NICAM Gel Ref.[7385] Active ingredients: Niacinamide Nicotinic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts SG4 7QR, UK

Contraindications

Contraindicated in persons who have shown hypersensitivity to any of its components.

Special warnings and precautions for use

For external use only and to be kept away from the eyes and mucous membranes, including those of the nose and mouth. If excessive dryness, irritation or peeling occurs reduce the dosage to one application per day or every other day.

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

Vitamin B derivative requirements such as nicotinamide, are increased during pregnancy and infancy. Nicotinamide is excreted in breast milk. As with all medicines, care should be exercised during the first trimester of pregnancy.

Effects on ability to drive and use machines

None known.

Undesirable effects

The most frequently encountered adverse effect reported is dryness of the skin. Other less frequent adverse effects include pruritus, erythema, burning sensation and irritation.

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 at: www.mhra.gov.uk/yellowcard.

Incompatibilities

None known.

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