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DIPROSONE 0.05 % W/W CREAM

Active substance(s): BETAMETHASONE DIPROPIONATE

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Package leaflet: Information for the user

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DiproSone® 0.05 % w/w Cream
Betamethasone dipropionate

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.
What is in this leaflet
1. What diprosone cream is and what it is used for
2. What you need to know before you use diprosone cream
3. How to use diprosone cream
4. Possible side effects
5. How to store diprosone cream
6. Contents of the pack and other information
1. What diprosone cream is and what it is used for
Diprosone cream contains the active ingredient betamethasone dipropionate.
Betamethasone dipropionate belongs to a group of medicines called topical corticosteroids which are
used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.
In adults and children, diprosone cream is used to treat skin problems, including eczema, and all types
of dermatitis and psoriasis of the scalp, hands and feet.
Eczema is a common skin disease, which causes the skin to become red and itchy. Dermatitis is
inflammation of the skin. Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the
elbows, knees, scalp and other parts of the body.
2. What you need to know before you use diprosone cream
Do not use diprosone cream
- if you are allergic to betamethasone dipropionate or any of the other ingredients in this medicine
(listed in section 6).
- on any other skin problem as it could make it worse especially rosacea (a skin condition affecting the
face), acne, dermatitis around the mouth, genital itching, nappy rash, cold sores, chickenpox, shingles
or other skin infections. Ask your doctor or pharmacist if you are not sure.
Warnings and precautions
Talk to your doctor or pharmacist before using diprosone cream. This medicine should not be used under
bandages or plasters.
Side effects that may happen with oral or injectables corticosteroids may also occur with corticosteroids
used on the skin, especially in infants and children.
Children
If the cream is used more often than it should, or more than prescribed, it can affect some of your child’s
hormones. This may affect their growth and development.
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.
Diprosone cream contains chlorocresol and cetostearyl alcohol
Diprosone cream contains chlorocresol, which may cause allergic reactions and cetostearyl alcohol,
which may cause local skin reactions (e.g. contact dermatitis).
3. How to use diprosone cream
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Recommended dose
Usually for adults and children, a thin layer of diprosone cream should be rubbed into the affected area
of skin twice a day.
You should always follow these instructions when using diprosone cream:
- Do not use the cream on your face for more than 5 days.
- Do not use a large amount of cream on large areas of the body, open wounds or areas of the body
where joints bend for a long time (for example every day for many weeks or months).
- Avoid getting the cream in your eyes.
Use in children
Use as stated above. Do not use diprosone cream on any part of your child’s body for more than 5 days.
Do not put the cream under your child’s nappy, as this makes it easier for the active ingredient of the
medicine to pass through the skin and possibly cause some unwanted effects.
If you use more diprosone cream than you should
If you (or somebody else) accidentally swallows the cream, it should not cause any problems. However,
if you are worried, you should see your doctor.
If you use the cream more often than you should, or on large areas of your body, it can affect some of
your hormones. In children this may affect their growth and development. If you have not used the
cream as you were told to do and have used it too often and/or for a long time, you should tell your
doctor or pharmacist.
If you forget to use diprosone cream
If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before.
If you stop using diprosone cream
If you have been using the cream for a long time and your skin problem seems to have got better, you
should not suddenly stop using the cream. If you do, you may find that your skin becomes red and you
may notice stinging or burning. To avoid this, you should speak to your doctor who will gradually reduce
how often you need to use the cream until you stop treatment altogether.
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.
Most people find that when the cream is used correctly, it does not cause any problems. However, if you
use the cream more than you should, particularly on your face, it can cause redness, stinging, blistering,
peeling, swelling, itching, burning, skin rash, dryness of the skin, inflammation of the hair follicles,
excessive hair growth, reduced skin pigmentation, allergic reactions, dermatitis (skin inflammation),
other skin infections, thinning of the skin and red marks. This can happen more easily in infants and
children. If you are worried by these or any other side effects, you should tell your doctor or pharmacist.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store diprosone cream
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 label and carton after ‘Use by’. The
expiry date refers to the last day of that month.
Do not store above 25°C.
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 information
What diprosone cream contains
- The active substance is betamethasone dipropionate 0.064 % w/w (equivalent to 0.05% w/w
betamethasone).
- The other ingredients are chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, white
soft paraffin, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, sodium hydroxide and purified water.
What diprosone cream looks like and contents of the pack
Diprosone cream is a smooth, white cream. It is available in tubes containing 5 g, 30 g or 100 g. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
The manufacturer is:
Schering-Plough Labo NV,
Heist-op-den Berg, Belgium.
This leaflet was last revised in January 2015.

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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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