TRAVOSEPT 0.1% + 1% Krem

Treść ulotki

1. Travosept 0.1% + 1% cream
   1. What Travosept is and what it is used for
   2. What you need to know before using Travosept
   3. How to use Travosept
   4. Possible side effects
   5. How to store Travosept
   6. Contents of the pack and other information

Travosept 0.1% + 1% cream

diflucortolone valerate + clorchinaldol

Read this leaflet carefully before you use 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 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 Travosept is and what it is used for
• 2. What you need to know before you use Travosept
• 3. How to use Travosept
• 4. Possible side effects
• 5. How to store Travosept
• 6. Contents of the pack and other information

1. What Travosept is and what it is used for

Travosept is a cream that contains the active ingredients diflucortolone valerate, which belongs to the group of
glucocorticoids, and chlorchinaldol, an antiseptic active against bacterial and fungal infections.
This cream is used for the local treatment of inflammatory (inflammatory skin diseases) and allergic
skin conditions sensitive to the action of glucocorticoids, caused or complicated by a bacterial and/or
fungal component. Eczematous manifestations (inflammatory skin reactions with
itching) with superinfection (skin infection occurring simultaneously with a pre-existing infection) bacterial
and/or fungal (yeast) and widespread reactions include:

• nummular, seborrheic, dyshidrotic eczema; stasis or varicose eczema (however not directly on the ulcer); bacteride; eczematide;
• bacterial dermatitis (with pustular or crusty manifestations) such as: pyoderma (impetigo, folliculitis), erythrasma;
• superficial fungal infections of the skin with a predominant inflammatory component or with secondary eczematization such as: tinea, candidiasis, pityriasis versicolor.

Prevention of bacterial and/or fungal (yeast) superinfections in inflammatory and
allergic skin conditions.

2. What you need to know before using Travosept

Do not use Travosept

• if you are allergic to the active ingredients 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 (severe flushing or redness of the skin and face), perioral dermatitis (red skin rashes around the mouth);
• if you have had skin reactions after the administration of vaccines.

Warnings and precautions
Consult your doctor or pharmacist before using Travosept:

• if you are pregnant. In this case, use the cream only if absolutely necessary and under the direct supervision of your doctor (see “Pregnancy and breastfeeding”);
• if there are extensive lesions, treat limited areas, one at a time in succession.

Children
Do not use the medicine for more than 5 – 7 days in infants and children if the areas to be treated are covered by
plastic diapers or briefs.
The application of glucocorticoid drugs to extensive areas of the body and/or for long periods of
time may cause undesirable effects due to the absorption of the substance into the body.
This is more frequent in the case of occlusive (non-breathable) bandaging, with the use of diapers and
in the skin folds in children.
Therefore, in the treatment of chronic diseases that require prolonged therapies, once a
improvement has been obtained, your doctor should reduce the dosage and frequency of applications to the minimum
necessary to control the symptoms and avoid recurrence of the disease (relapses), suspending the use
of the preparation as soon as possible.
Avoid contact with the eyes.
With the use of glucocorticoids for local use, the appearance of glaucoma (an eye disease in
which there is an increase in pressure inside the eye) is possible, for example after the use of excessive doses or on
extensive 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 in the anal or genital region, some of its ingredients may damage
latex products, such as condoms. Therefore, these may no longer be effective as contraceptives or
as protection against sexually transmitted diseases such as HIV infection. Consult your doctor or
pharmacist if you need more information.
If the skin becomes too dry with prolonged use of Travosept, a greasy neutral formulation should be applied in
addition or as an alternative.
Prolonged use of the product may promote the development of microorganisms that are not sensitive to the antiseptic
present in the preparation itself. In this case, your doctor will advise you on appropriate therapy.

Other medicines and Travosept
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicinal products.
No interactions between Travosept and other medicines or substances are known or predictable.

Pregnancy, breastfeeding, fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before using this medicine. The doctor will carefully assess the benefit-risk ratio
associated with the use of Travosept.
Glucocorticoids should not be applied during the first three months of pregnancy in order to avoid
any risk to the development of the unborn child.
If you are pregnant, you should particularly avoid applying Travosept covered with a bandage, to large areas or
using the cream for a long period.
It is not known whether the active ingredients of Travosept pass into breast milk. A risk to the baby cannot therefore be excluded.
If you are breastfeeding, you should

• do not apply Travosept to the breast;
• avoid applying Travosept covered with occlusive bandaging or to extensive areas of the body;
• avoid using Travosept for a prolonged period of time. There is no data to demonstrate that fertility is affected by the use of Travosept.

Driving and operating machinery
No known effects.

Travosept contains stearyl alcohol
This medicine contains stearyl alcohol which can cause localized skin reactions (e.g.
contact dermatitis).

3. How to use Travosept

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Apply a thin layer of Travosept to the area to be treated.
Unless otherwise prescribed by your doctor, start treatment with 2, possibly 3 applications per day.
Once improvement is achieved, it will be sufficient to continue treatment with a single application
daily.
Do not use this medicine for longer than 3 weeks. In particular, do not prolong therapy beyond 5 - 7
days in infants and children if the areas to be treated are covered by diapers or plastic underwear. If
extensive lesions are present, treat them in succession, one at a time, limited areas.

If you use more Travosept than you should
No risk of intoxication is predictable following a single local application of an
excessive amount of medicine (application to an extended area of skin under conditions that favor
absorption) or 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 everybody gets 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 (blister formation).

In rare cases, the following may occur:

• folliculitis (infection of the hair follicle),
• increased body hair growth (hypertrichosis),
• perioral dermatitis (red skin rash around the mouth),
• skin discoloration,
• allergic skin reactions (allergic contact dermatitis). With the use of Travosept under normal conditions of use, the occurrence of side effects due to absorption of the substance into the body is very unlikely.

With an unknown frequency (frequency cannot be estimated based on available data): Blurred vision.
It is advisable to avoid very prolonged treatments(over 3 weeks) and/or on large areas of skin
(about 10% or more of the body surface) as the following side effects may occur:

• skin atrophies (disease that makes the skin thin, wrinkled and lacking in elasticity),
• striae (stretch marks),
• telangiectasias (visible dilation of small blood vessels on the skin surface),
• acne and
• effects due to absorption into the body, whose symptoms include Cushing's syndrome (condition in which the body produces high levels of the hormone cortisol), hyperglycemia (increased blood glucose) and glycosuria (presence of sugars in the urine). A higher incidence of these side effects may be observed with the use of corticosteroid medicines on a large surface area, prolonged use, and the addition of an occlusive bandage.

In occlusive treatments, keep in mind that the films used for bandaging can themselves cause sensitization phenomena.

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 Travosept

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 25°C.
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 indicated refers to the product in
intact packaging correctly stored.
Validity after first opening: 3 months.
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 Travosept contains

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

Description of the appearance of Travosept and contents of the pack
Cream.
Tube containing 30 g.

Marketing authorisation holder and manufacturer
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.
Distributor in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129 – 00144 Rome