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, cream
Isoconazole nitrate + Diflucortolone valerate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Travocort and what is it 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 is Travocort and what is it used for

The medicine contains two active substances: isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal skin diseases.
Diflucortolone valerate belongs to a group of corticosteroids with strong effects, reduces
skin inflammation and alleviates symptoms such as itching, burning, and pain.
Travocort is indicated for the initial treatment of superficial fungal skin infections with concomitant
severe inflammatory or eczematous skin changes, e.g., on the hands, interdigital spaces of the feet,
and 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 any of the other ingredients of this medicine (listed in section 6),
• on syphilitic or tubercular lesions,
• on lesions caused by viral skin diseases (e.g., chickenpox, shingles, herpes),
• on lesions caused by rosacea, common acne, or perioral dermatitis, or on local reactions after vaccination.

Warnings and precautions

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

• In case of concomitant bacterial infection, the doctor will use antibacterial treatment.
• Avoid contact of the medicine with the eyes and mucous membranes. If the medicine gets into the eyes, rinse them thoroughly with water.
• Using the medicine on large skin surfaces or for a longer period, especially under occlusive dressings, increases the risk of systemic side effects.
• If the patient has glaucoma, they should tell their doctor. During treatment with Travocort, there is a risk of developing glaucoma if the medicine is used under dressings, on large skin surfaces, for a long time, or if the medicine is applied to the skin close to the eyes.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• If Travocort is used in the genital area, some of its components may cause damage to latex in condoms and diaphragms. Therefore, they may not be effective as mechanical contraceptives or as a means of preventing sexually transmitted diseases. For more detailed information, consult your doctor or pharmacist.

Particular caution and short-term use are required when applying the medicine to the facial skin and in children.
In children, there is a greater risk of systemic effects of topical corticosteroids than in adults.

• Hygiene measures are essential during treatment with Travocort. To prevent relapse of the disease, you should:
• change your personal underwear, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them,
• dry the areas between the toes well after washing,
• change your 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 taking or have recently taken, as well as any medicines you plan to take.
No studies on interactions between Travocort and other medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. The doctor will carefully weigh the benefits and risks for the mother and the fetus.
Pregnancy
Do not use Travocort in the first trimester of pregnancy. The decision to use the medicine in the remaining period of pregnancy is made by the doctor, after assessing the benefit-risk ratio. During pregnancy, avoid using the medicine on large skin surfaces, for a long time, or under dressings.
Breastfeeding
It is not known whether Travocort passes into breast milk, but the risk to the health of the breastfed child cannot be excluded.
During breastfeeding, avoid using Travocort:

• on the breast skin,
• under dressings or on large skin surfaces,
• for a long time.

Effects on fertility
There are no data on the negative effect of Travocort on fertility.

Driving and using machines

It is unlikely that Travocort will affect your ability to drive or use machines.

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

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Apply a thin layer of Travocort to the affected skin area twice a day.
Treatment with Travocort should be stopped when the skin condition improves. The treatment should not last longer than two weeks. If necessary, the doctor may continue treatment with an antifungal medicine that does not contain a corticosteroid, especially when using the medicine in the groin and external genital areas.
Hygiene measures are essential during treatment with Travocort (see section 2).

Use in children and adolescents

No dose adjustment of Travocort is necessary in children from 2 years of age and adolescents.
Do not use in children under 2 years of age.

Using more than the recommended dose of Travocort

It is unlikely that Travocort will cause acute poisoning after a single application of too much medicine or accidental ingestion of the medicine.

Missing a dose of Travocort

Do not take a double dose to make up for a missed dose.
Take the next dose at the right time and continue treatment as prescribed.
If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Travocort can cause side effects, although not everybody gets them.
The following side effects, observed in clinical trials, are presented according to their frequency:

Common(affect more than 1 in 10 people)

• skin irritation or burning sensation at the application site.

Uncommon(affect more than 1 in 100 people)

• redness, dryness at the application site,
• skin stretch marks.

Unknown(frequency cannot be estimated from the available data)

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

Additionally, as with the use of other topical corticosteroids, the following side effects may occur (frequency unknown):
skin thinning (atrophy), folliculitis at the application site, excessive body hair growth, superficial blood vessel dilation (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes, and (or) skin allergic reactions to any of the ingredients of Travocort. Systemic side effects may occur because the components of the medicine penetrate the skin.
It cannot be excluded that side effects may occur in newborns whose mothers used the medicine for a long time during pregnancy or breastfeeding, or used it on large skin surfaces.
For example, decreased adrenal cortex function or decreased child immunity to diseases may occur.
If any of the side effects get worse, or if you experience any side effects not listed in the leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 (22) 49 21 301,
fax: +48 (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Travocort

Keep 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 month.
Shelf life after first opening: 90 days.
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 of the medicine are: isoconazole nitrate and diflucortolone valerate.

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

• The other ingredients of the medicine are: white petrolatum, 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, non-transparent cream.
The packaging of the medicine is an aluminum tube containing 30 g of cream, with a PE cap, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, 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 (Milan), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Romania, the country of export: 13121/2020/01

Parallel import authorization number: 306/24

Date of leaflet approval: 25.07.2024

[Information about the trademark]