Travocort

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Travocort
(10 mg + 1 mg)/g (1 + 0.1% w/w), cream
Isoconazole nitrate + Diflucortolone valerate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Travocort is and what it is used for
2. Important information before using Travocort
3. How to use Travocort
4. Possible side effects
5. How to store Travocort
6. Contents of the pack and other information

1. What Travocort is and what it is used for

The medicine contains two active substances: isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal skin infections.
Diflucortolone valerate belongs to a group of medicines called corticosteroids with strong action, which reduces skin inflammation and relieves symptoms such as itching, burning, and pain.
Travocort is indicated for initial treatment of superficial fungal infections of the skin associated with significant inflammatory or eczematous skin changes, e.g. on hands, interdigital spaces of the feet, and in the groin and genital areas.

2. Important information before using Travocort
When not to use Travocort:

• if the patient is allergic (hypersensitive) to isoconazole nitrate and diflucortolone valerate or to any of the other ingredients of this medicine (listed in section 6),
• on syphilitic or tuberculous lesions,
• on skin lesions caused by viral skin diseases (e.g. chickenpox, shingles, herpes),
• on lesions caused by rosacea, common acne, perioral dermatitis, or local reactions after vaccination.

Warnings and precautions Before starting to use Travocort, discuss this with your
doctor or pharmacist.

• In case of concomitant bacterial superinfection, the doctor will apply antibacterial treatment.
• Avoid contact of the medicine with the eyes and mucous membranes. If the medicine gets into the eyes, rinse thoroughly with water.
• Using the medicine on large skin areas or for prolonged periods, especially under occlusive dressings, increases the risk of systemic adverse effects.
• If the patient has glaucoma, inform the doctor. There is a risk of developing glaucoma during treatment with Travocort, especially when used under occlusive dressings, on large skin areas, for long periods, or when applied to skin near the eyes.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.
• When Travocort is used in the genital area, some of its ingredients may damage latex in condoms and vaginal diaphragms. Therefore, they may become ineffective as mechanical contraceptives or as protection against sexually transmitted infections. For more detailed information, consult a doctor or pharmacist.

Travocort should be used with particular caution and for a short time on facial skin and in children.
In children, there is a higher risk of systemic effects from topically applied corticosteroids than in adults.

• Maintaining hygiene is essential during treatment with Travocort. To prevent recurrence of the disease, the following should be observed:
  • change personal clothing, bed linen, and towels (preferably cotton) daily and wash them in very hot water or boil them,
  • dry thoroughly between the toes after washing,
  • change socks or tights daily and wash them in very hot water or boil them.

Travocort and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use.
No interaction studies between Travocort and other medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will carefully assess whether the benefits to the mother outweigh the potential risks to the fetus.

Pregnancy
Travocort should not be used during the first trimester of pregnancy. Whether the medicine can be used during the remainder of pregnancy is decided by the doctor after considering the benefit-risk ratio. During pregnancy, particular care should be taken to avoid using the medicine on large skin areas, for prolonged periods, or under occlusive dressings.

Breastfeeding
It is not known whether Travocort passes into human milk, but a risk to the health of a breastfed child cannot be excluded.
During breastfeeding, avoid using Travocort:

• on the skin of the breasts,
• under occlusive dressings or on large skin areas,
• for prolonged periods.

Effect on fertility
There is no data on negative effects of Travocort on fertility.

• Driving and operating machinery It is unlikely that Travocort will affect the ability to drive or operate machinery.

Travocort contains a small amount of cetostearyl alcohol.
Travocort contains cetostearyl alcohol, which may cause skin reactions (e.g. contact dermatitis).

3. How to use Travocort

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Dosage
A thin layer of Travocort should be applied to the affected area of skin twice daily.

Treatment with Travocort should be discontinued once the skin condition has improved. Usually, treatment should not last longer than two weeks. If necessary, the doctor may continue treatment with an antifungal medicine not containing a glucocorticosteroid, particularly when treating the groin or genital areas.

Maintaining proper hygiene is essential during treatment with Travocort (see section 2).

Use in children and adolescents
Dosage adjustment of Travocort is not necessary in children aged 2 years and older and in adolescents.
Travocort should not be used in children under 2 years of age.

Use of a higher than recommended dose of Travocort
It is unlikely that Travocort would cause acute poisoning following a single application of an excessive amount or after accidental ingestion.

Missed dose of Travocort
Do not apply a double dose to make up for a missed dose.
Apply the next dose at the scheduled time and continue treatment according to the prescribed regimen.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The following adverse effects observed in clinical trials are listed according to their frequency of occurrence:
Common (occur in more than 1 in 10 patients)

• skin irritation or burning sensation at the application site.

Uncommon (occur in more than 1 in 100 patients)

• redness, dryness at the application site,
• skin cracking.

Unknown (frequency cannot be determined from available data)

• itching or blistering at the application site,
• blurred vision.

Additionally, as with topical use of other corticosteroids, the following adverse effects may occur (frequency unknown): skin thinning (atrophy), folliculitis at the application site, excessive hair growth (hypertrichosis), superficial blood vessel dilation (telangiectasia), perioral dermatitis, skin discoloration, acne-like changes and (or) skin allergic reactions to any of the components of Travocort.
Systemic adverse effects may occur, as the medicine's components can penetrate through the skin.
The occurrence of adverse effects in newborns whose mothers used the medicine for a prolonged period or over a large skin surface area during pregnancy or breastfeeding cannot be ruled out.
For example, reduced adrenal cortex function or reduced child's immunity to diseases may occur.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Travocort

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Do not use Travocort after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should 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 pack and other information

What Travocort contains

• The active substances in Travocort are: isokonazol nitrate and diflucortolone valerate. Each gram of cream contains 10 mg (1% w/w) of isokonazol nitrate and 1 mg (0.1% w/w) of diflucortolone valerate.
• Other components are: white vaseline, liquid paraffin, cetostearyl alcohol, polysorbate 60, sorbitan stearate, disodium edetate, and purified water.

What Travocort looks like and contents of the pack
Travocort is a white-yellow, opaque cream.
Packaging: An aluminium tube with a screw cap made of HDPE, containing 15 g of cream, placed in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Ireland, 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 (MI), Italy

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
Poland

Marketing Authorisation Number in Ireland, the country of export: PA 1025/12/1
Parallel Import Licence Number: 260/23