Jublia 10% Topical Solution - 8ml Bottle

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.

EFINACONAZOLE - TOPICAL

(EF-in-a-KON-a-zole)

COMMON BRAND NAME(S): Jublia

USES: This medication is used to treat toenail infection caused by fungus. It works by stopping the growth of certain types of fungus. Efinaconazole belongs to a class of drugs known as azole antifungals. This medication treats only fungal infections. It will not work for other types of infection, such as those caused by bacteria. Unnecessary use or overuse of any drug used to treat infection can lead to its decreased effectiveness.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using efinaconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before applying this medication, clean and dry the infected toenail(s). Wait at least 10 minutes after showering, bathing, or washing before applying. Use this medication only on the infected toenail(s) as directed by your doctor, usually once daily for 48 weeks. If this medication is used on a child, an adult should apply it for them. Using the provided brush, apply to the infected toenail(s). Be sure to completely cover the toenail, toenail folds, toenail bed, and under the edges of the toenail. Wash your hands after using it. Avoid getting this medication on any other part of your body. If this accidentally happens, wipe off the medication and rinse thoroughly with water. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Continue using it for the full time prescribed. Nail fungus treatment usually must be continued a long time so that healthy nails can grow and replace the infected toenail(s). Stopping the medication too early may allow fungus to continue to grow, which may result in a return of the infection. Tell your doctor if your condition does not improve or if it worsens. Since this product can catch on fire, do not use it near heat or an open flame (see also Storage section).

SIDE EFFECTS: Irritation or pain at the application site, blisters, or ingrown toenail may occur. If any of these effects persist or worsen, stop using this medication and 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. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 efinaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (such as clotrimazole, fluconazole, ketoconazole); 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. Before having surgery, tell your doctor 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 drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can 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 condition unless your doctor directs you to do so. 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 apply more of this medication to try to catch up.

STORAGE: Store the bottle tightly closed and in an upright position at room temperature. Do not freeze. This product can catch on fire. Keep away from heat or open flame. Keep all medications 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.

Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.