Elocon Scalp Lotion

1. Name Of The Medicinal Product

Elocon Scalp Lotion

2. Qualitative And Quantitative Composition

Mometasone Furoate 0.1% w/w

Propylene glycol 30.0% w/w

3. Pharmaceutical Form

Lotion

4. Clinical Particulars

4.1 Therapeutic Indications

Elocon Scalp Lotion is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis and seborrhoeic dermatitis of the scalp.

4.2 Posology And Method Of Administration

Adults, including elderly patients and Children: A few drops of Elocon Scalp Lotion should be applied to affected scalp sites, once daily; massage gently and thoroughly until the medication disappears.

Use of topical corticosteroids in children 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 Scalp Lotion is contraindicated in bacterial (e.g. impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and fungal (e.g. candida or dermatophyte) infections of the scalp. Elocon Scalp Lotion 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If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted.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. If used in childhood, courses should be limited to 5 days. 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 Scalp Lotion contains propylene glycol which may cause skin irritation.

Care must be taken to keep the preparation away from the eyes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

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 known.

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 dermatologic 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

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is indicated.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

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 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 this SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl alcohol;

propylene glycol;

hydroxypropyl cellulose;

sodium phosphate monobasic dihydrate;

phosphoric acid;

purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

30ml white LDPE bottles with LDPE dropper and white HDPE 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 00025/0579

9. Date Of First Authorisation/Renewal Of The Authorisation

5 May 1992 / 3 December 2007

10. Date Of Revision Of The Text

22 December 2010

11 LEGAL CATEGORY

Prescription Only Medicine

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

EloconSL/UK/12-10/7