MONOVO Cream Ref.[49808] Active ingredients: Mometasone

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

Monovo should not be applied to broken skin and mucous membranes.

Caution should be observed in patients who are hypersensitive to any other corticosteroid. If irritation or sensitization develops with the use of Monovo, treatment should be withdrawn and appropriate therapy instituted.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 favorable 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 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 centralized 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 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.

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

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

Monovo contains emulsifying cetostearyl alcohol and cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis) as well as butylated hydroxytoluene which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Visual disturbance

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.

No interaction studies have been performed.

Fertility

No effects known.

Pregnancy

Corticosteroids cross the placenta. There is very limited data on the use of topical mometasone during pregnancy. After systemic use of high dose corticosteroids, effects on the foetus/neonate has been described (intra-uterine growth retardation, adrenocortical suppression, cleft palate).

Animal studies have shown reproduction toxicity and teratogenicity (see section 5.3). The potential risk for humans is unknown.

Although systemic exposure is limited, Monovo should only be used during pregnancy after careful consideration of the benefit/risk assessment.

Breast-feeding

It is not known whether mometasone is excreted into breast milk. Monovo should only be administered to nursing mothers after careful consideration of the benefit/risk assessment. During the lactation period, Monovo must not be applied in the breast area.

Monovo has no or negligible influence on the ability to drive and use machines.

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).

Undesirable effects that have been reported in connection with external corticosteroid treatment include:

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

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 Monovo.

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-pituitaryadrenal 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie , e-mail: medsafety@hpra.ie.

When treating the genital or anal area with Monovo, the ingredients white soft paraffin and liquid paraffin can lead to a reduction in the functional capability of latex products (e.g. condoms, diaphragms) when used simultaneously and might thereby impair the safety of these products.