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 4 micrograms per square centimetre Tape
⚠ 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 Tape is a thin plastic surgical tape. Each square centimetre contains 4 micrograms of the corticosteroid fludroxycortide. The tape is used on difficult to treat skin conditions, especially when the skin is dry and scaly. 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 TAPE
Do not use Fludroxycortide Tape
- for chicken pox
- for skin reactions to smallpox vaccination
- for tuberculosis of the skin
- 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 Tape if you are allergic to fludroxycortide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Fludroxycortide Tape.
- If you have ever had an allergic reaction to Fludroxycortide Tape (an allergic reaction may include a rash, itching, swelling or breathing difficulties) tell your doctor.
- If you have a skin infection or think you have a skin infection tell your doctor.
- If you are using the tape on your face, you should only use the tape for five days.
- Follow your doctor's instructions. 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 tape 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 Tape on children's skin for more than five days and do not cover it up tightly. This is because children may absorb more steroid medicine into their bodies than adults. If this happened for a long time it might stop them from growing or developing properly. Other medicines and Fludroxycortide Tape 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 Tape 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.
How to take it
FLUDROXYCORTIDE TAPE Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Usual doses Check the label for how to use your medicine and how often to use it. Only put the tape on the parts of your skin your doctor wants to treat. Only use Fludroxycortide Tape on your skin. Do not put it in your mouth or over your eyes. Fludroxycortide Tape is easy to use. Please follow these instructions. Cleaning the skin Before you apply Fludroxycortide Tape, make sure the affected skin is clean and dry. If you need to shave the skin around the affected area, your doctor or nurse will tell you how to do it. Fludroxycortide Tape is waterproof so, once it is in place, you can wash, bathe, shower or even swim. Its matt surface means that you can apply make-up over it. Cutting the tape You cannot tear Fludroxycortide Tape. Always cut it with clean scissors.
LIMITED
Title:
Make sure that the piece you cut is big enough just to cover the affected area and about 0.5cm of unaffected skin all around. Your doctor will tell you which area to treat. Round off the corners of the patch to stop it curling or catching on your clothes.
- Applying Fludroxycortide Tape Once you have removed the paper backing, throw it away and apply the adhesive side of the clear tape to your skin. Take care the tape does not stick to itself as you take off the paper. The tape will stick better if you stroke the back of it gently from the middle outwards. If you need to cover an area of skin which is longer than 7 cm, do not take all the paper backing off when you cut the tape. Peel back a bit at a time as you stick the tape onto your skin.
- Fludroxycortide Tape is flexible If the affected area is likely to be moving constantly, for example, because it is on your hands, fingers, feet, knees or elbows, apply the tape while the skin is flexed. Segments can be cut from the tape to allow you to mould the tape into shape over the affected area. If you are applying it to the outer surface of a knee or elbow, stick it on while the joint is bent. Then you should be able to bend the joint without disturbing the dressing.
- 'Awkward' areas You may need someone to help you put Fludroxycortide Tape on areas which are difficult to reach. Your doctor will tell you how long to use the tape for, this is usually 12 hours per day but can be longer. Do not use Fludroxycortide Tape for long periods of time without speaking to your doctor. Do not cover the tape with other dressings or tightly fitting clothes. 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 tape is affecting your hormones, your doctor may tell you to stop using it. Then your hormones should return to normal. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. A few patients may have one or more of the following side effects in the area where they apply Fludroxycortide Tape.
- Burning, itching, irritated or dry skin.
- Excessive hair growth.
- Acne pimples.
- Pale skin.
- Limp, flabby or thin skin where the tape was.
- Inflammation at the bottom of skin hairs.
- Red spots or lines on the skin.
- Dermatitis around the mouth or contact dermatitis.
- The amount of sugar in your blood and urine may change or your hormones may be affected, causing weight gain, menstrual irregularities and hair growth. These effects are rare.
- Skin infections may get worse if they are not treated with an antibiotic or other medicine.
- Wounds may take longer to heal.
- 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
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 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 TAPE Keep this medicine out of the sight and reach of children. Keep the plastic bottle tightly closed in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in a dry place, below 25°C. 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 Tape contains
- The active substance is fludroxycortide (4 micrograms/cm2).
- The other ingredients are acrylate copolymer adhesive, low-density polyethylene backing and silicone coated paper release liner. What Fludroxycortide Tape looks like and contents of the pack Fludroxycortide Tape is a translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner. It is available as a 20cm, 50cm or 200cm roll. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Typharm Limited, First Floor, Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY. Tel: 01603 722480 Fax: 01603 263804 Email: [email protected] Website: www.typharm.com Manufacturer: Packpharm Limited, Ground Floor, Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY. Tel: 01603 722480 Fax: 01603 263804 Email: [email protected] This leaflet was last revised in May 2024. 1/FT/05/2401/898.v5
Frequently asked questions about Fludroxycortide 4 micrograms per square centimetre Tape
What is the active substance in Fludroxycortide 4 micrograms per square centimetre Tape?
The active substance in Fludroxycortide 4 micrograms per square centimetre Tape is fludroxycortide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fludroxycortide 4 micrograms per square centimetre Tape, 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 4 micrograms per square centimetre Tape 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
Occlusive topical steroid. Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions.
4.2. Posology and method of administration
Posology
Adults and the Elderly
For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours.
Method of administration
Fludroxycortide Tape is waterproof. Cosmetics may be applied over the tape.
Application: The tape cannot be torn and must be cut with clean scissors. The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively.
If the affected area is likely to be moving constantly, for example, on the hand, finger, knee or elbow, apply the tape while the skin/joint is flexed. Segments can be cut from the tape to allow it to mould around the joint.
If irritation or infection develops, remove tape and consult a physician.
Paediatric population
If used in children, courses should be limited to five days and occlusion should not be used (see section 4.4).
4.3. Contraindications
Chicken pox. Vaccinia. Tuberculosis of the skin. Hypersensitivity to any of the components. 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
Not advocated for acute and weeping dermatoses.
Local and systemic toxicity of medium and high potency topical corticosteroids 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.
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
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 of 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.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is 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 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 relevant.
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 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.
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 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 4 micrograms per square centimetre Tape. 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.