Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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Clobetasol propionate shampoo contains the active substance called clobetasol propionate; it belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups depending on their strength; clobetasol propionate is a very strong corticosteroid. « Topical » means that it should only be applied to the surface of the skin. Topical steroids reduce the redness, itchiness and inflammation associated with skin conditions. Scalp psoriasis is caused by the skin cells of your scalp being produced too quickly. clobetasol propionate shampoo is used to treat scalp psoriasis of moderate intensity in adults. 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. 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. 2.
e clobetasol propionate 500 micrograms/g shampoo
Do not use clobetasol propionate 500 micrograms/g shampoo
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Do not apply clobetasol propionate shampoo in the eyes or on eyelids (risk of glaucoma which is high pressure in the eye and risk of cataract which is a clouding of the lens in the eye).
Warnings and precautions Talk to your doctor or pharmacist before using clobetasol propionate 500 micrograms/g shampoo:
clobetasol propionate 500 micrograms/g shampoo
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual daily dose per application is an amount equivalent to around a half tablespoon (around 7.5 ml) sufficient to cover the entire scalp.
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Unless your doctor has instructed otherwise, wash your hands and apply clobetasol propionate shampoo directly to your dry scalp once daily taking care to well cover and massage the affected areas. Avoid using large amounts of clobetasol propionate shampoo, only use enough to cover your scalp when dry. Wash your hands carefully after application. Leave the product to work for 15 minutes without covering, and then add water, rinse and dry your hair as usual. Your regular shampoo can be used if more shampoo is required to wash your hair. Do not add more of clobetasol propionate shampoo to your hair. Your doctor will tell you how long you need to use clobetasol propionate shampoo to control your scalp psoriasis. Treatment should not normally continue for more than 4 weeks. However, if your scalp psoriasis is significantly improved before the end of treatment, please see your doctor. On the contrary, if no improvement is seen by the end of the treatment, please tell your doctor. This treatment needs careful supervision; you should let your doctor review your progress at regular intervals. Do not use clobetasol propionate shampoo for longer than your doctor tells you. Nonetheless, your doctor may ask you to use clobetasol propionate shampoo again in the future following a period of no use. Use in children and adolescents If this product has been prescribed for children or adolescents between the ages of 2 and 18 years, the instructions given by your doctor must be followed. You must check with the doctor every week before continuing treatment. If you use more clobetasol propionate 500 micrograms/g shampoo than you should If you have used clobetasol propionate shampoo for much longer than you should, please see your doctor. This product is for use on the scalp only. Do not swallow it. If you accidentally do so, small amounts are not harmful. If you are not sure, seek immediate medical advice. If you forget to use clobetasol propionate 500 micrograms/g shampoo If you forget to use clobetasol propionate shampoo, do not take a double dose to make up for a forgotten dose. Go back to your regular schedule. If you miss several doses, tell your doctor. If you stop using clobetasol propionate 500 micrograms/g shampoo If you stop using clobetasol propionate shampoo, please see your doctor. It may be that worsening of the disease occurs when treatment with clobetasol propionate shampoo is stopped, especially if it has been used for a long time. Tell your doctor if you observe such a worsening of your scalp psoriasis conditions. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. clobetasol propionate shampoo may cause the following side effects: Common side effects (may affect up to 1 in 10 people):
• • • • • • • • • • • • • • • • • • •
Glaucoma Hypersensitivity Headache Pain of skin Skin discomfort Itching Acne Skin oedema Telangiectasia (veins under the surface of your skin may becoming more noticeable) Psoriasis aggravation Hair loss Dryness of the skin Urticaria Skin atrophy (thinning of your skin) Skin irritation Skin tightness Allergic contact dermatitis Erythema Rash
Not known (frequency cannot be estimated from the available data)
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.
clobetasol propionate 500 micrograms/g shampoo
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of that month. Store in the original plastic bottle in order to protect from light. Discard the bottle 4 weeks after first opening. 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 protect the environment. 6.
What clobetasol propionate 500 micrograms/g shampoo contains
The other excipients are: Ethanol 96%, coco alkyl dimethyl betaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid monohydrate, purified water.
