Locoid Lipocream

Summary of Product Characteristics Updated 24-Jan-2020 | Leo Laboratories Limited

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.

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 propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly 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 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

(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 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. Pharmaceutical particulars
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 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 05293/0012

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 03 May 1983

Date of latest renewal: 24 August 2010.

10. Date of revision of the text

22 January 2020

Company Contact Details
Leo Laboratories Limited
Address

Horizon, Honey Lane, Hurley, Berkshire, SL6 6RJ, UK

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Telephone

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