Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Travocort
(10 mg + 1 mg)/g (1% + 0.1%), cream
Isoconazoli nitras + Diflucortoloni valeras
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Travocort is and what it is used for
Important information before using Travocort
How to use Travocort
Possible side effects
How to store Travocort
Contents of the pack and other information

1. What Travocort is and what it is used for

This 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, which 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., on the hands, between the toes, in the groin area, and on the genital organs.

2. Important information before using Travocort

When not to use Travocort:

if the patient is allergic (hypersensitive) to isoconazole nitrate and diflucortolone valerate or to any of the other ingredients of this medicine (listed in section 6),
for syphilitic or tuberculous skin lesions,
for skin changes caused by viral skin diseases (e.g. chickenpox, shingles, herpes),
for lesions caused by rosacea, common acne, perioral dermatitis or local reactions after 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 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 areas of skin or for prolonged periods, particularly 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, especially 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 components may damage latex in condoms and diaphragms. Therefore, they may become ineffective as mechanical contraceptives or as protection against sexually transmitted infections. For more detailed information, consult your doctor or pharmacist. Travocort should be used with particular caution and only for short periods on facial skin and in children. In children, the risk of systemic effects from topically applied corticosteroids is greater than in adults.
Maintaining proper hygiene is essential during treatment with Travocort. To prevent recurrence of infection, the following measures are recommended:
change personal underwear, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them,
dry thoroughly 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 using, has recently used, or plans to 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 will be decided by the doctor after evaluating the benefit-risk ratio. During pregnancy, special 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 breast milk, but a risk to 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 are no data regarding a negative effect of Travocort on fertility.

Driving and operating machinery
It is unlikely that Travocort will affect 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 exactly as directed by your doctor or pharmacist. If in doubt,
consult your 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, your doctor may continue treatment with an antifungal medicine that does not contain a corticosteroid, especially when treating areas such as the groin or external genital regions.
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 after a single application of an excessive amount or after 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 regimen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects 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 estimated from available data)

itching or blistering at the application site,
blurred vision.

Additionally, as with topical use of other corticosteroids, the following adverse effects may occur (frequency unknown):
skin thinning (atrophy), folliculitis at the application site, excessive hair growth (hypertrichosis), 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 effects may also occur, as the components of the medicine can penetrate through the skin.
Adverse effects in newborns cannot be ruled out if their mothers used the medicine for prolonged periods or over large skin areas during pregnancy or breastfeeding.
For example, reduced adrenal cortex function or decreased child's immunity to diseases may occur.
If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Travocort

Keep out of the sight and reach of children.
Store below 30°C.
Do not use Travocort after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Package contents and other information

What Travocort contains

The active substances in Travocort are: isokonazol nitrate and diflucortolone valerate. 1 g of cream contains 10 mg of isokonazol nitrate and 1 mg of diflucortolone valerate.
Other ingredients are: white vaseline, liquid paraffin, cetostearyl alcohol, polysorbate 60, stearyl sorbitan, disodium edetate, and 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 internally coated with epoxy resin, externally coated with polyester, with a tamper-evident ring and a cap made of HDPE, packed in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Responsible entity in Greece, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing authorization number in Greece, country of export: 103339/28-11-2019
Parallel import authorization number: 323/24