Travocort

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, cream
Isoconazole nitrate + Diflucortolone valerate
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 doubts, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 anti-inflammatory 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, and 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),
• in syphilitic or tuberculous skin lesions,
• in skin changes caused by viral infections (e.g. chickenpox, shingles, herpes),
• in skin 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 initiate 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 the medicine is used under occlusive dressings, over large skin areas, for long 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 ingredients may damage latex in condoms and vaginal diaphragms. Therefore, they may become ineffective as mechanical contraceptives or as protection against sexually transmitted diseases. For more detailed information, consult your doctor or pharmacist.

Travocort should be used with particular caution and for a short duration on 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 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 effects on fertility
If the patient is pregnant or 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 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 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.

Effects on fertility
There are no data regarding 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 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 that does not contain a corticosteroid, particularly when the medicine is used in 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 in 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 dosing schedule.

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 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 estimated based on available data)

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

Additionally, as with topical use of other corticosteroids, the following adverse reactions may occur (frequency unknown):
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) skin 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.
Occurrence of adverse reactions in newborns whose mothers used the medicine for a prolonged period or over a large skin surface area during pregnancy or breastfeeding cannot be ruled out.
For example, reduced adrenal cortex function or decreased immune resistance to diseases in the child 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 any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
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

Keep the medicine out of sight and reach of children.
Store below 30°C.
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.
Period of validity after first opening: 90 days.
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 packaging and other information

What Travocort contains

• The active substances in this medicine are: isoconazole nitrate and diflucortolone valerate.

1 g of cream contains 10 mg of isoconazole nitrate and 1 mg of diflucortolone valerate.

• Other ingredients 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 medicine is packed in an aluminium tube containing 30 g of cream, with a polyethylene cap, placed in a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Romania, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Romania, country of export: 13121/2020/01
Parallel import authorisation number: 306/24