Ciclopirox Olamine Topical solution

What is this medicine?

CICLOPIROX (sye kloe PEER ox) NAIL SOLUTION is an antifungal medicine. It used to treat fungal infections of the nails.

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:

• diabetes mellitus
• history of seizures
• HIV infection
• immune system problems or organ transplant
• large areas of burned or damaged skin
• peripheral vascular disease or poor circulation
• taking corticosteroid medication (including steroid inhalers, cream, or lotion)
• an unusual or allergic reaction to ciclopirox, isopropyl 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 external use only. Follow the directions that come with this medicine exactly. Wash and dry your hands before use. Avoid contact with the eyes, mouth or nose. If you do get this medicine in your eyes, rinse out with plenty of cool tap water. Contact your doctor or health care professional if eye irritation occurs. 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 medicine may be prescribed for children as young as 12 years 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 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 get worse. Four to six months of treatment may be needed for the nail(s) to improve. Some people may not achieve a complete cure or clearing of the nails by this time.

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

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
• severe irritation, redness, burning, blistering, peeling, swelling, oozing

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

• mild reddening of the skin
• nail discoloration
• temporary burning or mild stinging at the site of application

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 at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light by storing the bottle in the carton after every use. This medicine is flammable. Keep away from heat and flame. 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.