Mometasone furoate 0.1% w/w cream - Summary of Product Characteristics (SmPC) (2023)

Each gram of cream contains 1 mg mometasone furoate (0.1% w/w mometasone furoate).

For the full list of excipients see section 6.1

Creme

White to off-white smooth cream.

dosage

A thin film of mometasone furoate 0.1% w/w cream should be applied to the affected skin once daily.

type of administration

A fingertip unit (a line from the tip of an adult index finger to the first crease) is sufficient to cover an area twice the size of an adult hand.

The use of topical corticosteroids in children or on the face should be limited to the lowest amount consistent with an effective therapeutic regimen and the duration of treatment should not exceed 5 days.

Pediatric Population

Mometasone furoate 0.1% w/w cream is not recommended for use in children below 2 years of age as the safety and efficacy of mometasone furoate 0.1% w/w cream in this age group has not been established.

Hypersensitivity to the active substance mometasone furoate or 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, conjunctival rash, bacterial (e.g. impetigo, pyoderma), viral (e.g. herpes simplex , herpes zoster and varicella, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitic) and fungal infections (eg, candida or dermatophytes), varicella, tuberculosis, syphilis, or post-vaccination reactions.

Mometasone furoate 0.1% w/w cream should not be applied to wounds or to ulcerated skin.

If irritation or sensitization occurs with the use of mometasone furoate 0.1% w/w cream, treatment should be discontinued and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be initiated. If a positive response is not immediate, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteroids may result in reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the possibility of glucocorticosteroid insufficiency upon discontinuation of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may also be produced in some patients by systemic absorption of topical corticosteroids during treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be regularly evaluated for signs of HPA axis suppression.

All adverse reactions reported with systemic corticosteroid use, including adrenal suppression, may also occur with topical corticosteroids, particularly in infants and children.

Pediatric patients may be more susceptible to systemic toxicity at equivalent doses due to their greater skin surface area to body mass ratio. Since the safety and efficacy of mometasone furoate 0.1% w/w cream in pediatric 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, particularly after prolonged use on large areas of damaged skin, in flexures and at polyethylene occlusion. No occlusion should be used when used in childhood or on the face. When used on the face, treatments should be limited to 5 days and no occlusion should be used. Long-term maintenance therapy should be avoided in all patients, regardless of age.

Topical steroids can be dangerous in psoriasis for a number of reasons, including rebound flares after tolerance development, risk of centralized pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function. When used in psoriasis, careful monitoring of the patient is important.

As with all potent topical glucocorticoids, abrupt discontinuation of treatment should be avoided. Continued or inappropriate long-term use of topical steroids may result in the development of rebound episodes after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop, which takes the form of dermatitis with intense redness, stinging, and burning that can spread beyond the original treatment area. It is more likely to occur when treating sensitive skin areas such as the face and bends. If the disease recurs within days to weeks of successful treatment, a withdrawal reaction should be suspected. Re-administration should be done with caution and in these cases specialist advice is recommended or other treatment options should be considered. This can be prevented by slowly reducing treatment, e.g. by continuing treatment intermittently before stopping treatment.

Hyperglycaemia and glucosuria may occur in some patients after topical application due to systemic absorption.

Glucocorticoids can change the appearance of some lesions, making an adequate diagnosis more difficult and delaying healing.

visual disturbance

Visual disturbances have been reported with systemic and topical use of corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist for evaluation of possible causes other than cataract, glaucoma, or rare diseases such as cataracts. B. Central serous chorioretinopathy (CSCR) may have been reported after use of systemic and topical corticosteroids.

Mometasone furoate 0.1% w/w cream topical preparations are not for use in the eye, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.

pregnancy

During pregnancy and lactation, treatment with mometasone furoate 0.1% w/w cream should only take place on medical advice. In this case, however, use on large areas of the body or over a longer period of time should be avoided. There is insufficient evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in fetal development, including cleft palate and intrauterine growth retardation. There are no adequate and well-controlled studies of mometasone furoate 0.1% w/w cream in pregnant women and therefore the risk of such effects on the human fetus is unknown. However, as with all topical glucocorticoids, the possibility that fetal growth may be impaired by glucocorticoid passage across the placenta should be considered. Therefore, there may be a very small risk of such effects in the human fetus. As with other topical glucocorticoids, mometasone furoate 0.1% w/w cream should only be used in pregnant women if the potential benefit justifies the potential risk to the mother or the foetus.

breastfeeding

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Mometasone furoate 0.1% w/w cream should only be administered to nursing mothers after careful consideration of the risk/benefit ratio. If higher dose treatment or long-term use is indicated, breast-feeding should be discontinued.

Adverse reactions are listed in Table 1 by MedDRA system organ class and defined in order of decreasing frequency 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 (cannot be estimated from the available data)

Local adverse reactions that have been reported rarely with topical dermatological corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, skin maceration, miliaria, and telangiectasia.

Pediatric Population

Pediatric patients may have a greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than adult patients due to a greater skin surface area to body weight ratio.

Chronic treatment with corticosteroids can impair growth and development in children.

Reporting suspected side effects

It is important to report suspected side effects after the medicine has been approved. It allows continuous monitoring of the benefit-risk balance of the drug. 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 on Google Play or the Apple App Store.

Excessive and prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function, resulting in secondary adrenal insufficiency that is usually reversible.

If HPA axis suppression is noted, attempts should be made to discontinue the drug, decrease the frequency of its use, or replace it with a less potent steroid.

The steroid content of each container is so low that in the unlikely event of accidental oral ingestion, there is little or no toxic effect.

Pharmacotherapeutic group: corticosteroids, strong (group III)

ATC-Code: D07AC13

Mometasone furoate shows marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.

In the croton oil assay in mice, mometasone was equivalent to betamethasone valerate after a single dose and about 8 times more potent after five doses.

In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing M.ovalis-induced epidermal acanthosis (i.e., antipsoriatic activity) after 14 applications.

Pharmacokinetic studies have shown that systemic absorption after topical application of mometasone furoate cream 0.1% is minimal, approximately 0.4% of the administered human dose, the majority of which is eliminated within 72 hours of administration.

A characterization of the metabolites was not possible due to the small amounts in plasma and excrement.

Hexylenglykol

water, cleaned

beeswax white

Hydrogenated soy lecithin

Titanium Dioxide (E171)

aluminum starch octenyl succinate

Phosphoric acid concentrated (for pH adjustment)

Paraffin, white soft

All-rac-α-tocopherol – as an antioxidant in paraffin, white soft.

2 years

After opening: 12 weeks

This medicinal product does not require special storage conditions.

Do not refrigerate or freeze.

10g, 15g, 20g, 30g, 50g, 60g and 100g latex coated aluminum tubes with high density polyethylene screw cap in a carton. Each carton contains one tube.

Not all pack sizes may be marketed.

Glenmark Pharmaceuticals Europe Limited,

Laxmi-Haus, 2 B Draycott Avenue,

Kenton, Middlesex HA3 0BU,

Great Britain