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.
Fludroxycortide 0.0125% w/w Cream
⚠ 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 Fludroxycortide 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 Fludroxycortide 0.0125% w/w Cream is a white cream for application to the skin. Fludroxycortide 0.0125% w/w Cream belongs to a group of medicines called topical corticosteroids and is used to treat skin conditions such as eczema and dermatitis of all types, especially when the skin is moist or weeping. Fludroxycortide 0.0125% w/w Cream can be used in adults and children. 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. Fludroxycortide is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
What you need to know before you take it
E FLUDROXYCORTIDE 0.0125% W/W CREAM Do not use Fludroxycortide 0.0125% w/w Cream
- for skin tuberculosis.
- for rosacea of the face.
- for acne.
- for dermatitis around the mouth.
- for itchiness of the genitals or anus.
- for skin conditions in babies including eczema or napkin rash.
- for bacterial skin infections such as impetigo.
- for viral skin infections such as cold sores.
- for fungal skin infections such as athlete's foot. Do not use Fludroxycortide 0.0125% w/w Cream if you are allergic to fludroxycortide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
- 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.
- Talk to your doctor or pharmacist before using Fludroxycortide 0.0125% w/w Cream.
- The cream should not be used on or near your eyes or inside your mouth.
- Do not use Fludroxycortide 0.0125% w/w Cream for long periods of time and do not cover it tightly under dressings or clothes.
- Do not use Fludroxycortide 0.0125% w/w Cream on large areas of damaged skin or in skin folds such as the armpits or groin area.
- Do not use Fludroxycortide 0.0125% w/w Cream on your face for more than five days and do not cover it up tightly.
- If you have a skin infection or think you have a skin infection, tell your doctor. 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. Children
- Do not use Fludroxycortide 0.0125% w/w Cream on children's skin for more than five days and do not cover it up tightly. Other medicines and Fludroxycortide 0.0125% w/w Cream Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding Do not use Fludroxycortide 0.0125% w/w Cream 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 taking this medicine.
Title:
Fludroxycortide Cream 0.125%
Ref:
FC/TY/PIL
Date:
08/11/15
Colours (Printed)
Colours (Non printed)
Black
TRIM
Process
REFERENCE
LIMITED
Size (mm): 148(W) x 300(H) Modified:
03/02/24
Important information about some of the ingredients of Fludroxycortide 0.0125% w/w Cream Fludroxycortide 0.0125% w/w Cream contains cetyl alcohol and propylene glycol Fludroxycortide 0.0125% w/w Cream contains cetyl alcohol which may cause local skin reactions such as contact dermatitis and propylene glycol which may cause skin irritation.
How to take it
FLUDROXYCORTIDE 0.0125% W/W CREAM Always use this medicine exactly as your doctor has told you. Check the label for how to use your medicine and how often to use it. Only put the cream on the parts of your skin your doctor wants to treat. Check with your doctor or pharmacist if you are not sure. Usual dose Only use Fludroxycortide 0.0125% w/w Cream on your skin. Do not put it in your mouth or eyes. Apply the cream gently to the affected area of skin two or three times each day. If you are elderly your skin may be thin so you will need to apply the cream sparingly. If your doctor has told you to cover the skin tightly where you are using Fludroxycortide 0.0125% w/w Cream, you should only have to cover a small area. If you forget to use Fludroxycortide 0.0125% w/w Cream If you forget to use Fludroxycortide 0.0125% w/w Cream do not worry, just put on the next application when it is due. If accidently swallowed, contact your nearest hospital casualty department or tell your doctor immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may have one or more of the following side effects in the area where they apply Fludroxycortide 0.0125% w/w Cream:
- Burning, itching, irritated or dry skin.
- Inflammation at the bottom of skin hairs.
- Excess hair growth.
- Acne pimples.
- Pale skin.
- Dermatitis around the mouth.
- Allergic contact dermatitis.
- Limp, flabby or thin skin where the cream was.
- Skin softening.
- Skin infections may get worse.
- Red spots or lines on the skin.
- Blood vessels in the skin become visible.
