Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
Silkis is indicated in topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up to 35% of body surface area involvement.
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.
There is no experience of the use of Silkis in children (see 4.4. Special Warnings and Precautions for Use).
Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contraindications).
The most common symptoms which may occur after accidental administration are anorexia, nausea, vomiting, constipation, hypotonia and depression. Lethargy and coma are occasionally observed. If hypercalcaemia or hypercalciuria occurs, the use of Silkis should be discontinued until the serum or urinary calcium levels have returned to normal.
If the medication is applied excessively no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
3 years.
Shelf life after first opening: 8 weeks.
No special precautions for storage.
The product is packaged in collapsible aluminium tubes coated internally with an epoxy – phenolic resin and fitted with a white high density polyethylene or polypropylene screw cap.
Tubes contain either 15, 30 or 100g of ointment.
Not all pack sizes may be marketed.
No special requirements.
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