JUBLIA

PACKAGE LEAFLET

Package leaflet: Information for the patient

Jublia 89 mg/ml cutaneous solution

Efinaconazole

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Jublia is and what it is used for
2. What you need to know before using Jublia
3. How to use Jublia
4. Possible adverse reactions
5. How to store Jublia
6. Contents of the pack and other information

1. What Jublia is and what it is used for

Jublia contains the active substance efinaconazole, which belongs to a group of medicines known as antifungal agents. It kills a wide range of fungi that can cause nail infections.
Jublia is used to treat mild to moderate onychomycosis (fungal infections of the nails) of the toenails caused by dermatophytes (fungi) in adults, adolescents, and children aged 6 years and older.

2. What you need to know before using Jublia

Do not use Jublia

• if you are allergic to efinaconazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Jublia:

• if more than 3 nails are affected.
• if you have a history of immune system disorders.
• the safety and efficacy of daily use of JUBLIA for longer than 48 weeks have not been established.

Other important warnings

• Jublia is for external use only.
• Avoid contact with eyes or mucous membranes (e.g., mouth and nostrils). In case of accidental eye contact, rinse thoroughly with running water.
• Keep the bottle tightly closed when not in use.
• The product is flammable; keep away from sources of heat and open flames.
• The duration of the disease, the extent of nail plate involvement, and nail thickness may influence treatment outcomes.
• If symptoms of hypersensitivity or persistent irritation occur at the application site (e.g., severe redness, itching, or swelling) during use of Jublia, stop treatment and inform your doctor, who will initiate appropriate therapy.

Children and adolescents
Jublia must not be used in children under 6 years of age due to lack of clinical experience in this age group.
Other medicines and Jublia
Topical administration of Jublia results in very low systemic exposure; therefore, the potential for pharmacological interactions is considered low.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Due to the low systemic exposure following topical application of Jublia, no risk to the unborn child or breastfed infant is expected. However, you should use Jublia during pregnancy or while breastfeeding only if your doctor considers it necessary.
Driving and operating machinery
Jublia has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.
Jublia contains ethanol (96 percent)
This medicine contains 479 mg of alcohol (ethanol (96 percent)) per ml. It may cause a burning sensation on damaged skin.
Jublia contains butylated hydroxytoluene (E321)
This medicine contains 0.89 mg of butylated hydroxytoluene per ml. It may cause localized skin reactions (e.g., contact dermatitis) or irritation to eyes and mucous membranes.

3. How to use Jublia

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. For topical use on the toenails and only on the immediately adjacent skin (lateral and proximal nail folds and the skin beneath the nail).
Instructions for use
Apply Jublia to the affected toenails once daily for 48 weeks, using the integrated continuous-flow applicator. When applying Jublia, ensure that the nail, nail folds, nail bed, hyponychium, and the underside of the nail plate are completely covered.
Before applying Jublia, clean and thoroughly dry the affected areas. Wait at least 10 minutes after showering, bathing, or washing before applying Jublia.
Do not disassemble the continuous-flow brush applicator to avoid damaging the medicine.
Step 1: Remove the cap from the Jublia bottle.

Step 2: Hold the bottle upside down directly over the affected nail. Before applying Jublia, gently squeeze the bottle to moisten the entire brush with the solution.
During application of Jublia, do not squeeze the bottle or press or rub the brush firmly against the nail.

Step 3: Apply Jublia to each affected nail. Use the brush to spread Jublia over the entire surface of the nail.

Step 4: Apply Jublia, including the cuticle, the skin folds alongside the sides of the nail, and under the nail.

Step 5: Repeat steps 2 to 4 to apply Jublia to each affected nail. If necessary, repeat step 2 to re-moisten the brush.
Step 6: Wait until Jublia is completely dry before covering the treated area with bed linen, socks, or other clothing. Application in the evening before going to bed is recommended.
Step 7: After applying Jublia to the affected nails, replace the cap on the bottle and screw it on tightly.
Step 8: Wash your hands with soap and water after applying Jublia.
Jublia should not be removed with any solvent or abrasive (e.g., nail filing). It is sufficient to wash the nails thoroughly with water.
Treatment should be continued without interruption until complete healing and full regrowth of healthy nail.
Use in children and adolescents
The dosage for children aged 6 years and older is the same as for adults.
If you accidentally ingest Jublia
Contact your doctor, pharmacist, or nearest hospital if you or someone else has swallowed the nail polish. If possible, bring any remaining medicine and this leaflet with you.
If you forget to use Jublia
Do not use a double dose to make up for a forgotten dose. If you miss an application, apply Jublia as soon as possible and then continue treatment as before. If you only remember at the time of your next scheduled application, apply Jublia once and continue as usual. It is important to try to use Jublia at the correct times, as missed applications may reduce the effectiveness of treatment.
If you stop using Jublia
If you stop treatment with Jublia before a healthy nail has fully regrown, the fungi may not have been eliminated. In this case, the nail condition may worsen again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common: may affect up to 1 in 10 people:

• Dermatitis at the application site,
• Blisters at the application site,
• Pain at the application site,
• Ingrown nail.

Uncommon: may affect up to 1 in 100 people:

• Onychomadesis (partial or complete nail detachment).

Not known (frequency cannot be estimated from the available data):

• Skin exfoliation,
• Discoloration of nails,
• Erythema (redness).

Additional side effects in children and adolescents
Side effects in children aged 6 years and older are expected to be similar to those observed in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jublia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening, keep the bottle tightly closed to prevent evaporation of the solution.
After first opening, use the bottle within 3 months.
This solution is flammable. Keep away from heat sources and open flames.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Jublia contains

• The active substance is efinaconazole. One ml of cutaneous solution contains 89 mg of efinaconazole.
• The other components are cyclomethicone 5, diisopropyl adipate, C12-15 alkyl lactate, butylhydroxytoluene (E321), citric acid, disodium edetate, purified water and ethanol (96 percent).

Description of the appearance of Jublia and contents of the pack
Jublia is a cutaneous solution ranging from clear to pale yellow, supplied in a white plastic bottle with an inner cap and an integrated brush applicator. Packs contain either 1 x 4 ml of cutaneous solution or a multipack containing 8 ml (2 x 4 ml) of cutaneous solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre 151
08022 Barcelona
Spain

Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany