Calcipotriol 50micrograms/ml scalp solution

Summary of Product characteristics

                                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
                                
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