Travocort

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Travocort
(10 mg + 1 mg)/g (1% + 0.1%), cream
Isoconazol 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, 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 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 anti-inflammatory action; 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 spaces of the feet, groin area, and genital organs.

2. Important information before using Travocort
When not to use Travocort:

• if you are allergic (hypersensitive) to isoconazole nitrate or diflucortolone valerate or to any of the other ingredients of this medicine (listed in section 6),
• for syphilitic or tuberculous skin lesions,
• for skin lesions caused by viral skin diseases (e.g. chickenpox, shingles, herpes simplex),
• for lesions caused by rosacea, acne vulgaris, perioral dermatitis, or local reactions after vaccination.

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

• In case of concomitant bacterial superinfection, your doctor will prescribe appropriate 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 skin areas or for prolonged periods, particularly under occlusive dressings, increases the risk of systemic adverse effects.
• If you have glaucoma, inform your 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 long periods, or on skin close to the eyes.
• If you experience blurred vision or other visual disturbances, contact your 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, consult 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 higher than in adults.

• Maintaining good hygiene is essential during treatment with Travocort. To prevent recurrence of the infection, you should:
  • 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
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interaction studies between Travocort and other medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Your 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 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.

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 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, your doctor may continue treatment with an antifungal medicine that does not contain a corticosteroid, especially when treating areas such as the groin or external genital organs.
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 Travocort than recommended
It is unlikely that Travocort would cause acute poisoning after a single application of an excessive amount or after accidental ingestion of the medicine.
If you forget to use 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 doubts 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 will experience them.
The following adverse reactions observed in clinical trials are listed below 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 cracking.

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), folliculitis at the application site, excessive body 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.
The occurrence of 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 reduced immunity 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, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Travocort

Keep out of the sight and reach of children.
Store below 30°C.
After first opening, store for 3 months at a temperature below 25°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 how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Travocort contains

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

What Travocort looks like and contents of the pack
Travocort is a white-yellow, opaque cream.
Packaging: An aluminum tube with an inner coating of epoxy resin, with a polyethylene (PE) cap, containing 25 g of cream, placed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Germany, 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 Germany, the country of export: 88.00.00
Parallel import authorisation number: 276/24