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.
Dermovate Ointment
⚠ 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
Dermovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Dermovate is used to help reduce the redness and itchiness of certain skin problems. These skin problems include:
- frequently relapsing eczema
- psoriasis (thickened patches of inflamed, red skin, often covered by silvery scales), excluding widespread plaque psoriasis
- lichen planus (a skin disease that causes itchy, reddish-purple, flat-topped bumps on the wrists, forearms or lower legs)
- discoid lupus erythematosus (a disease of the skin most often affecting the face, ears and scalp causing scarring and increased sensitivity of the affected skin to sunlight)
- dermatitis and other skin conditions that have not responded to milder steroid creams or ointments.
2.
What you need to know before you take it
e Dermovate
Do not use Dermovate:
- if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in Section 6)
- on a child under 1 year of age
- to treat any of the following skin problems, it could make them worse:
- acne
- severe flushing of skin on and around your nose (rosacea)
–
spotty red rash around your mouth (perioral dermatitis) itching around your anus or genitals (penis or vagina) infected skin (unless the infection is being treated with an anti-infective medicine at the same time) itchy skin which is not inflamed widespread plaque psoriasis, except single lesions.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Dermovate. Warnings and precautions Talk to your doctor or pharmacist before using Dermovate if:
- you experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Dermovate especially if you have been using Dermovate 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 Dermovate with these medicines may result in serious infections.
- you have previously had an allergic reaction with another steroid
- you are applying the ointment under an airtight dressing, including a child's nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much ointment.
- make sure that the skin is cleansed before a fresh dressing is applied to prevent infections.
- you are applying the ointment on broken or damaged skin or within the skin folds.
- you are applying to a large surface area.
- you have psoriasis, your doctor will want to see you more often.
- you are using around a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
- you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the ointment repeatedly enters the eye.
- you are applying to thin skin such as the face, as Dermovate may cause skin thinning. Use on the face should be limited to 5 days. Dressings or bandages should not be used on the face where the ointment is applied. If an infection develops during the use of this medicine, talk to your doctor or pharmacist. Contact your doctor if you experience blurred vision or other visual disturbances. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream/ointment without consulting your
prescriber unless your prescriber has previously advised you to 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. Children
- Do not use this medicine in children under 1 year of age.
- Avoid continuous treatment for a long period of time in infants and children over 1 year of age, as their skin is thinner than adults and as a result may absorb larger amounts.
- Use on children should be limited to 5 days and reviewed weekly.
- Dressings or bandages should not be used on children where the ointment is applied. If this product comes into contact with dressings, clothing and bedding the fabric can be easily ignited with a naked flame. You should keep away from fire when using this product. Other medicines and Dermovate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications. Pregnancy, breast-feeding and fertility 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. If you do use Dermovate when breast-feeding, do not use it on your breast area to ensure that the baby does not accidentally get Dermovate in their mouth. Dermovate Ointment contains 50 mg propylene glycol per gram of product. Propylene glycol may cause skin irritation. Whilst using Dermovate do not smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressing etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it
3.
How to take it
Dermovate
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using this medicine
- You usually apply a thin layer of Dermovate once or twice a day. This may be reduced as your skin begins to get better, or stopped when it is better. Your doctor may prescribe a weaker steroid for you to use instead.
- If you are also using an emollient (moisturiser), allow time for Dermovate to be absorbed into your skin before applying the emollient.
- This ointment is for use on your skin only.
• • •
•
Do not use for more than 4 weeks without talking to your doctor. If you need treatment for a long time, your doctor may decide you need to use a milder cream or ointment. If your skin problem worsens or does not improve within 2 to 4 weeks, talk to your doctor. The germs that cause infections like the warm and moist conditions under dressings. If directed to cover the treated area with a dressing, always clean the skin before a fresh dressing is put on to help prevent infection of the skin beneath the dressing. If you are applying the ointment on someone else make sure you wash your hands after use or wear disposable plastic gloves.
