Travocort

Patient Information Leaflet

Warning! Keep this leaflet! 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 the patient.

• Keep this leaflet, as you may need to read it again.
• 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

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

• If there is a concurrent 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 them 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, especially when the medicine is used under occlusive dressings, over large skin areas, for prolonged periods, or when applied to the 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 ingredients 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, contact your doctor or pharmacist.

Particular caution and short-term use are required when applying the medicine to facial skin and in children. In children, the risk of systemic effects from topically applied corticosteroids is greater than in adults.

• Maintaining hygiene is essential during treatment with Travocort. To prevent recurrence of the disease:
• change personal 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 you are currently using, have recently used, or plan to use.
No studies on interactions between Travocort and other medicines have been conducted.
Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 is decided by the doctor after considering 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 a breastfed infant cannot be excluded.
During breastfeeding, avoid using Travocort:

• on the skin of the breasts,
• under dressings or over large skin areas,
• for prolonged periods.

Effect on fertility
There is no data available on the 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 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 in doubt, consult your doctor or pharmacist.
Dosage
A thin layer of Travocort should be applied to the affected area of skin 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
There is no need to adjust the dosage of Travocort 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 if the medicine is accidentally swallowed.
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 dosing regimen.
If you have any further questions about 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 below according to their frequency:
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 determined 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):
thinning (atrophy) of the skin, folliculitis at the application site, excessive body hair growth,
dilation of superficial blood vessels (telangiectasia), perioral dermatitis, skin discoloration, acne-like
and/or skin allergic reactions to any of the components of Travocort. Systemic adverse reactions may
occur, as the components of the medicine can penetrate through the skin.
The occurrence of adverse reactions in newborns whose mothers used the medicine for a prolonged period
during pregnancy or breastfeeding, or applied it over a large skin surface, cannot be excluded.
For example, decreased adrenal cortex function or reduced 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, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Travocort

Keep Travocort out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with 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: isoconazole nitrate and diflucortolone valerate. 1 g of cream contains 10 mg of isoconazole nitrate and 1 mg of diflucortolone valerate.
• Other components are: white soft paraffin, 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 packaging consists of an aluminium tube coated internally with epoxy resin and externally with a polyester layer, containing 30 g of cream, fitted with a tamper-evident ring and a closure cap made of HDPE, packed in a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Manufacturer:
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21, 20054 Segrate (Milan), Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Greece, country of export: 103339/28-11-2019
Parallel import authorisation number: 168/24