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MODRASONE OINTMENT

Active substance(s): ALCLOMETASONE DIPROPIONATE / ALCLOMETASONE DIPROPIONATE

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Modrasone® Ointment
Alclometasone Dipropionate

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Modrasone Ointment is and what it is used for
2. What you need to know before you use Modrasone Ointment
3. How to use Modrasone Ointment
4. Possible side effects
5. How to store Modrasone Ointment
6. Contents of the pack and other information

1. What Modrasone Ointment is and what it is used for
Modrasone Ointment contains an active ingredient called alclometasone dipropionate which belongs to a
group of medicines called topical corticosteroids. These medicines are used on the surface of the skin to
reduce the redness and itchiness caused by certain skin problems.
In adults and children, Modrasone Ointment is used to reduce redness and itchiness caused by certain
skin problems (for example eczema and dermatitis):
• Eczema is a common skin disease, which causes the skin to become red and itchy.
• Dermatitis

is a condition brought on by the skin reacting to outside agents e.g. detergents,
causing the skin to become red and itchy.

2. What you need to know before you use Modrasone Ointment
Do not use Modrasone Ointment:
• if
 you, or a child you are caring for are allergic to alclometasone dipropionate or any of the other
ingredients of this medicine (listed in section 6).
• for
 any other skin problems as it could make them worse, especially rosacea (a skin condition affecting
the face), acne, dermatitis (skin inflammation) around the mouth, cold sores, chickenpox, or skin
infections (including bacterial, fungal and viral infections).
Pregnancy and breast-feeding
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.
Modrasone Ointment contains Propylene glycol
This may cause skin irritation.

3. How to use Modrasone 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.
The recommended dose for children and adults
Apply a thin layer of Modrasone Ointment gently massaged into the affected area two or three
times a day.
• Gently massage the ointment until it disappears.
• Your

doctor may tell you to use Modrasone Ointment in a different way. If so, follow your doctor’s
instructions carefully.
• You
 must not use a large amount of Modrasone Ointment in the same area for a long time
(for example every day for many weeks or months).
• Do
 not put Modrasone Ointment under a dressing, such as a plaster or bandage, as this makes it easier
for the active ingredient to pass through the skin and possibly cause some unwanted effects.
Use in children
If the ointment is for your child, do not use it under a nappy, as this makes it easier for the active
ingredient to pass through the skin and possibly cause some unwanted effects.
If you use more Modrasone Ointment than you should
Tell your doctor if:
• you
 use the ointment more often than you should, or on large areas of your body as it can affect
some of your hormones.
• you
 have not followed the dosage instructions, or your doctor’s advice and have used the ointment
too frequently or for a longer time than prescribed.
• you
 (or somebody else) accidentally swallows the ointment, it should not produce any
undesirable effects.
If you forget to use Modrasone Ointment
If you forget to use your ointment at the right time, use it as soon as you remember then carry on as
before. Do not double the amount of ointment used to make up for a forgotten dose.

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 more ointment than you should, particularly on your face, it can cause:
• Thinning

of the skin, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the
skin and you may notice red marks. This happens 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.
This happens more easily in infants and children.
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 Modrasone Ointment
• Keep this medicine out of the sight and reach of children.
• The ointment should not be stored above 25°C.
• Do
 not use the ointment after the expiry date which is stamped on the pack. The expiry date
refers to the last day of that month.
• Do
 not throw away any medicines via wastewater. 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 Modrasone Ointment contains
The active substance is alclometasone dipropionate 0.05% w/w. The other ingredients are:
hexylene glycol, propylene glycol monostearate, white beeswax and white soft paraffin.
What Modrasone Ointment looks like and contents of the pack
Modrasone Ointment is a colourless to light yellow ointment. It is available in tubes containing 50g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK.
Manufacturer:
Schering-Plough Labo NV, Heist-op-den Berg, Belgium

This leaflet was last revised in September 2016.

1010327-P5.1

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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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