Diprosalic Scalp Application 0.05% W/W / 2% W/W Cutaneous Solution
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Package leaflet: Information for the user DiproSalic® Scalp Application 0.05% w/w / 2% w/w, cutaneous solution
Betamethasone dipropionate/salicylic acid
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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. 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. Howto store diprosalic scalp application
6. Contents of the pack and other information
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 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. 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.
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.
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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.
If you have any further questionson the use of this medicine, askyour 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.
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 diprosalic scalp application
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 that month.
Do not store 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 diprosalic scalp application contains
• The active substances are betamethasone dipropionate 0.064 % w/w (equivalent to 0.05 % w/w betamethasone) and salicylic acid 2.0 % w/w.
• 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 100 ml.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
Merck Sharp 8- Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK The manufacturer is:
Schering-Plough France 2 rue Louis Pasteur,
14200 Herouville-st-Clair France
This leaflet was last revised in January 201 5.
© Merck Sharp & Dohme Limited 2015. All rights reserved.
PIL.DSA. 14.UK.4453.Var-031