Modrasone Cream
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PACKAGE LEAFLET:
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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 Cream is and what it is used for
2. Before you use Modrasone Cream
3. How to use Modrasone Cream
4. Possible side effects
5. How to store Modrasone Cream
6. Further 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. 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 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 Cream.
Important information about some of the ingredients of Modrasone Cream
Modrasone Cream contains propylene glycol which may cause skin irritation.
3. HOW TO USE MODRASONE CREAM
Always use Modrasone Cream 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 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
If you (or somebody else) accidentally swallows the cream, 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 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.
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
Most people find that when the cream is used correctly, it does not cause any problems.
However, if you use more cream more 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.
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 CREAM
The cream should not be stored above 25°C.
Keep out of the reach and sight of children.
Do not use the cream after the expiry date which is stamped on the pack.
6. FURTHER INFORMATION What Modrasone Cream contains
The active substance is alclometasone dipropionate 0.05% w/w. The other ingredeients 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 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
The distributor is:
TEVA UK Limited, Eastbourne, BN22 9AG, UK.