SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Daivonex® Scalp Solution, 50 micrograms per ml

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Calcipotriol 50 micrograms per ml (as the hydrate).

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cutaneous solution.

Colourless, slightly viscous solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Daivonex Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis.

4.2    Posology and method of administration

Adults:    Daivonex Scalp Solution should be applied twice daily (morning

and evening) to the affected areas. Maximum weekly dose should not exceed 60 ml.

When used together with Daivonex Cream or Ointment, the total dose of calcipotriol should not exceed 5mg in any week, e.g. 60 ml of Scalp Solution plus one 30g tube of Cream or Ointment, or 30ml of Scalp Solution plus 60g (two 30g tubes) of Cream or Ointment.

Duration of treatment should be decided by the physician but should not normally be for longer than 22 weeks.

Children:    Not recommended as there is no experience of the use of

Daivonex Scalp Solution in children.

4.3 Contraindications

Daivonex 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, Daivonex Scalp Solution is contraindicated in patients with hypersensitivity to - the active substance or to any of the excipients.

4.4    Special warnings and precautions for use

Application of Daivonex® to the face may cause local irritation. Daivonex® 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 the face. Patients should be advised to use no more than the maximum weekly dose since hypercalcaemia, which rapidly reverses on cessation of treatment, may occur. There is no experience of the use of Daivonex® Scalp Solution in children and it is therefore not recommended in children.

During treatment with Daivonex® 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).

4.5    Interaction with other medicinal products and other forms of interaction

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

Pregnancy and lactation

Safety for use during human pregnancy and lactation has not yet been established, although studies in experimental animals have not shown teratogenic effects. Avoid use in pregnancy and lactation unless there is no safer alternative. It is not known whether calcipotriol is excreted in breast milk.

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

>1/10

>1/100 to <1/10 >1/1,000 to <1/100 >1/10,000 to <1/1,000 <1/10,000

Not known (Cannot be estimated from the available data)

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

•    Immune system disorders

Very rare: allergic reactions (including angioedema)

•    Metabolism and nutrition disorders

Very rare: hypercalcaemia, hypercalciuria, especially if the recommended total dose is exceeded (see section 4.2)

•    Skin and subcutaneous tissue disorders Very common: skin irritation

Common: rash¹, burning sensation, stinging sensation, dry skin, pruritus, erythema, contact dermatitis (including facial and perioral)

Uncommon: psoriasis aggravated, eczema

Not known: transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, periorbital or face oedema

Overdose

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

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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.

5.2    Pharmacokinetic properties

Calcipotriol is only slightly absorbed from the skin.

5.3    Preclinical safety data

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

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 90 pg/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 this finding is unknown.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hyprolose, 2-propanol, levomenthol, sodium citrate, propylene glycol, purified water.

6.2    Incompatibilities

Not applicable

6.3    Shelf life

2 years.

6.4    Special precautions for storage

Do not store above 25^oC.

The alcohol base is flammable.

6.5    Nature and contents of container

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

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

The alcohol base is flammable.

7    MARKETING AUTHORISATION HOLDER

LEO Laboratories Limited

Horizon

Honey Lane

Hurley

Maidenhead

Berkshire

SL6 6RJ

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00043/0194

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/08/2010

10    DATE OF REVISION OF THE TEXT

29/11/2013

1

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