Elocon Cream

1. Name Of The Medicinal Product

Elocon Cream

2. Qualitative And Quantitative Composition

Mometasone Furoate 0.1% w/w

Propylene glycol stearate 8.0% w/w

Stearyl alcohol 68.5-74.5 %w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Elocon Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

4.2 Posology And Method Of Administration

Adults, including elderly patients and Children : A thin film of Elocon Cream should be applied to the affected areas of skin once daily.

Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

4.3 Contraindications

Elocon is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Elocon should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids.

4.4 Special Warnings And Precautions For Use

If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.

Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

ELOCON Cream contains propylene glycol which may cause skin irritation. ELOCON Cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Elocon topical preparations are not for ophthalmic use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. 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.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Elocon should be administered to nursing mothers only after careful consideration of the benefit/risk relationship.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local adverse reactions occasionally reported with Elocon include paresthesia, folliculitis, burning, pruritis, tingling, stinging, application site reactions, allergic contact dermatitis, hypopigmentation, hypertrichosis, secondary infection, furunculosis, striae, acneiform reactions and signs of skin atrophy.

Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, perioral dermatitis, maceration of the skin and miliaria.

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Chronic corticosteroids therapy may interfere with the growth and development of children.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.

In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.

In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

5.2 Pharmacokinetic Properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hexylene glycol

phosphoric acid

propylene glycolstearate

stearyl alcohol and ceteareth-20

titanium dioxide

aluminium starch octenylsuccinate

white beeswax

white soft paraffin

purified water

6.2 Incompatibilities

None Known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store between 2 and 30°C.

6.5 Nature And Contents Of Container

5, 15, 30, 45 and 100gm aluminium tubes with low density polyethylene cap or laminated tubes with high density polyethylene head and polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 00025/0577

9. Date Of First Authorisation/Renewal Of The Authorisation

19 November 1991 / 15 April 2002

10. Date Of Revision Of The Text

22 December 2010

11. LEGAL CATEGORY

Prescription Only Medicine

© Merck Sharp & Dohme Limited 2011. All rights reserved.

Elocon-C/UK/12-10/2