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.
Clobetasol propionate 500 microgram/g Shampoo
⚠ 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
This medicine belongs to a group of medicines called topical corticosteroids (or steroids). '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. Corticosteroid topical preparations (e.g., shampoo, creams and ointments) come in four different strengths. These are known as mild, moderately potent, potent, or very potent. Clobetasol propionate is classed as a very potent corticosteroid. Scalp psoriasis is caused by the skin cells of your scalp being produced too quickly. Clobetasol Shampoo is used to treat scalp psoriasis of moderate intensity in adults. 2.
What you need to know before you take it
e Clobetasol Shampoo
Do not use this medicine •
if you have been told that you are allergic (hypersensitive) to Clobetasol propionate or any of the other ingredients in this medicine. Please check by reading the list of ingredients listed in section 6 below. If you answer yes, you must inform your doctor before starting treatment.
•
If you have bacterial, viral, fungal or parasitic skin infections such as cold sores, varicella (chicken pox), herpes zoster (shingles), impetigo (type of rash on the face), ringworm, athletes' foot, thrush, skin tuberculosis or skin disease caused by syphilis.
•
If you have ulcerous wounds (weeping wounds) on your scalp
•
In children under two years old
•
Do not apply this medicine 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 Shampoo: •
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 Clobetasol Shampoo with these medicines may result in serious infections.
Take special care with Clobetasol shampoo •
When using Clobetasol shampoo, it must only be used on the scalp, do not use it as a regular shampoo or on other areas of the body and do not use Clobetasol shampoo as a shower gel, body wash or bath foam.
•
When treating the scalp with Clobetasol shampoo you must not cover the area being treated, for example: a shower cap must not be used as it may make the active substance pass through the skin and affect the other parts of the body.
•
When using Clobetasol shampoo, avoid contact with the face, eyelids, axillae (armpits), erosive skin (chapped skin) surface and genital regions. Rinse off immediately with water if any product runs from the scalp.
•
If you get Clobetasol shampoo in your eye(s), wash the affected eye thoroughly with water. If any irritation persists, please seek advice from your doctor.
•
If you do not notice an improvement of your scalp psoriasis, please see your doctor.
•
Contact your doctor if you experience blurred vision or other visual disturbances.
•
Talk to your doctor or pharmacist if you experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Clobetasol shampoo, especially if you have been using Clobetasol shampoo for a prolonged time or repeatedly.
Children and adolescents • If this product has been prescribed for a child or adolescent below 18 years of age, you must check with your doctor every week before continuing to use this product. Other medicines and Clobetasol Shampoo Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines This medicine has no or very little influence on the ability to drive and use machines. This medicine contains ethanol 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. This medicine contains sodium laureth sulfate Sodium laureth sulfate may cause skin and eye irritation.
3.
How to take it
Clobetasol Shampoo
Always use Clobetasol shampoo exactly as your doctor has told you. You should 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 7.5ml) sufficient to cover the entire scalp. Unless your doctor has instructed otherwise, wash your hands and apply Clobetasol shampoo directly to your dry scalp once daily taking care to well cover and massage the affected areas. Avoid using large amounts of Clobetasol 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 shampoo to your hair. Your doctor will tell you how long you need to use Clobetasol shampoo to control your scalp psoriasis. Treatment should not 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 shampoo for longer than your doctor tells you. Nonetheless, your doctor may ask you to use Clobetasol 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 Shampoo than you should If you have used Clobetasol 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 this medicine If you forget to use Clobetasol shampoo, do not use a double dose on the next application to make up for a forgotten dose. Go back to your regular schedule. If you miss several doses, tell your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you stop using Clobetasol shampoo If you stop using Clobetasol shampoo, please see your doctor. It may be that worsening of the disease occurs when treatment with Clobetasol 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 product, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Clobetasol shampoo may cause the following side effects Common side effect (may affect up to 1 in 10 people): o Skin burning sensation o Inflammation of one or more hair follicles Uncommon side effects (may affect up to 1 in 100 people):
Endocrine disorders (such as adrenal suppression, Cushing syndrome), have been observed with potent topical steroids, especially when applied on large surface areas or used for prolonged periods o Eye stinging or burning o Eye irritation o Ocular tight sensation o Glaucoma o Hypersensitivity o Headache o Pain of skin o Skin discomfort o Itching o Acne o Skin oedema o Telangiectasia (veins under the surface of your skin may becoming more noticeable) o Psoriasis aggravation o Hair loss o Dryness of the skin o Urticaria o Skin atrophy (thinning of your skin) o Skin irritation o Skin tightness o Allergic contact dermatitis o Erythema o Rash Not known (frequency cannot be estimated from the available data) o Blurred vision Irritation, itching, urticaria, visible small vessels or thinning skin around the treated areas are generally of a mild to moderate nature. • If you have any signs of local intolerance, such as a burning sensation or redness to the areas that have been treated, do not use Clobetasol