Patient Leaflet Updated 25-May-2022 | Organon Pharma (UK) Limited
Diprosalic Ointment
Package leaflet: Information for the user
Diprosalic® 0.05% w/w / 3% w/w Ointment
betamethasone (as dipropionate 0.064%)/salicylic acid
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Diprosalic ointment is and what it is used for
2. What you need to know before you use Diprosalic ointment
3. How to use Diprosalic ointment
4. Possible side effects
5. How to store Diprosalic ointment
6. Contents of the pack and other information
1. What Diprosalic ointment is and what it is used for
Diprosalic ointment 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 ointment 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 ointment
Do not use Diprosalic ointment
If you have:
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 immediately 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 ointment 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 ointment 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 ointment and/or use it for longer than is recommended, it can affect your child’s hormones. Rarely this may lead to:
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 ointment
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 ointment should be gently rubbed into the affected area of skin twice a day.
You should always follow these instructions when using Diprosalic ointment:
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 ointment 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 ointment
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 ointment
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:
Steroid withdrawal reaction:
If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.
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.
5. How to store Diprosalic ointment
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 tube and carton after 'EXP'. 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 ointment contains
What Diprosalic Ointment looks like and contents of the pack
Diprosalic ointment is a smooth, off-white ointment. It is available in tubes containing 15 g, 30 g or 100 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
The manufacturer is:
This leaflet was last revised in March 2022.
© Organon Pharma (UK) Limited, 2022. All rights reserved.
PIL.DPSC-O.22.UK.0042.IB-007.RCN001381
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