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    Clobetasol, 0.05 % ointment

    Drug formSoft

    ATC categoryGlucocorticoids

    ATC subcategoryGlucocorticoids for external use

    Brand nameClobetasol

    Generic nameClobetasol

    What Clobetasol ointment is and what it is used for

    Clobetasol contains a medicine called clobetasol propionate.

    It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

    Clobetasole 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.
     
    What you need to know before you use Clobetasol

    Do not use Clobetasol:

    • if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine
    • 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 Clobetasol.

     
    Warning and precautions

    Talk to your doctor or pharmacist before using Clobetasol if:

    • 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 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 for 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 Clobetasol 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.

    If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

     

    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.

     

    Other medicines and Clobetasol

    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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

    If you do use Clobetasol when breast-feeding, do not use it on your breast area to ensure that the baby does not accidentally get Clobetasol in their mouth.

     

    Important information about ingredients

    The drug contains:

    • Propylparaben, which may cause allergic reactions (possibly delayed) and rarely, bronchospasm.
     
    How to use Clobetasol

    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 Clobetasol once or twice a day. This may be reduced as your skin begins to get better, or stopped when better. Your doctor may prescribe a weaker steroid for you to use instead.
    • If you are also using an emollient (moisturiser), allow time for Clobetasol 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.

     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 over the age of 1 year 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 Clobetasol to your face

    You should only apply the ointment to your face if your doctor tells you to. It should be limited to only 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 Clobetasol 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 Clobetasol

    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 Clobetasol to make up for a missed dose.

     

    If you stop using Clobetasol

    If you use Clobetasol 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.

     

    Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    Stop using Clobetasol 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 Clobetasol 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, this may cause stretch marks
    • 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 Clobetasol 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.

     

    How to store Clobetasol ointment
    • Store at a cool place , out of the reach of children. Protect from moisture and light.
    • Shelf life – 3 years. Do not take after the expiry date on the packaging. The expiry date refers to the last day of the month.
    • 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.

     

    Contents of the pack and other information

    What Clobetasol contains

    Each gram of Clobetasol 0.05% ointment contains:

    active ingredient: clobetasol propionate – 0.5 mg;

    other ingredients: liquid paraffin, propylparaben, white vaseline, ethanol.

     

    What Clobetasol ointment looks like and contents of the pack

    White odorless ointment.

     

    15 g 0.05% of ointment is filled into aluminum tube (inside package).

    The tube is packed and inserted with the leaflet into cardboard box (outer package).

     

    Prescription status

    Prescription drug.