Modrasone Ointment
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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.
by certain skin
In adults and children, Modrasone Ointment is used to reduce redness and itchiness caused problems (for example eczema. and dermatitis):
• Eczema is a common skin disease, which causes the skin to become red and itchy.
causing the
• Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, 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 irriation.
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 doctors 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.
• 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 50 g.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK.
The manufacturer is:
Schering-Plough Labo NV,
Heist-op-den Berg, Belgium.
This leaflet was last revised in January 2015.
PIL.MO.14.UK.4459.Var-015
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