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.
Fluticasone Propionate 0.05% 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 Fluticasone propionate 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 Fluticasone propionate 0.05% cream is one of a group of medicines known as corticosteroids, which have a high anti-inflammatory effect when used topically. Fluticasone is a corticosteroid that is applied to the skin to treat a wide variety of inflammatory skin diseases. It is used for the relief of inflamed skin, redness and itching in several skin problems not caused by germs and responsive to corticosteroids. 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. Fluticasone propionate 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 THIS MEDICINE Do not use this medicine:
- If you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
- If you suffer from rosacea (flushing and inflammation of the facial skin), acne vulgaris or perioral dermatitis (inflammatory rash around the mouth).
- If you have infections of the skin with viruses such as herpes simplex or chickenpox.
- If you suffer from perianal or genital pruritus (itching around the back passage and genitals).
- If you suffer from ulcers in the skin, atrophy (thinning of skin) or fragile skin vessels.
- If you suffer from ichthyosis (skin disorders characterised by dryness and fish skin-like scaling on the skin).
- If you suffer from juvenile dermatosis (any skin diseases characterised by inflammation) or dermatosis in infants under 1 year of age, including dermatitis (inflammation of the skin) and napkin eruptions.
- If you suffer from ulcerated injuries.
- If you suffer from infected skin lesions caused by infection with fungi or bacteria. Warnings and precautions Talk to your doctor or pharmacist before using this medicine:
- If you are pregnant, think you may be pregnant or if you are breast-feeding (see section Pregnancy, breast-feeding and fertility).
- If you use this medicine on large areas of the body for prolonged periods of time, especially when treating children, since it may increase the absorption of the product and the risk of toxicity.
- If you use this medicine on your face, since it may cause atrophic changes like thinning skin. It is important that you do not let the cream get in your eyes.
- If you use this medicine on covered parts of the body. Do not use this product under occlusive dressing; the affected zone has to be in contact with the air and not covered by dressing, tight clothes or similar. In infants, a nappy can act as an occlusive dressing. You should wash your skin before changing the dressing.
- If your doctor has prescribed this medicine for psoriasis. You should visit your doctor regularly to review your progress at periodic intervals.
- If you are using other products (including cosmetics) on the affected skin areas, as they can have a negative effect on this medicine's activity. Check with your doctor if you are not sure.
- 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 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. Children Do not use the product in children under 1 year. Tell your doctor if the symptoms do not improve within one or two weeks of starting treatment. Once the skin condition has improved (usually within one to two weeks), you should apply the cream less frequently. Using the cream daily for more than 4 weeks is not recommended. This medicine should only be used in children to relieve inflamed skin, redness and itching caused by atopic dermatitis under supervision of a medical specialist. You should consult a dermatologist before using this medicine in other types of dermatoses in children. Other medicines and fluticasone Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy This medicine should only be used during pregnancy if the expected benefit to the mother outweighs the possible risk to the unborn child. Breast-feeding It is not known whether fluticasone is secreted in breast milk. This medicine should only be used during lactation if the expected benefit to the mother outweighs the possible risk to the child. Driving and using machines Fluticasone is not known to negatively affect the ability to drive or operate machinery. This medicine contains cetostearyl alcohol, imidurea and propylene glycol. As this medicine contains cetostearyl alcohol it may cause local skin reactions (e.g. contact dermatitis). This medicine contains the preservative imidurea. Imidurea breaks down to release a very small amount of chemical called formaldehyde. Formaldehyde may cause local skin reactions (e.g. contact dermatitis). This medicine contains 100mg propylene glycol in 1 gram of cream.
How to take it
THIS MEDICINE The doctor will prescribe an appropriate dosage for you. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For adults and children aged 1 year and over, apply a thin film of this medicine to the affected skin areas once to twice daily unless otherwise instructed by your doctor. Ask your doctor about the duration of the treatment. In some diseases (psoriasis, atopic dermatitis) it is not advisable to stop the treatment suddenly; you have to progressively reduce the number of applications. Follow the instructions your doctor gives to you. Your doctor will tell you what the appropriate dose is for you if the symptoms appear again after a recovery. The usual dose is one application daily, 2 days per week. It is not advisable to stop the treatment in some skin diseases such as psoriasis or atopic dermatitis. You should check the best way to finish treatment with your doctor. Instructions for use: 1 Wash your hands. 2 Apply a thin film of the cream and rub gently until it has all disappeared. 3 Wash your hands, unless the cream is used to treat your hands. If your skin problems do not improve within one to two weeks of starting treatment, tell your doctor. If you use more of this medicine than you should If you used more of this medicine than you should, especially in children, wash the affected areas of skin carefully to remove all the cream and contact your doctor or pharmacist. In case of accidental ingestion, contact your doctor or pharmacist. If you forget to use this medicine Do not use a double dose to make up for a forgotten one. If you forget to apply your cream, apply the correct dose when you remember or, if it is close to your next application, then wait until this time. If you stop using this medicine Do not stop using this medicine, even if you feel better, unless advised by your doctor. 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. Common side effects (may affect up to 1 in 10 patients):
- Itching (pruritus). Uncommon side effects (may affect up to 1 in 100 patients):
- Local burning sensation. Very rare side effects (may affect up to 1 in 10,000 patients):
- Secondary infections (an infection that occurs during or following treatment of another already existing infection), especially when occlusive dressings are used or when skin folds are involved.
