TRAVOCORT Cream Ref.[8251] Active ingredients: Diflucortolone Isoconazole

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. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Extensive application of topical glucocorticoids to large areas of the body or for prolonged periods of time, in particular under occlusion, may increase the risk of systemic side effects.

As known from systemic glucocorticoids, glaucoma may also develop from using local glucocorticoids(e.g. after large-dosed or extensive application over a prolonged period, occlusive dressing techniques, or application to the skin around the eyes).

The physician should advise the patients on hygienic measures during the treatment. If Travocort is applied to the genital regions, the excipients liquid paraffin and soft paraffin may cause damage of latex products for barrier methods such as condoms and diaphragms used concomitantly, thus impairing their effectiveness.

This medicinal product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

No interaction studies have been performed.

Pregnancy

There are no data from the use of isoconazole nitrate/diflucortolon valerate in pregnant women

Studies in animals (mice, rats and rabbits) have shown reproductive toxicity for diflucortolone valerate. Travocort should be avoided during the first trimester of pregnancy. In particular, treating large areas, prolonged use or occlusive dressings should be avoided during the whole of pregnancy.

Epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with glucocorticoids during the first trimester of pregnancy.

Breast-feeding

It is unknown whether isoconazole nitrate/diflucortolone valerate are excreted in human milk. A risk to the suckling child cannot be excluded.

Nursing mothers should not be treated on the breasts.Treating large areas, prolonged use or occlusive dressings should be avoided during lactation.

The clinical indication for treatment with Travocort must be carefully reviewed and the benefits weighed against the risks in lactating women.

Fertility

Preclinical data did not indicate any risk on fertility.

No effects on ability to drive and use machines have been observed in patients treated with Travocort.

In clinical studies, most frequently observed adverse reactions included application site irritation and application site burning.

Frequencies of adverse reactions observed in clinical studies and given in the table below are defined according to the MedDRA frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

General disorders and administration site conditions

Common: Application site: irritation, burning

Uncommon: Application site: erythema, dryness

Frequency not known: Application site: pruritus, vesicles

Skin and sub-cutaneous tissue disorders

Uncommon: Skin striae

Eye disorders

Frequency not known: Blurred vision (see section 4.4)

As with other glucocorticoids for topical application, the following local adverse reactions may occur (frequency not known): Skin atrophy, application site folliculitis, hypertrichosis, telangiectasia, perioral dermatitis, skin discolouration, acne, and/or allergic skin reactions to any of the ingredients of the formulation. Systemic effects due to absorption may occur when topical preparations containing glucocorticoids are applied.

Adverse reactions cannot be excluded in neonates whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while lactating (for example, reduced adrenocortical function,immunosuppression).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.