Summary of Product Characteristics (SmPC) - Hydrocortisone 1.0% w/w ointment (15 g Pack)
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 1.0% w/w Ointment (15g pack)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 1.0% w/w (micronised).
Excipients with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Tube containing a faintly off-white translucent ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of irritant dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.
4.2 Posology and method of administration
For topical application only.
Adults and children 10 years and over: use sparingly over a small area once or twice a day for a maximum period of 7 days.
4.3 Contraindications
Use on the eyes/face, ano-genital region, broken or infected skin including cold sores, acne and athlete’s foot.
Not recommended for use on children under 10 years of age without medical supervision.
4.4 Special warnings and precautions for use
Tell your doctor or pharmacist if you suffer from a chronic skin disease marked by itchy, scaly red patches known as psoriasis.
Topical corticosteroids may be hazardous in psoriasis for number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin.
The application of hydrocortisone preparations under occlusive dressings on large areas of body should be avoided because of greater risk of toxicity resulting from increased systemic absorption.
The label will carry the following warnings:
For external use only.
Do not use in pregnancy without medical advice.
Do not use on the eyes or face, anal or genital regions or on broken or infected skin including cold sores, acne, and athlete’s foot.
If the condition does not improve after one week consult your doctor.
The label will state mild steroid.
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 steroid withdrawal syndrome (TSWS)
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 advise is recommended in these cases or other treatment options should be considered.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, Pregnancy and lactation
Pregnancy
Not recommended during pregnancy without first seeking medical advice.
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 intro-uterine growth retardation. There may therefore be a very small risk of such effects in human foetus.
Breast-feeding
It is not known if topical hydrocortisone is excreted in the breast milk. Problems in humans have not been documented, however risk-benefit must be considered when administering to nursing mothers.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Application of hydrocortisone ointment to the skin has led to loss of skin collagen and subcutaneous atrophy and striae.
Slight stinging irritation, burning and itching has been reported. Allergic contact dermatitis and steroid acne has also been reported.
Eye Disorders
Frequency uncommon (may affect up to 1 in 100 people)
Vision blurred (see also section 4.4).
Skin and Subcutaneous Tissue Disorders
Frequency not known (cannot be estimated from available data)
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)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group 1); ATC code: D07AA02
Hydrocortisone (cortisol) is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone ointment when applied topically acts locally at the site of application. When applied to the skin, the site of action may be the epidermis, dermis, or both.
Hydrocortisone ointment diffuses across the cell membranes and forms a complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus and bind to DNA and stimulate transcription of messenger RNA and subsequent protein synthesis of various enzymes that are thought to be responsible for anti-inflammatory effects of topical application of adrenocorticoids. When absorbed systemically in sufficient quantities, its principal pharmacological actions are gluconeogenesis, glycogen deposition, protein, and calcium metabolism, together with inhibition of corticotrophin secretion and anti-inflammatory activity.
5.2 Pharmacokinetic properties
Absorption
Some hydrocortisone ointment is absorbed systemically through the skin particularly in denuded areas.
The absorption of the topical dosage form is increased, when applied over an extensive area, after prolonged use or when an occlusive dressing is applied. It is also absorbed through the rectal mucosa and more so if the intestinal mucosa is inflamed.
Distribution
Hydrocortisone ointment is metabolised mostly in the skin. Half-life of hydrocortisone ointment is approximately 2 hours. Vehicles are very important in delivering the therapeutic agent at the site of action.
Biotransformation
Systemically absorbed hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as cortisone, tetrahydrocortisol, tetrahydrocortisone, cortol, cortolone, 11B-hydroxyetiocholanolone and 11-ketoetiocholanolone.
Elimination
These are excreted in the urine mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. The plasma elimination half-life of hydrocortisone is about 60 minutes.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Soft Paraffin
Liquid Paraffin
Wool Fat
6.2 Incompatibilities
None.
6.3 Shelf life
36 months unopened
6.4 Special precautions for storage
Store in a cool place and protect from light.
Keep out of the sight and reach of children
6.5 Nature and contents of container
Lacquered aluminium tubes fitted with plastic screw caps.
Pack size: 15g
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Merel Pharma Limited
34 Market Street,
Hyde,
SK14 1AH,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 60884/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 23 February 2001
Date of latest renewal: 31 August 2006
10 DATE OF REVISION OF THE TEXT
07/08/2025