Diprosalic Ointment
DIPROSALIC® OINTMENT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medication is available using the name Diprosalic Ointment but will be referred to as Diprosalic throughout 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 is and what it is used for
2. What you need to know before you use Diprosalic
3. How to use Diprosalic
4. Possible side effects
5. How to store Diprosalic
6. Contents of the pack and other information
1. What Diprosalic is and what it is used for
Diprosalic 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 is used to treat skin conditions where the outer surface of the skin is covered by a layer of scales. Your ointment 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
Do not use Diprosalic
■ 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.
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 ointment 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
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 thin layer of Diprosalic should be gently rubbed into the affected area of skin twice a day.
You should always follow these instructions when using Diprosalic:
■ Do not use the ointment on your face for more than 5 days.
■ Do not use a large amount of ointment on large areas of the body for a long time (for example every day for many weeks or months).
■ Avoid getting the ointment in your eyes.
Use in children
Use as stated above. Do not use this ointment on any part of your child's body for more than 5 days. Do not put the ointment under your child's nappy, as this makes it easier for the active ingredients of the medicine to pass through the skin and possibly cause some unwanted effects.
If you use more Diprosalic than you should
If you (or somebody else) accidentally swallow the ointment, it should not cause any problems. However, if you are worried, you should see your doctor. If you use the ointment 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. It also may cause you to feel and/or be sick and to hear ringing in your ears. If you have not used the ointment 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
If you forget to use your ointment at the right time, use it as soon as you remember, then carry on as before.
If you stop using Diprosalic
If you have been using the ointment for a long time and your skin problem seems to have got better, you should not suddenly stop using the ointment. 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 ointment until you stop treatment altogether.
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 ointment is used correctly, it does not cause any problems. However, if you use the ointment 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 hair follicles, excessive hair growth, reduced skin pigmentation and allergic skin reactions.
■ Dermatitis (skin inflammation), a condition brought on by the skin reacting to outside agent 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
■ Diprosalic should be stored in a cool place below 25°C.
■ Keep out of the sight and reach of children.
■ Do not use Diprosalic after the expiry date, which is printed on the pack. The expiry date refers to the last day of the month.
■ If your doctor tells you to stop using the ointment, please take it back to the pharmacist for safe disposal. Only keep the Diprosalic if your doctor tells you to.
■ If the ointment becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Diprosalic contains
Contains betamethasone (as the dipropionate ester) 0.05% w/w and 3% w/w salicylic acid. Diprosalic also contains liquid paraffin and white soft paraffin.
What Diprosalic looks like and contents of the pack
Diprosalic is a smooth, off-white, preservative-free ointment.
Diprosalic is available as 30g tubes of ointment.
Manufacturer
Manufactured by: Schering Plough SA, KM 36 Carretera National, 1, San Agustin de Guadalix, Madrid, Spain.
Or
Merck Sharp and Dohme de Espana, S.A., Josefa Valcarcel, 38, 28027, Madrid, Spain.
Or
Schering-Plough Labo N.V., Industriepark, 20,
B-2220 - Heist-op-den-Berg, Belgium.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 04423/0286
Leaflet revision and issue date (Ref): 05.11.15
Diprosalic® is a registered trademark of Merck Sharp 8i Dohme Corp.
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