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BOOTS PHARMACY ECZEMA AND DERMATITIS CREAM

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PATIENT INFORMATION LEAFLET Diprolieve Eczema and Dermatitis Cream Alclometasone Dipropionate 0.05%

Please read this leaflet carefully before you start using this medicine
This leaflet will tell you about Diprolieve Eczema and Dermatitis Cream which is available without a doctors prescription to treat eczema and dermatitis. You should follow the advice and instructions contained in this leaflet to make sure the cream works properly.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more help or advice.
The active ingredient in Diprolieve Eczema and Dermatitis Cream is alclometasone dipropionate 0.05%. Other ingredients are propylene glycol, white soft paraffin, cetostearyl alcohol, glyceryl stearate PEG 100 stearate, polyoxyethylene (20) cetyl ether, sodium dihydrogen phosphate dihydrate, chlorocresol, phosphoric acid, purified water. The cream comes in 15g tubes.

Marketing Authorisation Holder:
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Manufacturer:
Schering-Plough Labo NV, Heist-op-den-Berg, Belgium

1. What type of medicine is this?
Diprolieve Eczema and Dermatitis Cream is one of a group of medicines called topical corticosteroids. Topical means they are put on the skin. Corticosteroids are used to control inflammation. The cream works by stopping the skins over-reaction to the triggers that cause skin flare-ups. It reduces the inflammation that causes eczema and dermatitis. The cream has been available on prescription under a different name for many years. Topical corticosteroids should not be confused with anabolic steroids misused by some athletes and taken as tablets or injection. They are completely different.

2. What is the cream for?
Use Diprolieve Eczema and Dermatitis Cream on patches of itchy or inflamed skin to relieve the itching and irritation of eczema and dermatitis, for up to 7 days. If you are not sure what is causing your skin problem, ask a pharmacist or doctor.

3. Before using the cream
Make sure you have read the following points before using the cream. Do not use this cream: If you have ever had an allergic reaction to this cream or any of its ingredients. On children under the age of 12, unless a doctor tells you to. If you are pregnant, think that you may be pregnant, or breast-feeding. You should talk to a doctor or pharmacist

Do not use the cream on certain areas of the body
Do not use the cream: On your face as it may cause acne or spotty red rash around the mouth (perioral dermatitis) but its OK on the neck and ears On your groin, breast folds, genitals (private parts) or the anus (back passage) Between your toes

Be especially careful that you do not get the cream in your eyes due to risk of glaucoma.

Do not use the cream on any other skin problems as it could make them worse
Do not use the cream on: Rosacea (severe flushing of skin on and around the nose); spotty red rash around the mouth (perioral dermatitis) acne or seborrhoeic dermatitis (a flaky oily skin condition). These involve areas of skin where the cream should not be used. Skin infections such as cold sores, chickenpox; impetigo; ringworm; broken skin; TB of the skin; athletes foot and thrush. Psoriasis (a scaly skin condition) this needs to be treated by your doctor.

The cream contains propylene glycol, cetostearyl alcohol and chlorocresol, which may cause skin irritation; skin reactions, such as contact dermatitis, and allergic reactions.

Do not use hydrocortisone, or any other steroid- containing creams and ointments, on the skin whilst you are using Diprolieve Cream, as you would be increasing the risk of unwanted effects.
If your rash gets better but comes back Do not treat the same patch more than twice without taking advice from your doctor. It is possible that you are treating the wrong skin condition or that you are still in contact with your allergic triggers.

4. How to use the cream
Adults and children over the age of 12 years: Use the cream twice a day for up to 7 days. Knowing how much cream to use can be difficult. The fingertip unit method is one easy way. A fingertip unit is the amount of cream you can squeeze onto your fingertip from the tip to the first crease. Half a fingertip unit (see diagram) will cover a patch of skin the same size as the palm of your hand.

