Dovonex^® Scalp Solution

Calcipotriol 50 micrograms per ml (as the hydrate)

For full list of excipients, see section 6.1.

Solution

Colourless, slightly viscous solution.

Dovonex^® Scalp Solution is indicated for the topical treatment of scalp psoriasis.

Dovonex^® Scalp Solution is contraindicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex^® Scalp Solution is contraindicated in patients with hypersensitivity to the active substance or any of the excipients.

Application of Dovonex^® to the face may cause local irritation. Dovonex^® Scalp Solution should not therefore be applied directly to the face. Patients should be advised to wash their hands after applying the scalp solution and to avoid inadvertent transfer to other body areas, especially the face.

The risk of hypercalcaemia is minimal when the dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalised pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.

During treatment with Dovonex^® Scalp Solution physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).

There is no experience of concomitant therapy with other antipsoriatic products applied to the same skin area at the same time.

Pregnancy

The safety of the use of calcipotriol during human pregnancy has not been established, and studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.

Lactation

It is not known whether calcipotriol is excreted in breast milk. A decision on whether to abstain from breast-feeding or to abstain from therapy with Dovonex^® should be made taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Dovonex^® therapy to the woman.

Calcipotriol has no or negligible influence on the ability to drive and to use machines.

Approximately 25% of the patients treated with Dovonex^® Scalp Solution could experience an adverse reaction. These reactions are usually mild.

*Various types of rash reactions such as scaly, erythematous, maculo-papular, pustular, bullous have been reported.

Use above the recommended dose may cause elevated serum calcium which rapidly subsides when the treatment is discontinued.

ATC Code: D05A X02.

Pharmacotherapeutic group: Antipsoriatics for topical use.

Calcipotriol is a vitamin D derivative. In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes. This effect is the proposed basis for its effect in psoriasis.

Calcipotriol is only slightly absorbed from the skin.

The effect on the calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D₃.

Calcipotriol has shown maternal and foetal toxicity in rats and rabbits when given by the oral route at doses of 54 µg/kg/day and 12 µg/kg/day, respectively. The foetal abnormalities observed with concomitant maternal toxicity included signs indicative of skeletal immaturity (incomplete ossification of the pubic bones and forelimb phalanges, and enlarged fontanelles) and an increased incidence of supernumerary ribs.

There is insufficient pharmacokinetic data available to quantify the safety margin for the embryofoetal effects.

A dermal carcinogenicity study in mice revealed no special hazard to humans.

In a study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation and dermally administered calcipotriol for 40 weeks at dose levels corresponding to 9, 30 and 90µg/m²/day (equivalent to 0.25, 0.84, 2.5 times the maximum recommended daily dose for a 60 kg adult, respectively), a reduction in the time required for UV radiation to induce the formation of skin tumours was observed (statistically significant in males only), suggesting that calcipotriol may enhance the effect of UV radiation to induce skin tumours. The clinical relevance of these findings is unknown.

Hydroxypropyl cellulose, isopropyl alcohol, levomenthol, sodium citrate, propylene glycol, purified water.

Should not be mixed with other medicinal products.

2 years.

Store below 25°C.

The alcohol base is flammable.

30ml, 60ml, 100ml and 120ml polyethylene bottles with nozzle.

Not all pack sizes may be marketed.

No special requirements.

LEO Laboratories Limited,

Longwick Road,

Princes Risborough,

Buckinghamshire

HP27 9RR

United Kingdom.

PL 0043/0190

8^th June 1994

October 2010