Lotriderm Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lotriderm® Cream
(betamethasone dipropionate and clotrimazole)
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 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. See section 4.
In this leaflet:
1. What Lotriderm Cream is and what it is used for
2. What you need to know before you use Lotriderm Cream
3. How to use Lotriderm Cream
4. Possible side effects
5. How to store Lotriderm Cream
6. Further Information
1. WHAT LOTRIDERM CREAM IS AND WHAT IT IS USED FOR
Lotriderm Cream contains the active ingredients 0.064% w/w betamethasone dipropionate and 1.0% w/w clotrimazole. Betamethasone belongs to a group of medicines called topical corticosteroids which are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. Clotrimazole is a topical anti-fungal medicine used to treat some fungal infections of the skin.
Lotriderm Cream is used for the short-term treatment of certain fungal infections of the skin, when redness and itchiness may also be a problem.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOTRIDERM CREAM
Do not use Lotriderm Cream
• If you are allergic reaction to betamethasone dipropionate, clotrimazole or any of the other ingredients of this medicine (listed in section 6).
• If your skin becomes irritated, or you develop an allergic reaction.
• On any other skin infection as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, nappy rash or other skin infections.
Warning and precauctions
• If you have psoriasis
• If you or your child are under 12 years of age.
Other medicines and Lotriderm Cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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.
Lotriderm Cream contains
• propylene glycol - this may cause skin irritation.
• cetostearyl alcohol - this may cause local skin reaction (e.g. contact dermatitis)
3. HOW TO USE LOTRIDERM 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.
• For adults and children over the age of 12 years a layer of cream should be gently massaged into the affected and surrounding skin areas twice a day, in the morning and evening.
• Usually the cream should be used for either two weeks or four weeks, depending on the type of infection you have.
• Your doctor will tell you how long to use the cream for. Your skin infection should start to improve and the redness and itchiness will ease within the first few days of treatment.
• If your skin infection does not appear to get any better, you should see your doctor.
You should always follow these instructions when using Lotriderm Cream:
• Keep the cream away from your eyes.
• If Lotriderm Cream is used in children, it should not be used on any part of their body for more than 5 days.
• Do not put the cream under a dressing, such as a plaster or bandage, as this makes it easier for the active ingredient of the medicine to pass through the skin and possibly cause some unwanted effects.
• You must not use a large amount of cream on large areas of the body for a long time (for example every day for many weeks or months).
• Do not apply the cream to the face for more than 5 days, in places where the skin folds (e.g. the back of the knee) or on large areas of damaged skin.
If you use more Lotriderm Cream than you should
Tell your doctor if:
• You (or someone else) accidentally swallows the cream, it should not produce any undesirable effects.
• You use the cream more often than you should, or on large areas of the body, it may cause some side effects.
• You have not followed the dosage instructions, or your doctor's advice and have used the cream too frequently and/or for a long time.
If you forget to use your Lotriderm cream
If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before.
4. POSSIBLE SIDE EFFECTS
A few people may find that they suffer from some of the following side effects after using Lotriderm Cream:
- burning and stinging
- rash; swelling and other skin infections.
In addition, the following side effects have been reported to occur following the use of other medicines containing either clotrimazole or betamethasone dipropionate:
- redness, stinging, blistering, peeling,
swelling, itching, burning, skin rash, dryness of the skin
- inflammation of the hair follicles; excessive hair growth
- darkening of the skin; allergic skin reactions; dermatitis (skin inflammation) around the mouth; other skin infections, thinning of the skin and red marks.
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.
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 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 LOTRIDERM CREAM
Do not store above 25°C.
Do not use after expiry date on the carton. If the cream shows any signs of deterioration or discoloration consult your pharmacist for advice.
Keep out of the reach and sight of children.
Return any left-over medicine to your pharmacist.
Do not keep it for further use.
Remember this medicine has been prescribed just for you.
Never offer your medicines to other people. It may not be suitable for them, even if their symptoms seem the same as yours.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Lotriderm Cream contains 0.064 % w/w betamethasone dipropionate and 1.0 % w/w clotrimazole. The other ingredients are: liquid paraffin, vaseline, cetostearyl alcohol, cetomacrogol 1000; benzyl alcohol, sodium dihydrogen phosphate dehydrate, concentrated phosphoric acid, sodium hydroxide, propylene glycol, purified water.
What Lotriderm Cream looks like and contents of the pack
Lotriderm Cream is a smooth, white to off white cream. It is available in tubes containing 30 g.
This medicine is Manufactured by NV. Schering-Plough Labo, Industriepark 30, 2220 Heist-op-den-Berg, Belgium. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd.
Lotriderm is a registered trademark of Schering Corporation.
Lotriderm Cream PL20774/0970
Leaflet prepared 20th April 2015 PP2/0970/V2