Ovixan 1 mg/g cream – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Ovixan 1 mg/g cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One gram cream contains 1 mg mometasone furoate.

Excipients with known effect:

This medicine contains 250 mg propylene glycol (E1520) and 70 mg cetostearyl alcohol per gram cream.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

White, odourless cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Ovixan cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

4.2 Posology and method of administration

Posology

Adults, including elderly patients and Children:

A thin film of Ovixan 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.

4.3 Contraindications

Hypersensitivity to the active substance, mometasone furoate, to other corticosteroids or to any of the excipients listed in section 6.1.

Ovixan 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.

Ovixan cream should not be used on wounds or on skin which is ulcerated.

4.4 Special warnings and precautions for use

The label will state strong steroid.

If irritation or sensitization develop with the use of Ovixan cream, treatment should be withdrawn and appropriate therapy instituted.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 hypothalamicpituitaryadrenal

(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 Ovixan 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.

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.

Ovixan cream 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.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric

(clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

Ovixan cream contains propylene glycol (E1520) that may cause skin irritation and cetostearyl alcohol that may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Fertility, Pregnancy and lactation

Pregnancy

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.

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 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

Non stated.

4.8 Undesirable effects

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 corticosteroidinduced

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 at: www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Excessive, prolonged use of topical corticosteroids can suppress hypothalamicpituitary-

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 to a less potent steroid.

The steroid content of each tube is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Mometasone, ATC code: D07AC13

Mometasone is classed as a potent corticosteroid (group III).

Mometasone furoate exhibits marked anti-inflammatory activity and marked antipsoriatic

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.

Clinical efficacy and safety

In a 6 week study in 58 patients with psoriasis, Ovixan 1 mg/g cream, an oil in water emulsion, was compared with Elocon® 0.1% cream, a water in oil emulsion, as well as the vehicles for the two formulations. The preparations were applied according to a randomisation scheme on pair-wise lesions on the same person. The formulations were applied daily for 3 weeks, thereafter every second day for 1 week and then 2 times per week for 2 weeks. The results showed that Ovixan 1 mg/g cream was at least as effective (non-inferior) as Elocon 0.1 % cream regarding Total Severity Sign

(TSS).

5.2 Pharmacokinetic properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 1 mg/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.

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

Propylene glycol (E1520)

Cetostearyl alcohol

Coconut oil, refined

Stearic acid

Macrogol stearate

Glycerol monostearate 40-55

Sodium citrate (for pH adjustment)

Citric acid, anhydrous (for pH adjustment)

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

In-use shelf life: until the expiry date printed on the package

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Aluminium laminated plastic tube of polyethylene with white screw cap of polypropylene.

Pack sizes:

Tubes containing 15 g, 30 g, 35 g, 70 g, 90 g or 100 g cream.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Biofrontera Bioscience GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

8 MARKETING AUTHORISATION NUMBER(S)

PL 34942/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

01/04/2025

10 DATE OF REVISION OF THE TEXT

10/07/2025