Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcipotriol monohydrate
Sandoz Ltd
D05AX02
Calcipotriol monohydrate
50microgram/1ml
Cutaneous solution
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050200; GTIN: 5050650025040 5050650025057
OBJECT 1 CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION Summary of Product Characteristics Updated 24-Jan-2018 | Sandoz Limited 1. Name of the medicinal product Calcipotriol 50 micrograms/ml Scalp Solution 2. Qualitative and quantitative composition One ml of calcipotriol cutaneous solution contains 50 micrograms calcipotriol. Excipient with known effect: Propylene glycol 30 mg/ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Cutaneous solution Clear, colourless solution with an odour of menthol. 4. Clinical particulars 4.1 Therapeutic indications Calcipotriol 50 micrograms/ml Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis (psoriasis vulgaris). 4.2 Posology and method of administration Posology _Adults_ 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. _Renal/hepatic impairment_ Patients with known severe renal or liver impairment should not be treated with calcipotriol. _Children and adolescents (under 18 years of age) _ 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. 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients with severe renal or liver impairment. - Known disorders of calcium metabolism or treatment with other medicinal products which increase serum calcium level. - Hypercalcaemia. 4.4 Special warnin Read the complete document