Psorcutan Scalp Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Psorcutan® 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
Psorcutan Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis.
4.2. Posology and Method of Administration
Adults: Psorcutan 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 Psorcutan Cream or Ointment, the total dose of calcipotriol should not exceed 5 mg in any week, e.g. 60 ml of Scalp Solution plus one 30 g tube of Cream or Ointment, or 30 ml of Scalp Solution plus 60 g (two 30 g 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 Psorcutan Scalp
Solution in children.
4.3. Contra-indications
Psorcutan 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, Psorcutan 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 Psorcutan® to the face may cause local irritation. Psorcutan® 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 Psorcutan® Scalp Solution in children and it is therefore not recommended in children.
During treatment with Psorcutan® 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
4.6. 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
Very common Common Uncommon Rare Very rare
>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 Psorcutan® 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: rash*, 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
*Various types of rash reactions such as scaly, erythematous, maculo-papular, pustular, bullous have been reported.
4.9. 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: Antipsoratics 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
None known.
6.3. Shelf-Life
2 years.
6.4. Special Precautions for Storage
Do not store above 25°C.
The alcohol base is flammable.
6.5. Nature and Content of Container
30 ml, 60 ml and 120 ml polyethylene bottles with polyethylene nozzle. Not all pack sizes may be marketed.
6.6. Instructions for Use, Handling and 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 00043/0195
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/08/2010
10 DATE OF REVISION OF THE TEXT
24/03/2014