HYDROCORTISONE 1.0% CREAM BP - patient leaflet, side effects, dosage

1. What Hydrocortisone cream is and what it is used for

2. What you need to know before you use Hydrocortisone cream

3. How to use Hydrocortisone cream

4. Possible side effects

5. How to store Hydrocortisone cream

6. Contents of the pack and other information

1. what hydrocortisone cream is and what it is used 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 1.0% Cream BP 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 externa)
• prurigo nodularis- a long term skin condition where very itchy lumps appear
• neurodermatoses- long term skin condition where itchy skin becomes thick due to scratching
• nappy rash (if there is no infection present, or existing infection is being treated with appropriate antibiotics).

2. what you need to know before you use hydrocortisone cream are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of this medicine

• have any other skin infection such as athlete’s foot (tinea pedis), 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

• will be applying the cream to your face, particularly around the eyes. This cream should not be used for long on the face as it may damage the facial skin
• will be using the cream for the treatment of dermatitis or nappy rash on children and infants. Treatment in infants should be limited to a maximum of seven days.
• are applying the cream under an airtight dressing, including a child's nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much cream.
• have a skin infection. If the condition appears to be getting worse despite using antibiotics prescribed, stop using the cream and contact your doctor

Caution should be taken to keep away from the eyes. Contact your doctor if you experience blurred vision or other visual disturbances.

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 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.

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

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before using this medicine..

Hydrocortisone cream contains cetostearyl alcohol and chlorocresol

This cream contains cetostearyl alcohol which may cause local skin reactions such as contact dermatitis and chlorocresol which may cause allergic reactions, in some people.

3. how to use hydrocortisone cream

Always use Hydrocortisone cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For application to the skin.

The recommended dose is:

If you use more Hydrocortisone 1.0% Cream than you should

• Do not use the cream more often or for longer than your doctor tells you to.
• Do not use larger quantities than as directed, as this will increase the possibility of side effects.
• If you accidentally use too much on a few occasions do not worry.
• If you accidentally swallow some cream, small amounts are not harmful.
• 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 1.0% Cream

If you forget to use the cream, apply it as soon as you remember, unless it is nearly time to apply the next dose.

Possible side effects

Like all medicines, Hydrocortisone 1.0% Cream BP 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:

• a change in the colour of skin, or increased growth of hair in areas where the cream is used
• contact dermatitis – localised rash or irritation to the skin
• 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 continuously for prolonged periods a withdrawal reaction may occur on 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 side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
• Store below 25°C. Do not freeze.
• Do not use Hydrocortisone cream after the expiry date stated on the label/carton/bot­tle. The expiry date refers to the last day of that month.
• 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. contents of the pack and other information the active substance (the ingredient that makes the cream work) is hydrocortisone. each cream contains 1% w/w of the active ingredient.

• The other ingredients are chlorocresol, cetomacrogol, cetostearyl alcohol and paraffin.

What Hydrocortisone cream looks like and contents of the pack

Pack sizes of 15g, 30g and 50g.

Marketing Authorisation Holder and manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in August 2021.

More information on managing skin conditions may be obtained from:

National Eczema Society or the Skin Care Campaign

Hill House

Highgate Hill

London

N19 5NA