Diprosalic Scalp Application

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

Do not use Diprosalic Scalp Application

If you have:

• an allergy to betamethasone dipropionate, salicylic acid 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 (skin inflammation) around the mouth, genital itching, nappy rash, cold sores, chickenpox or other skin conditions.

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 inhaled or oral corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.

If you use more than the correct amount of scalp application 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.

Children

If you use more than the correct amount of scalp application 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.

Recommended dose

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

You should always follow these instructions when using Diprosalic Scalp Application:

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

Use in children

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

If you use more Diprosalic Scalp Application than you should

If you (or somebody else) accidentally swallows the scalp application, it should not cause any problems. However, if you are worried, you should see your doctor. If you use the scalp application 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. It also may cause you to feel and/or be sick and to hear ringing in your ears. If you have not used the scalp application 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 Diprosalic Scalp Application

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

If you stop using Diprosalic Scalp Application

If you have been using this medicine for a long time and your scalp problem seems to have got better, you should not suddenly stop using this medicine. If you do, you may find that your scalp becomes red and you may notice stinging and burning. To avoid this, you should speak to your doctor who will gradually reduce how often you need to use this medicine 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 Diprosalic Scalp Application contains

• The active substances are betamethasone dipropionate and salicylic acid. Each gram contains 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg betamethasone) and 20 mg of salicylic acid.
• The other ingredients are disodium edetate, hydroxypropyl methylcellulose, sodium hydroxide, isopropyl alcohol and purified water.

What Diprosalic Scalp Application looks like and contents of the pack

Diprosalic Scalp Application is a colourless, slightly thick solution. It is available in a bottle containing 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: