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 Hydrocortisone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Mildison Lipocream contains the active substance hydrocortisone, which belongs to the group of mildly potent corticosteroids. These medicines are used to reduce symptoms of inflammation such as itching and redness or flakiness of the skin which may occur in certain skin disorders. Mildison Lipocream is indicated in adults, children and infants. It is used to treat a variety of skin conditions such as eczema and dermatitis (itching) of all types including atopic (childhood) eczema, photodermatitis (a dermatitis caused by exposure to light), otitis externa (inflammation of the ear canal), dermatitis caused by skin irritants and allergies, intertrigo (inflammation of skin folds), prurigo nodularis (a skin change associated with a nervous condition), seborrhoeic dermatitis (eczema of areas of greasy skin) and insect bite reactions. In general, corticosteroids do not remove the cause of the symptoms. 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. Mildison Lipocream is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
e Mildison Lipocream Do not use Mildison Lipocream:
treat facial or thin skin as these areas are particularly sensitive to corticosteroids. You should not apply to your eyes or your eyelids treat your child (see further information below).
During treatment: 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, do not restart using the cream/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. Mildison Lipocream contains paraffin. 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 and adolescents Long term treatment of children should be avoided where possible. Treatment should be limited to seven days if possible. Your doctor will advise on duration of treatment for your child.
Other medicines and Mildison Lipocream Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding You should not use Mildison Lipocream if you are pregnant or breast-feeding unless clearly necessary. 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 using this medicine. Driving and using machines It is not likely that Mildison Lipocream affects your ability to drive or use machines. Mildison Lipocream contains cetostearyl alcohol, propyl parahydroxybenzoate (E216), and benzyl alcohol. Mildison Lipocream contains cetostearyl alcohol that may cause local skin reactions (e.g. contact dermatitis) and propyl parahydroxybenzoate (E216) that may cause allergic reactions (possibly delayed). This medicine also contains 7.5 mg of benzyl alcohol in each gram which is equivalent to 0.75% w/w. Benzyl alcohol may cause allergic reactions and mild local irritation.
Mildison Lipocream Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose is a little Mildison Lipocream 2 or 3 times daily. This medicine is for cutaneous use. Apply a thin layer of Mildison Lipocream to the affected skin. Gently massage the cream into the affected area. If you use more Mildison Lipocream than you should If you have used too much Mildison Lipocream the side effects as mentioned in section 4 "Possible side effects" can occur. Contact your doctor, pharmacist or nurse immediately. If you forget to use Mildison Lipocream Do not use a double dose to make up for a forgotten dose. If you stop using Mildison Lipocream You should always consult your doctor, if you think of stopping treatment. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Mildison Lipocream may cause the following side effects: Not known (frequency cannot be estimated from the available data) • • • • • •
Redness of the skin, rash/inflammation, bruising, stretch marks and skin thinning Facial spots, redness of the skin around the mouth Discolouration of skin Skin irritation Blurred vision Worsening of the skin condition after treatment has stopped (steroid withdrawal reaction): If used continuously for prolonged periods a withdrawal reaction may occur on 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.
If the cream is used for a long time it may affect the working of your adrenal glands, symptoms of which may include an increase in weight, puffiness around the face, muscle weakness, dizziness (particularly on standing), excessive hair growth or hair loss. Your doctor should monitor you for any signs or symptoms. As with other creams of this kind, this is more likely in infants and children or if the skin is covered by bandages or nappies. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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.
Mildison Lipocream 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 after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original packaging. 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 Mildison Lipocream contains
The active substance in Mildison Lipocream 1 %w/w is hydrocortisone.
This leaflet reproduces the patient information leaflet approved for Mildison Lipocream 1 %w/w, 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.
Mildison Lipocream is indicated in adults, children and infants. It is indicated in eczema and dermatitis of all types including atopic eczema, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.
For cutaneous use.
Posology
Adults, children and older people:
Apply a small quantity only sufficient to cover the affected area two or three times a day. Due to the formulation of the base the product may be used both for dry scaly lesions and for moist or weeping lesions.
Children and infants: Long term treatment should be avoided. Courses should be limited to seven days where possible.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.
As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.
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.
The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
This medicine also contains 7.5 mg of benzyl alcohol in each gram which is equivalent to 0.75% w/w.
Benzyl alcohol may cause allergic reactions and mild local irritation.
Keep away from the eyes.
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 advice is recommended in these cases or other treatment options should be considered.
Mildison Lipocream contains paraffin. 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.
The label will state mild steroid.
Infants
Although generally regarded as safe even for long term administration in adults there is a potential for overdosage in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients courses of treatment should not normally exceed seven days.
No interaction studies have been performed.
Pregnancy
There are no or limited amount of data from the use of hydrocortisone in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3).
Breast-feeding
Hydrocortisone/metabolites are excreted in human milk, but at therapeutic doses of Mildison no effects on the breast-fed newborns/infants are anticipated.
None known.
Local atrophic changes may occur, particularly in skin folds, intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Systemic absorption from such sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated. Napkins may act as occlusive dressings.
Not known (cannot be estimated from the available data)
Eye disorders: Vision, blurred (see also section 4.4).
Skin and subcutaneous tissue disorders (Not known (cannot be estimated from the available data): Skin atrophy, often irreversible, with thinning of the epidermis, telangiectasia, purpura and skin striae. Pustular acne, perioral dermatitis, skin depigmentation, contact dermatitis and rebound effect (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).
The cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and the propyl parahydroxybenzoate (E216) may cause allergic reactions which can be delayed.
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 use, especially under occlusive dressings or over a long period of time, may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically
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
⚠ 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. Polish medicines in the UK →
Ask anything about Mildison Lipocream 1 %w/w. 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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