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Drapolene Cream

Document: leaflet MAH BRAND_PL 02855-0016 change

RECTO


DRAPOLENE

Cream

Patient Information Leaflet

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Drapolene Cream carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

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•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist straightaway.

In this leaflet:

1.    What Drapolene Cream is and what it is used for

2.    Before you use Drapolene Cream

3.    How to use Drapolene Cream

4.    Possible side effects

5.    Storing Drapolene Cream

6.    Further information

1.    What Drapolene Cream is and what it is used for

Drapolene Cream contains benzalkonium chloride and cetrimide in a soothing cream. These are antiseptics that help stop bacteria growing.

Drapolene Cream is used to prevent and treat nappy rash in babies.

Drapolene Cream can also be used for adults with incontinence to help soothe skin that is sore or likely to become sore because of urine on their skin (urinary dermatitis).

Drapolene cream can also be used to give relief from minor burns, mild sunburn and sore skin caused by the effects of weather.

2.    Before you use Drapolene Cream

Do not use this medicine if:

• the person is allergic (hypersensitive) to benzalkonium chloride or cetrimide or any of the other ingredients of Drapolene Cream (see section 6).

Taking other medicines

Drapolene Cream does not interfere with other medicines.

Important Information about some of the ingredients of Drapolene Cream

Drapolene Cream contains benzalkonium chloride, cetyl alcohol, lanolin and chlorocresol. These are known irritants that may cause skin reactions such as rash, redness or itching in some cases.

DRAPOLENE Cream 100 g

Dimensions / Sizes : Code ac / stock No. 148 x 210 mm    F304751

COLOURS

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PMS 286 U

2

BLACK

3

4

5

6

7

3. How to use Drapolene Cream

The effected area should be washed and dried thoroughly. Apply Drapolene Cream as required, paying particular attention to folds in the skin.

For nappy rash, use Drapolene Cream at each nappy change, having first cleaned and dried the nappy area.

For urinary dermatitis, regular use is advised.

For minor burns, sunburn and weather effects, apply as required.

If the skin condition does not improve or becomes worse, talk to your doctor, nurse or pharmacist.

If you miss an application:

Use the cream as soon as your remember, for example at the next nappy change.

If you use too much:

Using too much cream will not cause harm. If the cream is accidentally eaten, tell your doctor or go to the Accident and Emergency department of your nearest hospital.

4.    Possible side effects

Like all medicines, Drapolene Cream can cause side effects such as skin rash or redness, but these are not common.

If you or your child feels ill after using Drapolene Cream, or you notice any unusual or unexpected symptoms, tell your doctor or pharmacist straightaway.

5.    Storing Drapolene Cream

Store below 25°C. Keep out the reach and sight of children. Do not use Drapolene Cream after the date (month and year) printed after "EXP" on the box. If the expiry date has passed, take the product back to your pharmacist for safe disposal.

6. Further Information

Drapolene Cream is a smooth pink cream that comes in a 100g tube, or in a 200g or 350g tub.

Active substances:

Benzalkonium chloride (0.01% w/w) and cetrimide (0.2 % w/w).

Other ingredients:

White soft paraffin, lanolin, cetyl alcohol, polawax, chlorocresol, amaranth (E123), purified water.

Marketing Authorisation holder

Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom. Send all enquiries to this address.

Manufacturer

Laleham Health and Beauty Limited, Sycamore Park, Alton, Hampshire, GU34 2PR, United Kingdom

DRA0023/220611v1

F304751-42


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Date of leaflet approval: January 2015.