LOCAPRED 0.1 %

LOCATOP is indicated in adults, infants, children and adolescents.

1. Preferred indications where local corticosteroid therapy is considered the best treatment:

· contact eczema

· atopic dermatitis

· lichenification

2. Indications where local corticosteroid therapy is one of the usual treatments:

· stasis dermatitis

· psoriasis (excluding very extensive plaques)

· lichen

· non-parasitic prurigo

· genital lichen sclerosus

· granuloma annulare

· discoid lupus erythematosus

· non-microbial palmoplantar pustulosis

· seborrheic dermatitis except for the face

· symptomatic treatment of pruritus in mycosis fungoides

3. Situational indications for a short duration

· insect bites and parasitic prurigo after etiological treatment.

Special warnings

· Use on the face

Prolonged use of strong activity corticosteroids on the face exposes to the occurrence of a cortico-induced and paradoxically cortico-sensitive dermatitis, with rebound after each stop. A progressive withdrawal, which is particularly difficult, is then necessary.

· Increase in systemic absorption of topical corticosteroids

Due to the passage of the corticosteroid into the general circulation, treatment over large areas or under occlusion, can lead to the systemic effects of general corticosteroid therapy, particularly in infants and young children. These consist of a cushinoid syndrome and a slowing of growth. These accidents disappear upon stopping the treatment, but a sudden stop can be followed by acute adrenal insufficiency.

· Visual disorders

Visual disorders may appear during systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom appearing during corticosteroid therapy, an ophthalmological examination is required to look in particular for cataracts, glaucoma (see precautions for use), or a rarer lesion such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.

Precautions for use

· Infections and infestations

In case of bacterial or fungal infection of a cortico-sensitive dermatosis, the use of the corticosteroid should be preceded by a specific treatment. It is nevertheless possible, in certain cases only, to use a combination of corticosteroid and specific treatment.

· Local intolerance

If a local intolerance appears, the treatment must be interrupted immediately and the cause must be sought.

· Ocular disorders

Repeated and/or prolonged applications of the product can cause ocular hypertension or a cataract in certain patients (See Special warnings). In the patient without known glaucoma or cataract, ophthalmological monitoring is necessary in case of prolonged palpebral use.

In the patient at risk of glaucoma, a reactive hypertension is slightly more frequent and topical corticosteroids must be applied under ophthalmological monitoring in case of treatment of more than one week (See Special warnings).

· Rebound effect

A rebound effect can be observed during a sudden stop after long-term treatment. Continuous or inappropriate long-term use of local corticosteroids can lead to the development of a rebound phenomenon after stopping the treatment (withdrawal reaction of local corticosteroids). A severe form of rebound phenomenon can develop in the form of dermatitis with intense redness, tingling and/or a burning sensation, itching, skin scaling, oozing pustules, which can extend beyond the initially treated area. This rebound phenomenon is more likely to occur during the treatment of sensitive skin sites such as the face and flexion areas, in case of sudden stop or too rapid progressive decrease after prolonged use.

In case of reappearance of symptoms in the days or weeks following successful treatment, a withdrawal reaction must be suspected. Reapplication must be carried out with caution and the advice of a specialist is recommended in these cases, or other treatment options must be considered.

· To be used with particular precaution in patients suffering from psoriasis since topical corticosteroids can be dangerous for a large number of reasons in case of psoriasis, among which we note the recurrence of the disease due to the development of tolerance, the risk of generalized pustular psoriasis and general toxicity due to skin disruption.

Pediatric population

In infants, it is preferable to avoid high-activity corticosteroids (classes I and II). Particular caution must be taken regarding spontaneous occlusion phenomena that may occur in skin folds or under diapers.

This medicine contains sorbic acid, cetylstearyl alcohol and cetostearyl macrogol ether which may cause local skin reactions (for example contact dermatitis).

No interaction study has been conducted.

At the recommended doses, desonide for topical use is not likely to cause medically significant drug interactions.

Pregnancy

There are no data or there is limited data on the use of desonide in pregnant women.

Studies conducted in animals have shown reproductive toxicity (see section 5.3).

The use of LOCATOP is not recommended during pregnancy.

Breastfeeding

There is insufficient data on the excretion of desonide in breast milk. A risk to the breastfed child cannot be excluded.

LOCATOP must not be used during breastfeeding.

Fertility

No studies have been conducted in animals to evaluate the effect of desonide on male or female fertility.

LOCATOP has no effect or a negligible effect on the ability to drive vehicles and use machines.