Intoxication after the use of HeliCap is not known and is not to be expected due to the composition of the preparation. Skin irritation caused by overdose subsides quickly when the preparation is discontinued.
The product should not be used extensively in patients with severe renal impairment.
Not applicable.
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
No specific information is presented given the widespread use of topically applied urea on humans over many years.
An emollient, moisturising and protective cream for the treatment of dry or damaged skin
Pharmacotherapeutic group: Protectives and emollients.
ATC code: D02 AE01
Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.
Not applicable. HeliCap is a topical (cutaneous) preparation.
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.
HeliCap has no or negligible influence on the ability to drive and use machines.
Adults, paediatric population and older people
Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
