SILKIS Ointment Ref.[8062] Active ingredients: Calcitriol

The ointment can be applied to the face with caution, as there is an increased risk of irritation in this area. Contact with the eyes should be avoided. The hands should be washed after applying the ointment in order to avoid unintentional application to non lesional areas. Not more than 35% of the body surface should be exposed to daily treatment. Not more than 30g of ointment should be used per day.

Due to potential effects on calcium metabolism, substances which stimulate absorption must not be added to the ointment, and the ointment must not be covered with an occlusive dressing.

In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.

Although no clinically significant hypercalcaemia was observed in clinical studies with a dosage under 30 g/day of Silkis ointment, some absorption of calcitriol through the skin does occur and excessive use of the ointment can lead to systemic side-effects, such as an increase in urine and serum calcium levels, which is a known class effect for calcitriol.

There is no information about the use of Silkis in other clinical forms of psoriasis (other than plaque psoriasis) i.e. Psoriasis guttata acuta, pustular psoriasis, psoriasis erythrodermica and rapid progressive plaque psoriasis.

Paediatric population

In view of the particular sensitivity of neonates versus adult rodents to the toxic effects of calcitriol, exposure of children to calcitriol ointment should be avoided (see also 4.2. Posology and Method of administration).

Silkis must be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics or medications with pharmacological effects impacted by a change in calcium levels such as digoxin. Caution must also be exercised in patients receiving calcium supplements or high doses of vitamin D. There is no experience of the concurrent use of calcitriol and other medications for the treatment of psoriasis.

Information on interaction of systemic medications after the use of calcitriol ointment is limited.

Silkis Ointment has a slight irritant potential, and therefore, it is possible that concomitant use of peeling agents, astringents or irritants products may produce additive irritant effects.

Pregnancy

There are no or limited amount of data from the use of Calcitriol in pregnant women. Studies in animals have shown developmental toxicity at doses which caused maternal toxicity (see section 5.3). The potential risk for humans is unknown. Silkis should only be used during pregnancy in restricted amounts when clearly necessary. Calcium levels should be monitored.

Breastfeeding

Calcitriol has been found in milk of lactating dams. Due to the lack of human data, it should not be used during breastfeeding.

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

Between 10% and 20% of patients can be expected to experience adverse reactions. Adverse reactions are usually localised to the application site and mild to moderate in nature.

Very common adverse reactions: Adverse reactions occurring in ≥1/10 of patients.

Common adverse reactions: Adverse reactions occurring in ≥1/100, <1/10 of patients.

Uncommon adverse reactions: Adverse reactions occurring in ≥1/1000, <1/100 of patients.

Rare adverse reactions: Adverse reactions occurring in ≥1/10000; <1/1000 of patients.

Very rare adverse reactions: Adverse reactions occurring in <1/10000 of patients

Adverse reactions reported by more than two patients in the clinical studies are included.

Not known: cannot be estimated from the available data

Skin and Subcutaneous disorders

Common: Pruritus, Skin discomfort, Skin irritation, Erythema

Uncommon: Dry skin, Psoriasis (aggravated)

Not known*: Skin oedema, Contact dermatitis

* Adverse reactions reported from post marketing surveillance

In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

There are no relevant data on the compatibility of Silkis with other medicinal products. Therefore, Silkis should be used according to the posology and method of administration provided above (Section 4.2).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.