Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Travogen, 10 mg/g, cream
Isoconazoli nitras
Please read carefully the entire 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a 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 packaging and other information

1. What Travogen is and what it is used for

Travogen cream is an antifungal medicine for topical application to the skin.
The active substance of the medicine – isoconazole nitrate – has 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. fungal infections of the hands, feet, groin, genital area; pityriasis versicolor; erythrasma.

2. Information before using Travogen

When not to use Travogen:

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

Warnings and precautions

Before starting to use Travogen cream, discuss it with your doctor or pharmacist.
Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, rinse them 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 cream depends on maintaining proper personal hygiene. In tinea pedis (athlete's foot), the interdigital space should be carefully dried after each washing. Socks and stockings should be changed daily.
If 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 contraceptives 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 all medicines currently used, recently used, or planned to be used.
There are no studies regarding interactions between Travogen and other medicines.

Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, or if pregnancy is suspected, or if planning a 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 child.
If the doctor decides that Travogen should be used during breastfeeding, it should not be applied to the nipple area to prevent the infant from ingesting the medicine.

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

Driving and operating machinery
Travogen has no effect 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 exactly as directed by your doctor. If in doubt, 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 continued for two to three weeks. In infections
that are difficult to treat (especially in interdigital spaces), the treatment duration may be extended
by the doctor up 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 impregnated with Travogen cream between the fingers or toes.
To prevent recurrence of fungal infection, treatment should continue 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 required when administering Travogen cream to infants, children, or adolescents.
Use of more Travogen than recommended
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.
If you forget to use Travogen
Do not apply a double dose to make up for a missed dose. If a dose is missed, apply the next dose
immediately and then continue treatment as recommended.
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 medicine can cause adverse reactions, although not everybody will experience them.
The adverse reactions are listed below by frequency of occurrence:
Common: may affect up to 1 in 10 people

Skin irritation or burning sensation at the application site.

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 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 effects occur, including any adverse effects 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of medicine safety and helps provide more information on the safe use of the medicine.

5. How to store Travogen

Store below 30°C, in the original packaging.
Keep the medicine out of the 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Travogen contains

The active substance is isocanozole nitrate. 1 g of cream contains 10 mg of isocanozole nitrate.
Other ingredients of the medicine 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 medicine is packed in a lacquered aluminium tube closed with a membrane and fitted with an HDPE cap, containing 30 g of cream, placed in a cardboard box.
For further information, please contact the responsible entity or parallel importer.
Responsible entity in Romania, 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, 20090 Segrate (MI), Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 13120/2020/02
Parallel import authorisation number: 368/22