□ ALLIANCE

PATIENT INFORMATION LEAFLET_

Hydromol® Intensive

urea

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 Hydromol Intensive 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.

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

The information in this leaflet has been divided into the following sections:

1.    What Hydromol Intensive is and what it is used for

2.    Check before you use Hydromol Intensive

3.    How to use Hydromol Intensive

4.    Possible side effects

5.    How to store Hydromol Intensive

6.    Further information

11. What Hydromol Intensive is and what it is used for_

Hydromol Intensive is an emollient used to treat dry, scaly skin conditions. The cream helps to soften and moisturise your skin.

Dry skin is caused by a lack of water in the outer layer of skin cells known as the stratum corneum (top layer of the skin). When this layer becomes dry it becomes cracked, scaly and sometimes itchy.

The skin dries out when too much water evaporates from its surface. This increases as we get older, and is made worse by washing, because hot water and soap can remove the layer of natural oil on the skin.

Hydromol Intensive contains urea, the skin's natural moisturiser. Urea is a substance that is found naturally in the stratum corneum. It helps the skin retain moisture. Water is also normally retained in the stratum corneum by a thin layer of natural oil (sebum), which slows down evaporation of water from the skin surface.

The urea in Hydromol Intensive is mixed with white soft paraffin which forms a layer of oil on the surface of the skin. This oily layer helps prevent water from evaporating from the skin’s surface which will reduce irritation, restore suppleness and improve the appearance of your skin.

| 2. Check before you use Hydromol Intensive_

Do not use Hydromol Intensive:

•    If you are allergic (hypersensitive) to urea or any of the ingredients of Hydromol Intensive (see Section 6 Further information).

If the above applies to you, or if you are not sure, speak to you doctor or pharmacist before you use Hydromol Intensive.

Take special care with Hydromol Intensive

Before you use Hydromol Intensive tell your doctor if:

•    you have moist or broken skin.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you use Hydromol Intensive. Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines which are applied to the skin as they may interfere with Hydromol Intensive.

Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

| 3. How to use Hydromol Intensive_

Always use Hydromol Intensive exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Hydromol Intensive is for external use only and should only be applied to the skin. It should not be used on moist or broken skin. Using Hydromol Intensive is easy, just follow the instructions below:

Your doctor may tell you to cover this with a special “occlusive” dressing (an air tight dressing), but this is not usually necessary.

What to do if you use more Hydromol Intensive than you should

Using too much Hydromol Intensive may cause skin irritation (redness, burning or itching). If this happens to you ask your doctor for advice.

The cream is for external use only and should only be applied to the skin. If you accidentally swallow the cream this may make you feel sick; drink plenty of water or milk. You should tell your doctor at once or contact your nearest accident and emergency department. Show any left-over medicines or the empty container to the doctor.

If you forget to use Hydromol Intensive

If you forget to use Hydromol Intensive on any occasion, do not worry, just continue as normal.

Some do’s and dont’s for Hydromol Intensive:

Do    Do    Do

use Hydromol Intensive    regularly    wash, rinse and dry affected areas    before    apply Hydromol Intensive to the    whole of

as directed    applying Hydromol Intensive    the affected area - twice daily

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Do not worry. Like all medicines, Hydromol Intensive can cause side effects, although not everyone gets them.

Some people experience local irritation when they apply Hydromol Intensive. If you notice this or any other unusual effect, tell your doctor. If you use Hydromol Intensive as your doctor tells you, it is unlikely to cause side effects.

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 Hydromol Intensive_

Keep out of the reach and sight of children.

Do not use Hydromol Intensive after the expiry date which is stated on the carton and on the base of the tube. The expiry date refers to the last day of that month.

Do not store Hydromol Intensive above 30°C.

Do not use Hydromol Intensive if you notice a change in the colour or feel of the cream.

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

6. Further information

What is in Hydromol Intensive?

The active ingredient in this medicine is urea 10% w/w contained in white soft paraffin.

The other ingredients are isopropyl myristate, maize starch, glyceryl tribehenate, palmitic acid, sorbitan laurate and polyoxyethylene fatty glyceride.

What Hydromol Intensive looks like and contents of the pack

Hydromol Intensive is a smooth, unperfumed, non greasy and off white cream.

Hydromol Intensive comes in tubes of 30g (grams) and 100g. A 30g tube of Hydromol Intensive contains 3g of urea and a 100g tube contains 10g of urea.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Hydromol Intensive is manufactured by: Laboratoires Chemineau, 93 Route de Monnaie, BP 16, 37210 Vouvray, France.

The information in this leaflet applies only to Hydromol Intensive. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last approved: 1st February 2015

Hydromol is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Ltd.

© Alliance Pharmaceuticals Ltd 2015.

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