Dovonex Scalp Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovonex Scalp Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of scalp solution contains 50 micrograms of calcipotriol (as the hydrate).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution.
Colourless, slightly viscous solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dovonex Scalp Solution is indicated for the topical treatment of scalp psoriasis.
4.2 Posology and method of administration
Adults: Dovonex 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 Dovonex Cream or Ointment, the total dose of calcipotriol should not exceed 5mg in any week, e.g. 60 ml of Scalp Solution plus 30g of Cream or Ointment, or 30ml of Scalp Solution plus 60g of Cream or Ointment.
Children: Not recommended as there is no experience of the use of Dovonex Scalp Solution in children.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Due to the content of calcipotriol, Dovonex® is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
4.4 Special warnings and precautions for use
Effects on calcium metabolism
Due to the content of calcipotriol, 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 postular or erythrodermic exfoliative psoriasis. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the dosage recommendations are followed. The maximum weekly dose in adults is 100 g of cream or ointment (equivalent to 5 mg of calcipotriol) or 60 ml of scalp solution (equivalent to 3 mg of calcipotriol). When cream, ointment or cutaneous solution are applied together, the total dose of calcipotriol should not exceed 5 mg per week.
Local adverse reactions
Dovonex® should not be used on the face, as it may cause skin irritation. The patient must be instructed in correct use of the product to avoid accidental transfer to the face and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
UV exposure
During Dovonex® Scalp Solution treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Dovonex® 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).
Unevaluated use
Due to lack of data, Dovonex® should be avoided in guttate, erythrodermic, exfoliative and pustular psoriasis.
Due to lack of data, Dovonex should be avoided in patients with severe liver and kidney disease.
Adverse reactions to excipients
Dovonex® scalp solution contains propylene glycol as an excipient which may cause skin irritation.
Interaction with other medicinal products and other forms of interaction
4.5
Dovonex®.
No interaction studies have been performed with
4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of the use of topical calcipotriol during human pregnancy has not been established, however studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is unknown whether calcipotriol is excreted in breast milk. Caution should be exercised when prescribing Daivonex® to women who breast-feed.
Fertility
Studies in rats with oral doses of calcipotriol demonstrated no impairment of male and female fertility.
4.7 Effects on ability to drive and use machines
Calcipotriol has no or negligible influence on the ability to drive and to use machines.
4.8 Undesirable effects
The most frequently reported adverse reactions during treatment are skin irritation, application site pain and erythema.
Systemic reactions (hypercalcaemia and hypercalciuria) have been reported. The risk of developing such reactions increases if the recommended total dose is exceeded (see section 4.4).
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (>1/10)
Common (>1/100 to < 1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10,000)
Approximately 25% of the patients treated with Dovonex®Scalp Solution could experience an adverse reaction. These reactions are usually mild.
|
Immune system disorders | |
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Uncommon (>1/1,000 to <1/100) |
Hypersensitivity |
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Metabolism and nutrition disorders | |
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Uncommon (>1/1,000 to <1/100) |
Hypercalcaemia |
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Eye disorders | |
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Uncommon (>1/1,000 to <1/100) |
Eye and eyelid irritation |
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Rare (>1/10,000 to <1/1,000) |
Periorbital oedema |
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Skin and subcutaneous tissue disorders | |
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Very common (>1/10) |
Skin irritation |
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Common (>1/100 to < 1/10) |
Psoriasis aggravated Dermatitis Erythema Rash* Skin exfoliation Skin burning sensation Dry skin Pruritus |
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Uncommon (>1/1,000 to <1/100) |
Photosensitivity reaction Skin oedema Urticaria Seborrhoeic dermatitis |
|
Renal and urinary disorders | |
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Uncommon (>1/1,000 to <1/100) |
Hypercalciuria |
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General disorders and administration site conditions | |
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Common (>1/100 to <1/10) |
Application site pain |
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Uncommon (>1/1,000 to <1/100) |
Application site pigmentation changes |
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Rare (>1/10,000 and <1/1,000) |
Face oedema |
*Various types of rash reactions such as rash erythematous, rash macular, rash papular and rash macular-papular have been reported.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion and coma.
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.
Calcipotriol has shown maternal and foetal toxicity in rats and rabbits when given by the oral route at doses of 54 pg/kg/day and 12 pg/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 and an oral carcinogenicity study in rats 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 90pg/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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydroxypropyl cellulose, isopropyl alcohol, levomenthol, sodium citrate, propylene glycol, purified water.
6.2 Incompatibilities
Should not be mixed with other medicinal products.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store below 25°C.
The alcohol base is flammable.
6.5 Nature and contents of container
30ml, 60ml, 100ml and 120ml polyethylene bottles with nozzle.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
LEO Laboratories Limited
Horizon
Honey Lane
Hurley
Maidenhead
Berkshire
SL6 6RJ
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00043/0190
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8th June 1994
10 DATE OF REVISION OF THE TEXT
13/02/2015