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.
Alclometasone Dipropionate 0.05% 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 Alclometasone dipropionate 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 This medicine contains an active ingredient called alclometasone dipropionate which belongs to a group of medicines called topical corticosteroids. These medicines are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. In adults and children, this medicine is used to reduce redness and itchiness caused by certain skin problems (for example eczema and dermatitis):
- Eczema is a common skin disease, which causes the skin to become red and itchy.
- Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy. 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. Alclometasone dipropionate is classed as a moderate 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 alclometasone Do not use this medicine:
- if you, or a child you are caring for, have ever had an allergic reaction to alclometasone or any of the other ingredients of this medicine (listed in section 6).
- for any other skin problems as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, cold sores, chickenpox, or skin infections (including bacterial, fungal and viral infections).
- in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.
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 taking this medicine. This medicine contains propylene glycol This medicine contains 250mg propylene glycol per gram of cream. Propylene glycol may cause skin irritation.
How to take it
alclometasone Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For adults and children, apply a thin layer of this medicine to the affected area two or three times a day, unless otherwise instructed by your doctor. Ask your doctor about the duration of the treatment. You must not use a large amount of this medicine in the same area for a long time (for example every day for many weeks and months). Do not apply this medicine under dressings, such as a plaster or bandage, as this makes it easier for the active ingredient to pass through the skin and possibly cause some unwanted effects. If the cream is for your child, do not use it under a nappy, as this makes it easier for the active ingredient to pass through the skin and possibly cause some unwanted effects. 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 you use more of this medicine than you should Tell your doctor if:
- you use this medicine more often than you should, or on large areas of your body as it can affect some of your hormones.
- you have not followed the dosage instructions or your doctors advice and have used this medicine too frequently or for a longer time than prescribed.
- you (or somebody else) accidentally swallows this medicine, however it should not produce any undesirable effects. If you forget to use this medicine If you forget to use your cream at the right time, use it as soon as you remember then carry on as before. Do not double the amount of cream used to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most people find that when the cream is used correctly, it does not cause any problems. However, if you use more cream than you should, particularly on your face, it can cause:
- Thinning of the skin, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin and you may notice red marks. This can happen more easily in infants and children.
- Inflammation of the hair follicles, excessive hair growth, reduced skin pigmentation and allergic skin reactions.
- Dermatitis (skin inflammation), a condition brought on by the skin reacting to an outside agent e.g. detergents, causing the skin to become red and itchy. This happens more easily in infants and children. 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.
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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 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 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 medicine burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
How to store it
alclometasone 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 pack. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicines via wastewater. 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 this medicine contains The active substance is alclometasone dipropionate 0.05% w/w. The other ingredients are: propylene glycol, white soft paraffin, cetostearyl alcohol, glyceryl stearate PEG 100 stearate, polyoxyethylene (20) cetyl ether, sodium dihydrogen phosphate dihydrate, 4-chloro-M-cresol, phosphoric acid, purified water. What this medicine looks like and contents of the pack This medicine is a smooth, white to off white cream contained in a 50g 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: TIOFARMA B.V. Benjamin Franklinstraat 5-10 3261 LW Oud-Beijerland The Netherlands. This leaflet was last revised in July 2024
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Frequently asked questions about Alclometasone Dipropionate 0.05% w/w Cream
How do I take Alclometasone Dipropionate 0.05% w/w Cream?
Alclometasone Dipropionate 0.05% 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 Alclometasone Dipropionate 0.05% w/w Cream?
The active substance in Alclometasone Dipropionate 0.05% w/w Cream is alclometasone dipropionate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Alclometasone Dipropionate 0.05% 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 Alclometasone Dipropionate 0.05% 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: alclometasone dipropionate
- 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
Alclometasone dipropionate is a non-fluorinated topically active synthetic corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
4.2. Posology and method of administration
For topical administration
For adults and children, apply a thin film of alclometasone cream to the affected area two or three times daily or as directed by the doctor.
Massage gently into the skin until the medication disappears.
4.3. Contraindications
Hypersensitivity to any of the ingredients; rosacea; acne and perioral dermatitis, tuberculous and viral lesions or the skin, particularly Herpes Simplex; vaccinia: varicella.
Alclometasone cream should not be used in fungal or bacterial skin infections.
4.4. Special warnings and precautions for use
The label will state moderate steroid.
As with all topical steroids, long term continuous therapy should be avoided where possible, particularly in infants and children as adrenal suppression may occur even without occlusion. In infants the napkin may act as an occlusive dressing and thus increase absorption.
For dermatologic use only.
If irritation or sensitization develops with the use of alclometasone, treatment should be discontinued and appropriate therapy instituted.
Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids may be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Paediatric Use:
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches, and bilateral papilledema.
Alclometasone cream products are not for ophthalmic use.
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 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.
4.5. Interaction with other medicinal products and other forms of interaction
None Known.
4.6. Fertility, pregnancy and lactation
Pregnancy
Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Drugs of this class should not be used extensively in large amounts for prolonged periods of time in pregnant patients.
Breast-feeding
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Alclometasone should be administered to nursing mothers only after careful consideration of the benefit/risk relationship.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Adverse reactions reported rarely with alclometasone dipropionate are itching, burning, erythema, dryness, irritation, and papular rashes.
Other local adverse reactions associated with topical corticosteroids, especially under occlusive dressings, include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae and miliaria.
Excessive prolonged use may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.
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 Play or Apple App Store).
4.9. Overdose
Acute overdosage with dermatologic application of corticosteroids is unlikely and would not be expected to lead to a life-threatening situation.
Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
The steroid content is so low as to have little or no effect in the unlikely event of accidental oral ingestion.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Alclometasone dipropionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Afloderm partial — not the same combinationAlclometasoni dipropionas · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Alclometasone Dipropionate 0.05% 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.