- Infected wounds may take longer to heal. The amount of sugar in your blood and urine may change or some of your hormones may be affected causing weight gain, menstrual irregularities and hair growth. These effects are very rare. Some steroids are known to affect certain hormones. If your doctor thinks you need to be treated for longer periods of time, they may arrange for you to have hormone tests. If the cream is affecting your hormones, your doctor may tell you to stop using it. Then your hormones should return to normal. Children treated with topical steroids have rarely had high fluid pressure in their skulls. This has caused headaches and swelling. 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card Scheme 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
FLUDROXYCORTIDE 0.0125% W/W CREAM Keep this medicine out of the sight and reach of children. Do not store above 250C. Do not use this medicine after the expiry date which is stated on the tube crimp and on the carton after EXP. The expiry date refers to the last day of that month. 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 Fludroxycortide 0.0125% w/w Cream contains
- The active substance is fludroxycortide, 0.0125%w/w.
- The other ingredients are stearic acid, cetyl alcohol, polyoxyl 40 stearate, liquid paraffin, propylene glycol, sodium citrate, citric acid anhydrous and water. What Fludroxycortide 0.0125% w/w Cream looks like and contents of the pack Fludroxycortide 0.0125% w/w Cream is white and comes in a 60g aluminium tube. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Typharm Ltd, Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY. Manufacturers PURNA PHARMACEUTICALS NV/SA, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in January 2024.
1/FC/05/2401/879.v7
Frequently asked questions about Fludroxycortide 0.0125% w/w Cream
How do I take Fludroxycortide 0.0125% w/w Cream?
Fludroxycortide 0.0125% w/w Cream 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 Fludroxycortide 0.0125% w/w Cream?
The active substance in Fludroxycortide 0.0125% w/w Cream is fludroxycortide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fludroxycortide 0.0125% w/w Cream, 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 Fludroxycortide 0.0125% w/w Cream 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: fludroxycortide
- 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
Adults and children: Eczema and dermatitis of all types including childhood and adult atopic eczema, photodermatitis, primary irritant and allergic dermatitis, lichen planus, lichen simplex, prurigo nodularis, discoid lupus erythematosus, necrobiosis lipoidica, pretibial myxoedema and erthroderma.
4.2. Posology and method of administration
Posology
For moist, weeping lesions, the cream should be applied gently to the affected area two or three times daily.
Method of administration
The elderly: As the skin is likely to be thin, apply sparingly to avoid development of atrophy.
Dilution is not recommended, but if considered necessary, aqueous cream BP may be used.
4.3. Contraindications
Tuberculosis of the skin, facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Preparations of Haelan are not intended for ophthalmic use.
Local and systemic toxicity is common especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (see section 4.8). Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete on discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.
Long-term continuous therapy should be avoided in all patients irrespective of age.
Application under occlusion should be restricted to dermatoses in very limited areas.
If used on the face, courses should be limited to five days and occlusion should not be used.
In the presence of skin infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, Fludroxycortide should be discontinued until the infection has been adequately controlled.
Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Propylene glycol may cause skin irritation.
Instruct patients not to 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.
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 strong steroid.
Paediatric population
Usage in children: If used in children, courses should be limited to five days and occlusion should not be used.
Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Children may also demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's Syndrome than do mature patients because a larger skin surface to body weight ratio. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
As with all topical steroids, the activity can be enhanced by the use of occlusive dressings. Preparations of Haelan are recommended only as a supplement to, and not as a substitute for, preparations (lotions, wet dressings etc.) used in the conventional management of skin lesions. Haelan Cream does not contain parahydroxybenzoates or lanolin.
4.5. Interaction with other medicinal products and other forms of interaction
Not known.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is an inadequate evidence of safety in human pregnancy. There may be a very small risk of cleft palate and intra-uterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals.
Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for mother and child.
Breast-feeding
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in the breast milk of nursing mothers. Systemically administered corticosteroids are secreted into the breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing mothers.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence; burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of the superficial blood vessels producing telangiectasia.
Prolonged use of large doses to extensive areas can result in sufficient systemic absorption to produce generalised manifestations of steroid toxicity and may result in depression of HPA function on discontinuing treatment.
Manifestations of Cushing's syndrome, hyperglycaemia and glycosuria have occurred in some patients.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Intracranial hypertension including bulging fontanelles, headaches and bilateral papilloedema have also been reported in children receiving topical corticosteroids.
Infected skin lesions, viral, bacterial or fungal may be substantially exacerbated by topical steroid therapy. Wound healing is significantly retarded.
Hypersensitivity reactions may occur.
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 Scheme in the Google Play or Apple App Store.
4.9. Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See section 4.4).
💬 Ask about this leaflet
Ask anything about Fludroxycortide 0.0125% w/w Cream. 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.