NUTRAPLUS Cream Ref.[8348] Active ingredients: Urea

Avoid contact with the eyes and mucous membranes. If irritation occurs, discontinue use temporarily and consult a physician.

Apply with caution only to damaged or inflamed skin or to the face.

The product should be used under medical supervision in babies.

Urea may enhance the efficacy of topical formulations of 5-fluorouracil and dithranol, and increase the release and the permeation into the skin of active ingredients from other topical products such as corticosteroids.

There are no clinical data available concerning use in pregnancy.

There are no adequate experimental animal studies available concerning the effects on pregnancy, embryonic development, foetal development and/or post-natal development.

Caution must be exercised for use during pregnancy. However, indications of risks associated with topical applications of urea during pregnancy and while breast-feeding are not known.

In breast-feeding women, the product should be removed from the breast area before breast-feeding.

Nutraplus has no or negligible influence on the ability to drive and use machines.

Skin and subcutaneous tissue

Hypersensitivity reactions to the ingredients or skin irritation in the treatment of acute inflammatory skin disorders are possible.

Erythema, skin burning sensation and pruritus have been reported during post-marketing surveillance.

Treatment must be discontinued in case of erythema, skin burning sensation, pruritus, rash or hypersensitivity reactions after application.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

Not applicable.