Package leaflet: Information for the user

Travocort 0.1% + 1% cream

diflucortolone valerate + isoconazole nitrate
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Travocort is and what it is used for
What you need to know before using Travocort
How to use Travocort
Possible side effects
How to store Travocort
Contents of the pack and other information

1. What Travocort is and what it is used for

Travocort contains the active substances diflucortolone valerate (a glucocorticoid) and isoconazole nitrate (an antifungal agent).
The antifungal agent acts locally against fungi causing infections (mycoses: dermatophytoses, candidiasis, pityriasis versicolor) of smooth (hairless) or hairy skin.
Due to the presence of the glucocorticoid (corticosteroid), Travocort is particularly indicated for the treatment of mycoses associated with clearly inflammatory or eczematous skin manifestations.

2. What you need to know before using Travocort

Do not use Travocort

if you are allergic to diflucortolone valerate or isoconazole nitrate, or to any of the other ingredients of this medicine (listed in section 6);
if there are tuberculous, luetic (caused by syphilis), or viral lesions (such as chickenpox, herpes zoster) in the area to be treated, rosacea (redness and dilation of small blood vessels in the central part of the face), perioral dermatitis (inflammation localized around the mouth), or skin reactions following vaccinations.

Warnings and precautions
Talk to your doctor or pharmacist before using Travocort.
Exercise particular caution with Travocort:

when using topical glucocorticoids over large body surface areas or for prolonged periods, especially under occlusive dressing, as this may increase the risk of adverse effects due to systemic absorption of the medicine;
when applying Travocort to the genital area, because the components liquid paraffin and white soft paraffin may reduce the resistance of latex products such as condoms and diaphragms used simultaneously, thereby compromising their safety. The use, especially prolonged use, of topical products may lead to sensitization reactions (allergy). This particularly concerns the groin and genital areas. In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.

As is known with systemic glucocorticoids (administered orally, by inhalation, or by injection),
the use of topical glucocorticoids may also lead to glaucoma, an eye disease characterized by increased
intraocular pressure and visual impairment (e.g., after excessive dosing or application over large areas
for prolonged periods, with occlusive bandaging techniques, or after application to the skin around the eyes).
When applying the product to the face, avoid contact with the eyes.
Prolonged use of the product may promote the growth of microorganisms not sensitive to the chemotherapeutic agent present in the preparation. In such cases, your doctor will take appropriate therapeutic measures.
Standard hygiene practices are essential for successful treatment with Travocort.
Ask your doctor which hygiene measures you should follow during treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Limited data are available on the safety and efficacy of Travocort in children under 12 years of age.
The safety and efficacy in children under 2 years of age have not yet been established.

Other medicines and Travocort
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted between Travocort and other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of topical preparations containing glucocorticoids is not recommended during the first trimester of pregnancy. In particular, treatment of extensive areas, prolonged use, or occlusive bandaging should be avoided during pregnancy. However, administration during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus, and only in cases of clear necessity and under direct medical supervision.
Epidemiological studies suggest there may be an increased risk of cleft palate (a congenital malformation of the palate with a fissure) in infants born to women treated with systemic corticosteroids during the first trimester of pregnancy.
The possibility of adverse reactions in newborns whose mothers were treated during pregnancy cannot be ruled out (see "Possible side effects").
It is not known whether the active ingredients are excreted in human milk. A risk to the nursing infant cannot be excluded.
Do not use the medicine on the breast during breastfeeding to avoid accidental ingestion by the infant.
The use of Travocort during breastfeeding is not recommended, especially for treatment of large areas, prolonged use, or occlusive bandaging.
Administration of Travocort during breastfeeding should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.
The possibility of adverse reactions in infants whose mothers were treated during breastfeeding cannot be excluded (see "Possible side effects").

Driving and using machines
No effects on the ability to drive or operate machinery have been observed in patients treated with Travocort.

Travocort contains cetyl stearyl alcohol
This medicine contains cetyl stearyl alcohol. It may cause local skin reactions (e.g., contact dermatitis).

3. How to use Travocort

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by a doctor, the recommended dose is 2 applications per day.
After resolution of inflammatory and eczematous skin manifestations, or at most after 2
weeks of treatment, it is advisable to discontinue the use of Travocort and, if necessary, continue with the simple antimycotic agent.
If you use more Travocort than you should
No risk of acute intoxication is known following a single excessive application of the medicine (application over a large surface area under conditions favouring absorption) or accidental ingestion.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)
Irritation and burning at the application site.
Uncommon (may affect up to 1 in 100 people)
Rash (erythema) and dryness at the application site.
Striae (a type of red stretch marks).
Unknown frequency (frequency cannot be estimated from the available data):
Itching and blisters at the application site.
Blurred vision.
As with other topical glucocorticoids, the following local adverse reactions may occur (frequency cannot be estimated from the available data):
cutaneous atrophy (thinning of the skin), folliculitis (inflammation of hair follicles) at the application site, hypertrichosis (excessive hair growth), telangiectasia (dilation of small blood vessels in the skin), perioral dermatitis (localized inflammation around the mouth), skin discoloration, acne and/or allergic skin reactions to any of the components of Travocort. Systemic effects due to absorption may occur when topical preparations containing glucocorticoids are applied.
Adverse reactions cannot be ruled out in children whose mothers were treated during pregnancy or breastfeeding with Travocort over large body surface areas or for prolonged periods. Reduced corticoadrenal function and immunosuppression may occur (see "Pregnancy and breastfeeding").
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Travocort

Keep this 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 that month. The expiry date applies to the product in its original packaging, stored correctly.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Travocort contains

The active substances are diflucortolone valerate and isoconazole nitrate. 1 g of Travocort contains 1 mg (0.1%) of diflucortolone valerate and 10 mg (1%) of isoconazole nitrate.
The other components are: polyethylene glycol sorbitan stearate, sorbitan stearate, cetyl alcohol , white soft paraffin, liquid paraffin, disodium edetate dihydrate and purified water.

Description of the appearance of Travocort and contents of the pack
Cream, tube of 20 g
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 (MI), Italy.
Local representative in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Rome.