Travocort 0.1 + 1% w/w Cream

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

DIFLUCORTOLONE VALERATE, ISOCONAZOLE NITRATE

Beschikbaar vanaf:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC-code:

D01AC20

INN (Algemene Internationale Benaming):

DIFLUCORTOLONE VALERATE 1 mg/g ISOCONAZOLE NITRATE 10 mg/g

farmaceutische vorm:

CREAM

Samenstelling:

DIFLUCORTOLONE VALERATE 1 mg/g ISOCONAZOLE NITRATE 10 mg/g

Prescription-type:

POM

Therapeutisch gebied:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Autorisatie-status:

Authorised

Autorisatie datum:

2008-01-23

Bijsluiter

15660
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOCORT
® 0.1 + 1 % w/w Cream
Diflucortolone valerate
Isoconazole nitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
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:
•
are allergic (hypersensitive) to isoconazole nitrate or
diflucortolone-valerate or any of the other ingredients of
this medicine (listed in section 6),
•
have skin lesions in the area to be treated which are
associated with a tuberculosis or syphilis infection,
•
have a viral infection e.g. herpes, shingles or chicken-
pox (varicella, herpes zoster),
•
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
•
TALK TO YOUR DOCTOR, P

Productkenmerken

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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 glucocortico