Travocort

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Travocort
(10 mg + 1 mg)/g (1 + 0.1% w/w), cream
Isoconazoli nitras + Diflucortoloni valeras
Please read the entire leaflet carefully before use, 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. The medicine may harm another person, 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

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 the initial treatment of superficial fungal infections of the skin associated with significant inflammatory or eczematous skin changes, e.g. of the hands, interdigital areas 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),
• for syphilitic or tuberculous skin lesions,
• for viral skin diseases (e.g. chickenpox, shingles, herpes),
• for lesions caused by rosacea, acne vulgaris, perioral dermatitis or local reactions following vaccination.

Warnings and precautions
Before starting to use Travocort, discuss this with your doctor or pharmacist.

• If there is a concurrent bacterial infection, your 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.

• Using the medicine 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 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 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.

• Use particular caution and only for short periods when applying the medicine to facial skin or in children. In children, there is a higher risk of systemic effects from topically applied corticosteroids than in adults.

• Maintaining good hygiene is essential during treatment with Travocort. To prevent recurrence of the disease, the following measures should be taken:

• change personal clothing, 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 if you are taking, have recently taken or might take any other medicines.
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 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 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 are no data on negative effects 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 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 corticosteroid, especially 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
Dosage adjustment of Travocort is not 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may 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 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), inflammation of hair follicles 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.
Adverse reactions in newborns cannot be ruled out if 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 immune resistance 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 those not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Travocort

Keep the medicine out of the 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Travocort contains

• The active substances are: isocotazole nitrate and diflucortolone valerate. Each 1 g of cream contains 10 mg (1% w/w) of isocotazole nitrate and 1 mg (0.1% w/w) of diflucortolone valerate.
• Other ingredients 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 medicine is supplied in an aluminium tube with a screw cap made of HDPE, containing 15 g of cream, packed in a cardboard carton.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Ireland, the 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 (MI)
Italy
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Ireland, the country of export: PA 1025/12/1
Parallel Import Licence Number: 200/25