Travogen

Leaflet attached to the packaging: patient information

TRAVOGEN, 10 mg/g, cream

Isoconazole nitrate

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 packaging 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 that cause skin infections in humans, such as dermatophytes, yeasts, yeast-like fungi (including those that cause pityriasis versicolor), molds, and fungi that cause 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

Warnings and precautions

• Before starting to use Travogen cream, the doctor or pharmacist should be consulted.
• Contact with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed 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. Cotton products are recommended.
• Effective treatment with Travogen cream depends on proper personal hygiene. In foot fungus, the interdigital space should be dried thoroughly 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 not be effective as contraceptive or protective measures against sexually transmitted diseases, such as HIV infection. For more information, the doctor or pharmacist should be consulted.

In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

Travogen and other medicines

The doctor or pharmacist should be informed about all medicines currently being used or recently used, as well as any medicines that the patient plans 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 pregnancy is suspected, or if pregnancy is planned, the doctor or pharmacist should be consulted 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 fetus.
If the doctor decides to use Travogen in a breastfeeding woman, it should not be applied to the breast area to prevent the infant from ingesting the medicine.

Fertility

There is 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 the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Travogen is intended for topical use on the skin only.
Travogen is usually applied once a day to the affected skin area.
Typically, in fungal infections, treatment is applied for a period of two to three weeks. In difficult-to-treat infections (especially in 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 smeared with Travogen cream between the fingers or toes.
To avoid recurrence of 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 rules 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 a higher dose of Travogen than recommended

Single use of the medicine on a large skin area or accidental ingestion does not pose a risk of acute poisoning. In case of any doubts, the doctor or pharmacist should be consulted.

Missing a dose of Travogen

A double dose should not be used to make up for a missed dose. If a dose is missed, the next dose should be applied as soon as possible, and then treatment should be continued as directed.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

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 1000 people
• Swelling at the application site, skin cracks.

Frequency not known:

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

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed.
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
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Travogen

Store at a temperature below 30°C.
The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the packaging 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 what the pack contains

Travogen is a white to slightly yellowish, non-transparent cream.
The packaging of the medicine is an aluminum tube with a polyethylene cap, containing 20 g or 50 g of cream, placed in a cardboard box.

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
20090 Segrate (Milan)
Italy
To obtain more detailed information, the marketing authorization holder should be contacted:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: 22 244 18 40

Date of last revision of the leaflet: