BETAMETHASONE VALERATE/CLIOQUINOL

Posology A small quantity of cream should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often. Paediatric population Courses should be limited to five days if possible.

Occlusion should not be used. Method of administration For topical administration.

Adverse reactions are listed below by MedDRA system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including isolated reports.

g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis Skin and Subcutaneous Tissue Disorders Common Pruritus, local skin burning/skin pain Very rare Allergic contact dermatitis/dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning*/skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes, hypertrichosis, exacerbation of underlying symptoms *Skin features secondary to local and or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

4) 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.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids.

9). Application to the Face The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema with this medicinal product.

Application to the Eyelids If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result. 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.

Chronic leg ulcers Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Paediatric population In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.

Use in Psoriasis Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised 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. Long term continuous or inappropriate 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.

Infection If infection persists, systemic chemotherapy is required. Any spread of infection requires withdrawal of topical corticosteroid therapy. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Do not continue for more than 7 days in the absence of clinical improvement, since occult extension of infection may occur due to the masking effect of the steroid. Staining This medicinal product may stain hair, skin or fabric, and the application should be covered with a dressing to protect clothing.

Dilution Products which contain antimicrobial agents should not be diluted. The least potent corticosteroid which will control the disease should be selected. Neurotoxicity There is a theoretical risk of neurotoxicity from the topical application of clioquinol, particularly when Betamethasone/Clioquinol skin preparations are used for prolonged periods or under occlusion.

Fire hazard in contact with dressings, clothing and bedding 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. Excipients This medicine contains chlorocresol, which may cause allergic reactions. This medicine contains cetostearyl alcohol, which may cause local skin reactions, such as contact dermatitis.

These preparations do not contain lanolin or parabens. The label will state strong steroid.

1. g. g. g. impetigo) - Primary or secondary infections due to yeast - Perianal or genital pruritus - Dermatoses in children under 2 years of age, including dermatitis and napkin eruptions.