LOCOID CRELO - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Locoid Crelo

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 gram of Locoid Crelo contains 1 mg of hydrocortisone butyrate.

Excipient(s) with known effect:

Cetostearyl alcohol (2% w/w)

Butylhydroxytoluene (0.02% w/w)

Propylene glycol (5% w/w)

Propyl parahydroxybenzoate (0.3% w/w)

Butyl parahydroxybenzoate (0.15% w/w)

For the full list of excipients, see section 6.1

Topical emulsion.

Practically white emulsion.

4.1 Therapeutic indications

Locoid Crelo is indicated in adults, children and infants above 3 months of age. The product is recommended for treatment of inflammatory skin disorders not caused by micro-organisms, e.g. eczema, dermatitis and psoriasis. The product is intended for topical application especially to the scalp or hirsute skin.

Topical corticosteroids are acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and precautions for use.

4.2 Posology and method of administration

Posology

Adults and older people

A thin and even layer should be applied to the affected area of the skin, 1 to 2 times daily.

The same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.

Paediatric population

Long term treatment, large amounts, and occlusion should be avoided.

Infants

Therapy should be limited to a maximum of seven days.

Method of administration

For cutaneous use.

The formulation of the product makes it suitable for use in both scaly lesions and for moist, weeping lesions.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

This preparation is contraindicated in the presence of untreated viral, fungal, yeast or parasitic infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.

4.4 Special warnings and precautions for use

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

Keep away from the eyes.

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.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

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 and butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis). The propylene glycol may cause skin irritation. The butylhydroxytoluene may cause irritation to the eyes and mucous membranes (e.g. nose). The propyl and butyl 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.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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

Skin and Subcutaneous Tissue Disorders – Frequency not known:

Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see 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.

4.9 Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02

The active constituent, hydrocortisone butyrate, is an established topical corticosteroid, equi-efficacious with those corticosteroids classified as potent.

5.2 Pharmacokinetic properties

In human in-vivo studies, the potency of this form of active ingredient has been shown to be of the same order as other topical corticosteroids classed as potent. The active ingredient metabolises to hydrocortisone and butyric acid.

5.3 Preclinical safety data

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation.

There may therefore be a very small risk of such effects in the human foetus.

Theoretically, there is the possibility that if maternal systemic absorption occurred the infant’s adrenal function could be affected.

6.1

Macrogol 25 cetostearyl ether

Cetostearyl Alcohol

White soft paraffin

Hard paraffin

Borage oil

Butylhydroxytoluene (E321)

Propylene glycol

Sodium citrate anhydrous (E331)

Anhydrous citric acid (E330)

Propyl parahydroxybenzoate (E216)

Butyl parahydroxybenzoate (E218) Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

White opaque low density polyethylene bottles of 15 g, 25 g, 30 g, 50 g and 100 g capacity, equipped with a natural low density polyethylene dropper applicator, closed with a white polypropylene screw cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Neon Healthcare Limited

Mill Studio Business Centre, Crane Mead,

Ware, Hertfordshire, SG12 9PY

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 45043/0072

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 May 1995

Date of latest renewal: 24 August 2010