LOTRIDERM

Posology Adults and children over the age of 12 years. Topical administration twice daily for two weeks (tinea cruris, tinea corporis and candidiasis) or for four weeks (tinea pedis). Paediatric population Lotriderm cream is not recommended for children under the age of twelve years.

Method of administration Topical administration only.

Adverse reactions reported for Lotriderm include: burning and stinging, maculopapular rash, oedema, paraesthesia and secondary infection. Reported reactions to clotrimazole include erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation of the skin.

Reactions to betamethasone dipropionate include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hyperpigmentation, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae miliaria, capillary fragility (ecchymoses), blurred vision and sensitisation.

In children receiving topical corticosteroids, Hypothalamic-pituitary adrenal (HPA) axis suppression (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported. 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.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin and in flexures. If used on the face, courses should be limited to 5 days. LOTRIDERM CREAM SHOULD NOT BE USED WITH OCCLUSIVE DRESSING.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following the development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, manifestation of Cushing’s syndrome, hyperglycemia, and glycosuria may also occur with topical steroids, especially in infants and children.

Lotriderm Cream is not intended for ophthalmic use. Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) 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 of visual disturbances 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.

Paediatric population • Long term continuous therapy should be avoided in all children irrespective of age. • Lotriderm cream should not be used with adhesive dressing. • The safety and effectiveness of Lotriderm cream has not been established in children below the age of 12.

• If used on children, courses should be limited to 5 days. Hypothalamic-pituitary adrenal axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.

Manifestation of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilloedema. g. contact dermatitis). Propylene glycol which may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns).

Benzyl alcohol which may cause allergic reactions or mild local irritation.

Lotriderm is contraindicated in those patients with a history of sensitivity to any of its components or to other corticosteroids or imidazoles. If irritation or sensitisation develops with the use of Lotriderm cream, treatment should be discontinued and appropriate therapy instituted.

Lotriderm is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, napkin eruptions and bacterial or viral infections.