This information is intended for use by health professionals

1. Name of the medicinal product

Locoid Crelo

2. Qualitative and quantitative composition

Locoid Crelo contains 0.1% w/w 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

3. Pharmaceutical form

Topical emulsion.

The product is a white emulsion.

4. Clinical particulars
4.1 Therapeutic indications

Locoid Crelo is indicated in adults, children and infants. The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids, e.g. eczema, dermatitis and psoriasis. The product is intended for topical application especially to the scalp or hirsute skin.

Topical corticosteroids are not generally indicated in psoriasis but may be 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

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 should be avoided where possible.

Infants

Therapy should be limited if possible to a maximum of seven days.

Method of administration

For cutaneous use.

Dosage: To be applied evenly and sparingly no more than twice daily.

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 or fungal 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

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including 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 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.

Infants

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.

Keep away from the eyes.

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. Studies in animals have shown reproductive toxicity (see section 5.3).

Breast-feeding

Hydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Crelo no effects on the breast-fed newborns/infants are anticipated.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Tabulated list of adverse reactions

System Organ Class

Rare

>/10,000,<1/1000

Very rare

</10,000

Not known

(cannot be estimated from the available data)

Immune system disorders

Hypersensitivity

Endocrine disorders

Adrenal suppression

Eye disorders

Vision, blurred*

Skin and subcutaneous tissue disorders

Skin atrophy, often irreversible, with thinning of the epidermis

Telangiectasia

Skin striae

Pustular acne

Perioral dermatitis

Rebound effect

Skin depigmentation

Dermatitis and eczema, including contact dermatitis

*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.

4.9 Overdose

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

5. Pharmacological properties
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. Pharmaceutical particulars
6.1 List of excipients

Macrogol cetostearyl ether

Cetostearyl Alcohol

White soft paraffin

Hard paraffin

Borage oil

Butylhydroxytoluene

Propylene glycol

Sodium citrate

Anhydrous citric acid

Propyl parahydroxybenzoate

Butyl parahydroxybenzoate

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 and other handling

No special requirements.

7. Marketing authorisation holder

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

8. Marketing authorisation number(s)

PL 05293/0011

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 23 May 1995

Date of latest renewal: 24 August 2010

10. Date of revision of the text

22 January 2020