Diprosone Lotion

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 lotion is and what it is used for
2. What you need to know before you use Diprosone lotion
3. How to use Diprosone lotion
4. Possible side effects
5. How to store Diprosone lotion
6. Contents of the pack and other information

Do not use Diprosone lotion

• 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

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 lotion 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 lotion 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 lotion 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
• A moon face 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.

Recommended dose

Usually for adults and children, a few drops of Diprosone lotion should be gently and completely rubbed into the affected area of scalp twice a day.

You should always follow these instructions when using Diprosone lotion:

• Only use this lotion on your scalp.
• Do not use a large amount of lotion for a long time (for example every day for many weeks or months).
• Avoid getting the lotion in your eyes.

Use in children

Use as stated above. Do not use Diprosone lotion on your child's scalp for more than 5 days.

If you use more Diprosone lotion than you should

If you (or somebody else) accidentally swallows the lotion, it should not cause any problems. However, if you are worried, you should see your doctor.

If you use the lotion more often than you should, or more than prescribed, it can affect some of your hormones. In children this may affect their growth and development. If you have not used the lotion 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 lotion

If you forget to use your lotion at the right time, use it as soon as you remember, then carry on as before.

If you stop using Diprosone lotion

If you have been using the lotion for a long time and your scalp problem seems to have got better, you should not suddenly stop using the lotion. If you do, you may find that your scalp 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 lotion 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 lotion 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 carbomer, isopropyl alcohol, sodium hydroxide and purified water.

What Diprosone lotion looks like and contents of the pack

Diprosone lotion is a colourless, translucent lotion. It is available in bottles containing 5 ml, 30 ml or 100 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

The manufacturer is: