ETRIVEX Shampoo Ref.[49925] Active ingredients: Clobetasol propionate

Hypersensitivity to corticosteroids can be observed.

Therefore, Clobetasol propionate, 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 immunosuppressors (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered.

Long-term continuous therapy with corticosteroids, use of occlusive mobcaps, treatment of large surface areas especially in children can enhance absorption and lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may 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 Cushing’s syndrome in some patients. Such systemic effects resolve when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children.

Patient with severe diabetes mellitus should be treated with special caution and closely monitored for side-effects.

Topical corticosteroids should be used with caution as development of tolerance (tachyphylaxis) may occur as well as local toxicity such as skin atrophy, infection and telangiectasia of the skin.

Etrivex 500 micrograms/g shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Etrivex 500 micrograms/g shampoo is not recommended for use in the face, intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of adverse events such as atrophic changes, telangiectasia, corticosteroid-induced dermatitis or secondary infection. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids.

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use.

Clobetasol propionate, is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

There may be a risk of post-treatment rebound or relapse upon abrupt discontinuation of treatment with clobetasol propionate. Medical supervision should therefore continue in the post-treatment period.

If Etrivex 500 micrograms/g shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.

Patients should be instructed to use Etrivex 500 micrograms/g shampoo for the minimum amount of time necessary to achieve the desired results. If signs of local intolerance appear, application should be suspended until they disappear. If signs of hypersensitivity appear, application should be stopped immediately.

In order to avoid interaction with hair colour dying product, such as hair colour changes, clobetasol propionate shampoo should be thoroughly rinsed.

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.

Paediatric population

In this age group, growth retardation may also be observed in case of systemic absorption of topical corticosteroids. Etrivex 500 micrograms/g Shampoo should not be used in children and adolescents between 2 and 18 years of age.

If Etrivex 500 micrograms/g shampoo is used in children and adolescents below 18 years of age, the treatment should be reviewed weekly.

This medicine contains 100 mg alcohol (ethanol) in each gram which is equivalent to 10% w/w.

It may cause burning sensation on damaged skin.

No interaction studies have been performed.

Pregnancy

There are no adequate data from the use of topical clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Etrivex 500 micrograms/g shampoo should not be used during pregnancy unless clearly necessary.

Breast-feeding

Systemically administered corticosteroids pass into breast milk. Damage to the infant is not reported to date. Nevertheless, as there are no adequate data on the possible milk transfer of topical clobetasol propionate and its biological or clinical repercussions, Etrivex 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.

Fertility

No clinical data is available. See section 5.3.

Etrivex 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

During clinical development of Etrivex 500 micrograms/g shampoo, in a total of 558 patients receiving Etrivex 500 micrograms/g shampoo, the most commonly reported adverse drug reaction was skin burning sensation. Its incidence was about 2.8%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. Clinical signs of skin irritation were uncommon (0.2%). No serious drug-related adverse events were reported during any of the clinical trials.

Tabulated list of adverse reactions

The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥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 Etrivex 500 micrograms/g Shampoo in clinical studies and post-marketing (see Table 1).

Table 1. Adverse reactions:

As Etrivex 500 micrograms/g shampoo is to be kept in place for only 15 minutes before rinsing, systemic absorption is seldom observed (see section 5.2) and therefore, the risk of appearance of HPA axis suppression is very low compared to non rinsed potent corticosteroids products. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values.

Cataract has been reported when corticosteroids where 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.

Although not observed with Etrivex 500 micrograms/g shampoo, prolonged and/or intensive treatment with potent corticosteroid preparations may cause striae, purpura, and generalised pustular psoriasis.

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.

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 Yellow Card Scheme at: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.