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
Please read this leaflet carefully before using this medicine because it contains important information for you.

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. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

The medicine contains two active substances: isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal skin infections.
Diflucortolone valerate belongs to a class of medicines called corticosteroids with strong anti-inflammatory activity; it reduces skin inflammation and relieves symptoms such as itching, burning, and pain.
Travocort is indicated for initial treatment of superficial fungal infections of the skin associated with significant inflammatory or eczematous skin changes, e.g. of the hands, interdigital areas 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 skin lesions,
for skin changes caused by viral infections (e.g. chickenpox, shingles, herpes),
for lesions caused by rosacea, acne vulgaris, perioral dermatitis, or local reactions following vaccination.

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

If there is a concurrent bacterial infection, the doctor will prescribe appropriate antibacterial treatment.
Avoid contact of the medicine with eyes and mucous membranes. If the medicine gets into the eyes, rinse thoroughly with water.
Use on large areas of skin 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 long durations, or when applied 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 vaginal diaphragms. Therefore, they may become ineffective as mechanical contraceptives or as protection against sexually transmitted infections. For more detailed information, consult a doctor or pharmacist. Travocort should be used with particular caution and for short periods on facial skin and in children. The risk of systemic effects of topically applied corticosteroids is higher in children than in adults.
Maintaining good hygiene is essential during treatment with Travocort. To prevent recurrence of the disease, the following measures should be taken: change underwear, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them; dry thoroughly between the toes 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 considering the benefit-risk ratio. During pregnancy, particular care should be taken to avoid using the medicine on large skin areas, for prolonged periods, or under occlusive dressings.

Breastfeeding
It is unknown whether Travocort passes into human 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 on large skin areas,
for prolonged periods.

Effect on fertility
There is no data on any 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 as directed by a doctor or pharmacist. If you have any doubts,
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, the doctor may continue treatment with an antifungal medicine not containing a corticosteroid, particularly 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 will cause acute poisoning after 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 regimen.
If you have any further doubts concerning 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 below according to their frequency of occurrence:
Common (affects more than 1 in 10 patients)

skin irritation or burning sensation at the application site.

Uncommon (affects 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), inflammation of hair follicles at the application site, excessive body hair growth,
dilation of superficial blood vessels (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.
Occurrence of adverse effects in newborns cannot be ruled out if their mothers used the medicine for a prolonged period during pregnancy or breastfeeding, or applied it over a large skin surface area.
For example, reduced adrenal cortex function or decreased child's resistance 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 those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects 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 effects allows the collection of additional information on the safety of the medicine.

5. How to store Travocort

Keep the medicine out of 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 stated month.
Medicines must 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. Contents of the pack and other information

What Travocort contains

The active substances are: isokonazol nitrate and diflucortolon valerate. 1 g of cream contains 10 mg (1%) of isokonazol nitrate and 1 mg (0.1%) of diflucortolon valerate.
Other components are: polysorbate 60, sorbitan stearate, cetostearyl alcohol, liquid paraffin, white vaseline, disodium edetate, purified water.

What Travocort looks like and contents of the pack
Travocort is a white-yellow, opaque cream.
The pack consists of an aluminium tube internally coated with epoxy resin and externally coated with polyester, with a tamper-evident ring and a cap made of HDPE, placed in a cardboard box containing 30 g of cream.
For further information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Greece, the country of export: 103339/28-11-2019
Parallel import authorisation number: 57/25