DIPROSALIC Pom T/30g

Micronised betamethasone dipropionate................................................................................. 0,064* g

Salicylic acid ........................................................................................................................... 3,000 g

per 100 g of ointment.

* Quantity corresponding to 0,05 g of betamethasone

Corticosensitive dermatoses with a keratotic or squamous component:

1. Preferred indications where topical corticotherapy is considered the best treatment:
   • lichenification.
2. Indications where corticotherapy is one of the usual treatments:
   • psoriasis,
   • lichen,
   • seborrhoeic dermatitis, except on the face.

Dosage

Applications will be limited to 2 per day for one to two weeks; for maintenance treatment, a single daily application may be sufficient. Increasing the number of applications risks worsening adverse effects without improving therapeutic effects.

Treatment of large areas requires particular monitoring (number of tubes used).

Treatment will be discontinued gradually by spacing out applications or by using a less potent or less concentrated corticosteroid, or by alternating with a base without dermocorticoid.

Method of administration

Gently spread the ointment over the lesions and work it in with light massage.

• primary bacterial, viral, fungal and parasitic infections, even if they include an inflammatory component,
• ulcerated lesions,
• acne and rosacea,
• hypersensitivity to the active substances or to any of the excipients listed in section Composition,
• the ointment form is not suitable for weeping lesions.

Special warnings

• Prolonged use of potent corticosteroids on the face exposes to the occurrence of corticosteroid-induced and paradoxically corticosteroid-sensitive dermatitis, with rebound after each discontinuation. Gradual withdrawal, which is particularly difficult, is then necessary.
• Due to the passage of the corticosteroid into the general circulation, treatment over large areas or under occlusion may cause the systemic effects of general corticotherapy, particularly in infants and young children. These consist of cushingoid syndrome and slowed growth: these effects disappear when treatment is stopped, but abrupt withdrawal may be followed by acute adrenal insufficiency.
• Salicylic acid, under the same conditions, may be responsible for salicylate intoxication.
• DIPROSALIC is not intended for ophthalmic use or for application to the eyelids or mucous membranes.

Precautions for use

• In infants and young children, it is preferable to avoid DIPROSALIC. Particular care should be taken regarding spontaneous occlusion phenomena that may occur in skin folds or under waterproof diaper covers.
• In case of bacterial or fungal infection of a corticosensitive dermatosis, either precede the use of the corticosteroid with a specific treatment or, possibly, and in certain cases only, use a combination of corticosteroid plus specific treatment.
• If local intolerance appears, treatment must be discontinued and the cause must be investigated.
• In patients sensitive to salicylates, in particular children, use with caution in all circumstances likely to favour systemic passage (see section Pharmacokinetics).
• Use under occlusion must be monitored due to the risk of superinfection.

Visual disturbances may occur during systemic or local corticosteroid therapy (notably by nasal, inhaled and intra-ocular route). In case of blurred vision or appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for visual disorders, notably cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.

• With prolonged use, especially of high-potency corticosteroids, the following are to be feared: skin atrophy, telangiectasias (particularly to be feared on the face), striae (notably at the root of the limbs and more readily occurring in adolescents), ecchymotic purpura secondary to atrophy, skin fragility.
• On the face, corticosteroids may cause perioral dermatitis or create or worsen rosacea (see sections Warnings and precautions and Contraindications).
• A delay in healing of atonic wounds, bedsores and leg ulcers may be observed (see section Contraindications).
• Possibility of systemic effects related to the corticosteroid and/or salicylic acid (see section Warnings and precautions).
• The following have been reported: acneiform or pustular eruptions, hypertrichosis, depigmentation.
• Blurred vision (see also section Warnings and precautions) has been reported with the use of corticosteroids (frequency not known).

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 the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr..

Pharmacotherapeutic class: High-potency corticosteroids, other combinations, ATC code: D07XC01

DIPROSALIC is a high-potency dermocorticosteroid (class II) combined with salicylic acid. The dermocorticosteroid is active on the inflammatory process and the pruritic effect associated with it. It has vasoconstrictive (antiexudative) properties and inhibits cell multiplication and synthesis processes in the dermis and epidermis.

Keratolytic action of salicylic acid.

Systemic passage of the corticosteroid, assessed by its impact on cortisolemia, always exists. The extent of the passage and of systemic effects depends on the surface area to be treated, the degree of epidermal alteration and the duration of treatment. Likewise, the systemic passage of salicylic acid is linked to these factors.

36 months.