Travocort

PATIENT INFORMATION LEAFLET: USER INFORMATION

WARNING: Keep the leaflet, the information on the immediate packaging in a foreign language.

Travocort, (10 mg + 1 mg)/g, cream

Isoconazole nitrate + Diflucortolone valerate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of 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 medicines called corticosteroids with strong effects, reduces
skin inflammation and alleviates symptoms such as itching, burning, pain.
Travocort is indicated for the initial treatment of superficial fungal skin infections with concomitant severe inflammatory or eczematous skin changes, e.g. hands, interdigital spaces of the feet and 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 to use Travocort, you should discuss it with your doctor or pharmacist.

• In case of concomitant bacterial infection, the doctor will use antibacterial treatment.
• You should avoid contact of the medicine with 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 surfaces 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 surfaces, for a long time, or if the medicine is applied to the skin close to 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 in condoms and diaphragms. Therefore, they may not be effective as mechanical contraceptives or as a means of preventing sexually transmitted diseases. For more detailed information, you should contact your doctor or pharmacist.
• The medicine should be used with special caution and for a short time on the skin of the face and in children. In children, there is a greater risk of systemic effects of topical corticosteroids than in adults.
• Hygiene rules must be observed during treatment with Travocort. To prevent relapse of the disease, you should:
• change your personal underwear, bedding, and towels (preferably cotton) daily and wash them in very hot water or boil them,
• dry the areas between the fingers well after washing,
• change your socks or tights daily and wash them in very hot water or boil them.

Travocort and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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, you should especially avoid using the medicine on large skin surfaces, 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, you should avoid using Travocort:

• on the breast skin,
• under dressings or on large skin surfaces,
• 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 your ability to drive or use machines.

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 exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your 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 the treatment with an antifungal medicine that does not contain a corticosteroid, especially when using the medicine in the groin and external genital areas.
Observing hygiene rules is necessary 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.
Travocort 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 too much medicine or accidental ingestion of the medicine.

Missing a dose of Travocort

You should not use a double dose to make up for a missed dose.
You should take the next dose at the right time and continue the treatment as prescribed.
If you have any further doubts about using the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

• skin irritation or burning sensation at the application site. Uncommon(affect more than 1 in 100 people)
• 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 dilatation (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 penetrate the skin. It cannot be ruled out that side effects may occur in newborns whose mothers used the medicine during pregnancy or breastfeeding for a long time or on large skin surfaces. For example, decreased adrenal cortex function or decreased child immunity may occur. If any of the side effects get worse or if you experience any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Travocort

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use Travocort after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines you 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 of isoconazole nitrate and 1 mg of diflucortolone valerate.
• The other ingredients are: white petrolatum, 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, non-transparent cream.
The pack contains a tube with 15 g of cream, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Bayer SA-NV, J.E. Mommaertslaan 14, B-1831 Diegem (Machelen), Belgium

Manufacturer:

Bayer HealthCare Manufacturing S.r.l., Via E. Schering 21, I-20090 Segrate (MI), Italy

Parallel importer:

PharmaVitae Sp. z o. o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Authorization number in Belgium, the country of export:BE137417
Parallel import authorization number:459/12
Date of leaflet approval: 30.06.2022