Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hydrocortisone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Hydrocortisone Ointment contains the active substance micronised hydrocortisone. Hydrocortisone belongs to a group of medicines called corticosteroids, which act to relieve pain and swelling. Hydrocortisone Ointment is a topical anti-inflammatory used in the treatment of
e Hydrocortisone Ointment Hydrocortisone 1% is classed as a mild corticosteroid. Do not use Hydrocortisone Ointment:
Hydrocortisone Ointment Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Wash your hands before and after applying Hydrocortisone Ointment, but if applying to the hands, do not wash after application.
Front Side
Dimensions – 150 x 300 mm
not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
Hydrocortisone Ointment Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Hydrocortisone Ointment contains The active substance is micronised hydrocortisone. The other ingredients are wool fat (see section 2), liquid paraffin and white soft paraffin. What Hydrocortisone Ointment looks like and contents of the pack A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex endseal band in the crimp seal area and a white plastic cap for reclosure after piercing membrane. Hydrocortisone Ointment is provided in a 15 g tube. Marketing Authorisation Holder Manufacturer Strides Pharma UK Ltd., Beltapharm SpA Unit 4, The Metro Centre Via Stelvio, 66 – 20095 Cusano Dwight Road, Watford, WD18 9SS Milanino – Milan – Italy United Kingdom This leaflet was last revised in 12/2023.
PL 13606/0189 PL 13606/0187
PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE OINTMENT 1% {Hydrocortisone}
1049422
Back side
Dimensions – 150 x 300 mm
Hydrocortisone Ointment 1% (Beltapharma) SPUK
Pack Insert
150 x 300 mm 1049422
15g 1047820
Black
PC-TSG/2023/150 – Record Number:395052 / PC-TSG/2023/169 – Record Number:397879 Front & Back Printing. To be supplied in folded size of 150 x 150mm 40 GSM Bible Paper Printing clarity to be clear & sharp. NA
1 2.0
Hydrocortisone ointment 1% PL 13606/0187 comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hydrocortisone ointment 1% PL 13606/0187 is hydrocortisone.
Medicines with the same active substance, strength and form include: Boots DermaCare Hydrocortisone 1% w/w Ointment, Hydrocortisone 0.5% Ointment / Efcortelan Ointment 0.5%, Hydrocortisone 1% Ointment / Efcortelan Ointment 1.0%. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Hydrocortisone ointment 1% PL 13606/0187, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.
Posology
Adults and elderly: A small amount to be applied to the affected area evenly and sparingly once or twice a day for a maximum period of one week. The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.
Children and infants: As for adults and the elderly. Long term therapy should be avoided and where possible limited to five to seven days.
This product is not recommended for use on children under 10 years of age without medical supervision.
Method of administration
For cutaneous use only.
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Use on the eyes, face or ano-genital region.
• Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
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.
Remarks on indications
1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal 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 excluding widespread plaque psoriasis provided that warnings are given.
In infants and children, long-term treatment should be avoided especially on the face as adrenal suppression can occur.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin; careful patient supervision is important.
Although generally regarded as safe, even for long-term administration in adults, there is potential for adverse effects if overused in infancy. Extreme caution is required in dermatoses of infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed seven days.
Appropriate antimicrobial therapy should be used treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
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 advise is recommended in these cases or other treatment options should be considered.
In infants and children particularly, care should be taken that the lowest strength of hydrocortisone ointment that is clinically effective is used. The 2.5% strength is normally only necessary in the more severe cases and is better avoided in infants.
The use of an occlusive dressing can considerably increase the degree of systemic absorption.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Caution should be taken to keep away from the eyes.
Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame.
Patients should be warned of this risk and advised to keep away from fire when using this product.
None known
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. Therefore there may be a small risk of such events to the human foetus. There is a theoretical risk of such effects on the human foetus.
Breast-feeding
There is no evidence against use in lactating women. However, caution should be exercised when hydrocortisone ointment 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.
None known
Treatment with hydrocortisone ointment is usually well tolerated but treatment should be stopped immediately if symptoms of hypersensitivity occur.
Epidermal thinning, telangiectasia 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.
Following prolonged topical use systemic absorption from sites may be sufficient to produce 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 are treated.
Eye disorders:
Frequency Not known: Vision, blurred (see section 4.4).
Skin and Subcutaneous Tissue Disorders
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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Hydrocortisone ointment 1% PL 13606/0187. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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