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 acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Hydrocortisone Cream 1%. Hydrocortisone Cream 1% contains the active ingredient hydrocortisone which belongs to a group of medicines called corticosteroids or 'steroids'. Steroids like hydrocortisone are applied to the skin to reduce inflammation. Hydrocortisone Cream 1% is used to treat all types of eczema and dermatitis and insect bite reactions. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. Be aware the percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Hydrocortisone Cream 1% is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
e Hydrocortisone Cream 1% Do not use Hydrocortisone Cream 1%:
•
If you have psoriasis (a skin condition).
Warnings and precautions Talk to your doctor or pharmacist before using Hydrocortisone Cream 1% if you:
Hydrocortisone Cream 1% Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Check that the tube seal is not broken before use. Use the point on the cap to break the seal. For adults and children Apply sparingly to the affected area of skin two or three times daily. Important Information
If you use more Hydrocortisone Cream 1% than you should If you accidentally use too much cream it is not likely to cause any harm. If anyone accidentally swallows any cream, rinse out the mouth and seek medical advice. Take the product and packaging with you. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice;
not listed in this leaflet. You can also report side effects 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 Cream 1% Keep this medicine out of the sight and reach of children. Do not store above 25°C.
Do not use any medicine after the expiry date on the carton and tube and keep them in their original pack. 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 Cream 1% contains The active ingredient is hydrocortisone acetate present at a concentration of 1%. The other inactive ingredients are: cetomacrogol emulsifying wax, liquid paraffin, white soft paraffin, chlorocresol and purified water. What Hydrocortisone Cream 1% looks like and the contents of the pack Hydrocortisone Cream 1% is a soft, white cream, with a faint characteristic odour. It is available in a tube containing either 15 g, 30 g or 50 g of cream. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK Manufacturer Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR UK This leaflet was last revised in: April 2024
PL 06464/0698
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
Hydrocortisone cream 1% w/w comes as cream. 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 cream 1% w/w is hydrocortisone acetate.
Medicines with the same active substance, strength and form include: Boots Derma Care 1% w/w Cream, Boots DermaCare Hydrocortisone 1% w/w Cream, Boots Insect Bite & Sting Treatment 1% Cream. In total there are 14 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Hydrocortisone cream 1% w/w, 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 Cream 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.
For topical 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.
Hydrocortisone Cream is contra-indicated in patients with bacterial, viral or fungal infections of the skin. Urticaria, rosacea, ulcers and local infection are also contra-indications.
Prolonged use in infants and children and on the face should be avoided.
Hydrocortisone Cream is for symptomatic relief and is not curative. For this reason, there is a possibility of rebound of symptoms.
Hydrocortisone Cream 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.
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.
The label will state mild steroid.
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.
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.
No known interactions.
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 Hydrocortisone Cream is used by nursing mothers.
No adverse effects known.
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, Hydrocortisone Cream 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.
Vision, blurred (see also section 4.4) (uncommon)
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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Hydrocortisone cream 1% w/w. 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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