Travogen
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
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:
- 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 package 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 tinea versicolor), moulds, and fungi causing erythrasma.
Indications
Superficial fungal skin infections, e.g. fungal infections of the hands, feet, groin, genital areas; tinea versicolor; erythrasma.
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 this with 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 re-infection, personal underwear (including body and face towels) should be changed daily and boiled. The 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 spaces 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 vaginal diaphragms. Therefore,
they may become ineffective as contraceptives or as protection against sexually transmitted infections, such as HIV infection. For further information, consult your doctor or pharmacist.
Travogen and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use. There are no studies on potential interactions between Travogen and other medicines.
Pregnancy, breastfeeding and fertility
During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning 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 doctor's opinion, 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 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 as directed by a physician. If in doubt, consult a doctor or pharmacist.
Travogen is intended for topical application on the skin only.
Travogen is usually applied once daily to the affected skin area.
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 period may be extended by the physician 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 strip of gauze, 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
Dose adjustment is not necessary when administering Travogen cream to infants, children, or adolescents.
Use of a higher than recommended dose of Travogen
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 a doctor or pharmacist.
Missed 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 directed.
If you have any further questions concerning the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone 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 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 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
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 in this medicine is isiconazole nitrate. 1 g of cream contains 10 mg of isiconazole nitrate.
- The 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 aluminum tube, 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, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
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 authorisation number in Romania, the country of export: 13120/2020/02
Parallel import licence number: 31/23