- Hypersensitivity. You should discontinue the use of this medicine if signs of hypersensitivity appear.
- Hypercortisolism (increase of corticosteroid levels) due to the prolonged use of large amounts of corticosteroids, or treatment of extensive areas. This is more likely to occur in infants and children and if occlusive dressings are used.
- Dilatation of superficial blood vessels, due to prolonged and intensive treatment with potent corticosteroid preparations.
- Allergic contact dermatitis (allergic skin reactions).
- Worsening of signs and symptoms of dermatosis (skin reaction that involves skin inflammation).
- Pustular psoriasis caused by the treatment or its withdrawal.
- Atrophic local changes of the skin such as thinning, striae, hypertrichosis (excessive hair growth in a defined area) and hypopigmentation (skin discolouration) caused by prolonged and intensive treatment with potent corticosteroid preparations. Not known (frequency cannot be estimated from the available data):
- Vascular purpura (a group of skin disorders characterised by purplish or brownish red discoloration).
- Skin fragility.
- Peri-oral dermatitis (inflammation of the skin around the mouth).
- Rosacea (flushing and inflammation of the facial skin).
- Scab.
- Leg ulcer.
- Acne.
- Impaired healing.
- Blurred vision.
- 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 (website: 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
THIS MEDICINE Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tube after 'exp'. The expiry date refers to the last day of that month. Do not store above 30oC. Use within 6 months after first opening. 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. Do not use this medicine if you notice any visible signs of deterioration.
Contents of the pack and other information
What this medicine contains
- The active substance is fluticasone propionate. Each 100g of cream contains 0.05g of fluticasone propionate.
- The other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate, paraffinum liquidum, purified water, propylene glycol (E-1520), citric acid monohydrate, disodium phosphate anhydrous, imidazolidinyl urea. What this medicine looks like and contents of the pack This medicine is a white, viscous cream contained in a 30g aluminium tube with a screw cap. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Ltd, Unit 4, Rotherbrook Court Bedford Road, Petersfield, Hampshire GU32 3QG, United Kingdom
Manufacturer Laboratorios Salvat, S.A. C/ Gall, 30-36 – 08950 Esplugues de Llobregat Barcelona Spain
This leaflet was last revised in 07/2024. Under licence from SALVAT. 1010594-P8.1
Packaging Information: Product Name: Fluticasone Propionate Pl No:35533/0205 Dimensions: 130mm x 360mm Type:Leaflet Version No: 8.1 Date amended: 12.7.24 Font:Times new roman Average font size: 8 Reason for change: MHRA update Software:Adobe Indesign CS6 Created by: NR
Colour: Pantone: PMS Black
Frequently asked questions about Fluticasone Propionate 0.05% cream
How do I take Fluticasone Propionate 0.05% cream?
Fluticasone Propionate 0.05% 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 Fluticasone Propionate 0.05% cream?
The active substance in Fluticasone Propionate 0.05% cream is fluticasone propionate.
Are there equivalent medicines to Fluticasone Propionate 0.05% cream?
Medicines with the same active substance, strength and form include: Cutivate Cream 0.05%. 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 Fluticasone Propionate 0.05% 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 Fluticasone Propionate 0.05% 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: fluticasone propionate
- 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
For adults and children aged 1 year and over:
Fluticasone propionate is indicated for symptomatic treatment of inflammatory dermatoses not caused by micro-organisms and responsive to corticosteroids such as:
• Eczema including atopic and discoid eczemas
• Psoriasis (excluding widespread plaque psoriasis)
• Lichen planus
• Lichen
• Contact sensitivity reactions
• Discoid lupus erythematosus
• As adjunct to systemic steroid therapy in generalised erythroderma
Children
For children aged 1 year and over who are unresponsive to lower potency corticosteroids, this medicine is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis under the supervision of a specialist. Expert opinion should be sought prior to the use of this medicine in other corticosteroid responsive dermatoses in children.
4.2. Posology and method of administration
For topical administration.
For adults and children aged 1 year and over, apply a thin film of fluticasone cream to the affected skin areas one to twice daily (see 4.4).
Duration of use:
Daily treatment should be continued until adequate control of the condition is achieved.
Frequency of application should thereafter be reduced to the lowest effective dose.
When fluticasone cream is used in the treatment of children, if there is no improvement within 7 – 14 days, treatment should be withdrawn and the child re-evaluated. Once the condition has been controlled (usually within 7-14 days) frequency of application should be reduced to the lowest effective dose for the shortest possible time. Continuous daily treatment for longer than 4 weeks is not recommended.
An increase in the number of daily applications might aggravate side effects without improving the therapeutic effects.
