Travocort

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIFLUCORTOLONE VALERATE, ISOCONAZOLE NITRATE

Available from:

Bayer Limited

ATC code:

D01AC20

INN (International Name):

DIFLUCORTOLONE VALERATE, ISOCONAZOLE NITRATE

Pharmaceutical form:

CREAM

Composition:

DIFLUCORTOLONE VALERATE 0.1 percent weight/weight ; ISOCONAZOLE NITRATE 1 percent weight/weight

Prescription type:

POM

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2008-01-23

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your
doctor, pharmacist or nurse.
R This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN 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 TRAVOCORT IS AND WHAT IT IS USED FOR
This medicine is used to treat fungal infections of the
skin where inflammation (redness, swelling, soreness)
is also a problem.
This medicine contains two active substances,
isoconazole nitrate and diflucortolone valerate.
Isoconazole nitrate treats fungal diseases of the skin
and diflucortolone valerate suppresses inflammation
of the skin and soothes complaints such as itching,
burning and pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
TRAVOCORT
DO NOT USE TRAVOCORT IF YOU:
R are allergic (hypersensitive) to isoconazole nitrate
or diflucortolone-valerate or any of the other
ingredients of this medicine (listed in section 6),
R have skin lesions in the area to be treated which
are associated with a tuberculosis or syphilis
infection,
R have a viral infection e.g. herpes, shingles or
chicken-pox (varicella, herpes zoster),
R have a chronic skin inflammation of the face
(rosacea), skin inflammation around the mouth
(perioral dermatitis) or a skin reaction following
vaccination in the area to be treated.
WARNINGS AND PRECAUTIONS
R TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE
USING TRAVOCORT. WHEN USING TRAVOCORT IT IS
IMPORTANT TO KNOW THE FOLLOWING: If you also
have a bacterial infection

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Travocort 0.1 + 1% w/w Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.1% w/w diflucortolone valerate (1 mg/g) and 1% w/w
isoconazole nitrate (10 mg/g).
Excipient with known effect: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
A white to yellowish opaque cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Initial or interim treatment of those superficial fungal infections of
the skin which are accompanied by
highly inflammatory or eczematous skin conditions, e.g. in the region
of the hands, the interdigital
spaces of the feet and in the inguinal and genital regions.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use
Travocort should be applied twice daily to the diseased areas of skin.
Treatment with Travocort must be terminated after regression of the
inflammatory or eczematous skin
conditions or at the latest after 2 weeks and therapy continued or
followed up with a glucocorticoid-free
anti-fungal preparation. This applies in particular for use in the
inguinal and genital regions.
_Paediatric population: _
Dose adjustments are not required when Travocort is administered to
children aged 2 years or older and
adolescents.
Only limited data on the safety of Travocort in children aged below 2
years are available, for more
details see section 5.1.
4.3 CONTRAINDICATIONS
Tuberculous or syphilitic processes in the area to be treated; virus
diseases (e.g. varicella, herpes
zoster), rosacea, perioral dermatitis and postvaccination skin
reactions in the area to be treated.
Hypersensitivity to the active substances or to any of the excipients.
In general, Travocort should be used without occlusion.
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4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Specific additional therapy is required for bacterial infections of
the skin..
Travocort should not be allowed to come into contact with the eyes
when being applied to the face.
Extensive application of topical glucocorticoids to l