Travocort 10 mg/1 mg Cream

1 g TRAVOCORT contains isoconazole nitrate 10 mg and 1 mg diflucortolone valerate in an easy to remove low fat base emulsion. The active substances in TRAVOCORT are isoconazole nitrate and diflucortolone valerate. Other excipients include: White soft paraffin, liquid paraffin, cetostearyl alcohol, polysorbate 60, sorbitan stearate, disodium edetate dihydrate, purified water.

TRAVOCORT is an anti-fungal medicine (an antimycotic) and an anti-inflammatory medicine (a corticosteroid) formulated as a cream to be used on the skin. One of TRAVOCORT's active ingredients, isoconazole nitrate, is effective against dermatophytes and yeasts, yeast-like fungi (including the causative organism of pityriasis versicolor) and moulds, as well as against the causative organism of erythrasma. The other active ingredient, diflucortolone valerate, suppresses inflammatory and allergic skin reactions. TRAVOCORT is used for the 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 groin and genital regions.

Do not use TRAVOCORT:

• If you are hypersensitive (allergic) to isoconazole nitrate or diflucortolone valerate or any of the other ingredients of TRAVOCORT (listed in section 6).
• If you are suffering from TB (tuberculosis), or syphilis in the area to be treated, from virus diseases (for example: chicken pox/varicella, herpes zoster), from rosacea, perioral dermatitis, or post-vaccination skin reactions in the area to be treated.
• If you are pregnant.

Warnings and precautions

If you are taking other medicines on a regular basis; please consult your doctor, pharmacist or other health care professional for advice as using this medicine at the same time with other medicines may cause undesirable interactions.

If your doctor diagnoses that your skin disease is accompanied by bacterial infections, additional specific therapy is required.

If you apply TRAVOCORT to the face it should not be allowed to come into contact with your eyes.

If you have already suffered a previous case of glaucoma, be sure to inform your doctor. Extensive application of topical corticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects.

Do not share medicines prescribed for you with any other person. Always use TRAVOCORT exactly as your doctor, or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is, unless otherwise prescribed by the doctor, for you to apply TRAVOCORT twice daily to the affected areas of skin. Your doctor will tell you how long your treatment with TRAVOCORT will last. In coordination with your doctor, the treatment with TRAVOCORT must be stopped after the inflammatory or eczematous skin condition has gone away.

If you have the impression that the effect of TRAVOCORT is too strong or too weak, tell your doctor or pharmacist.

If you use more TRAVOCORT than you should

In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of TRAVOCORT

Do not use increased amounts of TRAVOCORT CREAM to make up for a dose that you left out.

If you stop using TRAVOCORT

You should always consult your doctor before deciding to interrupt the course of treatment or stop using TRAVOCORT altogether.

TRAVOCORT can have side effects. Not all side effects reported for TRAVOCORT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRAVOCORT, please consult your health care provider for advice. If any of these side effects continue, are severe or bother you, tell your doctor or pharmacist.

In isolated cases under treatment with TRAVOCORT, symptoms such as itching, burning, redness (erythema), or blistering (vesiculation) in the area of the skin ailment may occur.

Tell your doctor if you notice any of the following:

Frequent side effects:

• application site irritation,
• application site burning.

Less frequent side effects:

• application site dryness,
• application site erythema,
• stretch marks.

Side effects with an unknown frequency:

• blurred vision,
• itching at the application site,
• blisters at the application site.

If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.

The following reactions may occur when TRAVOCORT is applied to large areas of the body (about 10% and more) or for prolonged periods of time (more than 4 weeks): thinning of the skin (atrophy), swollen red skin, stretch marks, acneform changes of the skin, and systemic effects of the corticosteroid due to absorption.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/. By reporting side effects, you can help provide more information on the safety of TRAVOCORT.

Store all medicines out of reach of children. Store at or below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).