Travogen
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Travogen, 10 mg/g, cream
Isoconazoli nitras
Please read the entire 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 another person, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet:
- 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 of the medicine – 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), molds, and fungi causing erythrasma.
Indications
Superficial fungal skin infections, e.g. tinea of the hands, feet, groin, genital area; pityriasis versicolor; erythrasma.
2. Important information before using Travogen
When not to use Travogen
- if the patient is allergic to isokonazol nitrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Before starting to use Travogen, 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 a large amount of water.
- To avoid re-infection, personal underwear (including body and face towels) should be changed daily and boiled. Use of cotton products is recommended.
- Effective treatment with Travogen depends on maintaining proper personal hygiene. In tinea pedis, 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 contained in this medicine may damage condoms and intrauterine devices.
Therefore, they may be ineffective as contraceptive methods or for protection against
sexually transmitted diseases, such as HIV infection. For further
information, consult your doctor or pharmacist.
Travogen and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to take.
There are no studies on interactions between Travogen and other medicines.
Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy,
consult your doctor or pharmacist before using this medicine.
Pregnancy
The 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 treatment for 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 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 area of skin.
In fungal infections, topical treatment is generally continued for two to three weeks. In infections
that are difficult to treat (particularly infections of the 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 the hands and feet, it is recommended to place a
gauze strip impregnated with Travogen between the fingers or toes.
To prevent recurrence of fungal infection, treatment should be continued for at least two weeks
after symptoms have resolved.
Very important for achieving a good treatment outcome with Travogen is daily adherence to
hygiene measures (see section "Warnings and precautions").
Children and adolescents
Dose adjustment is not necessary when Travogen is administered to infants, children, and adolescents.
Use of more Travogen than recommended
Single use of the medicine on a large skin surface or accidental ingestion does not pose a risk of
acute poisoning. If in doubt, contact your 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 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 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 1000 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 reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the packaging 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, cetostearyl alcohol, liquid paraffin, white vaseline, purified water.
What Travogen looks like and contents of the pack
Travogen is a white to slightly yellowish, opaque cream.
The packaging consists of an aluminium tube internally lacquered, sealed with a membrane and closed with a white cap made of HDPE, containing 30 g of cream, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Romania, country of export: 13120/2020/02
Parallel import licence number: 98/24