Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
CLARELUX 500 microgram/g cutaneous foam in pressurised container
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clobetasol propionate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
CLARELUX contains the active substance clobetasol propionate which belongs to a group of medicines known as topical corticosteroids. Clobetasol propionate is a very strong topical corticosteroid. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent, or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. CLARELUX 500 micrograms/g cutaneous foam in pressurised container (clobetasol propionate) is classed as a very strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. CLARELUX 500 micrograms/g cutaneous foam in pressurised container is a foam to be applied to the skin. CLARELUX 500 micrograms/g cutaneous foam in pressurised container is used in adult and adolescent patients from age of 12 years as a short-course treatment of steroid response dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids.
2.
What you need to know before you take it
e CLARELUX
Do not use CLARELUX: • If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of this medicine (listed in section 6).
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• • • • • •
If you have an infectious skin disease, either viral (e.g. herpes, shingles, chickenpox…), bacterial (e.g. impetigo …), fungal (caused by microscopic fungi) or parasitic. If you suffer from burns, ulcerated lesions or other skin conditions such as rosacea, acne, skin inflammation around the mouth. If you have itching (pruritus) around the anus or genitals. On any area of your body or face (including the eyelids), apart from your scalp. In application to the eyelids (risk of damage to the nerve in the eye (glaucoma) and clouding of the lens (cataract)). In infants (children under 2 years old).
Warnings and precautions Talk to your doctor or pharmacist before using CLARELUX. Inform your doctor if you previously had an allergy to corticosteroids and/or to any components of this medicine. Stop treatment immediately and talk to your doctor if there is a worsening of your condition during use
- you may be experiencing an allergic reaction, signs of which may include skin rash, itching or painless tissue swelling (oedema), have an infection or your condition requires a different treatment. Long-term treatment should be avoided. If you experience a recurrence of your condition shortly (within 2 weeks) after stopping treatment, do not restart using CLARELUX without consulting your doctor unless your doctor has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment, because a rebound phenomenon could be suspected (see section 4). Due to the deterioration of the skin barrier, there is a risk of sudden onset of painful pustules filled with non-infectious fluid that may be accompanied by fever (generalized pustular psoriasis) or the occurrence of local or systemic toxicity. Avoid contact with eyes or mucous membranes (nose, mouth). Do not apply CLARELUX on the eyelids or on the face due to risk of developing cloudy lens in the eyes (cataract) and increased pressure in the eye (glaucoma) which cause irreversible damage to the eyes. Contact your doctor if you experience blurred vision or other visual disturbances. Wash your hands carefully after each application. Do not touch your eyes until you have washed your hands. In the event of accidental contact with the face or eyes, rinse thoroughly with plenty of water. Unless supervised by a physician, the application of CLARELUX over a large surface area, or under bandaged and covered areas is to be avoided due to risk of some of the active ingredient passing to the bloodstream. Bacterial infection may occur, facilitated by the heat and moisture in skin under occlusive dressings. Do not use an occlusive dressing, unless directed by your doctor. In this case the skin should be cleaned before each dressing change. Report any irritation or infection to your doctor as appropriate treatment will need to be used if infection occurs. If the infection spreads, CLARELUX should be discontinued and the infection treated. As with all topical corticosteroids, CLARELUX can be absorbed through the skin with a risk of the active ingredient passing into the blood stream causing side effects such as the decreased production of adrenal glands hormones (pituitary adrenal system suppression) and Cushing's syndrome – see Section 4
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for all possible side effects. The risk of this corticosteroid passing into the bloodstream is increased in the following situations: • Long-term treatment; • Application to a large surface area; • Application under bandaged or covered areas, such as occlusive dressings; • Application on broken, damaged skin, such as wounds or open sores (ulcerations); • Application on thin skin area such as the face; • Increased skin hydration. Inform your doctor if: • You experience newly developed bone pain or worsening of previous bone symptoms during a treatment with CLARELUX, especially if you have been using CLARELUX for a prolonged time or repeatedly. • You use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining CLARELUX with these medicines may result in serious infections. • Your condition does not improve after 2 weeks of treatment. • An infection occurs, as this may require discontinuation of treatment with CLARELUX and administration of appropriate antimicrobial therapy. Children and adolescents Treatment is not recommended in children less than 12 years old. Other medicines and CLARELUX Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. CLARELUX with food, drink and alcohol Not applicable. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy CLARELUX should not be used during pregnancy unless advised by your doctor. Breast-feeding CLARELUX should not be used during breast-feeding unless advised by your doctor. Driving and using machines CLARELUX should not affect your ability to drive or operate machines. Important information about some of the ingredients in CLARELUX This medicine contains: ˗ 2145 mg of alcohol (ethanol) in each application, which may cause burning sensation on damaged skin, ˗ 74 mg of propylene glycol (E 1520) in each application, ˗ cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis), ˗ polysorbate 60 (E 435), which can cause allergic reactions.