Guidance on how to apply the ointment 1 Wash your hands. 2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Dermovate to use with your fingertip. For children you will need to use less ointment but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit. [Pictogram of 1 fingertip unit] 3 Unless you are meant to apply the ointment to your hands as a part of the treatment, wash them again after using the ointment. For adolescents (≥ 12 years old) and adults [Pictogram of an adult with fingertip units to be used as per text below with arrows pointing to relevant body part] Face and neck: 2 1⁄2 fingertip units. Back: 7 fingertip units. Front: 7 fingertip units. One arm (not including the hand): 3 fingertip units. Both sides of one hand: 1 fingertip unit. One leg (not including the foot): 6 fingertip units One foot: 2 fingertip units. Do not worry if you find you need a little more or less than this. It is only a rough guide. For a child aged 1 – 10
Number of fingertip units needed Child's age 1-2 years
3-5 years
6-10 years
Face and neck
Arm and hand
Leg and foot
Front
Back including buttocks
11⁄2
11⁄2
2
2
3
11⁄2
2
3
3
31⁄2
2
21⁄2
41⁄2
31⁄2
5
Use in children
- Do not use this medicine on children under 1 year of age.
- It is especially important in children not to exceed the prescribed amount.
- A course of treatment for a child should not normally last more than 5 days unless your doctor has told you to use it for longer. Your doctor may want to see the child every week, whilst using the ointment.
- Dressings or bandages should not be used on children where the ointment is applied. If you have psoriasis If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal. If you apply Dermovate to your face You should only apply the ointment to your face if your doctor tells you to. It should be limited to 5 days, as the skin on your face thins easily. Dressings or bandages should not be used on the face where the ointment is applied. Do not let the ointment get into your eyes. If it does, wash it out with plenty of water. If you use more Dermovate than you should If you apply too much or if accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible. If you forget to use Dermovate If you forget to apply your ointment, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time. Do not apply extra Dermovate to make up for a missed dose. If you stop using Dermovate
If you use Dermovate regularly make sure you talk to your doctor before you stop using it as your condition may get worse if stopped suddenly. If you have any further questions on the use of this medicine, 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 Dermovate and tell your doctor immediately if:
- you find that your skin problem gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to the ointment, have an infection or need other treatment.
- you have psoriasis and get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis. Other side effects you may notice when using Dermovate include: Common (may affect up to 1 in 10 people)
- a feeling of burning, pain, irritation or itching where the ointment is applied. Uncommon (may affect up to 1 in 100 people)
- skin thinning, stretch marks may develop.
- blood vessels under the surface of your skin may become more noticeable. Very Rare (may affect up to 1 in 10,000 people) Use of Dermovate for a long period of time, or use under an airtight dressing, may cause the following symptoms:
- increased weight
- moon face, rounding of the face
- obesity
- skin thinning
- skin wrinkling
- skin dryness
- changes to the colour of your skin
- increased body hair
- hair loss/lack of hair growth/damaged looking hair Other very rare skin reactions that may occur are:
- allergic reaction at the site of application
- worsening of condition
- application site irritation/pain
- redness
- rash or hives
- if you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis
- skin infection
- acne
In children, also look out for the following symptoms:
- delayed weight gain
- slow growth Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:
- a decrease in the level of the hormone cortisol in your blood
- increased levels of sugar in your blood or urine
- high blood pressure
- cloudy lens in the eye (cataract)
- increased pressure in the eye (glaucoma)
- vision problems caused by detachment of the retina in the eye (central serous chorioretinopathy)
- weakening of the bones through gradual loss of mineral (osteoporosis); additional tests may be needed after your medical examination to confirm if you have this condition Not Known (frequency cannot be estimated from the available data)
- blurred vision
- Steroid withdrawal reaction: 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 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. Dermovate Ointment is classed as a very strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. 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 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
Dermovate 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 tube or carton after (EXP). The expiry date refers to the last day of that month.
• •
6.
Do not store above 30°C. Do not throw away 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.
Contents of the pack and other information
What Dermovate contains
- The active ingredient is clobetasol propionate. Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w).
- The other ingredients are propylene glycol (see section 2), sorbitan sesquioleate and white soft paraffin. What Dermovate looks like and contents of the pack Within each carton is a tube with a plastic screw cap, which contains either 30 or 100 g of ointment. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Glaxo Wellcome UK Ltd, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK Manufacturer: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, DL12 8DT, United Kingdom Or Delpharm Poznań Spółka Akcyjna,ul. Grunwaldzka 189, 60-322 Poznań, Poland More Information If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. You may be able to find out more information from books in public libraries. Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only) Please be ready to give the following information: Product name Dermovate Ointment Reference number 10949/0028 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in April 2024 Trade marks are owned by or licensed to the GSK group of companies © 2024 GSK group of companies or its licensor
Frequently asked questions about Dermovate Ointment
How do I take Dermovate Ointment?
