Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
HYDROCORTISONE CREAM 1% PL 13606/0182
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
FOR Hydrocortisone belongs to a group of medicines called topical corticosteroids. These work by calming the inflammation that occurs during certain skin conditions or reactions. Hydrocortisone Cream may be used for treating various skin conditions including:
- Eczema
- Dermatitis, including intertrigo (irritation between skin folds)
- Insect bite reactions
- Inflammation of the external ear (otitis external)
- Prurigo nodularis- a long term skin condition where very itchy lumps appear
- Neurodermatoses- a long term skin condition where itchy skin becomes thick due to scratching
- Nappy rash, if infection exists it is being treated with appropriate antibiotics.
What you need to know before you take it
E HYDROCORTISONE CREAM Hydrocortisone 1% is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. Do not use Hydrocortisone Cream if you:
- Are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6)
- Have any other skin infection such as athlete's foot (tinea paedis), chickenpox (varicella) or shingles (Herpes zoster), coldsores (Herpes simplex), impetigo, ringworm or thrush, infected lesions, ulcerative conditions, red appearance on face, peri-oral dermatitis or acne. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Hydrocortisone Cream if you:
- Have psoriasis, the condition may become worse after stopping long-term treatment
- Will be applying the cream to your face. This cream should not be used for long on the face as it may damage the facial skin
- Are using this cream under occlusive dressing that can considerably increase the absorption of this cream.
- If there is a worsening of your condition during use consult your prescriber- you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment.
- If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream/ointment without consulting your prescriber unless your prescriber has previously advised you to so.
- If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Caution should be taken to keep away from the eyes. Contact you doctor if you experience blurred vision or other visual disturbances. Do not 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. Children Talk to your doctor or pharmacist or nurse before using Hydrocortisone Cream if you will be using the cream for the treatment of dermatitis or nappy rash on children and infants. In children and infants treatment should not normally exceed 7 days. Other medicines and Hydrocortisone Cream Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you are breastfeeding, do not apply the product to your chest area. Hydrocortisone Cream contains Chlorocresol This may cause allergic reactions.
How to take it
HYDROCORTISONE CREAM Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For application to the skin. Wash your hands before and after applying Hydrocortisone Cream, but if applying to the hands, do not wash after application.
- Apply sufficient cream to thinly cover the affected area and gently rub into the skin until it disappears
- If the affected area becomes weepy or infected, stop using the cream and speak to your doctor. You may need to start antibiotic treatment, especially if the infection spreads
- You should not normally use Hydrocortisone Cream on the face for many weeks or months, unless specifically prescribed by your doctor. The recommended dose is: Adults (including the elderly)
- Gently apply a thin layer of cream to the affected area(s) two or three times a day. Children and Infants
- Apply as for adults but avoid long term use. Treatment should be limited to seven days – especially in infants
- The lowest concentration suitable should be used
- Do not use under a nappy or an airtight dressing (such as a plaster) on an infant because this will enable too much active ingredient to pass through the skin. If you use more Hydrocortisone Cream than you should If you squeeze out too much cream, wipe off the excess with a paper towel. Do not use the cream under airtight dressings (such as plasters) or nappies, as too much hydrocortisone may be absorbed and may result in adverse effects upon adrenal gland function. If you forget to use Hydrocortisone Cream If you forget to apply the Hydrocortisone Cream, apply it as soon as possible and carry on as before. If it is 3 hours or less until the next application, then ignore the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Most patients using Hydrocortisone Cream will have no problems when used in the correct amount for the prescribed time. If the following happens, stop using the cream and tell your doctor immediately or go to the casualty department at your nearest hospital:
- An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Other effects which may occur:
- The skin may become thinner when used in the nappy areas of children where conditions are moist
- If Hydrocortisone Cream is used often over a large area of skin or for a long time, especially under dressings, adverse effects on adrenal gland function are more likely. These effects are also more likely in children and infants
- Prolonged use, especially on sensitive areas including skin folds, may result in thinning of the skin, widening of the blood vessels, stretch marks and may suppress the functioning of the adrenal gland.
