materials such as rayon or nylon. Wear clean cotton socks and change them daily or more if your feet sweat a lot. Try wearing sandals or shoes that are well-ventilated.

An absorbent powder such as talcum powder or an antifungal powder may be applied to the skin to keep it dry. Apply the powder to the affected skin in between applications of this medicine.

Tinea versicolor (sun fungus) may cause you to have patches of skin that are lighter or darker than the surrounding skin areas. Treatment with this medicine will not restore normal skin coloring right away. It may take a few months for the skin appearance to improve.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• skin peeling

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• mild burning, stinging, itching, swelling, or other signs of skin irritation
• redness of skin

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 5 and 25 degrees C (41 and 77 degrees F). Do not freeze. Store away from heat and direct sunlight. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.