What clobetasol propionate 500 micrograms/g shampoo looks like and contents of the pack This medicine is a colourless to slightly yellow viscous liquid shampoo clear to slightly cloudy in appearance. It is available on prescription from your doctor in HDPE (high density polyethylene) plastic bottles sealed by a polypropylene cap (125 ml bottles). Marketing Authorisation Holder Vygoris Limited 930 High Road London, N12 9RT United Kingdom Tel: +44 (0) 1223 395301 Manufacturer Farmaclair 440 Avenue du General de Gaulle 14200 Hérouville Saint Clair France Stradis 29 Rue Léon Faucher 51100 Reims France This leaflet was last revised in June 2026.
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The active substance in Clobetasol propionate 500 micrograms/g shampoo is clobetasol propionate.
Medicines with the same active substance, strength and form include: CLARELUX 500 microgram/g cutaneous foam in pressurised container, Etrivex 500 micrograms/g Shampoo, Clobetasol propionate 500 microgram/g Shampoo. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Clobetasol propionate 500 micrograms/g shampoo, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Topical treatment of moderate scalp psoriasis in adults.
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 (see details below).
Posology
Clobetasol propionate 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp.
The total dosage should not exceed 50 g per week.
Method of administration
For cutaneous use on the scalp only.
After application, clobetasol propionate 500 micrograms/g shampoo should be kept in place without covering for 15 minutes. Hands should be washed carefully after 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.
The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.
Repeated courses of clobetasol propionate 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.
Special population
Elderly
The safety and efficacy of clobetasol propionate 500 micrograms/g shampoo in geriatric patients aged 65 years and above have not been established.
Renal impairment
Clobetasol propionate 500 micrograms/g 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 experience in the paediatric population is limited. Clobetasol propionate 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age. It is contraindicated in children under 2 years of age (see sections 4.3 and 4.4).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clobetasol propionate 500 micrograms/g shampoo must not be applied on skin areas affected by bacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections, ulcerous wounds and specific skin diseases (skin tuberculosis, skin diseases caused by lues).
Clobetasol propionate 500 micrograms/g shampoo must not be applied to the eye and eyelids (risk of glaucoma, risk of cataract).
Children under 2 years of age.
Hypersensitivity to corticosteroids can be observed.
Therefore, clobetasol propionate, is not recommended in patients who are hypersensitive to other corticosteroids.
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.
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.
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.
Clobetasol propionate 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, Clobetasol propionate 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.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). 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. It is more likely to occur when delicate skin sites such as the face and flexures are treated. 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 advise is recommended in these cases or other treatment options should be considered.
If clobetasol propionate 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 clobetasol propionate 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. clobetasol propionate 500 micrograms/g shampoo should not be used in children and adolescents between 2 and 18 years of age.
If clobetasol propionate 500 micrograms/g shampoo is used in children and adolescents below 18 years of age, the treatment should be reviewed weekly.
The label will state very strong steroid.
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.
Clobetasol propionate 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, clobetasol propionate 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.
Fertility
No clinical data is available. See section 5.3.
Clobetasol propionate 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 clobetasol propionate 500 micrograms/g shampoo, in a total of 558 patients receiving clobetasol propionate 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 clobetasol propionate 500 micrograms/g shampoo in clinical studies and post-marketing (see Table 1).
Table 1 – Adverse reactions
System Organ Class
Frequency
Adverse reactions
Endocrine disorders
Uncommon
Adrenal suppression
Cushing syndrome
Eye disorders
Uncommon
Eye stinging/burning
Eye irritation
Ocular tight sensation
Uncommon
Glaucoma
Not known
Vision, blurred (see also section 4.4)
Immune System Disorders
Uncommon
Hypersensitivity
Nervous System disorders
Uncommon
Headache
Skin and subcutaneous tissue disorders
Common
Skin burning sensation, Folliculitis
Uncommon
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
Not known
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)
As clobetasol propionate 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 clobetasol propionate 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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision.
Ask anything about Clobetasol propionate 500 micrograms/g shampoo. 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.
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