Travocort

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Travocort, (10 mg + 1 mg)/g (1% + 0.1%), cream
Isoconazole nitrate + Diflucortolone valerate
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Travocort is and what it is used for
2. Important information before using Travocort
3. How to use Travocort
4. Possible side effects
5. How to store Travocort
6. Contents of the pack and other information

1. What Travocort is and what it is used for

The medicine contains two active substances: isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal skin infections.
Diflucortolone valerate belongs to a group of medicines called corticosteroids with strong action; it reduces skin inflammation and relieves symptoms such as itching, burning, and pain.
Travocort is indicated for the initial treatment of superficial fungal infections of the skin associated with significant inflammatory or eczematous skin changes, e.g., of the hands, interdigital spaces of the feet, as well as the groin and genital areas.

2. Important information before using Travocort

When not to use Travocort:

• if the patient is allergic (hypersensitive) to isokonazol nitrate and diflucortolone valerate or to any of the other ingredients of this medicine (listed in section 6),
• for syphilitic or tuberculous lesions,
• for skin changes caused by viral infections (e.g. chickenpox, shingles, herpes),
• for lesions caused by rosacea, common acne, perioral dermatitis, or local reactions following vaccination.

Warnings and precautions
Before starting treatment with Travocort, discuss this with your doctor or pharmacist.

• In case of concomitant bacterial superinfection, the doctor will initiate appropriate antibacterial treatment.
• Avoid contact of the medicine with eyes and mucous membranes. If the medicine gets into the eyes, rinse thoroughly with water.
• Application over large skin areas or for prolonged periods, especially under occlusive dressings, increases the risk of systemic adverse effects.
• If the patient has glaucoma, inform the doctor. There is a risk of developing glaucoma during treatment with Travocort, particularly when used under occlusive dressings, over large skin areas, for prolonged periods, or when applied to skin near the eyes.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.
• When Travocort is used in the genital area, some of its ingredients may damage latex in condoms and vaginal diaphragms. Therefore, they may become ineffective as mechanical contraceptives or as protection against sexually transmitted diseases. For more detailed information, consult your doctor or pharmacist.

Particular caution and short-term use are required when applying the medicine to facial skin and in children. In children,
there is a higher risk of systemic effects from topically applied corticosteroids
than in adults.

• Maintaining proper hygiene is essential during treatment with Travocort. To prevent recurrence of infection:
• change personal clothing, bed linens, and towels (preferably cotton) daily, and wash them in very hot water or boil them,
• thoroughly dry the spaces between fingers after washing,
• change socks or tights daily and wash them in very hot water or boil them.

Travocort and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No studies on interactions between Travocort and other medicines have been conducted.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will carefully assess whether the benefits to the mother outweigh the potential risks to the fetus.
Pregnancy
Travocort should not be used during the first trimester of pregnancy. Whether the medicine can be used during the remainder of pregnancy is determined by the doctor, after evaluating the benefit-risk ratio. During pregnancy, particular care should be taken to avoid using the medicine over large skin areas, for prolonged periods, or under occlusive dressings.
Breastfeeding
It is not known whether Travocort passes into human milk, but a risk to the health of the breastfed infant cannot be excluded.
During breastfeeding, avoid using Travocort:

• on the skin of the breasts,
• under occlusive dressings or over large skin areas,
• for prolonged periods.

Effect on fertility
There is no data available regarding a negative effect of Travocort on fertility.
Driving and operating machinery
It is unlikely that Travocort affects the ability to drive or operate machinery.
Travocort contains a small amount of cetostearyl alcohol.
Travocort contains cetostearyl alcohol, which may cause skin reactions (e.g. contact dermatitis).

3. How to use Travocort

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
A thin layer of Travocort should be applied to the affected skin area twice daily.
Treatment with Travocort should be discontinued once the skin condition has improved. Treatment usually should not last longer than two weeks. If necessary, the doctor may continue treatment with an antifungal medicine not containing a corticosteroid, especially when treating the groin or external genital areas.
Maintaining proper hygiene is essential during treatment with Travocort (see section 2).
Use in children and adolescents
No dosage adjustment of Travocort is necessary in children aged 2 years and older and adolescents.
Travocort should not be used in children under 2 years of age.
Use of more than the recommended dose of Travocort
It is unlikely that Travocort would cause acute poisoning following a single application of an excessive amount or accidental ingestion of the medicine.
Missed dose of Travocort
Do not apply a double dose to make up for a missed dose.
Apply the next dose at the scheduled time and continue treatment according to the prescribed dosing schedule.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions observed in clinical trials are listed according to their frequency of occurrence:
Common (occur in more than 1 in 10 patients)

• skin irritation or burning sensation at the application site.

Uncommon (occur in more than 1 in 100 patients)

• redness, dryness at the application site,
• skin stretch marks.

Unknown (frequency cannot be determined from available data)

• itching or blistering at the application site,
• blurred vision.

Additionally, as with topical use of other corticosteroids, the following adverse reactions may occur (frequency unknown):
skin thinning (atrophy), inflammation of hair follicles at the application site, excessive body hair growth,
superficial blood vessel dilation (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes and/or skin allergic reactions to any of the components of Travocort. Systemic adverse reactions may also occur, as the components of the medicine can penetrate through the skin.
The occurrence of adverse reactions in newborns cannot be ruled out when mothers have used the medicine long-term during pregnancy or breastfeeding, or applied it over a large skin surface area.
For example, reduced adrenal cortex function or decreased child's immunity to diseases may occur.
If any of the adverse reactions worsen, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Travocort

Keep Travocort out of sight and reach of children.
Store below 30°C.
After first opening, store for up to 3 months at a temperature below 25°C.
Do not use Travocort after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Travocort contains

• The active substances in Travocort are: isocotiazole nitrate and diflucortolone valerate. Each 1 g of cream contains 10 mg (1%) of isocotiazole nitrate and 1 mg (0.1%) of diflucortolone valerate.
• Other ingredients: white soft paraffin, liquid paraffin, cetostearyl alcohol, polysorbate 60, sorbitan stearate, disodium edetate, purified water.

What Travocort looks like and contents of the pack
Travocort is a white-yellow, opaque cream.
The packaging consists of an aluminium tube with an internal epoxy resin layer and a polyethylene cap, containing 25 g of cream, packed in a cardboard box.
For further detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Germany, country of export:
LEO Pharma A/S
Industriparken 55
2750 Ballerup, Denmark
Manufacturer:
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20054 Segrate (Milan), Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Germany, country of export: 88.00.00
Parallel Import Licence Number: 33/23