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 (1% + 0.1%), cream
Isoconazole nitrate + Diflucortolone valerate
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 similar.
• 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

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

The 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; it reduces skin inflammation and relieves symptoms such as itching, burning, and pain.
Travocort is indicated for initial treatment of superficial fungal skin infections associated with pronounced 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),
• for syphilitic or tuberculous 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 following vaccination.

Warnings and precautions
Before starting treatment with Travocort, discuss this 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 thoroughly with water.
• Use on large skin areas 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 used under occlusive dressings, on 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 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 hygiene is essential during treatment with Travocort. To prevent recurrence of infection:
  • change personal clothing, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them,
  • thoroughly dry the areas 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 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 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, particular care should be taken to avoid using the medicine on 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 health of a breastfed infant cannot be excluded.
During breastfeeding, avoid using Travocort:

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

Effects on fertility
There are 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 physician or pharmacist. If in doubt,
consult a physician 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 physician may continue treatment with an antifungal medicine not containing a glucocorticosteroid, 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
It is not necessary 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 a larger than recommended dose of Travocort
It is unlikely that Travocort will cause acute poisoning following 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 physician 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 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 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 depigmentation, acne-like changes and (or) skin allergic reactions to any of the ingredients 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 or over large areas of skin during pregnancy or breastfeeding.
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 you experience any adverse reactions, including any not listed in this leaflet, tell 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

Keep out of the 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.
Medicines should 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 are: isiconazole nitrate and diflucortolone valerate. 1 g of cream contains 10 mg of isiconazole nitrate and 1 mg of diflucortolone valerate.
• Other components 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 coated internally with epoxy resin and externally with a polyester layer, with a tamper-evident ring and a cap made of HDPE, placed in a cardboard box. The tube contains 30 g of cream.
For further information, please contact the responsible party 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:
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 Greece, country of export: 103339/28-11-2019
Parallel import authorisation number: 11/24