Method of administration:
In adults and children, use the method of finger-tip unit to specify the quantity of cream applied to a given surface. The finger-tip unit corresponds to the amount of cream applied from the distal skin-crease to the tip of the index finger. This quantity permits to treat a skin surface corresponding to 2 hands of an adult (approximately 250 to 300 cm2). A finger-tip unit corresponds to approx. 0.5g of product. A tube of 30 grams contains 60 finger-tip unities.
4.3. Contraindications
• Rosacea
• Acne vulgaris
• Perioral dermatitis
• Primary cutaneous viral infections (e.g.: herpes simplex, chickenpox)
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Perianal and genital pruritus
• Ulceration of the skin
• Atrophy of the skin
• Fragile skin vessels
• Ichthyosis
• Juvenile dermatosis
• Dermatoses in infants under 1 year of age, including dermatitis and napkin eruptions
• Injuries ulcerated
• The use of fluticasone cream is not indicated in the treatment of primary infected skin lesions caused by infection with fungi or bacteria.
4.4. Special warnings and precautions for use
The label will state strong steroid.
Prolonged application of high doses to large areas of body surface, especially in infants and small children, might lead to adrenal suppression. Children and infants have a greater surface area to body weight ratio compared with adults. Therefore, in comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. This effect is more likely to occur in infants and children if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing. Care should be taken when using fluticasone cream to ensure the amount applied is the minimum that provides therapeutic benefit.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.
The prolonged use of corticosteroids on the face may cause steroid-induced dermatitis.
These incidents disappear at withdrawal of treatment, but a sudden withdrawal may be followed by an acute adrenal insufficiency.
Overt suppression of the HPA-axis (morning plasma cortisol less than 5 micrograms/dL) is very unlikely to result from therapeutic use of fluticasone propionate cream unless treating more than 50% of an adult's body surface and applying more than 20g per day.
Long-term continuous use should be avoided in children. The safety and efficacy of fluticasone propionate when used continuously for more than 4 weeks has not been established.
If signs of hypersensitivity appear, application should stop immediately.
The safety and efficacy in paediatric patients below 1 year of age have not been established.
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye so as to avoid the risk of local irritation or glaucoma.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Topical steroids may be hazardous in psoriasis for a number of reasons, including rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important and referral to a dermatologist is required before using Fluticasone to treat psoriasis in children.
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 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.
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 systemic administration of antimicrobial agents.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.
Contains cetostearyl alcohol, which may cause local skin reactions (e.g.: contact dermatitis).
Contains imidurea which releases traces of formaldehyde as a breakdown product. Formaldehyde may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg propylene glycol in 1 gram of cream.
Fire hazard
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.
4.5. Interaction with other medicinal products and other forms of interaction
None reported.
4.6. Fertility, pregnancy and lactation
Pregnancy:
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation:
The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the milk. However, plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low.
4.7. Effects on ability to drive and use machines
None reported.
4.8. Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000) very rare (< 1/10,000, including isolated reports) and not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally derived from spontaneous data.
Infections and infestations
Very rare: secondary infections (particularly when occlusive dressings are used or when skin folds are involved) have been reported with corticosteroid use.
Immune system disorders
Very rare: hypersensitivity.
If signs of hypersensitivity appear, application should stop immediately.
Endocrine disorders
Very rare: features of hypercortisolism
Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing (see Special Warnings and precautions for use).
Vascular disorders
Very rare: dilation of superficial blood vessels
Prolonged and intensive treatment with potent corticosteroid preparations may cause dilation of the superficial blood vessels.
Eye disorders
Not known: Vision, blurred (see section 4.4)
Skin and subcutaneous tissue disorders
Common: pruritus
Uncommon: local burning
Very rare: Thinning, striae, hypertrichosis, hypopigmentation, allergic contact dermatitis, exacerbation of dermatoses, pustular psoriasis.
Not known: Vascular purpura, skin fragility, peri-oral dermatitis, rosacea, scab, leg ulcer, acne, impaired healing.
Local burning and pruritus have been reported, however in clinical trials the incidence of these adverse reactions was generally comparable to placebo and comparator groups.
Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, hypertrichosis and hypopigmentation.
Exacerbation of the signs and symptoms of the dermatoses and allergic contact dermatitis have been reported with corticosteroid use.
Treatment of psoriasis with a corticosteroid (or its withdrawal) may provoke the pustular form of the disease.
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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse the features of hypercortisolism may appear.
Treatment
In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency.
💬 Ask about this leaflet
Ask anything about Fluticasone Propionate 0.05% 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.
Medicines containing Fluticasone propionate
- Cutivate Cream 0.05%
- Cutivate Ointment 0.005%
- Flixonase Aqueous Nasal Spray
- Flixotide 125 micrograms Evohaler
- Flixotide 250 micrograms Evohaler
- Flixotide 50 micrograms Evohaler
- Flixotide Accuhaler
- Fluticasone propionate 400 micrograms (1mg/ml), nasal drops suspension
- Pirinase Allergy 0.05% Nasal Spray
- Pirinase Hayfever Once Daily 0.05% Nasal Spray