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3.
How to take it
CLARELUX WARNINGS: The canister contains a pressurised, flammable liquid. Do not use or store near a naked flame, source of ignition, any heat generating material or electrical device in use. Do not smoke whilst using or holding this can.
Always use CLARELUX exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Use this medication only for the condition for which it was prescribed. CLARELUX must only be applied to the scalp and should not be swallowed. Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Apply CLARELUX to the affected area of the scalp twice a day, once in the morning and once at night, as follows: Attention: for proper dispensing of foam, it is important to hold the container upside down! 1.
Shake the can well.
2.
Turn the can upside down and squirt a small amount (the size of a walnut) either directly onto the scalp, or into the cap of the can, onto a saucer or other cool surface and then onto the scalp. CLARELUX should always be applied thinly, so use as little as possible when covering the affected areas. The exact amount you need depends on the size of the affected area. Do not squirt CLARELUX onto your hands, as the foam will begin to melt immediately upon contact with warm skin.
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3.
Move the hair away from the foam and gently massage into the scalp, until it disappears and is absorbed. Repeat if necessary, to treat the entire affected area.
Wash your hands after applying CLARELUX and discard any unused foam. Do not use CLARELUX on your face or to your eyelids. If some foam accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a stinging sensation. Contact your doctor, if the pain continues. The treated areas should not be bandaged or covered unless directed by your doctor. Do not wash or rinse the treated scalp areas immediately after applying CLARELUX. Duration of treatment Do not use more than 50 g of CLARELUX foam per week. Treatment should not be given for more than 2 weeks. After this period CLARELUX may be used occasionally if needed. Alternatively, your doctor may prescribe a weaker steroid to control your condition. If you use more CLARELUX than you should Inform your doctor immediately if you have applied CLARELUX in quantities larger than the prescribed dose or for a longer period than that stated on your prescription. In these cases, there is a risk of the active ingredient passing into the blood stream causing side effects such as symptoms of hypercorticoidism (weight gain, fat build-up on the face, high blood pressure). The use of CLARELUX should be withdrawn gradually and under medical supervision, by reducing the frequency of application or by substituting to a less potent corticosteroid. If you forget to use CLARELUX Use it as soon as you remember, then continue as before. If you only remember at the time of your next dose, use a single dose and continue as before (do not apply a double dose to make up for the forgotten dose). If you miss several doses, tell your doctor. If you stop using CLARELUX Do not stop using CLARELUX suddenly as this may harm you. Your doctor may need to discontinue the treatment gradually and you may need regular check-ups. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using CLARELUX 500 micrograms/g cutaneous foam and contact your doctor immediately if 5/8
allergic reactions (hypersensitivity) occur, such as local irritation. The side effects may include: Common side effects (may affect up to 1 in 10 people but more than 1 in 100): • Burning sensation of skin where CLARELUX is applied • Other skin reactions where CLARELUX is applied Rare effects (may affect up to 1 in 1,000 people): • Pustular psoriasis (chronic skin inflammation accompanied by pustules) Very rare effects (may affect up to 1 in 10,000 people): • Decreased production of adrenal glands hormones (Hypothalamic Pituitary adrenal system suppression) • Sensation like numbness, tingling or pricking (paraesthesia) • Eye irritation • Swollen blood vessels (vasodilation) • Skin irritation, pain of skin (tenderness), skin tightness • Itchy skin rash (contact dermatitis), inflammation of the skin (dermatitis) • Aggravation of psoriasis • Redness (erythema) at the application site • Itching (pruritus) at the application site • Pain • Presence of blood, protein and nitrogen in your urine may be detected by a doctor • Alterations in the blood test indicating that red blood cells are larger than average (mean cell volume increased) Additional side effects may include with an unknown frequency (cannot be estimated from the available data): • Secondary infection may occur, particularly in the event of treatment covered by an occlusive dressing or in skinfolds (armpits, anal and genital region). Signs of infection include redness of the skin, possibly accompanied by pain or itching. • Excessive hairiness (hypertrichosis) • Changes in skin colour • Inflammation of hair follicles (folliculitis) • Mouth rashes (perioral dermatitis) • Redness and eruptions on the face (rosacea-like dermatitis) • Delay in wound healing • Cloudy lens on the eyes (cataract), high pressure in the eye (glaucoma) • Blurred vision
Possible side effects
caused by prolonged use include with an unknown frequency (cannot be estimated from the available data): • As with other topical corticosteroids, when CLARELUX is used in large amounts and for a long period of time, this can lead to a disorder called Cushing's syndrome which include signs such as weight gain, fat build-up on the face and bruising caused by too much of corticosteroid hormone.
