CLARELUX Cutaneous foam Ref.[7162] Active ingredients: Clobetasol propionate

Special warnings

Hypersensitivity

CLARELUX should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see section 4.8) may resemble symptoms of the condition under treatment.

Stop using immediately if signs of hypersensitivity appear.

Infections and infestations

The use of CLARELUX on wounds or ulcerations is not recommended.

Secondary infection may develop; bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

Adrenal suppression

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals, particularly in children as a result of increased systemic absorption of topical steroids.

If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see section 4.8).

Long-term continuous topical therapy should be avoided as adrenal suppression can occur readily even without use with an occlusive dressing. Upon clearing of lesions or after a maximum treatment period of two weeks, change to intermittent therapy or consider replacing with a weaker steroid.

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 (see Precautions for use) or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Precautions for use

Increased systemic absorption of topical steroids

Increased systemic absorption of topical steroids can lead to occurrence of systemic adverse reactions (i.e. adrenal suppression, immunosuppression). Increased systemic absorption of topical steroids can be facilitated by:

• long term exposure,
• application to a large surface area,
• use on occluded skin areas (e.g. on intertriginous areas or under occlusive dressings),
• use on thin areas (e.g. face),
• use on broken skin or other conditions where the skin barrier may be impaired,
• and increasing hydration of the stratum corneum.

Unless supervised by a physician, CLARELUX should not be used with occlusive dressings.

Rebound phenomenon

A rebound phenomenon in the form of flushing, stinging and burning of the skin may be seen in the event of sudden discontinuation after long-term use. This can be avoided by withdrawing treatment gradually.

Topical corticosteroids may be hazardous because rebound relapses can follow development of tolerance. Patients may also be exposed to the risk of developing generalised pustular psoriasis and local or systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.

Eye disorders

Systemic corticosteroids therapy is associated with glaucoma and cataract formation. This risk has also been reported during ophthalmic treatment, and during regular local corticosteroid application to the eyelids. Additionally there have been reports of cataracts and glaucoma in patients following prolonged potent topical corticosteroid overuse on the face and/or the body. Although hypertensive effect of topical steroid is usually reversible after cessation of treatment, the visual defects resulting from glaucoma and cataracts are irreversible.

CLARELUX should not be applied on the eyelids.

Patients should wash their hands after each application to avoid eye contamination with CLARELUX. If CLARELUX becomes in contact with the eye, the affected eye should be bathed in copious amounts of water.

Patients on prolonged courses of potent topical steroids should be screened for cataract and glaucoma on a regular basis, especially patients with known risk factors for cataract (e.g. diabetes, smokers) or for glaucoma (e.g. personal or family history of glaucoma).

Paediatric population

CLARELUX is not recommended for use in children less than 12 years old (see section 5.1).

Excipients with known effect

This medicinal product contains propylene glycol, which may cause skin irritation. This medicinal product also contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

No interaction studies have been performed.

Pregnancy

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see section 5.3). There are no adequate and well-controlled studies of clobetasol propionate in pregnant women. Epidemiological studies in pregnant women following use of oral corticosteroids have indicated little or no risk with regard to an association with cleft palate. Limited evidence suggests a small risk for low birth weight when using large amounts of potent/very potent topical corticosteroids such as clobetasol propionate in pregnancy.

CLARELUX in pressurised container should not be used during pregnancy unless clearly necessary.

Breast-feeding

The safe use of clobetasol propionate during lactation has not been established. Glucocorticosteroids are excreted in breast milk, therefore CLARELUX 500 micrograms/g, cutaneous foam in pressurised container should not be used in breast-feeding women unless clearly necessary.

Fertility

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

Clobetasol administered subcutaneously to rats decreased fertility in females at the highest dose (see section 5.3).

No studies on the effects on the ability to drive and use machines have been performed.

Summary of the safety profile

As with other topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas can result in adrenocortical suppression. This is likely to be transient if the weekly dosage does not exceed 50g in adults.

Prolonged and intensive treatment with a highly active corticosteroid preparation may cause local changes in the skin such as skin atrophy, ecchymoses secondary to skin atrophy, skin fragility, telangiectasia, especially on the face, striae particularly affecting the proximal limbs.

Additional local adverse events associated with glucorticosteroids include perioral dermatitis, rosacea-like dermatitis, delayed wound healing, rebound phenomenon which can lead to dependence on corticosteroids, and effects on the eyes. Rise of intraocular pressure and increased risk for cataract are known side effects for glucocorticosteroids (see section 4.4).

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease (see section 4.4).

Secondary infection may develop; bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied. If the product is not used properly, bacterial, viral, parasitic, and fungal infections may be masked and/or aggravated (see section 4.4). Folliculitis has also been reported.

Contact allergy to CLARELUX or one of the excipients may occur. If signs of hypersensitivity appear, applications should be stopped immediately. Exacerbation of symptoms may occur.

The most commonly observed adverse reactions associated with the use of clobetasol propionate cutaneous foam formulations in clinical trials were application site reactions including burning (5%) and other non-specified reactions (2%).

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)".

Infections and infestations

Unknown: Secondary infections, Folliculitis

Endocrine disorders

Very rare: Pituitary adrenal system suppression

Nervous system disorders

Very rare: Paraesthesia

Eye disorders

Very rare: Eye irritation

Unknown: Cataract, Blurred vision

Skin and subcutaneous tissue disorders

Very rare: Vasodilatation, Dermatitis NOS, Contact dermatitis, Psoriasis aggravated, Skin irritation, Skin tenderness, Skin tightness

Unknown: Pigmentation change, Hypertrichosis

General disorders and administration site conditions

Very rare: Application site burning, Application site reaction NOS, Application site erythema, Application site pruritus, Pain NOS

Investigations

Very rare: Blood urine present, Mean cell volume increased, Protein urine present, Urine nitrogen

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 United Kingdom, Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.