UREA

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
UREA
Available from:
Alliance Pharmaceuticals Ltd.
ATC code:
D02AE01
INN (International Name):
UREA
Dosage:
10 %w/w
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
carbamide
Authorization status:
Not marketed
Authorization number:
PA0943/005/001
Authorization date:
1975-01-07

Urea10% w/w Cream PIL UK ROI 006

PATIENT INFORMATION LEAFLET

Urea 10% w/w Cream

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

Urea 10% w/w 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.

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

1.

What Urea 10% w/w Cream is and what it is used for

2. Check before you use Urea 10% w/w Cream

3. How to use Urea 10% w/w Cream

4. Possible side effects

5.

How to store Urea 10% w/w Cream

6.

Further information

1. What Urea 10% w/w Cream is and what it is used for

Urea 10% w/w Cream 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.

Urea 10% w/w Cream 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 Urea 10% w/w Cream is mixed with white soft paraffin which

forms a layer of oil on the surface of the skin. This oily layer helps prevent

Urea10% w/w Cream PIL UK ROI 006

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 Urea 10% w/w Cream

Do not use Urea 10% w/w Cream:

if you are allergic (hypersensitive) to urea or any of the ingredients of Urea

10% w/w 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 Urea 10% w/w Cream.

Take special care with Urea 10% w/w Cream

Before you use Urea 10% w/w Cream 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 Urea 10% w/w 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 Urea 10%

w/we Cream.

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 Urea 10% w/w Cream

Always use Urea 10% w/w Cream exactly as your doctor has told you to. You

should check with your doctor or pharmacist if you are not sure.

Urea 10% w/w Cream is for external use only and should only be applied to

the skin. It should not be used on moist or broken skin.

Using Urea 10% w/w Cream is easy, just follow the instructions below:

Urea10% w/w Cream PIL UK ROI 006

Wash the affected

areas well and rinse

off any traces of soap

apply a suitable

amount of cream

twice daily

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 Urea 10% w/w Cream than you should

Using too much Urea 10% w/w Cream 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 Urea 10% w/w Cream

If you forget to use Urea 10% w/w Cream on any occasion, do not worry, just

continue as normal.

Some do’s and dont’s for Urea 10% w/w Cream:

Do

Do

Do

use Urea 10% w/w

Cream regularly as

directed

wash, rinse and dry

affected areas before

applying Urea 10% w/w

Cream

Apply Urea 10% w/w

Cream to the whole of the

affected area - twice daily

Don’t

Don’t

Don’t

use Urea 10% w/w

Cream if you’ve had a

past reaction to it or any

of its ingredients

use Urea 10% w/w

Cream on moist or

broken skin

worry if you occasionally

forget to use Urea 10%

w/w Cream - continue

using it as before

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

nurse or pharmacist.

4. Possible side effects

Urea10% w/w Cream PIL UK ROI 006

Do not worry. Like all medicines, Urea 10% w/w Cream can cause side

effects, although not everyone gets them.

Some people experience local irritation when they apply Urea 10% w/w

Cream. If you notice this or any other unusual effect, tell your doctor.

If you use Urea 10% w/w Cream 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:

UK:

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

IE:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie, E-mail:

medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety

of this medicine.

5. How to store Urea 10% w/w Cream

Keep out of the reach and sight of children.

Do not use Urea 10% w/w Cream 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 Urea 10% w/w Cream above 30ºC.

Do not use Urea 10% w/w 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.

6. Further information

What is in Urea 10% w/w Cream?

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

paraffin.

Urea10% w/w Cream PIL UK ROI 006

The other ingredients are isopropyl myristate, maize starch, glyceryl

tribehenate, palmitic acid, sorbitan laurate and polyoxyethylene fatty

glyceride.

What Urea 10% w/w Cream looks like and contents of the pack

Urea 10% w/w Cream is a smooth, unperfumed, non greasy and off white

cream.

Urea 10% w/w Cream comes in tubes of 30g (grams) and 100g. A 30g tube

of Urea 10% w/w Cream 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.

Urea 10% w/w Cream is manufactured by: Laboratoires Chemineau, 93 Route

de Monnaie, BP 16, 37210 Vouvray, France.

The information in this leaflet applies only to Urea 10% w/w Cream. If you

have any questions or you are not sure about anything, ask your doctor or a

pharmacist.

This leaflet was last approved: January 2017.

Alliance, Alliance Pharmaceuticals and associated devices are registered

trade marks of Alliance Pharmaceuticals Ltd.

© Alliance Pharmaceuticals Ltd 2017

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Urea 10% w/w Cream.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Urea 10% w/w cream contains Urea 10% w/w.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

A smooth, unperfumed, non-greasy, off-white cream for topical administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the management of ichthyosis, xeroderma, hyperkeratosis and other chronic dry skin conditions.

4.2 Posology and method of administration

Urea 10% w/w Cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply

sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature

of the cream.

4.3 Contraindications

Known hypersensitivity to the product.

4.4 Special warnings and precautions for use

Avoid application to moist or broken skin.

4.5 Interaction with other medicinal products and other forms of interaction

Urea 10% w/w Cream may increase the penetration through the skin barrier of other topically applied medicaments.

4.6 Fertility, pregnancy and lactation

Animal reproduction studies have not been conducted with Urea 10% w/w Cream . Urea 10% w/w Cream should only

be used if the anticipated benefits outweigh the risks.

4.7 Effects on ability to drive and use machines

Urea 10% w/w Cream does not interfere with the ability to drive or use machines.

4.8 Undesirable effects

May cause local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive skin.

If the

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condition is aggravated or there is no improvement, the doctor should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie

4.9 Overdose

Topical applications of excessive amounts of Urea 10% w/w Cream might cause skin irritation but no other effects

would be expected.

Ingestion of a large amount of Urea 10% w/w Cream would be expected to result in

gastrointestinal irritation (nausea and vomiting).

Symptomatic and supportive care should be given.

Liberal oral

administration of milk or water may be helpful.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Urea acts as a hydrating and keratolytic agent.

5.2 Pharmacokinetic properties

Urea is primarily excreted in the urine. A small amount is also eliminated in sweat.

5.3 Preclinical safety data

In man, doses of up to 80g/day iv or 100g/day p.o urea are considered safe.

Whilst only very limited preclinical data is available, there is no evidence to suggest that urea would have teratogenic,

carcinogenic or mutagenic potential in therapeutic use.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

The cream also contains:

White soft paraffin

Maize starch

Isopropyl myristate

Glyceryl tribehenate

Palmitic acid

Sorbitan laurate

Polyoxyethylene fatty glyceride

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

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6.4 Special precautions for storage

Do not store above 30

6.5 Nature and contents of container

Urea 10% w/w Cream is available in tubes of 30 g and 100g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Ltd.

Avonbridge House

Bath Road

Chippenham

Wiltshire SN15 2BB

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA0943/005/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation:

07 January 1975

Date of last Renewal:

07 January 2010

10 DATE OF REVISION OF THE TEXT

April 2017

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