Locoid Crelo
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
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 |
|
Immune system disorders |
Hypersensitivity | ||
|
Endocrine disorders |
Adrenal suppression | ||
|
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 |
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.
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 Propyleneglycol Sodium citrate Anhydrous citric acid Propyl parahydroxybenzoate Butyl parahydroxybenzoate Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4
6.5
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.
No special requirements.
7
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
8
MARKETING AUTHORISATION NUMBER(S)
PL 05293/0011
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
05/09/2016