shampoo until these symptoms have disappeared. • Stop using the medicine and tell your doctor as soon as possible if you find your condition gets worse during treatment (this is more likely to happen if you have been using Clobetasol shampoo longer than prescribed) or if you experience swelling of the eyelids, face or lips as you may be allergic to the product or have a skin infection. • Using large amounts or keeping the product on the scalp for more than 15 minutes may: cause the skin to become thinner so that it can damage more easily allow the active substance to pass through the skin ; this can affect other parts of the body, especially in children, and during pregnancy • Repeated courses of topical steroids over a long time may also sometimes cause, pustular eruptions (big pimples) and changes in hair growth and skin colour. Striae (stretch marks) and purpura (bruising) may become noticeable • If you have rosacea (facial erythema associated with flushing of the skin, and possible papulopustules) the application of Clobetasol shampoo on the face may cause your skin condition to worsen. • Application of Clobetasol shampoo on the face may induce perioral dermatitis (spotty red rash around the mouth). • Application of Clobetasol shampoo to the skin may cause thinning of skin and therefore it should never be used on the face or on other areas of the skin than the scalp. • In order to avoid interaction with hair colour dying product, such as hair colour changes, Clobetasol shampoo should be thoroughly rinsed. • If you have any unusual discomfort that you do not understand, tell your doctor as soon as possible. o
If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning of stinging sensation, intense itching, peeling of the skin, oozing open sores. 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 at: 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
Clobetasol Shampoo
Keep out of the sight and reach of children. Store in the original plastic bottle in order to protect from light. Discard the bottle 6 months after first opening. Do not use the shampoo after the expiry date which is stated on the carton and bottle labels after 'Exp'. The expiry date refers to the last day of that month. If the shampoo becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Clobetasol shampoo contains
- The active substance is clobetasol propionate. Each gram of shampoo contains 500 micrograms of clobetasol propionate.
- The other ingredients are ethanol 96%, sodium laureth sulfate, coco alkyl dimethyl betaine, polyquaternium 10, citric acid monohydrate, sodium citrate, and purified water. What Clobetasol shampoo looks like and contents of the pack Clobetasol 500 micrograms/g shampoo is viscous, semitransparent, colourless to pale yellow liquid shampoo with an alcoholic odour. 60 ml or 125 ml of shampoo in high density polyethylene (HDPE) bottles with polypropylene (PP) closure and tamper-proof system in carton box. Not all pack sizes may be marketed. Marketing Authorisation Holder Penlan Healthcare Limited 45-47 Monument Hill Weybridge KT13 8RN Manufacturer BELUPO lijekovi i kozmetika, d.d. Danica 5 48 000 Koprivnica Croatia
This leaflet was last revised in 02/2025
Frequently asked questions about Clobetasol propionate 500 microgram/g Shampoo
What is the active substance in Clobetasol propionate 500 microgram/g Shampoo?
The active substance in Clobetasol propionate 500 microgram/g Shampoo is clobetasol propionate.
Are there equivalent medicines to Clobetasol propionate 500 microgram/g Shampoo?
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 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 Clobetasol propionate 500 microgram/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.
Can I get Clobetasol propionate 500 microgram/g Shampoo 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
Topical treatment of moderate scalp psoriasis in adults.
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 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 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 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 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.
Special populations
Elderly
The safety and efficacy of Clobetasol 500 micrograms/g shampoo in geriatric patients aged 65 years and above have not been established.
Renal impairment
Clobetasol 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 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).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clobetasol 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 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
4.4. Special warnings and precautions for use
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.
Clobetasol 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 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 Clobetasol 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 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 500 micrograms/g Shampoo should not be used in children and adolescents between 2 and 18 years of age.
If Clobetasol 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.
This medicine contains sodium laureth sulfate
Sodium laureth sulfate may cause skin and eye irritation.
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
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 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 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.
Fertility
No clinical data is available. See section 5.3.
4.7. Effects on ability to drive and use machines
Clobetasol 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
During clinical development of Clobetasol 500 micrograms/g shampoo, in a total of 558 patients receiving Clobetasol 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 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
Uncommon
Allergic contact dermatitis, erythema, rash
As Clobetasol 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 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.
4.9. Overdose
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.
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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.