Summary of Product Characteristics Updated 04-Aug-2020 | Accord-UK Ltd
Mometasone Furoate 1mg/g Cream
1 g of cream contains 1 mg of mometasone furoate (0.1% w/w mometasone furoate).
Excipients with known effect:
70 mg propylene glycol monopalmitostearate per gram of cream (7.0% w/w)
41.1 mg – 44.7 mg stearyl alcohol per gram of cream (4.11 – 4.47% w/w)
For the full list of excipients, see section 6.1.
White or almost white cream with no visible particles or phase separation.
Mometasone Furoate 1mg/g Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
Adults, including elderly patients and children: A thin film of Mometasone Furoate 1mg/g Cream should be applied to the affected areas of skin once daily.
Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to other corticosteroids.
Mometasone Furoate 1mg/g Cream is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster, chickenpox, verrucae vulgares, condylomata acuminate and molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Mometasone Furoate 1mg/g Cream should not be used on wounds or on skin which is ulcerated.
If irritation or sensitisation develop with the use of Mometasone Furoate 1mg/g Cream, treatment should be withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Mometasone Furoate in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised 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.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.
Mometasone Furoate 1mg/g Cream topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
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.
Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame and is a serious fire hazard. Patients should be warned of the risk of severe burns and advised not to smoke or go near naked flames when using this product. Washing clothing and bedding may reduce product build-up but not totally remove it.
Stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Propylene glycol monopalmitostearate
Propylene glycol may cause skin irritation.
During pregnancy treatment with Mometasone Furoate should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided. 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 intra-uterine growth retardation. There are no adequate and well-controlled studies with Mometasone Furoate in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Mometasone Furoate should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Mometasone Furoate 1mg/g Cream should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast feeding should be discontinued.
Table 1: Treatment-related adverse reactions reported with Mometasone Furoate by body system and frequency
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10 000); not known (cannot be estimated from the available data)
Infections and infestations
Nervous system disorders
Skin and subcutaneous tissue disorders
General disorders and administration site conditions
Vision blurred (see also section 4.4)
Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy
Application site pain, application site reactions
Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of children.
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 Website: 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 hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
Pharmacotherapeutic group: Mometasone, ATC code: D07AC13
Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.
In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.
In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.
Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 1mg/g is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Stearyl alcohol & macrogol cetostearyl ether
Propylene glycol monopalmitostearate
Titanium dioxide (E171)
Aluminium starch octenylsuccinate
Dilute phosphoric acid
White soft paraffin
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
In-use shelf life: 3 months
Store below 30 °C.
Collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a polypropylene cap.
Pack sizes: 30g, 60g or 100g.
Not all pack sizes may be marketed.
(Trading style: Accord)
Date of first authorisation: 20th June 2012
Date of latest renewal: 25th May 2017
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 385 200
+44 (0)1271 385 257
+44 (0)1271 346 106