Calcipotriol 50 micrograms/ml Scalp Solution
Summary of Product Characteristics Updated 24-Jan-2018 | Sandoz Limited
1. Name of the medicinal product
Calcipotriol 50 micrograms/ml Scalp Solution
2. Qualitative and quantitative composition
One ml of calcipotriol cutaneous solution contains 50 micrograms calcipotriol.
Excipient with known effect: Propylene glycol 30 mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, colourless solution with an odour of menthol.
4. Clinical particulars
4.1 Therapeutic indications
Calcipotriol 50 micrograms/ml Scalp Solution is indicated for the topical treatment of mild to moderate
scalp psoriasis (psoriasis vulgaris).
4.2 Posology and method of administration
Calcipotriol 50 micrograms/ml Scalp Solution should be applied to the affected areas twice daily
(morning and evening).
The maximum weekly dose should not exceed 60 ml.
If this solution is used together with cream or ointment containing calcipotriol, the total weekly dose of
calcipotriol should not exceed 5 mg (for example 60 ml of Calcipotriol 50 micrograms/ml Scalp Solution
plus 40 g of cream or ointment, or 40 ml of Calcipotriol 50 micrograms/ml Scalp Solution plus 60 g of
cream or ointment.
Duration of treatment should be decided by the physician, but should normally not be for longer than 22
Patients with known severe renal or liver impairment should not be treated with calcipotriol.
Children and adolescents (under 18 years of age)
Calcipotriol 50 micrograms/ml Scalp Solution is not recommended for use in children and adolescents
below 18 years due to a lack of data on safety and efficacy.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Patients with severe renal or liver impairment.
- Known disorders of calcium metabolism or treatment with other medicinal products which increase
serum calcium level.
4.4 Special warnings and precautions for use
Calcipotriol 50 micrograms/ml Scalp Solution should not be used on the face.
Patients should be advised to wash their hands after applying the solution and to avoid inadvertent
transfer to other body areas, especially 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.
The risk of hypercalcaemia is minimal when the dosage recommendations are followed.
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.
Hypercalcaemia may occur if the maximum weekly dose (60 ml) is exceeded.
However, serum calcium is quickly normalised when treatment is discontinued.
In view of a possible effect on calcium metabolism, patients should be advised to use no more than the
recommended dose and the addition of penetration-promoting substances (such as salicylic acid) to the
solution is not permitted. Occlusion is undesirable for the same reason.
The clinical symptoms of hypercalcaemia may resemble those of cholecalciferol overdose, i.e. the
hypercalcaemia syndrome or calcium intoxication (see section 4.9), depending on the intensity and
duration of the hypercalcaemia. Persistent hypercalcaemia may result in ectopic deposits of calcium in the
blood vessel walls, joint capsules, gastric mucosa, cornea and renal parenchyma.
During calcipotriol treatment 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
Patients with known severe renal or liver impairment should not be treated with this medicinal product
due to limited experience.
The efficacy and long-term safety of this solution in children has not been established. Therefore its use
in this population cannot be recommended.
Calcipotriol 50 micrograms/ml Scalp Solution contains propylene glycol (may cause skin irritation).
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant administration of calcipotriol and salicylic acid externals may cause an inactivation of
There is no experience of concomitant therapy with other antipsoriatic products applied to the same area
of skin at the same time.
4.6 Fertility, pregnancy and lactation
The safety of the use of calcipotriol during human pregnancy has not been established. Studies in animals
have shown reproductive toxicity when calcipotriol was administered orally (see section 5.3). Topically
applied calcipotriol is slightly systemically absorbed, but a disruption of calcium homeostasis is not
expected. As a precautionary measure, it is preferable to avoid the use of Calcipotriol 50 micrograms/ml
Scalp Solution in pregnancy.
It is unknown whether calcipotriol is excreted in breast milk.
Short-term use on small surfaces is not expected to lead to a relevant systemic absorption and no effects
on the breastfed child are anticipated. In all other cases, breast-feeding is not recommended during
treatment with calcipotriol.
There are no data on the effect of calcipotriol therapy on human fertility.
4.7 Effects on ability to drive and use machines
Calcipotriol has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Based on the clinical data, approximately 25% of the patients treated with calcipotriol could experience
an adverse reaction. These reactions are usually mild.
The most frequently reported undesirable effects are various transient skin reactions, in particular
The undesirable effects are listed by MedDra SOC and the individual undesirable effects are listed
starting with the most frequently reported.
Immune system disorders
Very rare (<1/10,000)
Hypersensitivity reactions (including urticaria, face
or periorbital oedema, angioedema)
Metabolism and nutrition disorders
Very rare (<1/10,000)
Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10)
Pruritus, skin burning sensation, skin stinging
sensation, skin dry, erythema, rash (including
erythematous, maculo-papular pustular and bullous
Uncommon (≥1/1,000 to <1/100)
Eczema, contact dermatitis, aggravated psoriasis
Very rare (<1/10,000)
Transient changes in skin pigmentation, transient
photosensitivity, facial and perioral dermatitis
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
Use above the recommended dose (see section 4.2) may cause elevated serum calcium which disappears
rapidly after cessation of treatment.
The clinical signs of hypercalcaemia include anorexia, nausea, vomiting, constipation, hypotonia,
cognitive dysfunction, depression, lethargy, coma and renal dysfunction.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antipsoriatics for topical use, ATC code: D05AX02
Calcipotriol is a vitamin D derivative. In vitro data show that calcipotriol induces differentiation and
suppresses proliferation of keratinocytes. The effect of calcipotriol in psoriasis is ascribed mainly to this.
An effect, first of all on the desquamation, then on the infiltration and finally on the erythema, is seen
after two to four weeks of treatment. The maximum effect is usually achieved after six weeks.
5.2 Pharmacokinetic properties
No data are available on the absorption of calcipotriol following use of the scalp solution.
Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3 – 1.7 g of a 50
micrograms/g tritium labelled calcipotriol ointment suggested that less than 1% of the dose was absorbed.
However, total recovery of the tritium label over a 96 hour period ranged from 6.7 to 32.6%, figures
maximised by uncorrected chemiluminescence. There were no data on
H tissue distribution or excretion
from the lungs.
5.3 Preclinical safety data
The effect on 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 hazards for humans.
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
The significance for humans is unknown.
In another study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation
and topically applied calcipotriol for 40 weeks at doses which correspond to 9, 30 and 90 µg/m
(equivalent to 0.25, 0.84 and 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
6.3 Shelf life
After first opening:
6.4 Special precautions for storage
Do not store above 25°C.
Keep the bottle in the outer carton in order to protect from light.
Do not refrigerate or freeze.
Keep the cutaneous solution away from fire or flames (the alcohol base is inflammable).
6.5 Nature and contents of container
Polyethene bottle fitted with polyethene nozzle and closed with polypropylene screw cap.
Pack sizes: 30, 60, 100 and 120 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Frimley Business Park,
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 13 May 2009
Date of latest renewal: 25 August 2014
10. Date of revision of the text
Company Contact Details
200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
+44 (0) 1276 698020
Medical Information e-mail
+44 (0) 1276 698324
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+44 (0) 1276 698468