Clobex Shampoo 0.5 mg

Clobex u00ae Shampoo is indicated for the topical treatment of moderate to severe scalp psoriasis in adults over 18 years of age and the maintenance treatment for prevention of recurrence.

Posology
Clobex u00ae Shampoo should be applied on dry scalp once daily, massaging the lesions. The initial treatment with a once daily regimen should be limited to 4 consecutive weeks because of the potential of Clobex u00ae Shampoo to suppress the hypothalamic-pituitary- adrenal axis. The total dosage should not exceed 50 ml per week.

Method of Administration
For cutaneous use on the scalp only. After application, Clobex u00ae Shampoo should be kept in place without covering for 15 minutes. Hands should be washed carefully after each application. After 15 minutes, the product must be thoroughly rinsed with water and / or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

Initial treatment course with once daily application:
The initial treatment with a once daily regimen should be limited to 4 consecutive weeks at a maximum dose of 50 ml per week. If no improvement is seen within four weeks, re- assessment of the diagnosis may be necessary.

Maintenance treatment with twice weekly applications:
Repeated courses of Clobex u00ae Shampoo may be used to control exacerbations provided the patient is under regular medical supervision. As soon as clinical results are observed or if the patient has mild plaque psoriasis after 4 weeks with the once daily treatment regimen, Clobex u00ae Shampoo may be used twice weekly to maintain the therapeutic effect and to prevent recurrence. The effectiveness and safety of a twice weekly maintenance regimen with Clobex u00ae Shampoo in preventing scalp psoriasis recurrence has not been demonstrated for more than a 6-month period. If Clobex u00ae Shampoo accidentally enters the eye, the affected eye should be rinsed with copious amounts of water.

Special Populations
Elderly
The safety and efficacy of Clobex u00ae Shampoo in elderly patients aged 65 years and above has not been established.
Renal Impairment
Clobex u00ae Shampoo has not been studied in patients with renal impairment.
Hepatic Impairment
Patients with severe liver dysfunction should be treated with special caution and closely monitored for side-effects.
Paediatric Population
The safety and efficacy of Clobex u00ae Shampoo in children < 18 years of age has not been established. Clobex u00ae Shampoo is not recommended for use in children and adolescents below 18 years of age (see sections 4.3 and 4.4).

Hypersensitivity to clobetasol propionate or to any of the excipients of Clobexu00ae Shampoo listed in section 6.1. Clobex u00ae Shampoo must not be applied to scalp areas affected by bacterial and mycobacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by lues). Clobex u00ae Shampoo must not be applied on areas other than the scalp, and should not be used in ulcerative skin lesions. Clobex u00ae Shampoo must not be applied to the eyes and eyelids (risk of glaucoma, risk of cataract). Children under the age of 18 years. Pregnancy and lactation (see section 4.6)

Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations. Hypersensitivity to corticosteroids can be observed. Therefore, Clobex u00ae Shampoo is not recommended in patients who are hypersensitive to other corticosteroids. Cases of osteonecrosis serious infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see section 4.2). In some cases patients used concomitantly other potent oral/topical corticosteroids or immunosuppressive medicines (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Clobex u00ae Shampoo should be used with caution for a number of reasons including post treatment rebound relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity such as skin atrophy, infection, telangiectasia of the skin or hypothalamic-pituitary-adrenal axis suppression.

Long-term continuous therapy with daily use of corticosteroids, use of occlusive dressings or treatment of large surface areas can enhance absorption and may lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients should be evaluated periodically for evidence of HPA axis suppression. Systemic absorption of topical corticosteroids induced by prolonged use especially on large surface areas has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency, manifestations of Cushingu2019s syndrome, hyperglycaemia, and glycosuria in some patients. Such systemic effects disappear when treatment is terminated. However, abrupt discontinuation can lead to acute adrenal insufficiency. Clobex u00ae Shampoo must not be applied in intertriginous areas (axillae and genito-anal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangiectasia or corticosteroid induced dermatitis or secondary infection. Use with caution near the eyes. If Clobex u00ae Shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water. If a secondary bacterial infection is present, suitable concomitant antimicrobial therapy should be applied. Treatment of psoriasis with corticosteroids (or its withdrawal) may provoke the pustular form of the disease. 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. Paediatric population
Growth retardation may also be observed in case of systemic absorption of topical corticosteroids. Clobex u00ae Shampoo is not recommended for use in children and adolescents below 18 years of age (see section 4.3).

Interaction studies have not been done.

Pregnancy
Clobex u00ae Shampoo has been shown to be teratogenic following dermal application in animals. Clobex u00ae Shampoo should therefore not be used during pregnancy (see section 4.3).
Breastfeeding
Clobex u00ae Shampoo should not be used in breastfeeding mothers (see section 4.3).
Fertility
No clinical data is available

Clobex u00ae Shampoo has no or negligible influence on the ability to drive and use machines.

Long-term continuous therapy with Clobex u00ae Shampoo may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasia and ecchymoses, especially if applied to the face or if occlusive dressings are used. Discontinue treatment if irritation or sensitisation occurs and treat appropriately.
Endocrine system:
Less frequent: Systemic absorption may occur, especially when large quantities of the shampoo are used or applied to large areas of the body or to damaged skin and when an occlusive dressing technique is applied. This may result in benign intracranial hypertension, a Cushingoid state, depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland and growth retardation.
Skin and subcutaneous tissue disorders:
Less frequent: Dryness, irritation, skin atrophy, hypopigmentation, maceration of the skin and striae, have been reported.
Tabulated list of adverse reactions
The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (u2265 1/10), common (u2265 1/100 to < 1/10), uncommon (u2265 1/1000 to < 1/100), rare (u2265 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data) and were reported with Clobex u00ae Shampoo in clinical studies and post- marketing (see Table 1).
Table 1 u2013 Adverse reactions:
System Organ Class Frequency Adverse Drug Reaction
Immune System disorders Uncommon (u2265 1/1 000 to < 1/100) Hypersensitivity
Endocrine disorders Uncommon (u2265 1/1 000 to < 1/100) Adrenal suppression Cushing syndrome
Nervous System disorders Uncommon (u2265 1/1 000 to < 1/100) Headache
Eye disorders Uncommon (u2265 1/1 000 to < 1/100) Eye stinging/burning Eye irritation Ocular tight sensation Glaucoma Not known Vision, blurred (see section 4.4)
Skin and subcutaneous issue disorders Common (u2265 1/100 to < 1/10) Skin burning sensation Folliculitis Uncommon (u2265 1/1 000 to < 1/100) Pain of skin Skin discomfort Pruritus Acne Skin oedema Telangiectasia Psoriasis (aggravation) Alopecia Dry skin Urticaria Skin atrophy
Skin irritation Skin tightness Allergic contact dermatitis Erythema Rash Cataract has been reported when corticosteroids were applied to the eyes or eyelids. Immunosuppression and opportunistic infections have been reported in case of prolonged use of potent topical corticosteroids in rare instances. Growth retardation may be observed in children in case of systemic absorption of topical corticosteroids (See section 4.3). Rebound effects may occur upon discontinuation of treatment. When applied to the face, very potent corticosteroids can also induce perioral dermatitis or worsen rosacea. There are reports of pigmentation changes, pustular eruptions and hypertrichosis with topical corticosteroids.

See section 4.4 and 4.8. Acute overdosage is unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision. TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.