Insect bite and sting reactions

For topical administration.

Apply sparingly to a small area, once or twice a day, for a maximum of 2-3 days. Do not use in pregnancy without medical advice or in children under 10.

Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1

The product should not be used on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne, athlete's foot, scabies or infected bites or stings.

In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

Not for use with an occlusive dressing or on large areas of the body.

The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).

The product labelling shall include the following statements:

If the condition does not improve consult your doctor. Do not use on the eyes or face, anal or genital areas or on broken skin or infected skin, e.g. impetigo, cold sores, acne, athlete's foot, scabies or infected bites or stings. Do not use for other bites or stings or for other skin conditions.

Visual impairment:

Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

None known.

Pregnancy

This product should not be used in pregnancy without medical advice. There is no information about effects on lactation.

Breast-feeding

This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.

None known.

Treatment with hydrocortisone is usually well tolerated but treatment should be stopped if symptoms of hypersensitivity occur, including allergic contact dermatitis or worsening of the original condition.

Eye disorders:

Frequency not known: blurred vision (see also section 4.4)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

No special precautions or antidotes are likely to be needed.

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

Not applicable.

There are no preclinical safety data of relevance to the consumer.

White soft paraffin

Liquid paraffin

Phenoxyethanol

Purified water

Cetomacrogol emulsifying wax

None known.

3 years.

Do not store above 25° C.

Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 10g.

None.