Travogen

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Travogen

10 mg/g (1%), cream

Isoconazole nitrate

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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. Package contents 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 you are 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, discuss it with your doctor or pharmacist.
• Avoid contact with the eyes. If the medicine gets into your eyes, rinse them immediately with plenty of water.
• To avoid re-infection, personal clothing (including towels for the body and face) should be changed daily and boiled. Cotton products are recommended.
• Effective treatment with Travogen depends on proper personal hygiene. In foot fungus, the interdigital space should be thoroughly dried after each washing. Socks and stockings should be changed daily.
• If Travogen is used in the genital area, some of the excipients in this medicine may damage condoms and diaphragms. Therefore, they may not be effective as contraceptive devices or protect 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 the medicines you are 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 think you may be pregnant, or are planning to become pregnant, 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 doctor's opinion, the benefits of using the medicine for the mother outweigh the potential risks for 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 Cetostearyl Alcohol

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

3. How to Use Travogen

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Travogen is intended for topical use on the skin only.
Travogen is usually applied once a day to the affected skin area.
Typically, fungal infections are treated 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 fungal infections of the interdigital spaces of the hands and feet, it is recommended to place a gauze strip coated with Travogen between the fingers or toes.
To avoid recurrence of the fungal infection, treatment should be continued for at least two weeks after the symptoms of the disease have disappeared.
It is very important for the effective treatment of Travogen to follow the principles of hygiene daily (see "Warnings and Precautions").
Children and Adolescents
No dose adjustment is necessary when administering Travogen 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 take a double dose to make up for a missed dose.
If you miss a dose, apply the next dose as soon as possible, and then continue treatment as directed.
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 of occurrence:
Common:may affect up to 1 in 10 people

• Skin irritation or burning at the application site.

Uncommon:may affect up to 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 up to 1 in 1,000 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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

Do not store above 25°C.
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. Package Contents and Other Information

What Travogen Contains

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

What Travogen Looks Like and Contents of the Package

Travogen is a white to slightly yellowish, non-transparent cream.
The package of the medicine is a tube containing 15 g or 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 Greece, 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
License number in Greece, the country of export: 32260/5-9-1995
103340/19/03-02-2020

Parallel Import License Number: 434/22 Date of approval of the leaflet: 19.12.2022

[Information about the trademark]