Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Calcipotriol 50 micrograms/ml Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis (psoriasis vulgaris).
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 weeks.
Patients with known severe renal or liver impairment should not be treated with calcipotriol.
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.
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.
Before opening: 2 years.
After first opening: 3 months.
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).
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.
No special requirements.
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