Ovixan
SUMMARY OF PRODUCT CHARACTERISTICS
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:
250 mg propylene glycol 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 is indicated for the symptomatic treatment of inflammatory skin conditions which respond to topical treatment with glucocorticoids, such as atopic dermatitis and psoriasis (excluding widespread plaque psoriasis).
4.2 Posology and method of administration
Posology
Adults (including older people)and children (from 6 years):
Ovixan is applied in a thin film once daily on the affected areas of skin. The application frequency is then gradually decreased. Use of a less potent corticosteroid is often preferred when clinical improvement is achieved.
As for all strong topical glucocorticoids Ovixan should not be applied on the face other than under close supervision by a doctor.
Ovixan should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% body surface area should be treated.
Paediatric population
Children below 6 years:
Ovixan is a strong glucocorticoid (group III) and it is usually not recommended for children below 6 years since relevant safety data are lacking (see section 4.4).
Method of administration
Topical use.
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 is contraindicated for patients with facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritus, napkin eruptions, bacterial infections (e.g. impetigo), viral infections (e.g. herpes simplex, herpes zoster and chickenpox) and fungal infections (e.g. candida or dermatophyte), varicella, tuberculosis, syphilis or post-vaccine reactions. Ovixan should not be used on wounds or on skin which is ulcerated.
4.4 Special warnings and precautions for use
If irritation or sensitisation develops with the use of Ovixan, treatment should be withdrawn and appropriate therapy instituted.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 corticosteroids 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.
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 on the face, occlusion should not be
used. If used on the face, courses should be limited to 5 days. 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 should not be applied to the eyelids because of the potential risk for glaucoma simplex or
subcapsular cataract. Ovixan topical preparations are not for ophthalmic use.
Ovixan cream contains propylene glycol that may cause skin irritation and cetostearyl alcohol that may
cause local skin reactions (e.g. contact dermatitis).
Paediatric population
Use with care in children. The side effects that have been reported during systemic use of corticosteroids,
including inhibition of adrenal cortex, may also appear with local use of corticosteroids, especially in
children. Children may be more sensitive to the influence of topical glucocorticoids on the hypothalamic-
pituitary- adrenal system (HPA-axis) and to Cushing’s syndrome than adults because the skin surface
is larger in relation to the body weight. Chronic treatment with glucocorticoids may influence the growth
and development in children (see section 4.8).
Treatment with occlusive dressing should not be used in the childhood.
As the safety and efficacy of mometasone furoate in paediatric patients below 2 years of age have not been
established, Ovixan is not recommended in this age group.
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
Corticosteroids passes the placenta. There are no clinical data from the use of mometasone furoate during pregnancy. Studies of mometasone furoate in animals following oral administration have shown teratogenic effects, see section 5.3. The potential risk for humans is unknown.
Although systemic exposure is limited, mometasone furoate cream should only be used during pregnancy after careful consideration of risks and benefit.
During pregnancy corticosteroids with low potency should be prescribed for treatment of larger body surfaces during longer periods.
Breast-feeding
It has not been established if mometasone furoate passes over to maternal milk. Mometasone furoate should only be given to lactating mothers after careful consideration of risk and benefit. Ovixan should not be applied on the breast or adjacent skin during lactation.
Fertility
No known effects.
4.7 Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The adverse events are presented according to MedRA system organ classification within each frequency
area and after decreasing degree of severity:
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 events that have been reported during use of glucocorticoids for topical use include:
-
Treatment related adverse events reported according to system organ classification and frequency
Infections and infestations
Not known
Secondary infection, furuncolosis
Very rare
Folliculitis
Nervous system disorders
Not known
Paresthesia
Very rare
Burning sensation
Vascular disorders
Very rare
Telangiectasis
Skin and subcutaneous tissue disorders
Not known
Allergic contact dermatitis, perioral dermatitis, hypopigmentation, hypertrichosis, striae, maceration of skin, miliaria, acneiform reactions, local skin atrophy, irritation, papulous rosacea like dermatitis (facial skin) , capillary sensitivity (ekkymosis), dryness, hypersensitivity (mometasone)
Very rare
Pruritus
General disorders and administration site conditions
Not known
Application site pain, application site reactions
Increased risk for systemic effects and local adverse events is present with frequent administration, when treating large areas or during long-term as well as during treatment of intertriginous areas or with occlusion. Hypo- or hyper-pigmentation has been reported in rare cases in connection with other cortisone medicines and may therefore appear with mometasone furoate.
Adverse events that have been reported during systemic treatment with glucocorticoids – including adrenal suppression- may also appear with topically applied corticosteroids.
Treatment of widespread psoriasis or sudden stopping of prolonged therapy with a potent corticosteroid may induce pustular or erythrodemic psoriasis.
Flare-up of eczema may be seen as a rebound phenomenon after abrupt stopping of therapy.
Paediatric populationPaediatric patients may demonstrate greater susceptibility to topical glucocorticoid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface to body weight ratio. Chronic glucocorticoid therapy may interfere with the growth and development of children.
Intracranial hypertension has been reported in paediatric patients receiving topical glucocorticoids. 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 reaction via the national reporting system listed in Appendix V.
Overdose
Exaggerated long-term use of topical glucocorticosteroids may suppress the HPA-axis function and give rise to secondary adrenal cortex suppression. If suppression of the HPA-axis is reported, the number of applications times should be decreased or treatment should be stopped while observing necessary caution in these situations.
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. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, Dermatological preparations. Corticosteroids, Plain.
ATC code: D07AC13
Mechanism of action and pharmacodynamics effects
Mometasone furoate is a strong glucocorticoid, group III
The active substance, mometasone furoate, is a synthetic, non-fluorinated glucocorticoid with a furoate esther in position 17.
As for other corticosteroids for topical use mometasone furoate has anti-inflammatory, antipruritic and anti-allergic effects.
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
Absorption
Results from percutaneous absorption studies show that the systemic absorption is less than 1 %.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety toxicology, genotoxicity and carcinogenicity (nasal administration) of mometasone furoate besides what is already known for glucocorticoids.
Studies of corticosteroids in animals following oral administration have shown reproduction toxicity (cleft palate, skeletal malformations).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Coconut oil, refined
Stearic acid
Cetostearyl alcohol
Macrogol stearate
Glycerolmonostearate 40-55
Propylene glycol
Sodium citrate (for pH adjustment)
Citric acid, anhydrous (for pH adjustment)
Water, purified
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
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
To be completed nationally
8. MARKETING AUTHORISATION NUMBER(S)
To be completed nationally
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14 December 2011
10. DATE OF REVISION OF THE TEXT
11 February 2016
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