Umecta nail film

Umecta nail film Medicine

Overdose

Intoxication after the use of Umecta Nail Film 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.

Contraindications

The product should not be used extensively in patients with severe renal impairment.

Incompatibilities

Not applicable.

Pharmaceutical form

Topical film

Undesirable effects

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

Preclinical safety data

No specific information is presented given the widespread use of topically applied urea on humans over many years.

Therapeutic indications

An emollient, moisturising and protective cream for the treatment of dry or damaged skin

Pharmacotherapeutic group

Protectives and emollients.

Pharmacodynamic properties

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.

Pharmacokinetic properties

Not applicable. Umecta Nail Film is a topical (cutaneous) preparation.

Name of the medicinal product

Umecta Nail Film

Qualitative and quantitative composition

Carbamide Peroxide

Special warnings and precautions for use

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.

Effects on ability to drive and use machines

Umecta Nail Film has no or negligible influence on the ability to drive and use machines.

Dosage (Posology) and method of administration

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.

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.