Travocort

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Travocort
(10 mg + 1 mg)/g, cream
Isoconazole nitrate + Diflucortolone valerate
Please read the entire leaflet carefully before using this medicine, as 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. It may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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

The medicine 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 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. on the hands, interdigital areas of the feet, as well as in 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 skin lesions,
• for viral skin infections (e.g. chickenpox, shingles, herpes),
• for skin changes caused by rosacea, acne vulgaris, perioral dermatitis or local reactions after 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 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, particularly when 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 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 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 infection:
  • change underwear, bed linen, and towels (preferably cotton) daily, and wash them in very hot water or boil them,
  • thoroughly dry the spaces 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 currently used or recently used, as well as any medicines the patient intends to use.
No studies on interactions between Travocort and other medicines have been conducted.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, 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 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 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.

Fertility
There is no data available regarding a 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 local 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 not containing a glucocorticosteroid, 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
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 following a single application of an excessive amount or 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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects 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 fissures.

Unknown (frequency cannot be determined from available data)

• itching or blisters 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), inflammation of hair follicles (folliculitis) at the application site, excessive hair growth (hypertrichosis), superficial blood vessel dilation (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes, and (or) cutaneous allergic reactions to any of the components of Travocort. Systemic adverse effects may also occur, as the components of the medicine can penetrate through the skin.
Adverse effects in newborns cannot be ruled out if their mothers used the medicine for prolonged periods or applied it over large areas of skin during pregnancy or breastfeeding.
For example, reduced adrenal cortex function or decreased immune resistance to diseases in the child may occur.
If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects 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, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Travocort

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Do not use Travocort after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. After first opening – 13 weeks.
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 pack and other information

What Travocort contains

• The active substances in this medicinal product are: isoconazole nitrate and diflucortolone valerate. Each 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, and purified water.

What Travocort looks like and contents of the pack
Travocort is a white to yellowish, opaque cream.
The packaging consists of an aluminium tube with a screw 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
20054 Segrate (Milan)
Italy

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Austrian Marketing Authorisation Number (country of export): 16909
Parallel Import Authorisation Number: 439/22