Medine.co.uk

Emcrem Cream

Document: leaflet MAH BRAND_PL 19876-0013 change
21/8/15

: Package leaflet: Information for the user

EmcremCream

White Soft Paraffin 15% w/w, Liquid Paraffin 6% w/w


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

;This medicine is available without prescription. Nevertheless, you still need to use Emcrem carefully to! iget 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 see a doctor if your symptoms worsen or do not improve.

» If any of the side effects become serious or if you notice any side effects not listed in this leaflet,

! please tell your doctor or pharmacist.

;ln this leaflet:

;1. What Emcrem is and what it is used for 4. Possible side effects

2.    Before you use Emcrem    5. How to store Emcrem

3.    How to use Emcrem    6. Further information

I1.WHAT EMCREM IS AND WHAT IT IS USED FOR

jEmcrem is an emollient, moisturising and protective cream. It helps to smooth, soothe and hydrate |the skin and prevent moisture loss.

jEmcrem is used to treat red, inflamed, damaged, dry or chapped skin in adults and children, and to Iprotect raw skin areas. If you suffer from a skin condition called eczema and your skin is dry, the pream can be applied before having a bath to prevent your skin from drying any further. lEmcrem can also be used during or after treatment with topical steroid creams, gels or ointments.

''2. BEFORE YOU USE EMCREM ;Do not use Emcrem:

If you are hypersensitive (allergic) to white soft paraffin, liquid paraffin or any of the other ingredients of! lEmcrem. Tell your doctor so that he or she can give you another medicine.

Using other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, pven those not prescribed.

Pregnancy and breast-feeding:

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

Driving and using machines:

jEmcrem has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Emcrem:

jSome of the ingredients in your cream may cause a reaction such as cetostearyl alcohol which jmay cause a local skin reaction (e.g. contact dermatitis) and chlorocresol which may cause an lallergic reaction.


3. HOW TO USE EMCREM

Always use Emcrem exactly as your doctor has instructed you. You should check with your ploctor or pharmacist if you are unsure.

Your doctor may have told you when and how often to use the cream and how long to use it for. jlf so, check the label to remind you what they said. The cream should be thinly applied to cover the I Effected area completely, massaging gently and thoroughly into the skin as often as is required. If your; pondition worsens, or your symptoms persist beyond the period of treatment specified by your doctor, you should consult your doctor or pharmacist.

jlf you have the impression that the effect of Emcrem is too strong or too weak, talk to your doctor or I pharmacist. Emcrem is for external use only.

If you forget to use Emcrem:

;lf you forget to use your cream at the right time, use the usual amount as soon as you remember, then carry on as before.

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

4- POSSIBLE SIDE EFFECTS

jLike all medicines, Emcrem can have side effects although not everybody may get them. If your Symptoms persist or the condition worsens, stop using the cream and consult your doctor or pharmacist. Skin reactions including itching, rash, redness, peeling, burning, pain, dryness and skin j jinflammation (dermatitis) have been reported. If you are worried by this or any other effects, you Should tell your doctor or pharmacist.

Ilf any of the side effects become serious or if you experience any side-effects not mentioned in this I leaflet, please tell your doctor or pharmacist.

Reporting of side effects

jlf you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side j Pffects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at I ywvw.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the; safety of this medicine.

HOW TO STORE EMCREM Keep out of the reach and sight of children.

Do not use Emcrem after the expiry date which is stated on the packaging. The expiry date refers to ; fhe last day of that month. Do not store above 25°C.

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

6. FURTHER INFORMATION What Emcrem contains:

The active ingredients are white soft paraffin 15%w/w and liquid paraffin 6%w/w.

[The other ingredients are chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, dilute jphosphoric acid, sodium dihydrogen phosphate and purified water.

What Emcrem looks like and contents of the pack:

Emcrem is a smooth, white cream. It is available in a tube containing 50g and a pump dispenser ; pontaining 500g. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

Derma UK Ltd, ARC Progress, Mill Lane, Stotfold, Bedfordshire SG5 4NY, United Kingdom.

The manufacturer of Emcrem is: jBioglan AB, PO Box 50310, SE-202 13 Malmo, Sweden.

This leaflet was last approved AugusL2015.


oooom

21/8/15

What Emcrem looks like and contents- ~[ of the pack:

Emcrem is a smooth, white cream. It is [available in a tube containing 50g and a pump dispenser containing 500g. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is: Derma Ltd

ARC Progress, Mill Lane [Stotfold, Bedfordshire SG5 4NY United Kingdom

The manufacturer of Emcrem is Bioglan AB

[PO Box 50310, SE-202 13 Malmo,

Sweden


This leaflet was last approved August 2015    000000


PAGE six


4. POSSIBLE SIDE EFFECTS

Like all medicines, Emcrem can have side Effects although not everybody may get them. If your symptoms persist or the condition worsens, stop using the cream and consult your doctor or pharmacist.

Skin reactions including itching, rash, redness, [peeling, burning, pain, dryness and skin inflammation (dermatitis) have been reported.

)f you are worried by this or any other effects, you should tell your doctor or pharmacist.

[if any of the side effects become serious or if you experience any side-effects not mentioned in this leaflet, please tell your doctor or pharmacist.'

Reporting of side effects

)f 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 fellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting Side effects you can help provide more [information on the safety of this medicine.

________________________d


The active substances are white soft [paraffin 15% and liquid paraffin 6% w/w. Also contains:

IChlorocresol, macrogol cetostearyl ether, [cetostearyl alcohol, dilute phosphoric acid, sodium dihydrogen phosphate, purified water.

Read package leaflet before use.


For topical application:

Apply a thin layer of cream and [massage thoroughly into affected areas of skin as often as required or as advised by your doctor.

Keep out of the reach and sight of children.


FOR EXTERNAL USE ONLY Do not store above 25°C


MA Holder Derma UK Ltd

ARC Progress, Mill Lane, Stotfold 'Bedfordshire SG5 4 NY United Kingdom

PL 19876/0013 _

5 "012564"005082



PAGE THREE


In this leaflet:

1. What Emcrem is and what it is used for

[2. Before you use Emcrem

'3. How to use Emcrem

A. Possible side effects

[5. How to store Emcrem

6. Further information

1. WHAT EMCREM IS AND WHAT IT IS USED FOR

Emcrem is an emollient, moisturising and [protective cream. It helps to smooth, soothe 'and hydrate the skin and prevent moisture loss. Emcrem is used to treat red, inflamed, [damaged, dry or chapped skin in adults and 'children, and to protect raw skin areas. If you suffer from a skin condition called eczema and your skin is dry, the cream can be applied 'before having a bath to prevent your skin from drying any further.

Emcrem can also be used during or after treatment with topical steroid creams, gels or [ointments.

________________________[2]


PULL HERE


Package leaflet: Information for the user

Emcrem

Cream

White Soft Paraffin 15% w/w Liquid Paraffin 6% w/w

Please read all of this leaflet Carefully because it contains important information for you.

Xhis medicine is available without prescription. [Nevertheless, you still need to use Emcrem 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 see a doctor if your symptoms worsen or do not improve.

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

L___________________________________I1J


5.    HOW TO STORE EMCREM

Keep out of the reach and sight of children.

iDo not use Emcrem after the expiry date yvhich is stated on the packaging. The expiry date refers to the last day of that month.

;Do not store above 25°C.

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

6.    FURTHER INFORMATION What Emcrem contains:

The active ingredients are white soft paraffin ;15%w/w and liquid paraffin 6%w/w.

The other ingredients are chlorocresol, macrogol cetostearyl ether, cetostearyl ialcohol, dilute phosphoric acid, sodium dihydrogen phosphate and purified water.


I6j


PAGE FOUR


PAGE FIVE


2. BEFORE YOU USE EMCREM Do not use Emcrem:

If you are hypersensitive (allergic) to white soft paraffin, liquid paraffin or any of the other ingredients of Emcrem. Tell your doctor so that; he or she can give you another medicine. Using other medicines:

;Please inform your doctor or pharmacist if you are taking or have recently taken any other ;medicines, even those not prescribed. Pregnancy and breast-feeding:

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

Driving and using machines:

;Emcrem has no influence on the ability to drive; and use machines.

Important information about some of the ingredients of Emcrem:

feome of the ingredients in your cream may pause a reaction such as cetostearyl alcohol which may cause a local skin reaction (e.g. Pontact dermatitis) and chlorocresol which jmay cause an allergic reaction.

L___________________________________I3j


3. HOW TO USE EMCREM

Always use Emcrem exactly as your doctor das instructed you. You should check with your doctor or pharmacist if you are unsure, (/our doctor may have told you when and how often to use the cream and how long to use it for. If so, check the label to remind you what ithey said. The cream should be thinly applied [to cover the affected area completely, hnassaging gently and thoroughly into the skin as often as is required.

!lf your condition worsens, or your symptoms persist beyond the period of treatment specified by your doctor, you should consult your doctor or pharmacist.

;lf you have the impression that the effect of Emcrem is too strong or too weak, talk to your! doctor or pharmacist. Emcrem is for external pse only.

[If you forget to use Emcrem:

if you forget to use your cream at the right fime, use the usual amount as soon as you temember, then carry on as before.

Ilf you have any further questions on the use of! ihisjaroduct,_askyoui: doctQr_or_pbacmacisl._ Ml