CALCIPOTRIOL Cutaneous solution Ref.[6476] Active ingredients: Calcipotriol

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 5.3).

Patients with known severe renal or liver impairment should not be treated with this medicinal product due to limited experience.

Paediatric population

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).

Concomitant administration of calcipotriol and salicylic acid externals may cause an inactivation of calcipotriol.

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

Pregnancy

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.

Lactation

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.

ertility

There are no data on the effect of calcipotriol therapy on human fertility.

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

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 lesional/perilesional irritation.

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): Hypercalcaemia, hypercalciuria

Skin and subcutaneous tissue disorders

Very common: Skin irritation

Common (≥1/100 to <1/10): Pruritus, skin burning sensation, skin stinging sensation, skin dry, erythema, rash (including erythematous, maculo-papular pustular and bullous reactions)

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 (www.mhra.gov.uk/yellowcard).

Not applicable.