Summary of Product Characteristics (SmPC) - Hydrocortisone Skin ointment 1%
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Skin Ointment 1%.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10mg hydrocortisone BP (micro).
3 PHARMACEUTICAL FORM
Ointment, in an off-white, soft paraffin base
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Indications
Eczema and dermatitis of all types including atopic, infantile and discoid eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.
Remarks on indications
- 1. There is no good evidence that topical corticosteroids are efficacious against immediate (type I) allergic skin reactions or short-lived wheal and flare reactions from other causes.
- 2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
- 3. Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see Section 4.4 Special Warnings and Special Precautions for Use.
4.2 Posology and method of administration
Posology
Adults (including elderly)
Gently apply a thin layer of ointment to the affected area two or three times daily.
Children and infants
Gently apply a thin layer of ointment to the affected area two or three times daily. Avoid prolonged use. In infants, therapy should be limited to five to seven days.
Hydrocortisone ointment should be considered for dry, scaly or lichenified conditions whereas the cream formulation is usually suitable for moist or weeping surfaces.
Method of Administration
For topical application warnings are given, see Section 4.4 Special Warnings and Special Precautions for Use.
4.3 Contraindications
Hypersensitivity to hydrocortisone or any of the other excipients listed in section 6.1.
Untreated bacterial (eg impetigo) viral (eg herpes simplex) or fungal (eg candida or dermatophyte) infections.
Scabetic infections.
Rosacea.
Perioral dermatitis.
Infected lesions,
Ulcerative conditions
Acne
4.1 Special warnings and precautions for use
The use of an occlusive dressing can considerably increase the degree of systemic absorption. If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. 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.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Prolonged application to the face is undesirable.
Caution should be taken to keep away from the eyes.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
Instruct patients not to smoke or go near naked flames - risk of severe burns.
Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not totally remove it.
Paediatric population
In infants and children particularly, care should be taken that the lowest strength of hydrocortisone skin ointment that is clinically effective is used. Long-term continuous topical therapy should be avoided, where possible, as adrenal suppression can occur, even without occlusion.
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin rash. In infants, the napkin may act as an occlusive dressing, and increase absorption.
Treatment should therefore be limited, where possible, to a maximum of 7 days.
The label will state mild steroid.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
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. Theoretically, there is the possibility that if maternal systemic absorption occurred the infant's adrenal function could be affected.
Breast-feeding
There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers.
In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately.
Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption.
Sufficient systemic absorption from such sites may be sufficient to produce the features of hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated.
Eye disorders:
Frequency Not known: Vision, blurred (see also section 4.4).
Skin and Subcutaneous Tissue Disorders:
Frequency not known:
Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4).
There are reports of pigmentation changes and hypertrichosis with topical steroids. Contact dermatitis may also occur.
Exacerbation of symptoms may occur.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
4.9 Overdose
Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote.
Treat any adverse effects symptomatically. 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D07 AA02
Pharmacotherapeutic group: Weak dermatological corticosteroid (group 1).
Corticosteroids used in topical presentations for anti-inflammatory activity are of value in the treatment of a wide variety of dermatological conditions. The anti-inflammatory actions are mediated by reducing prostaglandin synthesis in several skin cell types. This interrupts the release of mediators such as leukotrienes, which play a part in the development of eczema and dermatitis.
5.2 Pharmacokinetic properties
Absorption
Hydrocortisone is absorbed through skin, particularly in denuded areas.
Distribution
Corticosteroids are rapidly distributed to all body tissues. They cross the placenta to varying degrees and may be excreted in small amounts in breast milk. Corticosteroids in the circulation are usually extensively bound to plasma proteins, mainly to globulin and less so to albumin.
Metabolism
Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol.
Excretion
The metabolites are excreted in the urine mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
5.3 Preclinical safety data
Not required.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Wool fat, liquid paraffin, white soft paraffin.
6.2 Incompatibilities
None.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Store below 25oC.
6.5 Nature and contents of container
Container: A collapsible aluminium tube, with internal epoxylacquer and a white plastic cap.
Pack sizes: 5gm, 10gm, 15gm, 20gm and 30gm.
6.6 Special precautions for disposal
For external use only.
7 MARKETING AUTHORISATION HOLDER
Ennogen IP Ltd
Unit G4, Riverside Industrial Estate, Riverside Way,
Dartford, DA1 5BS, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 55612/0037
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2000
10 DATE OF REVISION OF THE TEXT
06/05/2025