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NOTICE RECTO 135x210

PLAN n* 2.GD.02.DRA.0350.R01

Nutraplus™ 10% w/w Cream

urea

CREAM

PACKAGE LEAFLET: INFORMATION FOR THE USER Nutraplus 10% w/w Cream

Urea

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

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

-    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.

-    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What Nutraplus is and what it is used for

2.    What you need to know before you use Nutraplus

3.    How to use Nutraplus

4.    Possible side effects

5.    How to store Nutraplus

6.    Contents of the pack and other information

1.    What Nutraplus is and what it is used for

•    Nutraplus is an emollient, a moisturising and protective cream for the treatment of dry or damaged skin.

•    The active substance in this product is urea, a natural substance found in healthy skin.

•    The presence of urea in the cream moisturises the skin. This helps bring back soft and supple skin.

2.    What you need to know before you use Nutraplus Do not use Nutraplus

•    If you are allergic to urea or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using Nutraplus.

•    If irritation occurs, discontinue use temporarily.

•    Avoid getting Nutraplus in your eyes, mouth, nose or ears (mucous membranes). Upon accidental contact, rinse the affected area with clean water.

Other medicines and Nutraplus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Nutraplus might interfere with other medicines applied to the skin such as:

•    topical corticosteroids, which are a group of medicines used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.

•    5-fluorouracil, used to treat skin conditions such as horny growths of the skin (keratoses) and some skin cancers.

•    dithranol, which is used to treat psoriasis.

Pregnancy and breast-feeding

•    If you are pregnant or breast-feeding, it may not be advisable to use this product, unless your doctor considers it essential. 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.

Nutraplus contains:

-    cetearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

-    propylene glycol which may cause skin irritation

-    propyl parahydroxybenzoate and methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

3.    How to use Nutraplus

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

•    Nutraplus is for external use only.

•    First gently wash and dry the affected areas of your skin.

•    Apply evenly to dry skin areas 2 to 3 times a day, or as advised by your doctor or pharmacist.

•    Wipe away any excess cream with a tissue.

•    How long you will have to use this cream will depend on how quickly your condition improves.

If you use more Nutraplus than you should or accidentally swallow any of the cream

In the rare event that you accidentally swallow any of this product, seek medical advice.

If you forget to use Nutraplus

Do not worry if you forget to use your cream at the right time. When you remember, start using the product again as you did before.

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

4.    Possible side effects

•    Like all medicines, this medicine can cause side effects, although not everybody gets them.

•    When used normally, your skin may become slightly red in appearance and you may experience a burning sensation or itching of the skin. These effects are usually mild and stop altogether with further use of the cream.

•    If you continue to get discomfort when you have been applying Nutraplus, wash the cream off and stop using it for a few days. If the effects still persist or are severe when you start using it again, stop using the product altogether and seek the advice of 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 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 Nutraplus

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Store the closed container away from direct heat.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Nutraplus contains

•    The active substance is urea. Each gram of Nutraplus contains 100mg of urea.

•    The other ingredients are glyceryl monostearate, octyl palmitate, myristyl lactate, mineral oil, cetearyl alcohol, ceteareth-20, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.

What Nutraplus looks like and contents of the pack

•    Nutraplus is a white cream.

•    It is available in 60 and 100 g tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts.,

WD17 1DS, UK. PL 10590/0002 (UK)

Manufacturer: Laboratoires Galderma, ZI-Montdesir, 74540 Alby-sur-Cheran, France.

This leaflet was last revised in 03/2016.

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