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DIPROSONE OINTMENT

Active substance(s): BETAMETHASONE DIPROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diprosone® Ointment
BETAMETHASONE DIPROPIONATE

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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 Ointment is and what it is used for
2. What you need to know before you use Diprosone Ointment
3. How to use Diprosone Ointment
4. Possible side effects
5. How to store Diprosone Ointment
6. Contents of the pack and other information
1. What Diprosone Ointment is and what it is used for
Diprosone Ointment contains the active ingredient 0.064% w/w 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 Ointment is used to treat skin problems, including eczema,
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 Ointment
Do not use Diprosone Ointment
- 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 (skin inflammation) 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.
- If Diprosone Ointment is used in children, it should not be used on any part of their body for
more than 5 days.
- Do not put the ointment 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.
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 taking this medicine.
3. How to use Diprosone Ointment
Always use Diprosone Ointment 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 Ointment should be rubbed into the
affected area of skin twice a day.
You should always follow these instructions when using Diprosone Ointment:
- Do not use the ointment on your face for more than 5 days.
- Do not use a large amount of ointment 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 ointment in your eyes.
Use in children
- Use as stated above. Do not use Diprosone Ointment on any part of your child’s body for
more than 5 days.
- Do not put the ointment 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 Ointment than you should
If you (or somebody else) accidentally swallows the ointment, it should not cause any
problems. However, if you are worried, you should see your doctor.
If you use the ointment 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 ointment as you were told to do and have used it too often and/or for
a long time, you should tell your doctor.
If you forget to use Diprosone Ointment
If you forget to use your ointment at the right time, use it as soon as you remember, then carry
on as before.
If you stop using Diprosone Ointment
If you have been using the ointment for a long time and your skin problem seems to have got
better, you should not suddenly stop using the ointment. 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 ointment 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, Diprosone Ointment can cause side effects, although not everybody gets
them.
Most people find that when the ointment is used correctly, it does not cause any problems.
However, if you use the lotion more than you should, particularly on your face, it can cause
redness, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin,
in the skin, inflammation of the hair follicles; excessive hair growth, reduced skin pigmentation;
allergic skin 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
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 Ointment
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 the month.
Do not store the ointment 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 Ointment contains
- The active substance is betamethasone dipropionate Ph.Eur 0.064% w/w (equivalent to
0.05% w/w betamethasone)
- The other ingredients are liquid paraffin and white soft paraffin.
What Diprosone Ointment looks like and contents of the pack
Diprosone Ointment is a smooth, opaque (not clear) ointment. It is available in tubes containing
30g or 100g.
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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