TRAVOCORT 0.1% + 1% Cream

Зміст інструкції

1. Travocort 0.1% + 1% cream
   1. What is Travocort and what is it used for
   2. What you need to know 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

Travocort 0.1% + 1% cream

diflucortolone valerate + isoconazole nitrate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Travocort is and what it is used for
• 2. What you need to know before you use 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 is Travocort and what is it used for

Travocort contains the active ingredients diflucortolone valerate (a glucocorticoid) and isoconazole nitrate
(an antifungal).
The antifungal acts locally against fungi that cause infections (mycoses: dermatophytoses,
candidiasis, pityriasis versicolor) of glabrous (hairless) or hairy skin.
Due to the presence of the glucocorticoid (cortisone-like), Travocort is particularly indicated for the
treatment of mycoses that present with cutaneous manifestations of a decidedly inflammatory
or eczematous nature.

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, syphilitic (due to syphilis) and viral lesions (chickenpox, herpes zoster) present in the area to be treated, rosacea (redness and dilation of small blood vessels in the central part of the face), perioral dermatitis (localized inflammation around the mouth) and skin reactions to vaccinations.

Warnings and precautions
Consult your doctor or pharmacist before using Travocort.

Take special care with Travocort:

• in case of use of topical glucocorticoids on large body surfaces or for prolonged periods of time, especially under occlusive dressing, as this may increase the risk of undesirable effects due to absorption of the medicine into the body;
• if you apply Travocort to the genital area, as the paraffin liquid and white petrolatum components may reduce the resistance of latex products such as condoms and diaphragms used simultaneously, thereby compromising their safety. The use, especially if prolonged, of topical products can give rise to sensitization phenomena (allergy). This particularly concerns the inguinal and genital regions. In this case, discontinue treatment and consult your doctor to establish appropriate therapy.

As is known for systemic glucocorticoids (administered orally, by inhalation or injection),
the appearance of glaucoma, a disease of the
eyes characterized by increased intraocular pressure and impaired vision (e.g.
after use at excessive doses or on extensive areas for prolonged periods, with occlusive dressing techniques
or after application to the skin around the eyes) is also possible with the use of topical glucocorticoids.
When applying to the face, avoid contact of the preparation with the eyes.
Prolonged use of the product may promote the development of microorganisms that are not sensitive to the
chemotherapeutic agent present in the preparation itself. In this case, your doctor will take appropriate
therapeutic measures.
Normal hygiene rules are essential for the success of treatment with Travocort.
Ask your doctor what hygiene measures to take during treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Only 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No studies on interactions between Travocort and other medicines have been conducted.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 dressing should be avoided during pregnancy. However, administration during pregnancy should be
considered only if the expected benefit for the mother outweighs the risk to the fetus, therefore in
cases of actual need and under the direct control of the doctor.
Epidemiological studies suggest that there may be an increased risk of cleft palate
(a malformation of the palate, which has a fissure) in newborns from women treated with systemic corticosteroids
during the first trimester of pregnancy.
The possibility of adverse reactions in newborns whose mothers have been treated during pregnancy cannot be excluded (see “Possible side effects”).
It is not known whether the active ingredients are excreted in human milk. A risk to the
infant cannot be excluded.
Do not use the medicine on the breast during breastfeeding to avoid accidental ingestion by the
child.
The use of Travocort during breastfeeding is not recommended, especially for the treatment of extensive
areas, prolonged use or occlusive dressing.
The administration of Travocort during breastfeeding should be considered only if the
benefit expected for the mother outweighs the risk to the child.
The possibility of adverse reactions in children whose mothers have been treated during breastfeeding cannot be excluded (see “Possible side effects”).

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

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

3. How to use Travocort

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 2 applications per day.
After the remission of inflammatory and eczematous skin manifestations, or at most after 2
weeks of treatment, it is advisable not to continue applying Travocort but to continue, if
necessary, with the simple antifungal agent.

If you use more Travocort than you should
No risk of acute intoxication is known following a single cutaneous application of an
excessive quantity of the medicine (application to a large area under conditions favoring
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 everybody gets 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)
Skin rash (erythema) and dryness at the application site.
Striae (a type of stretch marks that are reddish in color).

Not known(frequency cannot be estimated from available data):
Itching and blisters at the application site.
Blurred vision.
As with other topical glucocorticoids, the following local adverse reactions may occur
(their frequency cannot be estimated from available data):
skin atrophy (thinning of the skin), folliculitis (inflammation of the hair follicles) at the site of
application, hypertrichosis (increased hair growth), telangiectasias (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 excluded in children whose mothers have been treated during
pregnancy or during breastfeeding with Travocort on extensive areas of the body or for prolonged periods of
time. Reduced adrenal function and immunosuppression may occur (see
“Pregnancy and breastfeeding”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can 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 which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Travocort contains

• The active ingredients 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 ingredients are: polyethylene glycol-sorbitan stearate, sorbitan stearate, cetostearyl alcohol, white petrolatum, 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 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 (MI), Italy.
Marketing Authorisation Holder in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Roma.