Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Travogen, 10 mg/g (1%), cream
Isoconazoli nitras
Please read carefully all the information in this leaflet 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 further questions, 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 someone else, 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 of the leaflet:

What Travogen is and what it is used for
Important information before using Travogen
How to use Travogen
Possible side effects
How to store Travogen
Contents of the pack and other information

1. What Travogen is and what it is used for

Travogen cream is an antifungal medicine intended for topical application to the skin.
The active substance, isoconazole nitrate, exerts antifungal activity against various species of fungi
causing skin infections in humans, such as dermatophytes, yeasts, yeast-like fungi
(including those causing pityriasis versicolor), moulds, and fungi causing erythrasma.
Indications
Superficial fungal skin infections, e.g. tinea of hands, feet, groin, genital areas; pityriasis versicolor; erythrasma.

2. Important information before using Travogen

When not to use Travogen:

If the patient is allergic to isokonazole nitrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Travogen, discuss it with your doctor or pharmacist.
Avoid contact with the eyes. If the medicine gets into the eyes, rinse immediately with plenty of water.
To avoid re-infection, personal underwear (including body and face towels) should be changed daily and boiled. Use of cotton products is recommended.
Effective treatment with Travogen depends on maintaining proper personal hygiene. In athlete's foot, the space between the toes should be carefully dried after each washing. Socks and stockings should be changed daily.
When Travogen is used in the genital area, some of the excipients contained in this medicine may damage condoms and diaphragms. Therefore, they may become ineffective as contraceptive methods or as protection against sexually transmitted diseases, such as HIV infection. For further information, please consult your doctor or pharmacist.

Travogen and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
There are no studies regarding interactions between Travogen and other medicines.

Pregnancy, breastfeeding and fertility
During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult your doctor or pharmacist before using this medicine.

Pregnancy
Your doctor will exercise caution when prescribing this medicine to pregnant women.

Breastfeeding
Women who are breastfeeding may use Travogen only if, in the opinion of the doctor, the benefits to the mother outweigh the potential risks to the infant.
If the doctor decides that Travogen should be used during breastfeeding, it should not be applied to the area of the nipples to prevent the infant from ingesting the medicine.

Effect on fertility
There are no data indicating that the use of Travogen affects fertility.

Driving and operating machinery
Travogen has no influence on the ability to drive motor vehicles or operate mechanical equipment.

Travogen contains cetostearyl alcohol
This ingredient may cause skin reactions (e.g. contact dermatitis).

3. How to use Travogen

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
Travogen is intended for topical use on the skin only.
Travogen is usually applied once daily to the affected area of skin.
In fungal infections, topical treatment is typically administered for two to three weeks. In infections
that are difficult to treat (especially interdigital space infections), the treatment duration may be
extended by the physician to four weeks. Longer treatment periods are also possible.
In fungal infections of the interdigital spaces of hands and feet, it is recommended to place a gauze
strip, coated with Travogen, between the fingers or toes.
To prevent recurrence of fungal infection, treatment should be continued for at least two weeks
after symptoms have resolved.
Very important for achieving a good therapeutic effect with Travogen is daily adherence to hygiene
measures (see section "Warnings and precautions").
Children and adolescents
Dose adjustment is not necessary when administering Travogen to infants, children, and adolescents.
Use of a higher than recommended dose of Travogen
Single use of the medicine on a large skin surface area or accidental ingestion does not pose a risk
of acute poisoning. In case of any doubts, contact your doctor or pharmacist.
Missed dose of Travogen
Do not use a double dose to make up for a missed dose. If a dose is missed, apply the next dose
immediately, then continue treatment as directed.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The adverse reactions are listed below by frequency of occurrence:
Common: may affect 1 in 10 people

Skin irritation or burning sensation at the application site.

Uncommon: may affect 1 in 100 people

Itching or excessive skin dryness at the application site; weeping lesions, small fluid-filled blisters (miliaria), skin inflammation (contact dermatitis).

Rare: may affect 1 in 1000 people

Swelling at the application site, skin fissures.

Frequency not known :

Redness (erythema) or blisters at the application site, allergic skin reactions.

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 of Monitoring Adverse Drug Reactions of 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.
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Travogen

Do not store above 30°C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube - 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Travogen contains

The active substance is isoconazole nitrate. 1 g of cream contains 10 mg of isoconazole nitrate.
The other components are: polysorbate 60, sorbitan stearate, cetostearyl alcohol, liquid paraffin, white soft paraffin, purified water.

What Travogen looks like and contents of the pack
Travogen is a white to slightly yellowish, opaque cream.
The pack consists of an aluminium tube internally coated with an epoxy resin, closed with a cap made of high-density polyethylene (HDPE), containing 30 g of cream, placed in a cardboard box.

For further detailed information, please contact the responsible party or the parallel importer.

Responsible party in Austria, country of export:
LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark

Manufacturer:
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21, 20090 Segrate (Milan), Italy

Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorisation number in Austria, country of export: 1-16910
Parallel import authorisation number: 185/24