Travocort

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Travocort (Travocort Creme), (10 mg + 1 mg)/g
cream
Isoconazoli nitras + Diflucortoloni valeras
Travocort and Travocort Creme are different trade names for the same medicine.
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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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

Travocort 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 action; it reduces skin inflammation and relieves symptoms such as itching, burning, and pain.
Travocort is indicated for the initial treatment of superficial fungal skin infections 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 isocanozole 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.

• In case of concomitant bacterial superinfection, 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.
• Application over 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 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 vaginal 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.
• Particular caution and short-term use are advised when applying the medicine to facial skin and in children. Children are at higher risk of systemic effects from topically applied corticosteroids than adults.
• Maintaining good hygiene is essential during treatment with Travocort. To prevent recurrence of infection:
• 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 currently or recently used, as well as any medicines you plan to use.
No studies on interactions between Travocort and other medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your 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 Travocort can be used during the remainder of pregnancy is decided 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 unknown 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.

Fertility
There is no data available regarding any 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 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 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, particularly when the medicine is used in the groin or 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 after a single application of an excessive amount
or accidental ingestion of the medicine.
Missed dose of Travocort
Do not use 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 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 striae.

Not known (frequency cannot be estimated from the available data)

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

Additionally, as with topical application of other corticosteroids, the following adverse effects may occur (frequency not known):
skin thinning (atrophy), folliculitis at the application site, excessive hair growth (hypertrichosis), dilation of superficial blood vessels (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes and/or cutaneous 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.
Adverse reactions in newborns cannot be ruled out if their mothers used the medicine for prolonged periods 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, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE TRAVOCORT MEDICINE

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
The medicine must be used within 13 weeks of first opening.
Do not use Travocort cream after the expiry date stated on the packaging.
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 in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Travocort contains

• The active substances in this medicinal product are: isokonazol nitrate and diflucortolone valerate. 1 g of cream contains 10 mg of isokonazol nitrate and 1 mg of diflucortolone valerate.
• Other components of the medicinal product are: white vaseline, 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 medicinal product is packed in an aluminium tube with a cap made of HDPE, containing 15 g of cream, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Austria, 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
20090 Segrate (Milan)
Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorisation number, country of export: 16.909
Parallel import authorisation number: 303/15