LOCOID Cream Ref.[27966] Active ingredients: Hydrocortisone butyrate

Locoid should not be applied to the eyelids in view of the risk of glaucoma simplex or subcapsular cataract.

Keep away from the eyes.

Application under occlusion should be restricted to dermatoses involving limited areas.

As with all corticosteroids, application to the face, genitals, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided. Hands must be washed after each application unless Locoid is used to treat the hands.

There is an increased risk of systemic and local adverse reactions in treatment of intertriginous areas, large areas of skin or, under occlusion, as well as with frequent dosing or treatment over a long period of time. Attention must be paid to the risks of systemic adverse reactions including adrenocortical suppression.

Due to the immunosuppressant and anti-inflammatory effect of corticosteroids, Locoid may be associated with increased susceptibility to skin infections, aggravation of existing infection, and activation of latent infection. As such, Locoid® is contraindicated against use on infected skin and should be used with particular caution at the site of previous or suspected infections.

In some patients with psoriasis, topical corticosteroids may cause rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

The cetostearyl alcohol may cause local skin reactions (e.g contact dermatitis) and the butyl and propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Paediatric population

Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients courses of treatment should not normally exceed 7 days.

No interaction studies have been performed.

Pregnancy

There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity of hydrocortisone 17-butyrate (see section 5.3). Although, animal studies have shown the more potent corticosteroids to be teratogenic after dermal application, the clinical relevance in humans has not been established.

Therefore, during pregnancy Locoid should only be used when the potential benefit justifies the potential risk.

Breast-feeding

It is unknown whether hydrocortisone 17-butyrate/metabolites are present in maternal milk following topical application.

The use of Locoid during breastfeeding is not expected to affect breastfed infants since the systemic absorption of topically applied hydrocortisone 17-butyrate is low.

Locoid can be used during breastfeeding, but it is recommended to avoid applying Locoid directly on the breast.

Fertility

No animal or human data on Locoid and fertility is available.

None known.

In clinical studies, cases of skin irritation and hypersensitivity were reported.

The most frequently reported adverse reactions post-marketing are hypersensitivity and skin reactions such as erythema, pruritus and skin infection.

Adverse reactions are listed by MedDRA System Organ Class.

Frequencies are defined as very rare (<1/10,000), rare (≥1/10,000 to <1/1,000), uncommon (≥1/1,000 to <1/100), common (≥ 1/100 to <1/10), very common (≥1/10), and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

^* See also section 4.4
^** often irreversible, with thinning of the epidermis
^*** Dermatitis and eczema, including contact dermatitis

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.

None stated.