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Locoid Lipocream

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Locoid Lipocream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Locoid Lipocream contains 0.1% w/w hydrocortisone butyrate.

Excipient(s) with known effect:

Cetostearyl alcohol (6% w/w)

Propyl parahydroxybenzoate (E216) (0.05% w/w)

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Cream.

The product is a white cream with a high percentage (about 70%) of fats and oils.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Locoid Lipocream 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.

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 the elderly.

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 Application may be made under occlusion in the more resistant lesions such as thickened psoriatic plaques on elbows and knees.

Due to the formulation of the base the product may be used both for dry scaly lesions and for moist or 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

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

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 may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly 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 animal have shown reproductive toxicity (see section 5.3).

Breast-feeding

Hydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Lipocream 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 substance, 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 formulation has been shown to be of the same order as other topical corticosteroids classified as potent. The active substance 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. List of excipients

Macrogol Cetostearyl ether Cetostearyl alcohol White soft paraffin Light liquid paraffin Sodium citrate anhydrous E331

Citric acid anhydrous E330 Propyl parahydroxybenzoate E216 Benzyl Alcohol Purified water

6.2 Incompatibilities

None stated.

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5    Nature and contents of container

Collapsible aluminium tube with plastic screw cap containing 15 g, 30 g, 50 g or 100 g.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Astellas Pharma Ltd.

2000 Hillswood Drive

Chertsey

Surrey

KT16 0RS

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00166/0112

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 03 May 1983 Date of latest renewal: 24 August 2010.

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DATE OF REVISION OF THE TEXT

21/04/2015