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Product ID: *CICPIR8
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
CICLOPIROX LACQUER - TOPICAL
(cyc-low-PIE-rocks)
COMMON BRAND NAME(S): PENLAC
USES: This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ciclopirox and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before starting treatment, remove any loose nail material using nail clippers or a file. If you have diabetes or numbness in your fingers/toes, talk to your doctor before filing or trimming your nails. It may be safer for your doctor to file or remove your nails. Use this medication on the nails and skin next to the nails only. Apply ciclopirox as directed by your doctor, usually once daily at bedtime. Using the applicator provided, apply this medication evenly over the entire affected nail and to the area of the skin next to the nail (5 millimeters or 1/5 of an inch around the nail). If the applicator can reach the undersurface of the nail and the skin under the nail, apply the medication to those areas as well. Avoid contact with skin that is not right next to the affected nail. Do not use nail cosmetic products (such as nail polish) on the treated nails. Do not apply the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, rinse with plenty of water. Let the medication dry (around 30 seconds) before putting on socks or stockings. Do not wash the treated area for at least 8 hours. Every 7 days, remove the medication from the nail by applying alcohol. Then trim the nail and file away any loose nail material. Since this product is flammable, do not use this product near heat or open flame. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Continue to use this medication for the full time prescribed, even if symptoms disappear. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition worsens or does not improve after 6 months of treatment. It may take up to one year for the nail to be clear or almost clear.
SIDE EFFECTS: Redness/burning of treated skin or changes in shape/color of nail may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. 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 immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing at the application site. 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, numbness in fingers/toes (such as diabetic neuropathy). Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.
OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact a poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.
NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light, heat, or open flame. To protect the medication from light, store the bottle in the carton after each use. Keep bottle tightly closed. To prevent the cap from sticking to the bottle, avoid getting the medication on the bottle threads. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.
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