CLOBADERM 500 MICROGRAMS / G OINTMENT - patient leaflet, side effects, dosage

5. how to store clobaderm

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 carton and the tube after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

This medicine should be disposed of 3 months after first opening.

Do not use the ointment if any visible signs of deterioration, such as noticeable changes in colour, are observed. If you are not sure, please check with your pharmacist.

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. contents of the pack and other informationwhat clobaderm containsthe active ingredient is clobetasol propionate.

1g of ClobaDerm contains 0.5mg of clobetasol propionate (500 micrograms/g).

The other ingredients are propylene glycol, sorbitan sesquioleate and white soft paraffin.

What ClobaDerm looks like and contents of the pack

ClobaDerm Ointment is an opaque ointment.

Within each carton is a tube with a plastic screw cap, which contains either 30 or 100g of ointment.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturers

Tiofarma B.V.

Benjamin Franklinstraat 5–10, 3261 LW Oud-Beijerland, The Netherlands

Tiofarma B.V.

Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands

More Information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.

You may also be able to find out more information from books in public libraries.

This leaflet was last revised in September 2021.

If you would like a leaflet with larger text, please contact 01271 385257.

Package leaflet: Information for the user

ClobaDerm® 500 micrograms/g Ointment (clobetasol propionate)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What ClobaDerm is and what it is used for

• 2. What you need to know before you use ClobaDerm

• 3. How to use ClobaDerm

• 4. Possible side effects

• 5. How to store ClobaDerm

• 6. Contents of the pack and other information

1. what clobaderm is and what it is used for

ClobaDerm contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

ClobaDerm 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 use clobadermdo not use clobaderm: if you are allergic 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, as 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 this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using ClobaDerm.

Warnings and precautions

Talk to your doctor or pharmacist before using ClobaDerm if you:

• have previously had an allergic reaction with another steroid
• 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
• are applying the ointment on broken or damaged skin or within the skin folds
• are applying to a large surface area
• have psoriasis, as your doctor will want to see you more often
• are using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection
• are applying near eyes or on eyelids, as cataracts or glaucoma may result if the ointment repeatedly enters the eye
• are applying to thin skin such as the face, as ClobaDerm 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

• experience newly developed bone pain or worsening of previous bone symptoms during treatment with ClobaDerm, especially if you have been using ClobaDerm for a prolonged time or repeatedly
• 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 ClobaDerm with these medicines may result in serious infections.

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Contact your doctor if you experience blurred vision or other visual disturbances.

If an infection develops during the use of this medicine, talk to your doctor or pharmacist.

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 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.

Do not smoke or go near naked flames – 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.

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 on 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 ClobaDerm

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 and breast-feeding

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 using this medicine.

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

ClobaDerm Ointment contains propylene glycol

May cause skin irritation.

3. how to use clobaderm

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

• You usually apply a thin layer of ClobaDerm 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 ClobaDerm 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 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 ClobaDerm 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.

• 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 an adult

For a child aged 1–10

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 ClobaDerm 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 ClobaDerm 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 ClobaDerm

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 ClobaDerm to make up for a missed dose.

If you stop using ClobaDerm

If you use ClobaDerm 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 ClobaDerm 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

• 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 ClobaDerm 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 ClobaDerm for a long period of time, or use under an airtight dressing, may cause the following symptoms:

• increased weight, obesity
• moon face, rounding of the face
• skin wrinkling or dryness, changes to the colour of your skin
• increased body hair
• hair loss/lack of hair growth/damaged looking hair.
• worsening of condition
• application site irritation/pain
• redness
• rash or hives
• skin infection
• acne.