SILKIS

Posology Silkis Ointment should be applied to the psoriasis affected areas twice per day, once in the morning and once in the evening before retiring and after washing. It is recommended that not more than 35% of the body surface be exposed to daily treatment.

Not more than 30 g of ointment should be used per day. There is limited clinical experience available for the use of this dosage regimen of more than 6 weeks. Paediatric population The safety and efficacy of Silkis in children less than 18 years have not been established.

3 but no recommendation on a posology can be made. Special population Patients with kidney or liver dysfunction should not use Silkis (see also

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 Not known: cannot be estimated from the available data Adverse reactions reported by more than two patients in the clinical studies are included. MedDRA System Organ Class Frequency Preferred term Common Pruritus, Skin discomfort, Skin irritation, Erythema Skin and Subcutaneous disorders 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. uk/yellowcard.

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.

e. Psoriasis guttata acuta, pustular psoriasis, psoriasis erythrodermica and rapid progressive plaque psoriasis. Instruct patients not to smoke or go near naked flames - risk of severe burns. ) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it. 1). 3).

). 1. • Patients with kidney or liver dysfunction. • Patients with hypercalcaemia and patients known to suffer from abnormal calcium metabolism. • Patients with known hypersensitivity to the active substance or to any of the excipients.