Travocort

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Travocort

(10 mg + 1 mg)/g (1% + 0.1%), cream
Isoconazole nitrate + Diflucortolone valerate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Travocort and what is it 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 is Travocort and what is it used for

The medicine contains two active substances: isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal skin diseases.
Diflucortolone valerate belongs to a group of corticosteroids with strong effects, reduces
skin inflammation and alleviates symptoms such as itching, burning, and pain.
Travocort is indicated for the initial treatment of superficial fungal skin infections with concomitant
severe inflammatory or eczematous skin changes, e.g. on the hands, interdigital spaces of the feet, and
in the groin and genital areas.

2. Important information before using Travocort

When not to use Travocort:

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

Warnings and precautions

Before starting treatment with Travocort, the patient should discuss it with their doctor or pharmacist.

• In case of concomitant bacterial infection, the doctor will prescribe antibacterial treatment.
• The patient should avoid contact between the medicine and the eyes and mucous membranes. If the medicine gets into the eyes, they should be rinsed thoroughly with water.
• Using the medicine on large skin areas or for a long time, especially under occlusive dressings, increases the risk of systemic side effects.
• If the patient has glaucoma, they should tell their doctor.
• During treatment with Travocort, there is a risk of developing glaucoma if the medicine is used under dressings, on large skin areas, for a long time, or if it is applied to the skin near the eyes.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• If Travocort is used in the genital area, some of its ingredients may damage latex condoms and diaphragms. Therefore, they may not be effective as mechanical contraceptive measures or as measures to prevent sexually transmitted diseases. For more detailed information, the patient should consult their doctor or pharmacist. The medicine should be used with caution and for a short time on the skin of the face and in children. Children are at greater risk of systemic effects of topical corticosteroids than adults.
• It is essential to follow hygiene rules during treatment with Travocort. To prevent relapse, the patient should: change their personal underwear, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them, dry the areas between the toes thoroughly after washing, change their socks or tights daily and wash them in very hot water or boil them.

Travocort and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No studies have been conducted on the interaction of Travocort with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The doctor will carefully assess whether the benefits to the mother outweigh the potential risk to the fetus.
Pregnancy
Travocort should not be used during the first trimester of pregnancy. The decision to use the medicine during the remaining period of pregnancy is made by the doctor, after weighing the benefits and risks. During pregnancy, the patient should especially avoid using the medicine on large skin areas, for a long time, or under dressings.
Breastfeeding
It is not known whether Travocort passes into breast milk, but it cannot be ruled out that it may pose a risk to the health of the breastfed child.
During breastfeeding, the patient should avoid using Travocort:

• on the breast skin,
• under dressings or on large skin areas,
• for a long time.

Fertility
There are no data on the negative effect of Travocort on fertility.

Driving and using machines

It is unlikely that Travocort will affect the ability to drive or use machines.

Travocort contains a small amount of cetyl alcohol.

Travocort contains cetyl alcohol, which may cause skin reactions (e.g. contact dermatitis).

3. How to use Travocort

This medicine should always be used as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Dosage

A thin layer of Travocort should be applied to the affected skin area twice a day.
Treatment with Travocort should be stopped when the skin condition improves. The treatment should not last longer than two weeks. If necessary, the doctor may continue treatment with an antifungal medicine that does not contain a corticosteroid, especially when using the medicine in the groin and external genital areas.
Following hygiene rules is essential during treatment with Travocort (see section 2).

Use in children and adolescents

No dose adjustment of Travocort is necessary in children from 2 years of age and adolescents.
The medicine should not be used in children under 2 years of age.

Using more than the recommended dose of Travocort

It is unlikely that Travocort will cause acute poisoning after a single use of an excessive amount of the medicine or after accidental ingestion.

Missing a dose of Travocort

The patient should not take a double dose to make up for a missed dose.
The next dose should be taken at the scheduled time, and the treatment should be continued as prescribed.
If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Travocort can cause side effects, although not everybody gets them.
The following side effects, observed in clinical trials, are presented according to their frequency:
Common(occurring in more than 1 in 10 patients)

• skin irritation or burning sensation at the application site.

Uncommon(occurring in more than 1 in 100 patients)

• redness, dryness at the application site,
• skin striae.

Unknown(frequency cannot be estimated from the available data)

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

Additionally, as with the use of other topical corticosteroids, the following side effects may occur (frequency unknown):
skin thinning (atrophy), folliculitis at the application site, excessive body hair growth, superficial vessel dilation (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes, and (or) skin allergic reactions to any of the ingredients of Travocort. Systemic side effects may occur because the ingredients of the medicine can penetrate the skin.
It cannot be ruled out that side effects may occur in newborns whose mothers used the medicine for a long time during pregnancy or breastfeeding, or used it on large skin areas. For example, decreased adrenal cortex function or decreased child immunity may occur.
If any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 side effects will help gather more information on the safety of the medicine.

5. How to store Travocort

Keep out of the sight and reach of children.
Store at a temperature below 30°C.
Do not use Travocort after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Travocort contains

• The active substances of the medicine are isoconazole nitrate and diflucortolone valerate. 1 g of cream contains 10 mg (1%) of isoconazole nitrate and 1 mg (0.1%) of diflucortolone valerate.
• The other ingredients are polysorbate 60, sorbitan stearate, cetyl alcohol, liquid paraffin, white petrolatum, disodium edetate, purified water.

What Travocort looks like and contents of the pack

Travocort is a white-yellow, non-transparent cream.
The packaging of the medicine is an aluminum tube coated with epoxy resin on the inside, with a polyester coating on the outside, with a tamper-evident ring and a HDPE cap, in a cardboard box, containing 30 g of cream.
For more detailed information, the patient should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 103339/28-11-2019

Parallel import authorization number: 57/25

Date of approval of the leaflet: 10.02.2025

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