Efinaconazole Topical Solution

What is this medication?

EFINACONAZOLE (e FEE na KON a zole) is an antifungal medicine. It is used to treat certain kinds of fungal infections of the toenail.

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

COMMON BRAND NAME(S): JUBLIA

What should I tell my care team before I take this medication?

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

• an unusual or allergic reaction to efinaconazole, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for external use only. Do not take by mouth. Follow the directions on the label. Wash hands before and after use. Apply this medicine using the provided brush to cover the entire toenail. 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 your condition is better. Do not stop using except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 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 medication?

Interactions have not been studied. Do not use any other nail products (i.e., nail polish, pedicures) during treatment with this medicine.

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 medication?

Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water.

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

Wait for at least 10 minutes after bathing before applying this medication. After bathing, make sure that your feet are very dry. Fungal infections like moist conditions. Do not walk around barefoot. To help prevent reinfection, wear freshly washed cotton, not synthetic clothing. Tell your doctor or health care professional if you develop sores or blisters that do not heal properly. If your nail infection returns after you stop using this medicine, contact your doctor or health care professional.

What side effects may I notice from receiving this medication?

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
• ingrown toenail

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

• mild skin irritation, burning, or itching

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 medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

This medicine is flammable. Avoid exposure to heat, fire, flame, and smoking.

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.