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MODRASONE CREAM

Active substance(s): ALCLOMETASONE DIPROPIONATE / ALCLOMETASONE DIPROPIONATE / ALCLOMETASONE DIPROPIONATE

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

1. What Modrasone Cream is and what it is used for
Modrasone Cream 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 Cream 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 Cream
Do not use Modrasone Cream:
• if
 you, or a child you are caring for, have ever had an allergic reaction to Modrasone Cream 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 Cream contains propylene glycol
This may cause skin irritation.

3. How to use Modrasone Cream
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 usual dose for children and adults, a thin layer of Modrasone Cream gently massaged into the
affected area two or three times a day.
• Gently massage the cream until it disappears.
• Your

doctor may tell you to use Modrasone Cream in a different way. If so, follow your doctor’s
instructions carefully.
• If
 the cream 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.
• You
 must not use a large amount of Modrasone Cream in the same area for a long time
(for example every day for many weeks and months).
• Do
 not put Modrasone Cream under 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.
If you use more Modrasone Cream than you should
Tell your doctor if:
• you
 use the cream 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 doctors advice and have used the cream
too frequently or for a longer time than prescribed.
• you
 (or somebody else) accidentally swallows the cream, however it should not produce any
undesirable effects.
If you forget to use Modrasone Cream
If you forget to use your cream at the right time, use it as soon as you remember then carry on as before.
Do not double the amount of cream 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 cream is used correctly, it does not cause any problems.
However, if you use more cream 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 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.
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 Cream
• Keep this medicine out of the sight and reach of children.
• The cream should not be stored above 25°C.
• Do
 not use this medicine after the expiry date which is stated 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 Cream contains
The active substance is alclometasone dipropionate 0.05% w/w. The other ingredients are:
Propylene glycol Ph.Eur; White Soft Paraffin BP; Cetostearyl Alcohol BP; Glyceryl Stearate PEG 100
stearate; Polyoxyethylene (20) Cetyl Ether; Sodium Dihydrogen Phosphate Dihydrate Ph.Eur;
4-Chloro-M-Cresol BP; Phosphoric Acid Ph.Eur; Purified Water Ph.Eur.
What Modrasone Cream looks like and contents of the pack
Modrasone Cream is a smooth, white to off white cream. 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.

1010326-P 4.1

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Aspire Pharma Limited
Modrasone Cream
50g
Black
Leaflet
580mm x 170mm
Yes
24 May 2016
Aspire address change submission only
4.1
16/09/2016
As swatch(es)
Headings Trebuchet Text 10pt Milo
InDesign CS6
T988

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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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