Package leaflet: Information for the user

Travosept 0,1% + 1% cream

diflucortolone valerato + clorchinaldolo
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, consult 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Travosept is and what it is used for

Travosept is a cream containing the active substances diflucortolone valerate, which belongs to the group of glucocorticoids, and chlorquinaldol, an antiseptic active against bacterial and fungal infections.
This cream is used for the local treatment of inflammatory skin diseases (inflammatory skin conditions) and allergic conditions responsive to the action of glucocorticoids, when caused or complicated by a bacterial and/or fungal component. Eczematous manifestations (inflammatory skin reactions with itching) with bacterial and/or fungal superinfection (skin infection occurring alongside a pre-existing infection) and diffuse reactions include:

nummular, seborrheic, and dyshidrotic eczema; stasis or varicose dermatitis (however, not directly on the ulcer); bacterid; eczematid;
bacterial dermatitides (with pustular or crusted manifestations) such as: pyodermas (impetigo, folliculitis), erythrasma;
superficial fungal infections of the skin with predominant inflammatory component or secondary eczematization, such as: ringworm, candidiasis, pityriasis versicolor.

Prevention of bacterial and/or fungal superinfections in inflammatory and allergic skin diseases.

2. What you need to know before using Travosept

Do not use Travosept

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the area of skin to be treated is affected by tuberculosis or syphilis;
if you suffer from viral diseases (chickenpox, herpes zoster);
if you suffer from rosacea (intense flushing or redness of the skin and face), perioral dermatitis (red skin eruptions around the mouth);
if you have had skin reactions after vaccination.

Warnings and precautions
Talk to your doctor or pharmacist before using Travosept:

if you are pregnant. In this case, use the cream only if strictly necessary and under direct medical supervision (see "Pregnancy and breastfeeding");
if there are extensive lesions, treat limited areas sequentially, one at a time.

Children
Do not use the medicine for longer than 5–7 days in infants and children if the treated areas are covered by diapers or plastic pants.
Applying glucocorticoid medicines to the skin over large body areas and/or for long periods may lead to unwanted effects due to absorption of the substance into the body.
This is more likely to occur with occlusive bandaging (non-breathable), use of diapers, or in skin folds in children.
Therefore, when treating chronic conditions requiring prolonged therapy, once improvement has been achieved, your doctor should reduce the dosage and frequency of applications to the minimum necessary to control symptoms and prevent recurrence, discontinuing the product as soon as possible.
Avoid contact with the eyes.
When using topical glucocorticoids, glaucoma (an eye disease characterized by increased pressure inside the eye) may develop, for example after excessive doses or application over large areas for prolonged periods, with occlusive bandaging techniques, or after application to the skin around the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.
If Travosept is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms. Therefore, these may no longer be effective as contraceptives or for protection against sexually transmitted diseases such as HIV infection. Consult your doctor or pharmacist if you need further information.
If the skin becomes excessively dry during prolonged use of Travosept, a neutral fatty formulation should be applied additionally or alternatively.
Prolonged use of the product may promote the development of microorganisms that are not sensitive to the antiseptic contained in the preparation. In such cases, your doctor will advise appropriate therapy.

Other medicines and Travosept
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between Travosept and other medicines or substances are known or expected.

Pregnancy, breastfeeding, fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine. Your doctor will carefully evaluate the benefit-risk ratio related to the use of Travosept.
Glucocorticoids should not be applied during the first three months of pregnancy in order to avoid any risk to fetal development.
If you are pregnant, you should especially avoid applying Travosept under an occlusive dressing, over large areas, or for prolonged periods.
It is not known whether the active substances of Travosept pass into breast milk. Therefore, a risk to the infant cannot be excluded.
If you are breastfeeding, you must:

not apply Travosept to the breast;
avoid applying Travosept under occlusive dressings or over large body areas;
avoid using Travosept for prolonged periods.
There are no data showing that fertility is affected by the use of Travosept.

Driving and using machines
There are no known effects.
Travosept contains stearyl alcohol
This medicine contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Travosept

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply a thin layer of Travosept to the affected area.
Unless otherwise prescribed by your doctor, begin treatment with 2, or possibly 3 applications per day.
Once improvement has been achieved, continuing treatment with a single daily application is sufficient.
Do not use this medicine for longer than 3 weeks. In particular, do not extend treatment beyond 5–7
days in infants and children if the treated areas are covered by diapers or plastic pants. If extensive lesions are present, treat limited areas successively, one at a time.
If you use more Travosept than you should
No risk of intoxication is expected following a single local application of an excessive amount of the medicine (application over a large skin area under conditions favoring absorption) or after accidental ingestion of the entire contents of a package.
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.
During treatment with Travosept, local side effects may occur:
In isolated cases, the following may occur during treatment:

itching,
burning,
erythema (redness of the skin),
vesiculation (formation of blisters).

In rare cases, the following may occur:

folliculitis (infection of the hair follicle),
increased body hair growth (hypertrichosis),
perioral dermatitis (red skin rashes around the mouth),
skin discoloration,
allergic skin reactions (allergic contact dermatitis). When Travosept is used under normal conditions of use, it is highly unlikely that side effects due to systemic absorption of the substance will occur.

The following side effect may occur with unknown frequency (frequency cannot be estimated from the available data): Blurred vision.
It is advisable to avoid very prolonged treatments (more than 3 weeks) and/or on large areas of skin (approximately 10% or more of the body surface area), as the following side effects may occur:

skin atrophy (a condition causing the skin to become thin, wrinkled and lacking elasticity),
striae (stretch marks),
telangiectasias (visible dilation of small blood vessels on the skin surface),
acne, and
effects due to systemic absorption, whose symptoms include Cushing's syndrome (a condition in which the body produces high levels of the hormone cortisol), hyperglycaemia (increased blood glucose), and glycosuria (presence of sugar in the urine). A higher incidence of these side effects may be observed with the use of corticosteroid medicines over large skin surfaces, prolonged use, or when occlusive dressings are applied.

With occlusive treatment, it should be borne in mind that the films used for bandaging may themselves cause sensitization reactions.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: 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 Travosept

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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 indicated expiry date applies to the product in its original, unopened packaging stored correctly.
Usable duration after first opening: 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Travosept contains

The active substances are: diflucortolone valerate and chlorchinaldol. 100 g of cream contain 0.1 g (0.1%) of diflucortolone valerate and 1 g (1%) of chlorchinaldol.
The other components are: macrogol stearate, stearyl alcohol, liquid paraffin, white vaseline, disodium edetate, polyacrylic acid, sodium hydroxide, purified water.

Description of the appearance of Travosept and contents of the pack
Cream.
30 g tube.
Marketing Authorization Holder and Manufacturer
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.
Authorized distributor in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129 – 00144 Rome