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:
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:
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.
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) | ✔ |
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
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