Consumer Information for: JUBLIA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

JUBLIA is used on the toenail (topical) to treata fungal infection (onychomycosis) caused by certain fungi (Trichophyton species). It is not known if JUBLIA is safe and effective in children.

What it does

JUBLIA blocks the production of ergosterol, an important part of the fungal membrane leading to loss of proper function, fungal death and reduction of the infection.

When it should not be used

Do not use JUBLIA if you are allergic to efinaconazole or any of the ingredients in JUBLIA (see What the nonmedicinal ingredients are).

What the medicinal ingredient is

Efinaconazole

What the non-medicinal ingredients are

Alcohol, Butylated Hydroxytoluene, C12-15 Alkyl Lactate, Citric Acid,Cyclomethicone, DiisopropylAdipate, DisodiumEdetate, and Purified Water.

What dosage form it comes in

JUBLIA contains efinaconazole 10% w/w in a clear solution for topical application. One bottle of JUBLIA contains approximately 380 applications.

Warnings and precautions

JUBLIA is not for eyes, mouth, nose, lips or intravaginal use. Avoid contact of JUBLIA with your eyes, mouth, nose, lips, or open wounds. It is for external use on toenails and immediately adjacent skin only. In case of accidental contact rinse thoroughly with water. Consult with your healthcare professional if symptoms persist.

Flammable:
JUBLIA is flammable; keep away from heat or flame.

Avoid the use of toenail polish, cosmetic toenail products, or having non-healthcare professional providedpedicures while using JUBLIA.

BEFORE you use JUBLIA talk to your doctor or pharmacist if you:

  • are allergic to efinaconazole or any of the ingredients in JUBLIA.
  • have any other skin or nail infection.
  • are pregnant or plan to become pregnant. It is not known if JUBLIA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if JUBLIA passes into your breast milk.
  • have any HIV infections, uncontrolled diabetes, other infections or a history or signs of immunosuppression (e.g. you can get infections easily).
  • Interactions with this medication

    Drug interaction studies have not been done for JUBLIA.

    Tell your healthcare professional about all the medicines and skin products you use, including prescription and non-prescription medicines, vitamins, and herbal supplements. Use of othernail fungus therapies with JUBLIA has not been assessed.

    Proper use of this medication

    For use on toenails.

    Use JUBLIA only on the affected toenail(s) as directed by your healthcare professional.

    To help clear up your infection completely, it is important that you keep using JUBLIA for the prescribed treatment period determined by your doctor, even if your symptoms begin to clear up. Stopping JUBLIA too soon may cause the infection to restart.

    Usual adult dose:
    Apply JUBLIA once daily to clean, dry toenails.If you shower, bath or wash your feet before applying JUBLIA,wait at least 10 minutes for your feet and toenails to dry. Let JUBLIA dry before covering the treated toenail(s) with bedding, socks or other clothing. No removal of dead, damaged, or infected tissue is needed.

    The big toenail requires 2 applications. All other toenails require 1 application.

    TOENAIL

    Clip your toenails every four weeks and always discard the clippings. Be sure to clip unaffected toenails before clipping affected toenails. To avoid the possibility of spreading the infection, do not share toenail clippers with others. Be sure to clean the toenail clippers after each use. Daily clipping of the toenails is not needed.

    Apply JUBLIA as follows:

    Step 1: Remove the cap from the JUBLIA bottle.


    Step 2: Before the FIRST APPLICATION on DAY 1: Hold the bottle upside down directly over the affected toenail and gently squeeze the bottle to wet the brush. The entire brush will become moistened with the solution.

    Step 3: For all applications: a) Hold the bottle upside down and with the moistened brush attached to the bottle, apply JUBLIA by brushing it gently onto the affected toenail(s). The bottle may be gently squeezed to re-wet the brush if needed.


    b) Gently spread the solution around the cuticle, folds of the skin next to the sides of the toenail, and underneath the end of the toenail.


    Step 4: For the big toenail, repeat the JUBLIA application a second time. Gently brush the solution around the cuticle, nail folds of the skin next to the sides of the toenail, and on the end of the toenail and surrounding skin


    Do not squeeze the bottle while spreading the solution.
    Do not press or rub the brush firmly against the toenail.

    Step 5: After applying JUBLIA, the entire toenail and surrounding skin should briefly glisten with a layer of the solution. Let the treated area dry before covering it with bedding, socks or other clothing.

    Step 6: Replace the cap tightly on the bottle when finished and store upright.

    Step 7: Wash your hands with soap and water after applying JUBLIA.

    Overdose:

    If you think you have used too much JUBLIA, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

    Missed Dose:
    Try not to miss any doses. If you miss a dose of JUBLIA, apply it as soon as possible. However,if it is almost time for your next dose, skip the missed dose and resume the normal dosing schedule of once a day. Do not double the doses and nevermake up for the missed dose. Use as prescribed by your healthcare professional.
    Side effects and what to do about them

    Like all medicines, JUBLIA can cause side effects, although not everybody gets them.

    Possible side effects ofJUBLIA include: skin irritation around the toenail such as redness, itching, burning, or stinging in the surrounding skin. Stop use of JUBLIA and call your healthcare professional if you develop a severe skin rash or the skin becomes very red, itchy, swollen, blistered, or crusted.

    These are not all the possible side effects you may feel when using JUBLIA. If you experience any side effects not listed here, contact your healthcare professional.

    Serious side effects and what to do about them
    Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Sop taking drug and call your doctor or pharmacist
    Common
    Skin reactions (skin irritation around the toenail such as redness, itching, burning, or stinging in the surrounding skin)    
    Uncommon
    Serious skin reactions (skin develops a rash, becomes very red, itchy, swollen, blistered or crusted)    
    This is not a complete list of side effects. For any unexpected effects while takingJUBLIA, contact your doctor or pharmacist
    How to store

    Keep JUBLIA and all medicines out of the reachand sight of children.

    Store at controlled room temperature (15-30°C).

    Store in an upright position.

    Keep away from heat or open flame.

    Keep the bottle tightly closed when not in use.

    Reporting side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

    This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor:

    Bausch Health, Canada Inc.
    2150 St. Elzéar Blvd., West
    Laval, Quebec, H7L 4A8
    1-800-361-4261

    Or online at https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/drugproduct-database.html

    This leaflet was prepared by Bausch Health, Canada Inc.

    Last revised:January 20, 2020