Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Beclometasone dipropionate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Beclometasone dipropionate Cream contains a medicine called beclometasone dipropionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. This medicine is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis or dermatitis.
e Beclometasone dipropionate 0.25 mg/g Cream Do not use Beclometasone dipropionate 0.25 mg/g Cream:
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if you are applying the cream under an airtight dressing, including a child's nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much cream if you have psoriasis. Your doctor will want to see you more often.
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 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. Contact your doctor if you experience blurred vision or other visual disturbances. 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. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. Other medicines and Beclometasone dipropionate 0.25 mg/g Cream Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 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.
Driving and using machines Beclometasone dipropionate 0.25 mg/g Cream is unlikely to affect your ability to operate
machinery or to drive. Beclometasone dipropionate 0.25 mg/g Cream contains chlorocresol and cetostearyl alcohol including cetyl alcohol This medicine contains chlorocresol, which may cause allergic reactions. This medicine also contains cetostearyl alcohol including cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). 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. Beclometasone dipropionate 0.25 mg/g Cream is classed as a moderate corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
Beclometasone dipropionate 0.25 mg/g Cream Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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Using this medicine
3. Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream. For an adult You should find that:
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For a child
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If you stop using Beclometasone dipropionate 0.25 mg/g Cream If you use Beclometasone dipropionate Cream regularly make sure you talk to your doctor before you stop using it. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP using Beclometasone dipropionate 0.25 mg/g Cream and tell your doctor as soon as possible if:
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.
Beclometasone dipropionate 0.25 mg/g Cream Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the tube and on the carton after EXP. The expiry date refers to the last day of that month. •
Do not store above 25°C. Store in the original package in order to protect from light.
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.
What Beclometasone dipropionate 0.25 mg/g Cream contains
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Beclometasone dipropionate 0.25 mg/g Cream comes as cream containing 0.25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Beclometasone dipropionate 0.25 mg/g Cream is beclometasone dipropionate.
This leaflet reproduces the patient information leaflet approved for Beclometasone dipropionate 0.25 mg/g Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Beclometasone dipropionate Cream is indicated for the treatment of the various forms of eczema in children and adults including atopic and discoid eczemas; primary irritant and allergic dermatitis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex; intertrigo; discoid lupus erythematosus.
The cream is often appropriate for moist or weeping surfaces and the ointment for dry, lichenified or scaly lesions but this is not invariably so.
Posology
Beclometasone dipropionate Cream should be applied thinly over the whole of the affected area and gently rubbed in. Initially, application should be made twice daily, but when improvement is seen, the intervals between applications may be extended and treatment eventually stopped. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral may be necessary. After cessation of treatment, should the condition recur, twice daily treatment should be re-instituted. However, when improvement is seen again, the intervals between applications may be gradually extended until maintenance dosing of application every third or fourth day is achieved. This is likely to avoid subsequent reappearance of the condition.
The beneficial effects may be enhanced by preliminary use of hot soaks, or by intermittent applications or occlusive dressings.
Method of administration
For topical administration
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
The cream should not be applied to the eyes. Rosacea, acne vulgaris; perioral dermatitis. Primary cutaneous viral infections (e.g. herpex simplex, chickenpox). Hypersensitivity to the preparation. Varicose ulcers or any other stasis ulcers.
Use of Beclometasone dipropionate Cream is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo); primary or secondary infections due to yeasts; perianal and genital pruritus; dermatoses in children under 1 year of age, including dermatitis and napkin eruptions.
Long-term continuous therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion.
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. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.
If used in childhood, or on the face, courses should be limited if possible to five days and occlusion should not be used.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, 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.
Long term continuous or inappropriate 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.
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 dressings, and so the skin should be cleansed before a fresh dressing is applied.
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.
Fire hazard in contact with dressings, clothing and bedding
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.
Excipients
This medicine contains chlorocresol and cetostearyil alcohol.
Chlorocresol may cause allergic reactions.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
The label will state moderate steroid.
No interaction studies have been performed.
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 intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
Beclometasone dipropionate 0.25 mg/g cream has no or negligible influence on the ability to drive and use machines
Eye disorders
Not known (cannot be estimated from the available data): Vision, blurred (see also section 4.4).
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)
Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.
As with other topical corticosteroids, prolonged used of large amounts, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. The 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.
Should systemic corticosteroid effects arise from application of Beclometasone dipropionate Cream, topical treatment should be discontinued. If adrenal function is impaired the patient will need to be protected from any harmful effects of stress with oral corticosteroid preparations until normal adrenal function is established.
There are reports of pigmentation changes and hypertrichosis with topical steroids.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease (see precautions).
Beclometasone dipropionate Cream is usually well tolerated, but if signs of hypersensitivity appear, application should stop immediately. Exacerbation of symptoms 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.
Should systemic corticosteroid effects arise from application of Beclometasone dipropionate Cream topical treatment should be discontinued. If adrenal function is impaired the patient will need to be protected from any harmful effects of stress with oral corticosteroid preparations until normal adrenal function is established.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Beclometasone dipropionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
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 anything about Beclometasone dipropionate 0.25 mg/g 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.
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