Patient leaflet - Hydrocortisone 1%w/w cream
1. WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR
Hydrocortisone Cream is a smooth white cream for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Hydrocortisone Cream is used to reduce inflammation in a variety of inflammatory skin conditions including eczema and dermatitis of all types, such as:
- inherited skin inflammation, scaliness or itchiness (atopic eczema)
- light-sensitive skin (photodermatitis)
- dermatitis between folds of skin (intertrigo)
- dermatitis caused by irritants or allergens
- lumps in the skin with itching (prurigo nodularis)
- scaly or crusty skin, ‘cradle cap’ (seborrhoeic dermatitis)
- 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. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Hydrocortisone Cream is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
2. BEFORE YOU USE HYDROCORTISONE CREAM
Do not use Hydrocortisone Cream if you:
- are allergic to hydrocortisone or to any of the other ingredients of Hydrocortisone Cream (see Section 6 and end of Section 2).
- have a bacterial infection (e.g. impetigo), viral infection (e.g. herpes simplex) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin.
Take special care with Hydrocortisone Cream
Hydrocortisone Cream is not suitable for use in the following:
- allergic skin reactions including temporary red or raised areas on your skin (short lived ‘wheal and flare’ reactions)
- conditions involving the deeper skin layers, such as granulomas
- psoriasis (long term scaly skin condition); only use this product on medical advice and with careful supervision by your doctor.
Take great care to apply the cream sparingly to the skin of infants or children, especially in the nappy area which can be covered for long periods. Covering the treated area can increase absorption. Treatment for infants must not exceed 7 days.
Your doctor may advise the use of antimicrobial medicine at the same time as Hydrocortisone Cream if the area has become infected.
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.
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 do 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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. There is a very small risk of abnormalities in the unborn child if this product is used during pregnancy.
If you are breast-feeding, do not apply the product to your chest area.
Important information about some of the ingredients
Hydrocortisone Cream contains
- chlorocresol - may cause allergic reactions
- cetomacrogol emulsifying wax - which contains cetostearyl alcohol - may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE HYDROCORTISONE CREAM
Always use Hydrocortisone Cream exactly as your doctor has told you. Your doctor will tell you how much to apply and how often, but you must check with your doctor if you are not sure.
Do not exceed the stated dose.
For application to the surface of the skin only:
- 1. Wash your hands thoroughly before use.
- 2. Apply the cream sparingly to the affected area, one to four times a day. Massage the cream gently into the affected area to help absorption into the skin.
- 3. Once applied, do not cover the area with a dressing or plaster.
Increase the intervals between applications as the condition improves. Treatment may be reduced to two to three times a week, or restarted when your symptoms return.
If you use more Hydrocortisone Cream than you should
If you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.
If you forget to use Hydrocortisone Cream
If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone Cream can cause side effects, although not everybody gets them.
You may notice the following:
- rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop using Hydrocortisone Cream immediately.
- ‘stretch marks’ may appear, especially in skin folds such as the groin or armpits.
- 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5. HOW TO STORE HYDROCORTISONE CREAM
Keep out of the sight and reach of children. Do not store above 25˚C. Do not use Hydrocortisone Cream after the expiry date which is stated on the tube/carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Hydrocortisone Cream contains:
- The active substance is hydrocortisone and the cream contains 10 mg in every 1 g (1%).
- The other ingredients are Cetomacrogol Emulsifying Wax, chlorocresol, liquid paraffin, Macrogol 300, white soft paraffin and purified water (see end of Section 2 for further information).
What Hydrocortisone Cream looks like and contents of the pack
The product is a homogenous, white cream and is available in aluminium tubes containing 5 g, 10 g, 15 g, 20 g, 30 g or 50 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0095
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Please be ready to give the following information:
| Product name | Reference number |
| Hydrocortisone 1 % w/w cream | 04917/0095 |
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