Follow these instructions:
Wash your hands and dry them Squeeze out the correct amount of cream on to your index finger. The diagram here gives you an idea of how much to use Gently rub the cream in to the area of skin which you are treating, until the cream disappears Wash your hands again (unless it is your hands you are treating)

Use the fingertip unit as a guide. For smaller areas, use a smaller amount. The cream isnt meant to treat large areas. If you forget or miss a dose, use it when you remember. Do not worry if you use a bit too much cream by mistake but try to keep to the fingertip unit. Using steroids on the skin continuously over many weeks or months can cause skin thinning. Do not cover the treated area of skin with anything other than your clothes. Plasters, dressings, gloves or cling film should not be used as they can cause more of the medicine to pass through the skin.

5. While using the cream
Diprolieve Eczema and Dermatitis Cream is meant to control skin conditions that improve within 7 days of starting treatment. If you think you need further treatment after 7 days, stop using the cream and see your pharmacist or doctor. If your skin condition clears up in less than 7 days, stop using the cream. Use of an emollient (see box opposite) may help maintain the condition of the skin. If your skin gets worse or does not improve within 7 days, stop using the cream and see your pharmacist or doctor.

If your skin condition improves after using the cream, but then your symptoms return, you may still be reacting to a trigger. Check the examples of common triggers in the box opposite. If you cant work out what is wrong, ask your doctor for advice.

6. Possible side effects
Most people find that when the cream is used correctly by following the advice in the leaflet, it does not cause any problems. However, rarely, a few people may find that their skin condition gets worse during treatment. This may be due to a skin infection, or trigger you havent recognised, or even an allergy to the cream. If you get any of these serious side effects, stop using the cream. See a doctor at once. Itching, burning, red marks, dryness of the skin, skin rash, stinging, and allergic skin reactions may occur rarely when the cream is applied to the skin. Thinning of the skin, blistering, peeling, swelling, inflammation of hair follicles, excessive hair growth, reduced skin pigmentation, acne, heat rash, dermatitis (skin inflammation), softening of the skin and stretch marks may occur with use of topical corticosteroids, especially under occlusive dressing. If your skin condition gets worse, or if your skin is irritated after applying the cream, stop using it and see your doctor. If you notice any side effect not listed here, please tell your pharmacist or doctor.

7. Storing the cream
The cream should be stored below 25 C. Do not use the cream after the expiry date stamped on the tube and carton Keep the cream out of the reach and sight of children

More about eczema and dermatitis
Dermatologists (skin specialists) often advise people with eczema or dermatitis to use emollients (moisturisers) in the form of creams and bath oils. Emollients coat the skin with a waterproof layer and prevent excessive water loss. So they help keep the skin moist, supple and soft, which can reduce flare-ups. Perfumed soaps and toiletries should be avoided. Ask your pharmacist for further information. Some people find that their skin rash returns after treatment, or never disappears completely. This is often because they are still in contact with the trigger, which is causing repeat reactions. Examples of common triggers are given below. If you cant work out whats wrong, ask your pharmacist or doctor for advice. Atopic eczema/dermatitis often runs in families and may be linked with other conditions such as asthma and hayfever. Triggers for this type of eczema include house dust, pets fur or pollen. Certain foods can also be a trigger. Allergic contact eczema/ dermatitis is set off by a chemical or substance coming into contact with the skin. Common examples include nickel in jewellery and clothing, zips, buckles and fastenings, chromate in cement, some plants, chemicals found in shampoos and cosmetics. Many different substances which you may use at work can also cause eczema, such as rubber and various dusts.

Irritant contact eczema / dermatitis occurs when the skin is repeatedly exposed to harsh or irritating substances such as detergents or excessive washing of the hands.

Self help tips
Avoid overheating, caused by too much clothing or bedding for example, as this can make your irritation worse. Very hot climates are not ideal because sweating makes eczema worse Keep nails short as scratching may damage you skin and can make your symptoms worse Try to avoid stress or emotional upsets Be aware that infections anywhere in the body such as colds or flu may make eczema worse.

Further information on eczema and dermatitis; You may be able to find out more from websites. You can contact the National Eczema Society, Hill House, Highgate Hill, London N19 5NA. Helpline 0870 241 3604, helpline@eczema.org, www.eczema.org If you have any other questions about Diprolieve Eczema and Dermatitis Cream or are not sure about anything, ask a pharmacist or doctor for advice. Date of preparation: March 2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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