Hydrocortisone Skin ointment 1% – patient leaflet, side effects, dosage

1. What Hydrocortisone Skin Ointment is and what it is used for

Hydrocortisone Skin Ointment contains the active substance hydrocortisone. Hydrocortisone belongs to a group of medicines called anti-inflammatory steroids. This means they act by reducing inflammation that occurs during certain skin conditions or reactions.

Hydrocortisone Skin Ointment is usually prescribed to treat all types of eczema and dermatitis. It is also used to treat 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 Skin Ointment is classed as a mild corticosteroid.

Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.

2. What you need to know before you use Hydrocortisone Skin Ointment

Do not use Hydrocortisone Skin Ointment if you:

! are allergic to hydrocortisone or any of the other

ingredients of this medicine (listed in section 6) ! are or might be pregnant

! have a bacterial infection (e.g. impetigo) ! have a viral infection (e.g. herpes simplex) ! have a fungal infection (e.g. thrush or ringworm) ! have an inflamed rash around the mouth (peri-

oral dermatitis)

! have acne (acne vulgaris)

! have infected lesions

! have ulcerative conditions

! have a condition called rosacea which causes

redness, bumps, pus containing spots (pustules) and visible blood vessels on the forehead, cheeks, nose and chin.

Warnings and precautions

! Hydrocortisone Skin Ointment and other topical

corticosteroids may be harmful if used in patients suffering from psoriasis (a chronic skin condition that can cause raised, scaly patches of skin to appear). The condition may become worse after stopping long-term treatment

! Caution is required when used in infants. If

overused may cause skin irritation including nappy rash. Treatment should not exceed 7 days.

! In infants and children particularly, care should

be taken that the lowest strength of hydrocortisone skin ointment that is clinically effective is used.

! Application to the face may damage the skin and

should be avoided.

Caution should be taken to keep away from the eyes. Contact your doctor if you experience blurred vision or other visual disturbances (see section 4).

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 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.

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.

Other medicines and Hydrocortisone Skin Ointment

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

Hydrocortisone Skin Ointment contains wool fat

This ointment contains wool fat which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Hydrocortisone Skin Ointment

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

The recommended dose is:

Adults and the elderly

Gently apply a thin layer of ointment to the affected area(s) two or three times a day.

Use in children and adolescents

Gently apply a thin layer of ointment to the affected areas(s) two or three times a day. The smaller the child the less you will need to use.

A course of treatment for a child should not normally last more than 7 days - unless your doctor has told you to use it for longer.

If you use more Hydrocortisone Skin Ointment than you should

! Do not use the ointment 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 accidently use too much on a few

occasions do not worry.

! If you accidently swallow some ointment, small

amounts are not harmful.

! If you squeeze out too much ointment, wipe off

the excess with a paper towel. Do not use the ointment, 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 Skin Ointment

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most patients using this medicine will have no problems when used in the correct amount for the prescribed time.

If the following happens, stop using Hydrocortisone Skin Ointment 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 ointment 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 Skin Ointment 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 ointment, or an infection. Stop using the ointment, 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 MHRA 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.

5. How to store Hydrocortisone Skin Ointment

Keep this medicine out of the sight and reach of children. Your medicines can harm them.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store below 25°C.

Do not use this medicine if you notice any defects such as lumps in your skin ointment, take it to your pharmacist for advice.

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.

6. Contents of the pack and other information

What Hydrocortisone Skin Ointment contains

The active substance is hydrocortisone. Each gram of ointment contains 10mg of the active substance hydrocortisone.

The other ingredients are wool fat, liquid paraffin and white soft paraffin.

What Hydrocortisone Skin Ointment looks like and contents of the pack

The product is an off-white ointment and is available in 5g, 10g, 15g, 20g and 30g tubes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Ennogen Healthcare International Ltd,

Unit G3, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in June 2025. Hydrocortisone Skin Ointment 1%

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