Mometasone Furoate 0.1% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 1 mg of mometasone furoate (0.1 % w/w mometasone furoate).
Excipient(s) with known effect:
80 mg propylene glycol monopalmitostearate per gram cream 70 mg stearyl alcohol per gram cream
Traces, up to a maximum of 0.015mg Butylated hydroxytoluene (E321) per gram cream
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
White to off-white, smooth cream.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Mometasone furoate 0.1% w/w Cream is indicated for the treatment of inflammatory pruritic manifestations of and psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
4.2 Posology and method of administration
Adults, including elderly patients and children:
A thin film of Mometasone furoate 0.1% w/w Cream should be applied to the affected areas of skin area once daily. One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand.
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.
4.3 Contraindications
Hypersensitivity to the active substance, to other corticosteroids or to any of the excipients listed in section 6.1.
Mometasone Furoate 0.1% w/w 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 and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical) and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions.
Mometasone Furoate 0.1% w/w Cream should not be used on wounds or on skin which is ulcerated.
4.4 Special warnings and precautions for use
If irritation or sensitisation develop with the use of Mometasone furoate 0.1% w/w Cream, treatment should be withdrawn and appropriate therapy instituted.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 corticosteriods can produce reversible hypothalamic-pituitaryadrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, 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 0.1% w/w Cream 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.
Mometasone furoate 0.1% w/w Cream should not be applied to broken skin.
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.
Hyperglycaemia and glucosuria can occur in some patients after topical application due to systemic absorption.
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 0.1% w/w Cream is not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
Mometasone furoate 0.1% w/w Cream contains propylene glycol, which may cause skin irritation.
Mometasone furoate 0.1% w/w Cream contains stearyl alcohol and also butylated hydroxytoluene, which may cause skin irritations/reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed
4.6 Fertility, pregnancy and lactation
During pregnancy and lactation treatment with Mometasone Furoate 0.1% w/w Cream 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 0.1% w/w Cream 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 0.1% w/w Cream 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 0.1% w/w 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. The product should not be applied on the breasts directly before breastfeeding.
4.7 Effects on ability to drive and use machines
Mometasone Furoate 0.1% w/w Cream has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions are listed in Table 1 according to MedDRA system organ class and in decreasing frequency defined as follows:
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 (frequency cannot be estimated from the available data)
Adverse reactions reported with topical mometasone furoate 0.1% w/w
|
Infections and infestations | |
|
Not known |
Infection, furuncle |
|
Very rare |
Folliculitis |
|
Nervous system disorder | |
|
Not known |
Paraesthesia |
|
Very rare |
burning sensation |
|
Skin and subcutaneous tissue disorders | |
|
Not known |
Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy |
|
Very rare |
Pruritus |
|
General disorders and administration site | |
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.
An increased risk of systemic effects and local adverse events exists with frequent dosing, treatment of large areas or in the long term and also the treatment of intertriginous areas or with occlusive dressings. Hypopigmentation or hyperpigmentation has been reported in isolated cases (rare) in connection with other steroids and may therefore occur with Mometasone furoate 0.1% w/w Cream.
Side effects which have been reported with systemic glucocorticoids - including adrenal suppression - may also occur with topically applied glucocorticoids.
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 to body weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.
Intracranial hypertension has been reported in paediatric patients receiving topical corticosteroids. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilloedema.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Excessive prolonged use of topical corticosteroids may suppress hypothalamic-pituitary-adrenal (HPA) function and give rise to secondary adrenocortical insufficiency which is usually reversible.
If suppression of the HPA axis is noted, it should be endeavoured, with the usual caution being exercised in these situations, to withdraw the drug, to reduce the frequency of application or to substitute for 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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticoids, potent (group III)
ATC code: D07AC13
Mometasone Furoate 0.1% w/w Cream is a potent glucocorticoid, group III. The active substance, mometasone furoate, is a synthetic, non-fluorinated glucocorticoid with a furoate ester in position 17.
Like other corticosteroids for external use, 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 (ED50 = 0.2 pg/ear) was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications (ED50 = 0.002 pg/ear/day versus 0.014 pg/ear/day).
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.
5.2 Pharmacokinetic properties
Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% 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.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hexylene Glycol Water, purified
Beeswax white
Propylene Glycol Monopalmitostearate Promulgen G (Stearyl alcohol and Ceteareth - 20)
Titanium Dioxide (E171)
Aluminium Starch octenylsuccinate Phosphoric acid concentrated (for pH adjustment)
Paraffin, white soft
Butylated hydroxytoluene (E321) - as an antioxidant in paraffin, white soft.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
After first opening: 12 weeks
6.4 Special precautions for storage
Store below 250C
Do not refrigerate or freeze
6.5 Nature and contents of container
15g, 20g, 30g latex lacquered aluminium tubes with high density polyethylene screw cap in a cardboard carton. Each carton contains one tube.
Not all packs sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue, Kenton,
Middlesex, HA3 0BU,
United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 25258/0118
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/04/2011
DATE OF REVISION OF THE TEXT
05/02/2016