Travogen Cream 1% w/w

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISOCONAZOLE NITRATE

Available from:

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

ATC code:

D01AC05

INN (International Name):

ISOCONAZOLE NITRATE 10 mg/g

Pharmaceutical form:

CREAM

Composition:

ISOCONAZOLE NITRATE 10 mg/g

Prescription type:

OTC

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Withdrawn

Authorization date:

2007-05-15

Patient Information leaflet

PL02402001
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAVOGEN - CREAM
Isoconazole nitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to your doctor if you do not feel better or if you feel
worse after
4 weeks.
A medical prescription is required for the treatment of fungal disease
in the genital
region. For this reason, the following also applies:
•
If you have any further questions, ask your doctor or pharmacist.
•
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.
WHAT IS IN THIS LEAFLET:
1.
WHAT TRAVOGEN CREAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOGEN CREAM
3.
HOW TO USE TRAVOGEN CREAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TRAVOGEN CREAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TRAVOGEN CREAM IS AND WHAT IT IS USED FOR
Travogen is a medicine used to treat superficial fungal diseases of
the skin, such as those
between the toes, on the hands, in the groin, for the treatment of
fungal diseases in the
genital region and erythrasma (inflammation of the skin due to a
specific group of bacteria).
You must talk to your doctor if you do not feel better or if you feel
worse after 4 weeks.
A medical prescription is required for the treatment of fungal disease
in the genital region.
Travogen is effective against all major types of fungus that occur on
human skin.
PL02402001
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOGEN CREAM
DO NOT USE TRAVOGEN CREAM
-
if you are allergic to isoconazole nitrate or any of

Summary of Product characteristics

SPC02402001
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRAVOGEN - CREAM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 10 mg isoconazole nitrate.
(Equivalent to 1% (w/w) isoconazole nitrate.)
1 cm Travogen cream contains 2 mg isoconazole nitrate
Excipient with known effect: 50 mg/g cetostearyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White to slightly yellowish transparent cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Superficial fungal infections of the skin, such as tinea pedum et
manuum,
tinea inguinalis, of the genital region and erythrasma. A medical
prescription
is required when the product is used in the genital region.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Cutaneous use.
Posology
Travogen cream should be applied once daily on the affected portions
of the
skin.
A general rule that applies to all fungal infections is that topical
treatment
must be performed over a period of 2-3 weeks, and in cases of
persistent
infection (especially when the interdigital spaces are affected), even
for
4 weeks. Depending on the symptoms, topical treatment may be used for
longer periods of time.
To avoid renewed infection, the treatment should be continued for at
least
2 weeks after clinical healing.
Paediatric population
Data on a limited number of infants, toddlers, children and
adolescents
indicate no negative effects with the use of Travogen cream. Currently
available data are described in section 5.1; however, no dosage
recommendation can be given.
SPC02402001
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
When using Travogen cream on the face, it should be ensured that the
cream does not come into contact with the eyes.
The physician should provide the patient with information on hygienic
measures during use.
If Travogen cream is used in the genital region, the components liquid
paraf