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Document: spc-doc_PL 04416-1421 change

• spc-doc_PL 00025-0577
• spc-doc_PL 04416-1421
• spc-doc_PL 17507-0111
• spc-doc_PL 25258-0009
• spc-doc_PL 25258-0118
• spc-doc_PL 33016-0002

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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).

Excipients 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 butylhydroxytoluene (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 in adults, adolescents and children aged 2 years and above for the symptomatic treatment of inflammatory skin conditions which respond to external treatment with glucocorticoids, such as atopic dermatitis and psoriasis (excluding widespread plaque psoriasis, see section 4.4).

4.2 Posology and method of administration

For application on the skin (cutaneous use).

Adults, including elderly patients and children aged 2 years and over:

A thin film of Mometasone Furoate 0.1% w/w Cream should be applied to the affected areas of skin once daily.

Strong topical corticosteroids generally should not be applied to the face without close monitoring by the physician.

Mometasone Furoate 0.1% w/w Cream should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children aged 2 years and older a maximum of 10% of body surface area should be treated.

It should not be used occlusively or intertriginously.Treatment duration is limited to a maximum of 3 weeks.

Use of a weaker corticosteroid is often advisable when there is a clinical improvement.

Local and systemic toxicity is more common following prolonged continuous application over large areas of damaged skin, in flexures and under occlusive dressings (see section 4.4).

Paediatric population Children below 2 years:

Mometasone Furoate 0.1% w/w Cream is a potent group III glucocorticoid. It is not recommended for use in children below 2 years due to insufficient data on safety.

Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen.

4.3 Contraindications

-    Hypersensitivity to the active substance 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 varicella, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, 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, treatment should be

withdrawn and appropriate therapy instituted.

Any contact with the eyes, and use on the eyelids should be avoided.

Mometasone Furoate 0.1% w/w Cream should not be applied to broken skin.

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.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. Caution should be exercised

when large areas of the body are treated and 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.

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 occur 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.

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.

Cocorticosteroids can alter the appearance of some dermatological lesions which can cause diagnostic difficulty. They can also delay healing. Mometasone Furoate 0.1% w/w Cream contains propylene glycol monopalmitostearate which may cause skin irritations and also butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membrane.

Mometasone Furoate 0.1% w/w Cream contains also stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Mometasone Furoate 0.1% w/w Cream topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

Lactation

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.

Fertility

Studies in animals have shown no effect on fertility.

4.7 Effects on ability to drive and use machines

Mometasone Furoate 0.1% w/w Cream 1 mg/g cream has no or negligible 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 (cannot be estimated from the available data)

Adverse reactions that have been reported in connection with external corticosteroid treatment include:

Table 1: Treatment-related frequency	adverse reactions reported by body system and
Infections and infestations
Not known		Infection, furuncle
Very rare		Folliculitis
Nervous system disorders

An increased risk of systemic effects and local undesirable effects 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 the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

Overdose

Excessive long-term use of topical applied corticosteroids may suppress HPA axis

function and result in secondary adrenocortical insufficiency. This is usually reversible and therefore an attempt should be made to cautiously withdraw the drug, reduce the frequency of application and/or use a less potent corticosteroid (see section 4.4).

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, dermatological preparations,

corticosteroids, 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.

Mometasone Furoate 0.1% w/w Cream was shown to have an equivalent pharmacodynamic (vasoconstriction) response profile to the reference ointment product containing 1mg/g mometasone furoate when applied to normal skin. The Negative Area Under Effect Curve ratio of Mometasone Furoate 0.1% w/w Cream to the reference product in the vasoconstrictor assay was 111% (90% CI 103-121%).

The therapeutic index of mometasone furoate (a ratio of desired to unwanted effects) determined from relevant literature data suggests that mometasone belongs to a category of topical glucocorticoids, in which desired effects clearly outweigh unwanted effects.

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

Results from percutaneous absorption studies have indicated that systemic absorption following topical application of mometasone furoate ointment 0.1% is minimal. The results show that about 0.7% of the active ingredient is absorbed by the intact skin in 8 hours (without using an occlusive dressing).

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.

6.1    List of excipients

Hexylene glycol

Water, purified Beeswax white

Propylene glycol monopalmitostearate Stearyl alcohol Macrogol 20 cetostearyl ether Titanium dioxide (E171)

Aluminium starch octenylsuccinate Phosphoric acid, 10% solution

White soft paraffin (contains butylhydroxytoluene (E321)

6.2    Incompatibilities

Not applicable

6.3 Shelf life

2 years

After first opening: 12 weeks

6.4    Special precautions for storage

Do not store above 25 °C. Do not refrigerate or freeze.

6.5    Nature and contents of container

The cream is filled in a latex-lined aluminium collapsible tube, lacquered with an

epoxy phenolic resin, fitted with a white high density polyethylene piercing screw cap.

Pack sizes:

Tube containing 10g, 15g, 20g, 30g, 50g, 60g or 100g of cream Not all packs sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

MARKETING AUTHORISATION HOLDER

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR United Kingdom

23/06/2015