DIPROSALIC OINTMENT

Active substance: SALICYLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DIPROSALIC® OINTMENT
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.
2.
3.
4.
5.
6.

What Diprosalic is and what it is used for
What you need to know before you use Diprosalic
How to use Diprosalic
Possible side effects
How to store Diprosalic
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 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 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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Pregnancy, breast-feeding and fertility

4. Possible side effects

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.

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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Diprosalic

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.

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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 sterile 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.
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.
PL No: 04423/0286

POM

Leaflet revision and issue date (Ref): 27.06.13
Diprosalic® is a registered trademark of Merck Sharp & Dohme
Corp.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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