SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortistab Ointment 1%

Hydrocortisone Ointment 1%

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone EP 1% w/w

3 PHARMACEUTICAL FORM

A smooth, white to off-white ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hydrocortisone Ointment is indicated for the treatment of eczema and dermatitis of all types, including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

4.2 Posology and method of administration

Adults and children: To be applied sparingly to the affected skin two or three times daily after gently cleansing the area. Courses of treatment in children should generally be limited to not more than seven to ten days.

4.3 Contraindications

Hydrocortistab Ointment is contra-indicated in patients with bacterial, viral or fungal infections of the skin. Urticaria, rosacea, ulcers and local infection are also contra-indications.

4.4 Special warnings and Special precautions for use

Prolonged use in infants and children and on the face should be avoided.

Hydrocortistab Ointment is for symptomatic relief and is not curative. For this reason, there is a possibility of rebound of symptoms.

Hydrocortistab Ointment is not recommended for pruritis.

Topical corticosteroids may be hazardous in patients with psoriasis and should therefore be avoided.

Long term use in patients with diabetes or tuberculosis is not recommended.

4.5    Interaction with other medicinal products and other forms of interaction

No known interactions.

4.6    Fertility, 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. Thus, there may be a very small risk of such effects in the human foetus.

No problems have been documented for neonates when Hydrocortistab Ointment is used by nursing mothers.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Side effects are rare but the following local effects have been reported frequently: spread of infection, irreversible striae atrophicae, thinning of the skin, changes in hair growth, acne, oily skin and mild depigmentation.

Serious systemic effects of pituitary suppression and hypercorticism may occur if significant systemic absorption occurs. This is likely if applied frequently or over prolonged periods or over a large areas or over moist and or/ denuded areas or if an occlusive dressing is present. Systemic absorption is more likely when used over intertriginous areas. Children are particularly at risk and in these patients, Hydrocortistab Ointment should only be used twice daily for a maximum of ten days over a body surface area not exceeding 10% and without an occlusive dressing.

4.9 Overdose

Following oral ingestion, symptoms may include nausea, vomiting and diarrhoea.

Treatment need only be symptomatic.

No special procedures or antidotes are likely to be needed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

5.2 Pharmacokinetic properties

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidennal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelids, face and scalp than from the forearm, knee, elbow, palm and sole.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

10 DATE OF REVISION OF THE TEXT

28/11/2007