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 Betamethasone dipropionate, Salicylic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Diprosalic ointment contains two active ingredients, betamethasone dipropionate and salicylic acid. Betamethasone dipropionate is one of a group of medicines called topical corticosteroids. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. 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. Diprosalic is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. Salicylic acid softens the top layer of scales on the surface of the skin, which are caused by your skin problem. This allows the betamethasone dipropionate to reach the diseased skin underneath to help heal it. In adults and children, Diprosalic ointment is used to treat skin conditions where the outer surface of the skin is covered by a layer of scales. Your ointment will remove the layer of scales and reduce the redness and itchiness caused by your skin problem. 2.
e Diprosalic ointment
Do not use Diprosalic ointment If you have:
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If you have psoriasis, your doctor may want to review your treatment regularly. Contact your doctor if your psoriasis gets worse or you get raised bumps filled with pus under your skin. Contact your doctor immediately if you, or your child, experience blurred vision or other visual disturbances. This medicine should not be used under bandages or plasters. Side effects that may happen with inhaled or oral corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children. If you use more than the correct amount of ointment and/or use it for longer than is recommended, it can affect the levels of certain hormones in the body, particularly in infants and children. In adults, the changes in hormone levels may lead rarely to puffiness or rounding of the face, weakness, tiredness, and dizziness when standing or sitting down. 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 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 ointment 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. Children If you use more than the correct amount of ointment and/or use it for longer than is recommended, it can affect your child's hormones. Rarely this may lead to:
Diprosalic ointment
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Recommended dose Usually for adults and children, a thin layer of Diprosalic ointment should be gently rubbed into the affected area of skin twice a day. You should always follow these instructions when using Diprosalic ointment:
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Do not use a large amount of ointment on large areas of the body for a long time (for example every day for many weeks or months). Avoid getting the ointment in your eyes or inside your nose or mouth.
Use in children Use as stated above. Do not use this ointment on any part of your child's body for more than 5 days. Do not put the ointment under your child's nappy, as this makes it easier for the active ingredients of the medicine to pass through the skin and possibly cause some unwanted effects. If you use more Diprosalic ointment than you should If you (or somebody else) accidentally swallow the ointment, it should not cause any problems. However, if you are worried, you should see your doctor. If you use the ointment more often than you should, or on large areas of your body, it can affect some of your hormones. In children this may affect their growth and development. It also may cause you to feel and/or be sick and to hear ringing in your ears. If you have not used the ointment as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist. If you forget to use Diprosalic ointment If you forget to use your ointment at the right time, use it as soon as you remember, then carry on as before. If you stop using Diprosalic ointment If you have been using the ointment for a long time and your skin problem seems to have got better, you should not suddenly stop using the ointment. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor who will gradually reduce how often you need to use the ointment until you stop treatment altogether. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most people find that when the ointment is used correctly, it does not cause any problems. However, if you use the ointment more often than you should, it can cause the following:
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5.
Diprosalic ointment
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 tube and carton after 'EXP'. 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 or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
What Diprosalic ointment contains
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Diprosalic Ointment comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Diprosalic Ointment is betamethasone dipropionate, salicylic acid.
This leaflet reproduces the patient information leaflet approved for Diprosalic Ointment, 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.
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and it is also effective in the less responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis.
Diprosalic presentations are therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The salicylic acid constituent of Diprosalic preparations, as a result of its descaling action, allows access of the dermis more rapidly than by applying steroid alone.
Adults:
Once to twice daily. In most cases a thin film should be applied to cover the affected area twice daily.
For some patients adequate maintenance therapy may be achieved with less frequent application.
It is recommended that Diprosalic preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60 g.
Children:
Dosage in children should be limited to 5 days.
Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosalic presentations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. Diprosalic should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy.
The label will state strong steroid.
Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid.
Local and systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion. If used in children or on the face courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
It is dangerous if Diprosalic presentations come into contact with the eyes. Avoid contact with the eyes and mucous membranes.
The systemic absorption of betamethasone dipropionate and salicylic acid may be increased if extensive body surface areas or skin folds are treated for prolonged periods or with excessive amounts of steroids. Suitable precautions should be taken in these circumstances, particularly with infants and children.
If irritation or sensitisation develops with the use of Diprosalic Ointment treatment should be discontinued.
Any side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
If excessive dryness or increased skin irritation develops, discontinue use of this preparation.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) 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 of visual disturbances 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.
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.
Paediatric population: Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
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.
None stated.
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 or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
None stated.
Diprosalic skin preparations are generally well tolerated and side effects are rare.
Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.
Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis.
The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Vision blurred (see also section 4.4) has been reported with corticosteroid use (frequency not known).
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).
In addition, prolonged use of salicylic acid preparations may cause dermatitis.
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.
Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions 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.
With topical preparations containing salicylic acid excessive prolonged use may result in symptoms of salicyclism. Treatment is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Administer oral sodium bicarbonate to alkalinise the urine and force diuresis.
The steroid content of each tube is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Betamethasone dipropionate, Salicylic acid. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
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. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. 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 Diprosalic Ointment. 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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