ENSTILAR® CUTANEOUS FOAM 50MCG/G + 0.5MG/G [SIN15892P]

Product Info

ENSTILAR® CUTANEOUS FOAM 50MCG/G + 0.5MG/G

[SIN15892P]

4.1 Therapeutic indications

Topical treatment of psoriasis vulgaris in adults.

4.2 Posology and method of administration

Posology
Flare treatment

Enstilar® foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision.

Long-term maintenance treatment
Patients who have responded at 4 weeks’ treatment using Enstilar® once daily are suitable for long-term maintenance treatment. Enstilar® should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2–3 days without Enstilar® treatment.

If signs of a relapse occur, flare treatment, as described above, should be re-initiated.

Maximum dose
The daily maximum dose of Enstilar® should not exceed 15 g, i.e. one 60 g can should last for at least 4 days. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand.

The maximum weekly dose of Enstilar® should not exceed 100g.

If using other topical products containing calcipotriol in addition to Enstilar®, the total dose of all calcipotriol containing products should not exceed 15 g per day.

The total body surface area treated should not exceed 30%.

Special populations

Renal and hepatic impairment

The safety and efficacy of Enstilar® foam in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Paediatric population

The safety and efficacy of Enstilar® foam in children below 18 years have not been established. Currently available data in children aged 12 to ≤17 years are described in sections 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and no recommendation on a posology can be made.

Method of administration

For cutaneous use.

The can should be shaken for a few seconds before use. Enstilar® should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally.

Enstilar® should be sprayed directly onto each affected skin area and rubbed in gently. The hands should be washed after using Enstilar® (unless Enstilar® is used to treat the hands) to avoid accidentally spreading to other parts of the body. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. It is recommended not to take a shower or bath immediately after application of Enstilar®.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Enstilar® is contraindicated in erythrodermic and pustular psoriasis.

Due to the content of calcipotriol, Enstilar® is contraindicated in patients with known disorders of calcium metabolism (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Due to the content of corticosteroid, Enstilar® is contraindicated in the following conditions if present in the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).