Travogen

Package leaflet: information for the patient

TRAVOGEN, 10 mg/g, cream
Isoconazoli nitras
Please read this leaflet carefully 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.

Leaflet contents:

1. What Travogen is and what it is 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 Travogen is and what it is used for
Travogen cream is an antifungal medicine 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 area; pityriasis versicolor; erythrasma.

2. Important information before using Travogen

When not to use Travogen

• if you are allergic to isoconazole nitrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting treatment with Travogen cream, consult your doctor or pharmacist.
• Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, rinse immediately with plenty of water.
• To avoid reinfection, personal clothing (including body and face towels) should be changed daily and boiled. Cotton garments are recommended.
• Effective treatment with Travogen cream depends on maintaining proper personal hygiene. In tinea pedis, the interdigital spaces 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 vaginal diaphragms. Therefore, they may become ineffective as contraceptives or as protection against sexually transmitted diseases, such as HIV infection. For further information, consult your doctor or pharmacist.
  Travogen with other medicines
  Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
  There are no studies on interactions between Travogen and other medicines.
  Pregnancy, breastfeeding and fertility
  During pregnancy, breastfeeding, or if pregnancy is suspected, or if 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 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 effect on the ability to drive or operate machinery.
  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 skin area.
Fungal infections are typically treated with topical therapy for two to three weeks. In infections
that are difficult to treat (especially in interdigital spaces), the treatment period may be extended
by the doctor 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 cream between the fingers or toes.
To prevent recurrence of fungal infection, treatment should be continued for at least two weeks
after symptoms have resolved.
Daily adherence to hygiene measures is very important for achieving a good therapeutic effect
with Travogen (see section "Warnings and precautions").

Children and adolescents
No dose adjustment is necessary when administering Travogen cream to infants, children, or
adolescents.

Use of more Travogen than recommended
Single application of the medicine over 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.

Missing a 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 as
soon as possible, 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 according to their 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; oozing 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.

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Travogen

Store below 30°C.
Keep the medicine in a place out of sight and reach of children. Do not use this medicine
after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Proper disposal helps protect the
environment.

6. Package contents and other information
What Travogen contains

• The active substance is isiconazole nitrate. Each 1 g of cream contains 10 mg of isiconazole nitrate.
• Other components are: polysorbate 60, sorbitan stearate, cetyl 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 an aluminium tube with a polyethylene cap containing 20 g or 50 g of cream, placed in a cardboard box.

Marketing Authorisation 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

For further information, please contact the Marketing Authorisation Holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel: 22 244 18 40