Artwork Information

Product Title:	Hydromol Cream leaflet
Date:	24-04-15	Product Size:	126mm x 150mm
Label Number:	15-047 Version 2	Colours Used:	!9', PMS 292, PMS274
Fonts Used:	Swiss 721, Palatino
Font size (min):	6.5pt

Magenta text, keylines and shading are NOT to be printed

Hydromol’

CREAM

Sodium Pyrrolidone Carboxylate

Information for Patients

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 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.

•    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.

11. What Hydromol Cream is and what it is used for_|

Hydromol Cream is a soft cream which moisturises the skin.

Hydromol Cream contains a naturally occurring moisturising agent as well as oils, which prevent moisture loss from the skin. This helps to relieve itch, lubricate and soften the skin.

Hydromol Cream is used to treat any condition in which dry skin is a feature such as eczema, ichthyosis (hereditary dry skin) and senile pruritus (itching that may occur in old age).

12. Check before you use Hydromol Cream_

Do not use Hydromol Cream:

• if you are allergic (hypersensitive) to sodium pyrrolidone carboxylate or any of the ingredients of Hydromol Cream (see section 6 Further information).

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

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 Cream.

Other medicines should not be mixed into Hydromol Cream.

Pregnancy and breast-feeding

It is safe to use Hydromol Cream if you are pregnant or breast-feeding.

Important Information about some of the Ingredients of Hydromol Cream

Hydromol Cream contains hydroxybenzoates and cetomacrogol emulsifying wax contains cetostearyl alcohol (see section 6 Further information) which may cause allergic reactions (itching, swelling or redness) in some people.

Hydromol Cream is for external use only and should only be applied to the skin.

Adults, elderly and children: Apply liberally to the affected area and massage into the skin. Hydromol Cream may be used as often as required. It is especially beneficial when used immediately after washing or bathing as the warmth of the skin will increase absorption.

Avoid contact with the eyes, in the event of accidental contact rinse well with water.

If you accidentally swallow some of the cream it is unlikely to cause you any harm.

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

Hydromol Cream should be applied liberally, so do not worry if you apply more cream than usual.

If you forget to use Hydromol Cream

If you forget to use Hydromol Cream on any occasion, do not worry, just apply the cream and continue as normal.

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

14. Possible side effects_|

If used correctly Hydromol Cream is unlikely to cause side effects.

Rarely some people may experience an allergic type reaction (e.g. rash) when using Hydromol Cream.

If your condition worsens consult 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 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.

15. Howto store Hydromol Cream_|

Keep out of the reach and sight of children.

Do not use Hydromol Cream after the expiry date which is stated on the carton, on the base of the tube or on the labelling of the tub.

The expiry date refers to the last day of that month after EXP.

Do not store above 30°C. Do not refrigerate or freeze.

Do not use Hydromol Cream 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.

16. Further Information_

What Is In Hydromol Cream?

The active ingredient in this medicine is sodium pyrrolidone carboxylate 2.5%.

The other ingredients are liquid paraffin, isopropyl myristate, sodium lactate solution, cetomacrogol emulsifying wax, myristyl myristate, macrogol cetostearyl ether, hydroxybenzoates (parabens)

(E218, E214, E216), phenoxyethanol and purified water.

What Hydromol Cream looks like and contents of the pack

Hydromol Cream is a soft, white, oil-in-water cream.

Hydromol Cream comes in plastic tubes of 10g (grams), 50g and 100g and tubs containing 500g with a pump dispenser.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire,

SN15 2BB, UK.

Hydromol cream is manufactured by: Dales Pharmaceuticals Limited, Skipton, North Yorkshire, BD23 2RW, UK.

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

This leaflet was last revised: April 2015.

Alliance and associated devices are registered trade marks of Alliance Pharmaceuticals Limited.

Hydromol is a registered trade mark of Alliance Pharmaceuticals Limited.

©Alliance Pharmaceuticals Limited 2015

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