SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortisone Ointment or Boots Derma Care Hydrocortisone 1% Ointment or Almus Hydrocortisone 1% Ointment

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient    %w/w

Hydrocortisone Ph Eur    1.0

3.    PHARMACEUTICAL FORM

Ointment

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

POM: For the treatment of mild to moderate inflammatory skin disorders such as eczema, including atopic, infantile, discoid and stasis eczema; seborrhoeic dermatitis, intertrigo, otitis externa, contact dermatitis, neurodermatitis flexural psoriasis and lichen simplex.

P: For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

4.2.    Posology and Method of Administration

POM: For adults and children: Apply sparingly twice a day.

P: For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.

Children under 10 years of age: Not recommended except under medical supervision.

4.3    Contraindications

POM: Should not be used if allergic to any of the ingredients or on untreated, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.

P: The product should not be used if allergic to any of the ingredients or on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete’s foot.

4.4    Special warnings and Special precautions for use

POM: Avoid prolonged, continuous use, particularly in children and especially on the face, as adrenal suppression may occur.

P: Medical advice should be sought if the condition does not improve.

4.5 Interaction with other medicinal products and other forms of interaction

P and POM: No clinically significant interactions known.

4.6. Pregnancy and Lactation

POM: There is inadequate evidence of safety in human pregnancy. Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development. There may, therefore, be a very small risk of such effects in the human foetus.

P: This product should not be used in pregnancy without medical advice. There is no information about effects during lactation.

4.7. Effects on Ability to Drive and Use Machines

P and POM: No adverse effects known.

4.8 Undesirable effects

POM: The product is usually well tolerated, but if hypersensitivity occurs use of the product should be discontinued.

Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and the nappy area and where occlusive dressings are used. Sufficient systemic absorption may occur at these sites to produce features of suppression of the HPA (hypothalamo-pituitary-adrenal) axis after prolonged treatment.

P: Hydrocortisone Ointment 1% is usually well tolerated but if hypersensitivity occurs discontinue use.

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

POM: Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation, topical steroids should be discontinued.

P: No special precautions or antidotes are likely to be needed.

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Hydrocortisone is a corticosteroid which has antiinflammatory 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 epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelid, face and scalp than from the forearm, knee, elbow, palm and sole.

5.3. Pre-clinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6 PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

White soft paraffin.

6.2.    Incompatibilities

Not applicable.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

Do not store above 25°C.

6.5.    Nature and Content of Container

P: 15 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

POM: 15, 30 and 50 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

6.6.    Instructions for Use, Handling and Disposal

7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

Trading as: BCM

8.    MARKETING AUTHORISATION NUMBER(S)

PL 00014/0364.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14 April 1987 / 17 June 1997

10 DATE OF REVISION OF THE TEXT

15 May 2015