Modrasone Ointment
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005442
Modrasone® Ointment
Alclometasone Dipropionate
I
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Modrasone Ointment is and what it is used for
2. Before you use Modrasone Ointment
3. How to use Modrasone Ointment
4. Possible side effects
5. How to store Modrasone Ointment
6. Further 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. BEFORE YOU USE MODRASONE OINTMENT Do not use Modrasone Ointment:
• if you, or a child you are caring for, have ever had an allergic reaction to Modrasone Ointment or any of its active or inactive ingredients. Please refer to section 6 for full list of excipients.
• 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
Tell your doctor if you are pregnant or breast-feeding, before you start using Modrasone Ointment.
Important information about some of the ingredients of Modrasone Ointment
Modrasone Ointment contains propylene glycol which may cause skin irritation.
3. HOW TO USE MODRASONE OINTMENT
Always use Modrasone Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for children and adults, a thin layer of Modrasone Ointment gently masaged 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.
• 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.
• 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.
If you use more Modrasone Ointment than you should
If you (or somebody else) accidentally swallows the ointment, it should not produce any undesirable effects. However, if you are worried, you should speak to your doctor.
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.
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
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, particularly on your face, it can cause:
• thinning of the skin
• red marks.
This happens more easily in infants and children.
If you are worried, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MODRASONE OINTMENT
The ointment should not be stored above 25°C.
Keep out of the reach and sight of children.
Do not use the ointment after the expiry date which is stamped on the pack.
6. FURTHER 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:
Schering-Plough Ltd Welwyn Garden City Herts, AL7 1TW, England.
The manufacturer is: The distributor is:
Schering-Plough Labo NV, PLIVA Pharma Limited, Vision House,
Heist-op-den-Berg, Belgium. Bedform Road, Petersfield,
Hampshire GU32 3QB.
® PLIVA This leaflet was last approved in 07/2009.