Travocort

Package Leaflet: Information for the User

Travocort, (10 mg + 1 mg)/g, Cream

Isoconazole nitrate + Diflucortolone valerate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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 medicines called corticosteroids with strong effects, reduces
skin inflammation and alleviates symptoms such as itching, burning, 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 the groin
and genital areas.

2. Important information before using Travocort

When not to use Travocort:

• if you are allergic (hypersensitive) to isoconazole nitrate and diflucortolone valerate or any of the other ingredients of this medicine (listed in section 6),
• on syphilitic or tuberculous lesions,
• on lesions caused by viral skin diseases (e.g. chickenpox, shingles, herpes),
• on lesions caused by rosacea, common acne, or seborrheic 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 areas of skin or for a long time, especially under occlusive dressings, increases the risk of systemic side effects.
• If you have glaucoma, tell your doctor. During treatment with Travocort, there is a risk of developing glaucoma if the medicine is used under dressings, on large areas of skin, for a long time, or if the medicine is applied to the skin close to the eyes.
• If you experience blurred vision or other vision disturbances, contact your doctor.
• If you use Travocort in the genital area, some of its components may damage 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 information, contact your doctor or pharmacist.

Particularly careful and short-term use is recommended on the skin of the face and in children. In children,
there is a greater risk of systemic effects of topical corticosteroids than in adults.

• Hygiene is essential during treatment with Travocort. To prevent relapse, you should: change your personal underwear, bedding, 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, have recently taken, or plan to take.
No studies on the interaction of Travocort with 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-to-risk ratio. During pregnancy, you should especially avoid using the medicine on large areas of skin, 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, you should avoid using Travocort:

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

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

A thin layer of Travocort is applied to the affected skin area 2 times a day.
Treatment with Travocort should be stopped when the skin condition improves. The treatment should not last longer than 2 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 is 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 use of too much medicine or accidental ingestion.

Missing a dose of Travocort

Do not take a double dose to make up for a forgotten 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, this medicine 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 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 ingredients 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 areas of skin.
For example, decreased adrenal cortex function or decreased child immunity to diseases may occur.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRAVOCORT

Keep out of the sight and reach of children.
Store below 30°C.
Do not use Travocort after the expiry date stated on the packaging. The expiry date refers to the last day of that 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 PACK AND OTHER INFORMATION

What Travocort contains

• The active substances 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 are: white petrolatum, 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, non-transparent cream.
The pack contains an aluminum tube with an HDPE cap, containing 15 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21

• I - 20090 Segrate (Milan) Italy

For further information, please contact your doctor or the marketing authorization holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40

Date of last revision of the leaflet: