BETESIL Plaster Ref.[27917] Active ingredients: Betamethasone

In general, use of topical corticosteroids on large areas of the body and for prolonged periods, as well as the use of occlusive dressing can cause a temporary suppression of the hypothalamus-pituitaryadrenal axis, leading to secondary hypoadrenalism and adrenal hypercorticism, including the Cushing’s syndrome. In these situations, treatment should be discontinued gradually and under strict control of a doctor due to the risk of acute adrenal insufficiency.

Sudden withdrawal of the treatment in psoriatic patients, may also lead to symptoms exacerbation or generalized pustular psoriasis.

Prolonged use of BETESIL in diffuse psoriasis (except for the treatment of isolated plaques) or diffuse eczema or application on lesions located in skin folds is not recommended, as these conditions may increase systemic absorption. The use of occlusive bandages, especially with plastic material, may increase this effect. The symptoms of this are: facial redness, weight changes (fat increase in body and face and loss in legs and arms), reddish streaks on stomach, headache, menstrual alterations, or an increase in unwanted face and body hair. In this regard, it is known that certain skin areas (face, eyelids, armpits, scalp and scrotum) absorb more easily than others (skin on the knees, elbows, palms of the hands and feet on soles).

Application of topical medicinal products, especially if prolonged, may give rise to hypersensitivity reaction. Skin atrophy has also been reported after three-week treatment periods. In case of drug intolerance, for example if skin irritation or contact dermatitis occurs during treatment, it is necessary to stop the medicated plaster application and start suitable treatment (see section 4.8 “Undesirable effects”).

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.

Corticosteroids may affect the results of the nitroblue tetrazolium test (NBT) for diagnosing bacterial infections by producing false negatives.

Medicinal products containing corticosteroids must be used with caution in patients with impaired immune system function (T-lymphocytes) or in those being treated with immunosuppressive therapy. The product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause hypersensitivity reactions (possibly delayed).

No interaction studies have been performed.

At recommended doses, betamethasone valerate for topical use is not known to cause medically significant drug interactions. BETESIL did not show significant systemic absorption of betamethasone valerate.

Pregnancy

Topical administration of corticosteroids to pregnant laboratory animals may cause impairment of foetal maturation. The importance of this preclinical data has not been evaluated in humans: however, topical steroids must not be used in pregnant women on large areas of skin and specifically, in large quantities or for long period of time.

Therefore, this medicinal product must only be used in case of need and under direct medical control, after having assessed the real benefits for the mother against the possible risks for the foetus and having evaluated the treatment period and the size of the skin area to be treated.

Breast-feeding

Systemic corticosteroids are excreted in human milk.

It is unknown whether topical corticosteroids are excreted in human milk. Therefore topical corticosteroids should be used with caution also in nursing women and should not be applied to the breast.

BETESIL has no or negligible influence on the ability to drive and use machine.

The commonly reported adverse reactions are skin and subcutaneous tissue disorders, occurring in about 15% of patients treated. These undesirable effects are mainly due to the pharmacological effects of the medicinal product. They are local effects on the skin in the plaster application area. No systemic effects have been observed.

The following list of adverse reactions has been observed during controlled clinical trials. Reported adverse reactions have been classified according to their frequency of observation using the following convention: very common (>1/10); common (>1/100, <1/10), uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000) and not known when cannot be estimated from the available data.

All cases reported were found to be common. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Other undesirable reactions not observed with BETESIL, but reported with topical corticosteroids are: contact dermatitis, hypersensitivity, oedema, purpura, striae atrophicae, dry skin, skin exfoliation, capillary fragility, skin irritation, hypertrichosis, hyperaesthesia, perioral dermatitis, burning or stretching sensation, folliculitis and skin hypopigmentation.

The use of topical corticosteroids on large areas of the body and for long periods, as well as the use of occlusive dressing can cause temporary suppression of the hypothalamus-pituitary-adrenal axis, leading to secondary hypoadrenalism and adrenal hypercorticism, including the Cushing’s syndrome. In these situations, treatment should be discontinued gradually and under strict control of a doctor due to the risk of acute adrenal insufficiency. Sudden withdrawal of the treatment in psoriatic patients may also lead to symptoms exacerbation or generalized pustular psoriasis (see section 4.4 “Special warnings and precautions for use”).

Hypersensitivity reactions to occlusive plastic material have been observed rarely.

Blurred vision may occur with a not known frequency (see also section 4.4)

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. 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.

Not applicable.