Diprosone Cream

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.

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

Do not use Diprosone cream

If you have:

• an allergy to betamethasone dipropionate or any of the other ingredients in this medicine (listed in section 6).
• 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

If you have psoriasis, your doctor may want to review your treatment regularly. Contact your doctor if your psoriasis gets worse or you get raised bumps filled with pus under your skin.

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

This medicine should not be used under bandages or plasters.

Side effects that may happen with oral or injectable corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.

If you use more than the correct amount of cream and/or use it for longer than is recommended, it can affect the levels of certain hormones in the body, particularly in infants and children.

In adults the changes in hormone levels may lead rarely to puffiness or rounding of the face, weakness, tiredness, and dizziness when standing or sitting down.

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 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 cream without consulting your prescriber unless your prescriber has previously advised you to do 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.

Children

If you use more than the correct amount of cream and/or use it for longer than is recommended, it can affect your child’s hormones. Rarely this may lead to:

• Delayed growth and development
• Puffiness or rounding of the face
• A build-up of pressure around the brain which can produce
  • a bulging of the fontanelle (the soft spot in the top of the skull) in infants
  • a constant thumping headache
  • blurred vision or other visual disturbances

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).

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What Diprosone cream contains

• The active substance is betamethasone dipropionate. Each gram contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg 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:

The manufacturer is: