Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIPOTRIOL
PCO Manufacturing
50 Microgram/ML
Cutaneous Solution
2004-06-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dovonex 50 micrograms/ml Scalp Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 50 micrograms calcipotriol, (as the hydrate). Excipient: Propylene glycol _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Cutaneous scalp solution _Product sourced from Greece and the UK:_ A clear, colourless slightly viscous scalp solution with an odour of menthol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dovonex Scalp Solution is indicated for the topical treatment of scalp psoriasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _Dovonex Scalp Solution should be applied twice daily (morning and evening) to the affected areas. Maximum weekly dose should not exceed 60ml. When used together with Dovonex Cream or Ointment, the total dose of calcipotriol should not exceed 5 mg in any week. _Children: _There is no experience of the use of Dovonex Scalp Solution in children. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients. Due to the content of calcipotriol, Dovonex is contraindicted in patients with known disorders of calcium metabolism. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dovonex Scalp Solution should not be used on the face. The patients must be instructed in correct use of the product to avoid application and accidental transfer to the face. Hands must be washed after each application. Use of Dovonex should be avoided in patients with severe renal failure or severe hepatic disorders. The risk of hypercalcaemia is minimal when dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose (60ml) is exceeded. However, serum calcium is quickly normalised when treatment is discontinued. During Dovonex ® treatment physician Read the complete document