Travogen

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Travogen

10 mg/g, cream

Isoconazole nitrate

Read the 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 a specific person. 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 or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Travogen and what is it used for
• 2. Important information before using Travogen
• 3. How to use Travogen
• 4. Possible side effects
• 5. How to store Travogen
• 6. Contents of the pack and other information

1. What is Travogen and what is it used for

Travogen cream is an antifungal medicine for topical use on the skin.
The active substance of the medicine, isoconazole nitrate, has an antifungal effect on various species of fungi
causing skin infections in humans, such as dermatophytes, yeasts, yeast-like fungi (including those causing pityriasis versicolor), molds, and fungi causing seborrheic dermatitis.

Indications for use

Superficial fungal skin infections, e.g. skin fungus of the hands, feet, groin, genital area; pityriasis versicolor; seborrheic dermatitis.

2. Important information before using Travogen

When not to use Travogen

• if the patient is allergic to isoconazole 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 a large amount of water.
• To avoid re-infection, personal clothing (including towels for the body and face) should be changed daily and boiled. It is recommended to use cotton products.
• Effective treatment with Travogen cream depends on proper personal hygiene. In foot fungus, the interdigital space should be dried thoroughly after each wash. 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 not be effective as contraceptive or protective measures against sexually transmitted diseases, such as HIV infection. For more information, ask your doctor or pharmacist.

Travogen and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. There are no studies on the interaction of Travogen with other medicines.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Breastfeeding women may use Travogen only if, in the doctor's opinion, the benefits of using the medicine for the mother outweigh the potential risks to the child. If the doctor decides to use Travogen in a breastfeeding woman, it should not be applied to the breast area to prevent the child from ingesting the medicine.

Fertility

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

Driving and using machines

Travogen does not affect the ability to drive vehicles or operate machinery.

Travogen contains cetyl alcohol

This substance may cause skin reactions (e.g. contact dermatitis).

3. How to use Travogen

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Travogen is for topical use on the skin only.
Travogen is usually applied once a day to the affected skin area.
Typically, in fungal infections, local treatment is used for a period of two to three weeks. In difficult-to-treat infections (especially interdigital infections), the treatment time may be extended by the doctor to four weeks. Longer treatment periods are also possible.
In the case of interdigital fungal infections of the hands and feet, it is recommended to place a gauze strip coated with Travogen cream between the fingers or toes.
To avoid re-infection, treatment should be continued for at least two weeks after the symptoms of the disease have disappeared.
It is very important for the effectiveness of the treatment with Travogen to follow the principles of hygiene daily (see "Warnings and precautions").
Children and adolescents
No dose adjustment is necessary when administering Travogen cream to infants, children, and adolescents.

Using more than the recommended dose of Travogen

Single use of the medicine on a large skin area or accidental ingestion does not pose a risk of acute poisoning. If you have any doubts, contact your doctor or pharmacist.

Missing a dose of Travogen

Do not use a double dose to make up for a missed dose. If you miss a dose, apply the next dose as soon as possible and continue treatment as recommended.
If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Travogen can cause side effects, although not everybody gets them.
Side effects are listed according to their frequency:

• Skin irritation or burning at the application site.

Uncommon:may affect 1 in 100 people

• Itching or excessive dryness of the skin at the application site; weeping changes, small fluid-filled blisters (dyshidrotic eczema), skin inflammation (contact dermatitis).

Rare:may affect 1 in 1000 people

• Swelling at the application site, skin cracks.

Frequency not known:

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this 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 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 Travogen contains

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

What Travogen looks like and contents of the pack

Travogen is a white to slightly yellowish non-transparent cream.
The packaging of the medicine is an aluminum tube, internally lacquered, sealed with a membrane, and closed with a white HDPE cap, containing 30 g of cream, placed 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
20090 Segrate (Milan)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 13120/2020/02
Parallel import authorization number: 31/23
Date of leaflet approval: 01.03.2023
[Information about the trademark]