This information is intended for use by health professionals

1. Name of the medicinal product

Mometasone Furoate 0.1% w/w Ointment

2. Qualitative and quantitative composition

One gram of ointment contains 1 mg of mometasone furoate (0.1 % w/w mometasone furoate).

Excipients with known effect: 20mg propylene glycol monopalmitostearate/gram ointment and traces, up to a maximum of 0.015mg Butylated hydroxytoluene (E321)/ gram ointment.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Ointment

A translucent white soft ointment.

4. Clinical particulars
4.1 Therapeutic indications

Mometasone Furoate 0.1% w/w Ointment is indicated in adults and children aged 2 years and older 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).

4.2 Posology and method of administration

A thin film of Mometasone Furoate 0.1% w/w Ointment should be applied to the affected skin area once daily. Strong topical corticosteroids generally should not be applied to the face without close monitoring by the physician. Use of Mometasone Furoate 0.1% w/w Ointment on the face should be no more than 5 days.

Mometasone Furoate 0.1% w/w Ointment should be preferably used to treat very dry, scaly and cracked skin complaints where a topical mometasone preparation is indicated.

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

Adults

Mometasone Furoate 0.1% w/w Ointment should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area).

Children aged 2 years and older

In children aged 2 years and older a maximum of 10% of body surface area should be treated. Treatment duration is limited to a maximum of 3 weeks. Occlusion should not be used.

Children below 2 years of age

Mometasone Furoate 0.1% w/w Ointment is a potent group III glucocorticoid. It should not be used in children below 2 years of age, as efficacy and safety have not been established.

4.3 Contraindications

- 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 Ointment is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo and pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminate, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions.

- Mometasone Furoate 0.1% w/w Ointment 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 Ointment, 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-pituitary-adrenal (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.

Mometasone Furoate 0.1% w/w Ointment may be used with caution in paediatric patients 2 years of age or older, although the safety and efficacy of the use of Mometasone Furoate 0.1% w/w Ointment for longer than 3 weeks have not been established.

As the safety and efficacy of Mometasone Furoate 0.1% w/w Ointment in paediatric patients below 2 years of age have not been established, it should not be used in this age group.

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. 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.

Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.

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.

Mometasone Furoate 0.1% w/w Ointment contains propylene glycol which may cause skin irritations and also butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membrane.

Mometasone Furoate 0.1% w/w Ointment 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 Ointment 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 (see section 5.3). There are no adequate and well-controlled studies with Mometasone Furoate 0.1% w/w Ointment 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. Like other topically applied glucocorticoids, Mometasone Furoate 0.1% w/w Ointment should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.

Breast-feeding

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 Ointment 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.

4.7 Effects on ability to drive and use machines

Mometasone Furoate 0.1% w/w Ointment 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 (frequency cannot be estimated from the available data)

Table 1: Treatment-related adverse reactions reported by body system and frequency

Infections and infestations

Not known

Very rare

Nervous system disorders

Not known

Very rare

Skin and subcutaneous tissue disorders

Not known
 

Very rare

General disorders and administration site conditions

Not known

Eye disorders

Not known

 

Infection, furuncle

Folliculitis

 

Paraesthesia,

burning sensation

 

Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy

Pruritus

 
 

Application site pain, application site reactions

 

Vision, blurred (see also section 4.4)

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 Ointment.

Side effects which have been reported with systemic glucocorticoids – including adrenal suppression – may also occur with topically applied glucocorticoids.

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 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 in the UK by visiting www.mhra.gov.uk/yellowcard.

4.9 Overdose

Excessive long-term use of external corticosteroids may 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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticoids, potent (group III)

ATC code: D07AC13

Mometasone Furoate 0.1% w/w Ointment 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 Ointment 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 Ointment 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 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.

5.2 Pharmacokinetic properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate ointment 0.1% is minimal, approximately 0.7% 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

Phosphoric acid, concentrated (for pH – adjustment)

Propylene glycol monopalmitostearate

Beeswax, white

Paraffin, white soft

Butylated hydroxytoluene (E321) (as an antioxidant in paraffin, white soft)

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

After first opening: 12 weeks

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

The ointment is filled in aluminium tubes fitted with a white low density polyethylene piercing screw cap in a cardboard carton. Carton of 1 tube.

Pack sizes:

Tubes with 10g, 15g, 20g, 30g, 50g, 60g and 100g of ointment

Not all packs sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Glenmark Pharmaceuticals Europe Ltd

Laxmi House, 2-B Draycott Avenue,

Kenton, Harrow, Middx, HA3 OBU.

United Kingdom

8. Marketing authorisation number(s)

PL 25258/0001

9. Date of first authorisation/renewal of the authorisation

07/07/2009

10. Date of revision of the text

Jul-2017