CURATODERM Ointment 4 mcg/gr Microgram

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Curatoderm Ointment 4 mcg/g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ointment contains tacalcitol monohydrate 4.17 mcg/g
equivalent to tacalcitol 
4 mcg/g.
For excipients, see 6.1. 
3 PHARMACEUTICAL FORM
Ointment
Homogeneous, glossy, translucent, white odourless ointment.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Psoriasis vulgaris
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults and Elderly: Apply sparingly, once daily to the affected
areas, preferably at bedtime. The amount applied should 
not exceed 5g of ointment/day. Normally duration
of treatment depends on the severity of the lesions and should
be 
decided by the physician.
Experience shows that treatment will not usually need to
exceed 2 periods of 12 weeks each 
year.
Children: Not recommended. There is no clinical experience in
children.
4.3 CONTRAINDICATIONS
Hypersensitivity to constituents; in patients with
hypercalcaemia or other known disorders of calcium metabolism.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In patients at risk of hypercalcaemia, albumin corrected
serum calcium levels should be closely monitored. Treatment 
should be stopped if hypercalcaemia occurs.
Serum calcium levels should also be monitored in patients with
renal 
impairment. Curatoderm is not recommended for use on the scalp.
Care should be exercised in patients with generalised
pustular or erythrodermic exfoliative psoriasis as the risk
of 
hypercalcaemia may be enhanced.
When applying to the face avoid contact with the eyes.
Patients should be advised to wash their hands after applying 
the ointment to avoid inadvertent transfer to
other parts of the body.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
No interactions are likely in patients using multivitamin
preparations with up to 5
                                
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