CURATODERM

Posology Adults and the Elderly:

Apply once daily to the affected areas, preferably at bedtime. The amount applied should not exceed 10 ml of lotion/day. g. 30 ml of Curatoderm Lotion plus 40 g of Curatoderm Ointment). Normally duration of treatment depends on the severity of the lesions and should be decided by the physician.

There is clinical trial experience with continuous and intermittent treatment in adults with tacalcitol ointment up to 18 months, and with tacalcitol lotion for up to 8 weeks. Curatoderm Lotion can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures).

Paediatric population:

Not recommended. There is limited clinical experience with tacalcitol in children.

The data given for frequency of adverse reactions is based on the following categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

g. burning, erythema), itching, contact dermatitis, worsening of psoriasis. Skin irritation and itching are generally mild and transient Frequency unknown: rash (erythematous, macular, papular, vesicular). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.

Children and adolescents (< 18 years):

The use of Curatoderm Lotion in children and adolescents under 18 years is not recommended as there is no experience. At the doctor’s discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) 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. Contact with the eyes should be avoided. If Curatoderm Lotion accidentally comes into contact with the eyes, thorough rinsing with water is recommended.

Patients should be advised to wash their hands after applying the lotion to avoid inadvertent transfer to other parts of the body. 2 mg dodecyl gallate in each gram. Propylene glycol may cause irritation of the skin. Dodecyl gallate may be mildly irritant to the skin, the eyes and mucous membrane.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

1 • Psoriasis punctata or psoriasis pustulosa • Patients with severe hepatic, renal or heart diseases because there is no experience • Patients with hypercalcaemia or other known disorders of calcium metabolism.