Dermovate Ointment comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Dermovate Ointment?
The active substance in Dermovate Ointment is clobetasol propionate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dermovate Ointment, 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 Dermovate Ointment 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
Clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids.
These include the following:
• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent 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 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).
Route of administration: Cutaneous
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Adults, Elderly and Children over 1 year
Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs (in the more responsive conditions this may be within a few days), then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient.
Repeated short courses of clobetasol propionate may be used to control exacerbations.
In more resistant lesions, especially where there is hyperkeratosis, the effect of clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be used.
The maximum weekly dose should not exceed 50gms/week.
Therapy with clobetasol should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of clobetasol.
Recalcitrant dermatoses: Patients who frequently relapse
Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly, without occlusion) may be considered. This has been shown to be helpful in reducing the frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential relapse. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis.
Paediatric population
Clobetasol is contraindicated in children under one year of age.
Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit.
Duration of treatment for children and infants
Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.
Application to the face
Courses should be limited to five days if possible and occlusion should not be used.
Elderly
Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment
In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
The following conditions should not be treated with clobetasol:
• Untreated cutaneous infections
• Rosacea
• Acne vulgaris
• Pruritus without inflammation
• Perianal and genital pruritus
• Perioral dermatitis.
Clobetasol is contraindicated in dermatoses in children under one year of age, including dermatitis and nappy eruptions.
4.4. Special warnings and precautions for 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 4 weeks, a less potent corticosteroid preparation should be considered.
Clobetasol should be used with caution in patients with a history of local hypersensitivity to other 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.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals 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).
Risk factors for increased systemic effects are:
• Potency and formulation of topical steroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing)
• Increasing hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on broken skin or other conditions where the skin barrier may be impaired
• In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Paediatric population
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.
Duration of treatment for children and infants
Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.
Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis
Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Concomitant infection
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Application to the face
Application to the face is undesirable as this area is more susceptible to atrophic changes.
If used on the face, treatment should be limited to only 5 days.
Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. If clobetasol does enter the eye, the affected eye should be bathed in copious amounts of water.
Visual disturbance
Visual disturbance has been 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.
Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
Dermovate Ointment contains 50 mg propylene glycol per gram of product. Propylene glycol may cause skin irritation.
Clobetasol ointment contains paraffin. Instruct patients not to smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
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.
The label will state very strong steroid.
4.5. Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data from the use of clobetasol in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see Nonclinical Information)
The relevance of this finding to humans has not been established. Administration of clobetasol during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
Breast-feeding
The safe use of topical corticosteroids during lactation has not been established.
It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of clobetasol during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation clobetasol should not be applied to the breasts to avoid accidental ingestion by the infant.
Fertility
There are no data in humans to evaluate the effect of topical corticosteroids on fertility
Clobetasol administered subcutaneously to rats had no effect upon mating performance; however, fertility was decreased at the highest dose (see section 5.2).
4.7. Effects on ability to drive and use machines
There have been no studies to investigate the effect of clobetasol on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasol.
4.8. Undesirable effects
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data
Infections and Infestations
Very rare
Opportunistic infection
Immune System Disorders
Very rare
Hypersensitivity, generalised rash
Endocrine Disorders
Very rare
Hypothalamic-pituitary adrenal (HPA) axis suppression:
Cushingoid features: (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis
Skin and Subcutaneous Tissue Disorders
Common
Pruritus, local skin burning /skin pain
Uncommon
Skin atrophy*, striae*, telangiectasias*
Very rare
Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne\
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)
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions
Very rare
Application site irritation/pain
Eye disorders
Very rare
Cataract, central serous chorioretinopathy, glaucoma
Not known (cannot be estimated from available data)
Vision, blurred
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the risk/benefit balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see section 4.8).
Management
In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CLOBETASOL MK 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- CLOBETAZOL ATB 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- INFILEA 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
- INFILEA 500 µg/g prescriptionCLOBETASOLUM · skin / topical
- DERMOVATE 0,5 mg/g prescriptionCLOBETASOLUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Clobetasol propionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Dermovate partial — not the same combinationClobetasoli propionas · skin / topical
- Clobetaxon partial — not the same combinationClobetasoli propionas · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Dermovate Ointment. 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.