SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Beclometasone dipropionate 0.25mg/g Ointment

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Beclometasone Dipropionate BP 0.025% w/w

3    PHARMACEUTICAL FORM

Ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Beclometasone dipropionate Ointment is indicated for the treatment of the various forms of eczema in children and adults including atopic and discoid eczemas; primary irritant and allergic dermatitis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex; intertrigo; discoid lupus erythematosus.

The cream is often appropriate for moist or weeping surfaces and the ointment for dry, lichenified or scaly lesions but this is not invariably so.

4.2    Posology and method of administration

Beclometasone dipropionate Ointment should be applied thinly over the whole of the affected area and gently rubbed in. Initially, application should be made twice daily, but when improvement is seen, the intervals between applications may be extended and treatment eventually stopped. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral may be necessary. After cessation of treatment, should the condition recur, twice daily treatment should be re-instituted. However, when improvement is seen again, the intervals between applications may be gradually extended until maintenance dosing of application every third or fourth day is achieved. This is likely to avoid subsequent reappearance of the condition.

The beneficial effects may be enhanced by preliminary use of hot soaks, or by intermittent applications or occlusive dressings.

For topical administration

4.3    Contraindications

The ointment should not be applied to the eyes. Rosacea, acne vulgaris; perioral dermatitis. Primary cutaneous viral infections (e.g. herpex simplex, chickenpox). Hypersensitivity to the preparation. Varicose ulcers or any other stasis ulcers.

Use of Beclometasone dipropionate Ointment is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo); primary or secondary infections due to yeasts; perianal and genital pruritus; dermatoses in children under 1 year of age, including dermatitis and napkin eruptions.

4.4 Special warnings and precautions for use

Long-term continuous therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion.

The face, more than the other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

If used in childhood, or on the face, courses should be limited if possible to five days and occlusion should not be used.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised 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.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents.

Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

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 intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects on ability to drive and use machines

None stated

Undesirable effects

Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

As with other topical corticosteroids, prolonged used of large amounts, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. The effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Should systemic corticosteroid effects arise from application of Beclometasone dipropionate Ointment, topical treatment should be discontinued. If adrenal function is impaired the patient will need to be protected from any harmful effects of stress with oral corticosteroid preparations until normal adrenal function is established.

There are reports of pigmentation changes and hypertrichosis with topical steroids.

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease (see precautions).

Beclometasone dipropionate Ointment is usually well tolerated, but if signs of hypersensitivity appear, application should stop immediately. Exacerbation of symptoms may occur 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

Should systemic corticosteroid effects arise from application of Beclometasone dipropionate Ointment topical treatment should be discontinued. If adrenal function is impaired the patient will need to be protected from any harmful effects of stress with oral corticosteroid preparations until normal adrenal function is established.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Beclometasone dipropionate is an active corticosteroid with topical antiinflammatory activity.

5.2    Pharmacokinetic properties

The extent of percutaneous absorption of topical corticosteroid is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to that in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Propylene Glycol EP White Soft Paraffin BP

6.2    Incompatibilities

None stated

6.3    Shelf life

18 months

6.4    Special precautions for storage

Store below 25°C and protect from light

6.5    Nature and contents of container

Collapsible aluminium tube internally either uncoated or coated with an epoxy

resin based lacquer, and closed with a wadless polypropylene cap

Pack size: 15g, 30g, 50g

Not all pack sizes may be marketed

6.6 Special precautions for disposal

No special instructions

7    MARKETING AUTHORISATION HOLDER

Chemidex Pharma Ltd

Trading as Essential Generics

7 Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0268

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/03/1993

10 DATE OF REVISION OF THE TEXT

08/08/2014