- Blurred vision. This side effect has been reported, but the frequency for it to occur is not known.
- Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. If your condition becomes worse during treatment, you may have an allergy to one of the ingredients of the cream or an infection. Stop using the cream and tell your doctor as soon as possible. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
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.
How to store it
HYDROCORTISONE CREAM Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date 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.
Contents of the pack and other information
What Hydrocortisone Cream contains The active substance is micronised hydrocortisone. The other ingredients are cetomacrogol emulsifying wax, chlorocresol (see section 2), liquid paraffin, macrogol 300, white soft paraffin and purified water. What Hydrocortisone Cream 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 Cream is provided in 15g, 30g and 50g tubes. Marketing Authorisation Holder Manufacturer Strides Pharma UK Ltd., Beltapharm SpA Unit 4, The Metro Centre Via Stelvio, 66 – 20095 Cusano Dwight Road, Watford Milanino – Milan – Italy WD18 9SS, United Kingdom.
PL 13606/0182
PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE CREAM 1% Hydrocortisone
1 2.0
Frequently asked questions about HYDROCORTISONE CREAM 1% PL 13606/0182
How do I take HYDROCORTISONE CREAM 1% PL 13606/0182?
HYDROCORTISONE CREAM 1% PL 13606/0182 comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in HYDROCORTISONE CREAM 1% PL 13606/0182?
The active substance in HYDROCORTISONE CREAM 1% PL 13606/0182 is hydrocortisone.
Are there equivalent medicines to HYDROCORTISONE CREAM 1% PL 13606/0182?
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.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for HYDROCORTISONE CREAM 1% PL 13606/0182, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get HYDROCORTISONE CREAM 1% PL 13606/0182 without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hydrocortisone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Hydrocortisone has topical anti-inflammatory activity of value in treatment of various dermatological conditions including:
• Eczema – atopic, infantile, discoid, stasis
• Dermatitis – Primary irritant, contact allergic, photo or seborrhoeic
• Insect bite reactions
• Prurigo nodularis
• Neurodermatoses
• Otitis externa
• Intertrigo
• Napkin rash, where concurrent infection is excluded or being addressed.
4.2. Posology and method of administration
Posology
To be applied evenly and sparingly two or three times daily.
Adults and the elderly
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
Long term therapy should be avoided where possible.
Infants
Therapy should be limited if possible to a maximum of seven days.
Method of administration
For topical application.
4.3. Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Untreated bacterial (e.g impetigo), viral (e.g. herpes simplex), or fungal (e.g candida or dermatophyte) infections of the skin.
• Infected lesions.
• Ulcerative conditions.
• Rosacea.
• Perioral dermatitis or acne.
4.4. Special warnings and precautions for use
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 the 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 cream 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.
Hydrocortisone Cream contains Chlorocresol which may cause allergic reactions.
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.
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. 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 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 known
4.8. Undesirable effects
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 also 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.
4.9. Overdose
Excessive use under occlusive dressings may produce adrenal suppression.
There are no special procedures or antidotes. Treat any adverse effects symptomatically.
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
💬 Ask about this leaflet
Ask anything about HYDROCORTISONE CREAM 1% PL 13606/0182. 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.
Medicines containing Hydrocortisone
- Alkindi 0.5 mg granules in capsules for opening
- Alkindi 1 mg granules in capsules for opening
- Alkindi 2 mg granules in capsules for opening
- Alkindi 5 mg granules in capsules for opening
- Dermacort Hydrocortisone Cream
- Efmody 10 mg capsule Modified-release capsule
- Efmody 5mg modified release hard capsules
- Hydrocortisone 0.5% Cream / Efcortelan Cream 0.5%
- Hydrocortisone 0.5% Ointment / Efcortelan Ointment 0.5%
- Hydrocortisone 1% Cream / Efcortelan Cream 1%
- Hydrocortisone 1% Ointment / Efcortelan Ointment 1.0%
- Hydrocortisone 1% w/w Ointment
- Hydrocortisone 1% w/w/ Cream POM
- Hydrocortisone 10 mg Tablets