MIBETIN

Posology Mibetin cream is applied once or twice daily. Frequency should be reduced as the clinical symptoms improve. Paediatric population Mibetin cream is applied once daily in children. Mibetin cream is contraindicated in newborns and infants less than 1 year old.

Method of administration Mibetin cream is applied thinly to the diseased skin areas and lightly rubbed in. The treated skin area should be no more than 10% body surface area. In children, Mibetin cream should only be used in the short term and over small areas.

In general, increased caution must be exercised when treating children with corticosteroid preparations, as there may be increased absorption of the corticosteroid through the child's skin compared to adults. Treatment under an occlusive dressing should also be avoided due to the risk of possible absorption of betamethasone dipropionate.

In particular, Mibetin cream is intended for use on greasy skin or for treatment of weeping skin conditions. Duration of use Duration of treatment with Mibetin cream should not exceed 10 days in adults and 7 days in children. If needed and clinically justified, further treatment should be administered as monotherapy with a glucocorticoid (if necessary, with a less potent topical glucocorticoid) or an antibiotic.

4) Vascular disorders Not known Intracranial hypertension in children Skin and subcutaneous tissue disorders Not known Burning, pruritus, irritation, dryness, folliculitis, hypertrichosis, steroid acne, acne-like rash, changes in skin pigmentation, rosacea- like (perioral) dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, erythema, hypersensitivity, skin discoloration Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.

4) Musculoskeletal and connective tissue disorders Not known Growth retardation in children With use over long periods (more than 4 weeks) and/or large areas (approximately 10 % of body surface area or more) and especially under occlusion, the following may occur: skin maceration, skin atrophy, telangiectasia, striae, steroid acne, miliaria, folliculitis, hypertrichosis, pigmentation changes and perioral dermatitis.

Transient mild irritation (erythema, pruritus) caused by gentamicin usually does not require discontinuation of treatment. If severe irritation, sensitisation or superinfection occurs, treatment should be discontinued and appropriate therapy initiated.

Topical use of gentamicin may lead to impaired wound granulation. Furthermore, oto-, vestibular- and nephrotoxic effects may occasionally occur even after external use of gentamicin, particularly with repeated use of gentamicin on extensive wounds.

Treatment with gentamicin caused transient irritation (erythema and pruritus). Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Paediatric population:

Suppression of the hypothalamic-pituitary-adrenal axis manifests in children as a low plasma cortisol level and lack of response to ACTH stimulation. Intracranial hypertension manifests as bulging fontanelles, headache and a bilateral papillary oedema.

Children are more susceptible than adult patients to glucocorticoid-induced suppressive effects on the hypothalamic-pituitary-adrenal axis and to exogenous glucocorticoid effects, due to the larger skin surface area to body weight ratio.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Gentamicin-containing products such as Mibetin cream should be carefully selected for each individual treatment. They should only be used if the response to antiseptic measures is slow to appear, response is insufficient or antiseptic therapy is contraindicated.

In some cases gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or large areas of damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.

Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur. 1555A > G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range.

Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. In the facial area Mibetin cream should be applied with particular caution.

As absorption of the active substances is possible, long-term treatment and/or use on large skin areas should be avoided. The adverse reactions reported for systemically administered glucocorticoids, including impaired adrenocortical function, may also occur with externally applied glucocorticoids after systemic absorption.

This particularly applies to infants and children. Systemic absorption of topically applied glucocorticoids generally increases with the potency of the glucocorticoids, duration of use, the extent of treated body surface areas and in the treatment of intertriginous skin areas.

The topical use of gentamicin in skin infections engenders the risk of allergic reactions. 4% with increasing tendency. The risk of sensitisation increases with increasing duration of therapy. Between gentamicin and other aminoglycosides, such as neomycin and kanamycin, there is a group allergy.

8). The risk of local skin infections may be increased with topical glucocorticoid use. Occasionally, prolonged or extensive topical use of antibiotics leads to colonisation by non-sensitive pathogens, including fungi. In this case, or at the onset of skin irritation, allergic reactions or superinfections, treatment with gentamicin should be discontinued and suitable therapy initiated.

Systemic absorption of topically applied gentamicin may be increased during treatment of extensive skin areas, particularly over prolonged periods or in the presence of skin fissures. Under these circumstances, caution must be exercised, especially in children, as there is a possibility that systemic adverse reactions may occur even after local use of gentamicin.

Due to the neuromuscular blocking effect of aminoglycosides upon systemic absorption, caution is advised in patients with myasthenia gravis, Parkinson's disease, other diseases with muscular weakness or concomitant use of other medicinal products with neuromuscular blocking effects.

Visual disturbances may occur with systemic and topical (including intranasal, inhalation and intraocular) use of corticosteroids. g. central serous chorioretinopathy (CSC), which have been reported after the use of systemic or topical corticosteroids.

Topical steroid withdrawal syndrome 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. Mibetin cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate (E218 and E216) and cetostearyl alcohol.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). g. contact dermatitis). Mibetin cream should not be applied to wounds or leg ulcers. If latex condoms are used concurrently during treatment with Mibetin cream in the genital or anal region, their tear resistance may be reduced by the white soft paraffin and liquid paraffin excipients, thereby compromising the safety of such condoms.

The label will state strong steroid.

1 or in cases of hypersensitivity to other medicinal substances of the glucocorticoid type or aminoglycoside antibiotic type. 6). g. herpes simplex, herpes zoster), - rosacea and rosacea-like dermatitis, - perioral dermatitis, - dermatomycosis, - ophthalmological disorders, - concomitant systemic use of aminoglycoside antibiotics, due to the risk of toxic serum levels, - advanced renal impairment, - babies and infants less than 1 year old.

Mibetin cream is not intended for use in the auditory canal, eyes or on mucous membranes. Airtight occlusive dressings must not be used.