PACKAGE LEAFLET: INFORMATION FOR THE USER Diprosalic® Scalp Application 0.05% w/w / 2% w/w, cutaneous solution

(betamethasone dipropionate & salicylic acid)

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.

Your medicine is known as the above but will be referred to

as Diprosalic throughout the remainder of this leaflet.

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 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

3. How to use diprosalic scalp application

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 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.

Use in children

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

1. What diprosalic scalp application is and what it is used for

Diprosalic scalp application contains two active ingredients, betamethasone dipropionate and salicylic acid.

Betamethasone dipropionate is one of a group of medicines called topical corticosteroids. It is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. Salicylic acid softens the top layer of scales on the surface of the skin, which are caused by your skin problem. This allows the betamethasone dipropionate to reach the diseased skin underneath to help heal it.

In adults and children, diprosalic scalp application is used to treat skin conditions where the outer surface of the skin is covered by a layer of scales. Your scalp application will remove the layer of scales and reduce the redness and itchiness caused by your skin problem.

2. What you need to know before you use diprosalic scalp application

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 a p plication 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 b u rning. 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.

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Do not use diprosalic scalp application

•    if you are allergic to betamethasone dipropionate, salicylic acid 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 or other skin conditions.

Warnings and precautions

Talk to your doctor or pharmacist before using diprosalic scalp application.

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.

Children

If the scalp application 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 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 scalp application is used correctly, it does not cause any problems. However, if you use the scalp application more often than you should, it can cause the following:

•    Thinning of the skin, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin and you may notice red marks. This can happen more easily in infants and children.

•    Inflammation of the skin follicles, excessive hair growth, reduced skin pigmentation and allergic reactions.

•    Dermatitis (skin inflammation), a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.

5. How to store diprosalic scalp application

6. Contents of the pack and other information

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