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Topical steroid withdrawal reaction (rebound phenomenon). If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. Local changes in the skin such as thinning (skin atrophy) and fragility, colorful bruises (ecchymoses), small visible blood vessels (telangiectasia) especially on the face, stretch marks (striae) particularly affecting the proximal limbs.
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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5.
How to store it
CLARELUX • •
• • •
The canister contains a pressurised, flammable liquid. Do not store near a naked flame, source of ignition, any heat generating material or electrical device in use. Do not expose to temperatures higher than 50oC or to direct sunlight. Do not pierce or burn the can even when empty. When you have finished your treatment, dispose of the can safely.
Keep out of the sight and reach of children. Do not use CLARELUX after the expiry date which is stated on the can and the outer carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate. Store upright. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6.
Contents of the pack and other information
What CLARELUX contains The active substance is clobetasol propionate and 1 g of cutaneous foam contains 500 micrograms of clobetasol propionate. The other ingredients are: ethanol anhydrous, purified water, propylene glycol (E 1520), cetyl alcohol,
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stearyl alcohol, polysorbate 60 (E 435), citric acid anhydrous, potassium citrate and a propane/nbutane/isobutane propellant mixture. What CLARELUX looks like and contents of the pack CLARELUX 500 micrograms/g cutaneous foam is a cutaneous white foam in pressurised container. Each can contains 50 or 100 grams. Not all pack sizes may be marketed. Marketing Authorisation Holder Pierre Fabre Limited 250 Longwater Avenue Green Park Reading RG2 6GP Manufacturer(s) Recipharm Uppsala AB Björkgatan 30 751 82 Uppsala Sweden Or Farmol Health Care S.r.L. Via del Maglio, 6 23868 Valmadrera (LC), Italy
This leaflet was last revised in 06/2025.
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Frequently asked questions about CLARELUX 500 microgram/g cutaneous foam in pressurised container
What is the active substance in CLARELUX 500 microgram/g cutaneous foam in pressurised container?
The active substance in CLARELUX 500 microgram/g cutaneous foam in pressurised container is clobetasol propionate.
Are there equivalent medicines to CLARELUX 500 microgram/g cutaneous foam in pressurised container?
Medicines with the same active substance, strength and form include: Etrivex 500 micrograms/g Shampoo, Clobetasol propionate 500 microgram/g Shampoo, Clobetasol propionate 500 micrograms/g shampoo. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for CLARELUX 500 microgram/g cutaneous foam in pressurised container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get CLARELUX 500 microgram/g cutaneous foam in pressurised container without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: clobetasol propionate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
CLARELUX 500 micrograms/g, cutaneous foam in pressurised container is indicated in adult and adolescent patients from age of 12 years for a short-course treatment of steroid responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids.
4.2. Posology and method of administration
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 2 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).
Posology
CLARELUX 500 micrograms/g, cutaneous foam in pressurised container is a highly potent topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.
Route of administration: for cutaneous use.
CLARELUX 500 micrograms/g, cutaneous foam in pressurised container should be applied to the affected area twice daily. There are no data from clinical studies evaluating the efficacy of once daily application.
Repeated courses of CLARELUX 500 micrograms/g may be used to control exacerbations provided the patient is under regular medical supervision (see section 4.4).
Paediatric population
CLARELUX is not recommended for use in children less than 12 years old (see section 5.1).
Method of administration
For cutaneous use
The foam application has been designed so that the preparation spreads easily without being too fluid and allows easy application direct to the affected area.
Note: for proper dispensing of foam, hold the container upside down and depress the actuator.
Invert the container and dispense a small amount (of the size of a walnut or one teaspoon) of CLARELUX directly on the lesions or dispense a small amount into the cap of the container, onto a saucer or other cool surface, taking care to avoid contact with eyes, nose, and mouth. Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Gently massage into affected area until the foam disappears and is absorbed. Repeat until entire affected area is treated. Move the hair away from the affected area so that the foam can be applied to each affected area.
Avoid contact with eyes, nose and mouth.
Do not use near a naked flame.
Hands should be washed carefully after application.
4.3. Contraindications
CLARELUX is contraindicated in patients with:
• hypersensitivity to clobetasol propionate, to other corticosteroids, or to any of the excipients listed in section 6.1;
• ulcerated lesions, burns;
• rosacea;
• acne vulgaris;
• perioral dermatitis;
• perianal and genital pruritus.
The use of CLARELUX is contraindicated in the treatment of primary infected skin lesions caused by infection with parasites, viruses, fungi or bacteria.
CLARELUX 500 micrograms/g, cutaneous foam in pressurised container:
• must not be used on the face.
• is contra-indicated in infants under 2 years old (see section 4.3).
• must not be applied to the eyelids (risk of glaucoma and cataract).
4.4. Special warnings and precautions for use
Special warnings
The label will state CLARELUX is a 'very strong steroid'.
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.
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.
Long term use
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 2 weeks, a less potent corticosteroid preparation should be considered.
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.
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.
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.
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
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal reaction). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. This rebound phenomenon is more likely to occur when delicate skin sites such as the face and flexures are treated and may be seen in the event of sudden discontinuation after long-term use. This can be minimised by withdrawing treatment gradually or by substituting a less potent corticosteroid.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
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
CLARELUX should not be applied on the eyelids (see section 4.3).
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:
˗ 2145 mg of ethanol in each application, which may cause burning sensation on damaged skin,
- 74 mg of propylene glycol (E 1520) in each application,
- cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
- polysorbate 60 (E 435), which can cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
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).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
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 50 g 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 glucocorticosteroids include perioral dermatitis, rosacea-like dermatitis, delayed wound healing, rebound phenomenon (topical steroid withdrawal reactions) which can lead to dependence on corticosteroids, and effects on the eyes. Rise of intraocular pressure and increased risk for cataract and blurred vision 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
Adverse reactions observed with the use of clobetasol propionate in clinical trials are classified by systems organ class and listed below as 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)”.
Post marketing data concerning adverse reactions reported with the use of foam have been classified by systems organ class and listed as not known (cannot be estimated from the available data).
SOC
Common
Very rare
Not known
Infections and infestations
Secondary infections
Folliculitis
Endocrine disorders
Hypothalamic pituitary adrenal axis suppression
Nervous system disorders
Paraesthesia
Eye disorders
Eye irritation
Cataract
Blurred vision (see section 4.4)
Vascular disorder
Vasodilatation
Skin and subcutaneous tissue disorders
Dermatitis
Contact dermatitis
Psoriasis aggravated
Skin irritation
Pain of skin
Skin tightness.
Pigmentation change
Hypertrichosis
Topical steroid withdrawal reactions* (see section 4.4)
General disorders and administration site conditions
Application site burning
Application site reaction
Application site erythema
Application site pruritus
Pain
Investigations
Blood urine present
Mean cell volume increased
Protein urine present
Urine nitrogen
* Topical steroid withdrawal reactions (redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules) (see 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; Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Topically applied CLARELUX in pressurised container can be absorbed in sufficient amounts to produce systemic effects. If features of hypercorticoidism appear topical steroids should be discontinued gradually and, because of the risk of acute adrenal suppression, this should be done under medical supervision (see section 4.4).
💬 Ask about this leaflet
Ask anything about CLARELUX 500 microgram/g cutaneous foam in pressurised container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.