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DIPROSALIC SCALP APPLICATION

Active substance(s): BETAMETHASONE / BETAMETHASONE DIPROPIONATE / SALICYLIC ACID

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Assessed against the UK PIL dated Jan 2015

Diprosalic® Scalp Application

0607
10.06.15[13]

(betamethasone dipropionate/ salicylic acid)
PATIENT INFORMATION LEAFLET

MOCK UP

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. How to 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.

By Caroline McDermott at 10:06 am, Jun 16, 2015

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 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.
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 out of the sight and reach of children.
Do not store above 25°C. Use within 6 weeks after opening.
Do not use Diprosalic Scalp Application after the expiry date, which is
stamped on the pack.
If the liquid becomes discoloured or shows any other signs of deterioration,
consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Diprosalic Scalp Application contains
The Diprosalic Scalp Application is a topical lotion containing
betamethasone dipropionate 0.064% w/w (equivalent to 0.05% w/w
betamethasone) and salicylic acid 2% w/w, as well as the following inactive
ingredients: disodium edetate; hydroxypropyl methylcellulose; sodium
hydroxide; isopropyl alcohol; purified water.
What Diprosalic Scalp Application looks like and contents of the pack
Diprosalic Scalp Application is available in bottles containing 100ml.
The bottle is of white plastic with a tamper-evident ring.
Manufacturer and Product Licence Holder
Manufactured by
Schering-Plough Labo NV, Industriepark 30, B-2220 Heist-op-den-Berg,
Belgium.
Schering-Plough France, 2 rue Louis Pasteur, 14200 Herouville-st-Clair,
France.

Procured from within the EU and Repackaged by the Product Licence holder
P.I.E. Pharma Ltd., 207 Kenton Road, Harrow, Middlesex HA3 0HD.
POM

PL 15361/0607

Leaflet revision and issue date (Ref.) 10.06.15[13]
Diprosalic® is a trademark of Schering Corporation, USA.

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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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