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.

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Hydrocortisone 1% w/w Ointment

⚠ 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.

Active substance: Hydrocortisone

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Hydrocortisone Ointment is a smooth off-white ointment for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Hydrocortisone Ointment is used to reduce inflammation in a variety of inflammatory skin conditions, such as:

  • mild to moderate eczema
  • dermatitis caused by irritants or allergens
  • insect bite reactions Hydrocortisone should not be confused with anabolic steroids, used by some body builders and taken as tablets or injections.

What you need to know before you take it

e Hydrocortisone Ointment Do not use Hydrocortisone Ointment:

  • if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
  • if you have a bacterial infection (e.g. impetigo), viral infection (e.g. cold sores 'herpes simplex', chicken pox) or fungal infection (e.g. tinea, also called 'athlete's foot', ringworm or thrush) of the skin.
  • on your face or near your eyes, on the anal or genital region, or on broken skin. Take special care with Hydrocortisone Ointment Hydrocortisone Ointment 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. Do not cover the area with a plaster or dressing of any kind after application of Hydrocortisone Ointment. Take great care to apply the ointment 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. Do not apply the product to your face for long periods of time. If your condition worsens during use consult a pharmacist or doctor – 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 a pharmacist or doctor. 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. Other medicines and Hydrocortisone Ointment 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. Hydrocortisone Ointment contains wool fat Hydrocortisone Ointment contains wool fat (lanolin) which may cause local skin reactions (e.g. contact dermatitis).

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Helvetica – 9pt – 8pt

Date

14/10/21

Dimensions:

260 x 148 mm

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How to take it

Hydrocortisone Ointment FOR EXTERNAL USE ONLY Always use this medicine exactly as instructed in this leaflet. Check with your doctor or pharmacist if you are not sure. Do not exceed the stated dose. Not for use by children under 10 years of age without medical advice. For application to the surface of the skin only: 1. Wash your hands thoroughly before use. 2. Apply the ointment sparingly to the affected area, once or twice a day for a maximum of 7 days. Massage the ointment gently into the affected area to help absorption into the skin. 3. Once applied, do not cover the area with a dressing or plaster. If the condition has not improved after 7 days, or worsens, consult your doctor. If you use more Hydrocortisone Ointment than you should If you or a child accidentally swallow the ointment, contact your doctor or nearest hospital immediately. Take the packet with you to help identification. If you forget to use Hydrocortisone Ointment If you miss a treatment, apply the ointment as soon as you remember, and apply the remaining dose for that day at evenly spaced intervals. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Hydrocortisone Ointment 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 Ointment immediately.
  • 'stretch marks' may appear, especially where skin is in folds such as the groin or armpits.
  • 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. 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 national reporting systems below: United Kingdom: Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Malta: ADR Reporting. Website: www.medicinesauthority.gov.uk/adrportal. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Hydrocortisone Ointment Keep out of the sight and reach of children. Do not store above 25 ̊C. Store in the original package and keep the tube in the outer carton. Do not use Hydrocortisone Ointment after the expiry date which is stated on the tube/carton. 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 Ointment contains:

  • The active substance is hydrocortisone and the ointment contains 10 mg in every 1 g (1%).
  • The other ingredients are wool fat (lanolin), liquid paraffin and white soft paraffin (see end of Section 2 for further information). What Hydrocortisone Ointment looks like and contents of the pack The product is a smooth, off-white ointment and is available in aluminium tubes containing 15 g. Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0020 MA 143/00102

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number Hydrocortisone 1% w/w Ointment 04917/0020

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 10/2021

23LF01885PW

>> READ DIRECTION 1ST BAR

LAST BAR

Artwork Code:

23LF01885PW

Font:

Helvetica – 9pt – 8pt

Date

14/10/21

Dimensions:

260 x 148 mm

Printing:

Black

***

***

***

***

***

Non-Printing:

Keyline

Text Free Area

***

***

***

***

Version:

2

Other information: Previous code – 23LF01574PW Safety Updates Aug-21 Keyline change from 210 x 148mm –> 260 x 148mm due to additional text

Frequently asked questions about Hydrocortisone 1% w/w Ointment

How do I take Hydrocortisone 1% w/w Ointment?

Hydrocortisone 1% w/w Ointment comes as ointment. 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 1% w/w Ointment?

The active substance in Hydrocortisone 1% w/w Ointment is hydrocortisone.

Are there equivalent medicines to Hydrocortisone 1% w/w Ointment?

Medicines with the same active substance, strength and form include: Boots DermaCare Hydrocortisone 1% w/w Ointment, Hydrocortisone 0.5% Ointment / Efcortelan Ointment 0.5%, Hydrocortisone 1% Ointment / Efcortelan Ointment 1.0%. In total there are 8 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 1% w/w Ointment, 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 1% w/w Ointment 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Hydrocortisone (42 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.

4.2. Posology and method of administration

Posology

Use sparingly over a small area once/twice a day for a maximum period of one week. If the condition has not improved, or worsens, consult your doctor.

This product should not be recommended for use on children under 10 years of age without medical supervision.

Method of administration

For cutaneous use

4.3. Contraindications

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Use on the eyes and face, ano-genital region, broken or infected skin including cold sores, acne and athlete's foot.

4.4. Special warnings and precautions for use

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.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systematic 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 overdosage in infants and children. Extreme caution is required in dermatoses of infancy especially napkin eruption where the napkin can act as an occlusive dressing and increase absorption. In infants and children, courses of treatment should therefore not normally exceed 7 days.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and a systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to the face is undesirable.

Do not use under an occlusive dressing.

This medicinal product contains wool fat (lanolin), which may cause local skin reactions (e.g. contact dermatitis).

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.

The label will state mild steroid.

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. There may therefore be a very small risk of such effects in the human foetus.

Breastfeeding

There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately.

Striae may occur especially in intertriginous areas.

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 Plat or Apple App Store.

4.9. Overdose

Not applicable.

💬 Ask about this leaflet

Ask anything about Hydrocortisone 1% w/w Ointment. 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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