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Lotriderm Cream

Document: leaflet MAH BRAND_PLPI 18799-2324 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lotriderm® cream

(betamethasone dipropionate/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. 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.

The name of your medicine is Lotriderm cream but will be referred to as Lotriderm throughout this leaflet.

In this leaflet:

1.    What Lotriderm is and what it is used for

2.    What you need to know before you use Lotriderm

3.    How to use Lotriderm

4.    Possible side effects

5.    How to store Lotriderm

6.    Contents of the pack and other information

1.    WHAT LOTRIDERM IS AND WHAT IT IS USED FOR

Lotriderm contains the active ingredients 0.643mg/g betamethasone dipropionate (equivalent to 0.5mg/g betamethasone) and clotrimazole 10mg/g. 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 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 Do not use Lotriderm

•    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 infections 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.

Warnings and Precautions

•    if you have psoriasis

•    if you or your child are under 12 years of age.

Other medicines and Lotriderm

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 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

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:

•    Keep the cream away from your eyes.

•    If Lotriderm 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 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 Lotriderm

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:

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 LOTRIDERM

-    Keep out of the sight and reach of children.

-    Do not apply Lotriderm after the expiry date which is stated on the carton after ‘Exp’. The expiry date refers to the last day of that month.

-    Do not store above 25°C.

-    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

-    If your medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.

6.    CONTENTS OF PACK AND OTHER INFORMATION What Lotriderm contains

The active ingredient is betamethasone dipropionate 0.643mg/g (equivalent to 0.5mg/g betamethasone) and clotrimazole 10mg/g.

The other ingredients are paraffin liquid, vaseline, cetostearyl alcohol, cetomacrogol 1000, benzylalcohol, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, propylene glycol and purified water.

What Lotriderm looks like and contents of the pack

Lotriderm is a smooth, white to off white cream. It is available in tubes containing 30g.

Manufactured by: NV Schering-Plough Labo, Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

Procured from within the EU and repackaged by Product Licence Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Lotriderm® cream - PL : 18799/2324    | POM |

Leaflet date: 24.08.2015

Lotriderm is a registered trademark of the Merck Sharp & Dohme Limited.