CURATODERM Ointment Ref.[7665] Active ingredients: Tacalcitol

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. Care should be exercised in patients with generalised pustular or erthrodermic 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.

Butylhydroxytoluene (E321) contained in the excipient Paraffin, white soft, may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

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.

No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D.

UVB radiation can be combined with Curatoderm Ointment. This approach increases the efficacy of the treatment and shortens the radiation period. UV radiation should be given in the morning and Curatoderm Ointment at bedtime. There has been limited experience of the concomitant use of Curatoderm Ointment with topical corticosteroids, urea, emollients, dithranol cream and PUVA.

Pregnancy

The safety of this medicinal product for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation or peri- or postnatal development. Avoid use in pregnancy unless there are no safer alternatives.

Lactation

During lactation the breast area should not be treated. It is not known whether tacalcitol is excreted in human breast milk.

Not relevant.

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 (frequency cannot be estimated from the available data)

Metabolism and nutrition disorders

Frequency not known: Hypercalcaemia

Skin and subcutaneous tissue disorders

Rare: Skin irritation (e.g. burning, erythema), itching, contact dermatitis, worsening of psoriasis

Skin irritation and itching are generally mild and transient.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.