Schering-Plough Leaflet Mock-up for 50g packs (no change)

06U224412IN 1/2

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UF code not centrally placed ■ because of small folding width

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224412

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diprobase® Ointment

224412

Read all of this leaflet carefully before you start using this medicine.

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

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Diprobase is and what it is used for

2.    Before you use Diprobase

3.    How to use Diprobase

4.    Possible side effects

5.    How to store Diprobase

6.    Further information

1. WHAT DIPROBASE IS AND WHAT IT IS USED FOR

Diprobase is an emollient, moisturising and protective ointment. It helps to soothe, smooth and hydrate the skin and prevent moisture loss.

In adults and children. Diprobase Ointment is used to treat red, inflamed, damaged, dry or chapped skin and to protect raw skin areas. If you are suffering from a skin condition called eczema, and your skin is dry, the ointment can be applied before having a bath, to prevent your skin from drying even further.

Eczema is a common skin disease, which causes the skin to become red and itchy.

2.    BEFORE YOU USE DIPROBASE Do not use DIPROBASE

- if you, or your child, have ever had an allergic reaction to Diprobase or any of its ingredients.

Ask your doctor or pharmacist if you are not sure.

3.    HOWTO USE DIPROBASE

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

For adults and children, the ointment should be applied thinly to cover the affected area completely, massaging gently and thoroughly into the skin.

If the symptoms persist or the condition worsens, stop using the ointment and consult your doctor or pharmacist.

If you forget to use DIPROBASE

If you forget to use your Diprobase at the right time, use it as soon as you remember, then carry on as before.

4. POSSIBLE SIDE EFFECTS

Like all medicines. Diprobase can cause side effects, although not everybody gets them.

If your symptoms persist or the condition worsens, stop using the ointment and consult your doctor or pharmacist.

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Profile Revision: Profile Revision Date: Dimensions (mm):

APO #: 2015-1349 03.25.15 -dw

Y = 44 mm

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

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

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

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 (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow card scheme - website: www.mhra.gov.uk/yellowcard Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2 Tel:+353 1 6764971; Fax:+353 1 6762517 Website: www.hpra.ie; e-mail: medsafety@hpra.ie

5.    HOW TO STORE DIPROBASE

The ointment should not be stored above 25°C.

Keep out of the reach and sight of children.

Do not use the ointment after the expiry date "use by" which is stamped on the pack. This can be found on both the carton and tube. This refers to the last date of that month.

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 protect the environment.

6.    FURTHER INFORMATION What DIPROBASE contains

- The ingredients are white soft paraffin and liquid paraffin.

What DIPROBASE looks like and contents of the pack

Diprobase ointment is a smooth white ointment. It is available in an aluminium tube containing 50g and a plastic jar containing 500g.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

MAH (UK): Bayer pic. Consumer Care Division, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

MAH (Ireland): Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18, Ireland The manufacturer is: Schering-Plough Labo NV, Heist-op-den-Berg, Belgium This leaflet was last revised in March 2015.

Bayer

06U224412IN

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Profile Revision: Profile Revision Date: Dimensions (mm):

I APO #: 2015-1349 IN31GR/V    H3.18.15 ■ dw

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270814

170mm x 265mm Folding Size 170 x 23mm

Famar Leaflet Mock-up for 50g packs

170 mm

PACKAGFLEAFLETf INFORMATTONTFORTHE USER

Diprobase® Ointment

Range:    Di probase

Product:    Ointment

Pack Type:    Leaflet

Pack Size:    50g

CAD Ref No:    PIL 170x265

Font Size

(Smallest on artwork): 9.50pt

Technical ft Non Printing Items Cutter | Guides

Colours

Read all of this leaflet carefully before you start using this medicine.

- Keep this leaflet. You may need to read it again, r If you have any further questions, ask your doctor or pharmacist, r This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

|1. What Diprobase is and what it is used for

2.    Before you use Diprobase

3.    Howto use Diprobase

4.    Possible side effects

5.    Howto store Diprobase |6. Further information

1.    WHAT DIPROBASE IS AND WHAT IT IS USED FOR

Diprobase is an emollient, moisturising and protective ointment. It helps to soothe, smooth and hydrate the skin and prevent moisture loss.

|ln adults and children, Diprobase Ointment is used to treat red, inflamed, damaged, dry or chapped skin and to protect raw skin areas. If you are suffering from a skin condition called eczema, and your skin is dry, the ointment can be applied before having a bath, to prevent your skin from drying even further.

Eczema is a common skin disease, which causes the skin to become red and itchy.

2.    BEFORE YOU USE DIPROBASE Do not use DIPROBASE

|- if you, or your child, have ever had an allergic reaction to Diprobase or any of its ingredients.

Ask your doctor or pharmacist if you are not sure.

3.    HOW TO USE DIPROBASE

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

For adults and children, the ointment should be applied thinly to cover the affected area completely, massaging gently and thoroughly into the skin.

If the symptoms persist or the condition worsens, stop using the ointment and consult your doctor or pharmacist.

If you forget to use DIPROBASE

If you forget to use your Diprobase at the right time, use it as soon as you remember, then carry on as before.

A POSSIBLE SIDE EFFECTS

Like all medicines, Diprobase can cause side effects, although not everybody gets them.

If your symptoms persist or the condition worsens, stop using the ointment and consult your doctor or pharmacist.

170 mm

2G5 mm

Skin reactions! ncludlng itching, rash, redness, peeling, burning, pain, dryness ancTskln Inflammation (dermatitis) have been reported with product use.

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

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

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 (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Vellow card scheme - website: www.mhra.gov.uk/yellowcard Ireland

IHPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2 Tel: +353 1 6764971; Fax: +353 1 6762517 Website: www.hpra.ie; e-mail: medsafety@hpra.ie

HOW TO STORE DIPROBASE

The ointment should not be stored above 25°C.

Keep out of the sight and reach of children.

Do not use the ointment after the expiry date "EXP" which is stamped on the pack. This can be found on both the carton and tube. This refers to the last date of that month.

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

6. FURTHER INFORMATION VVhat DIPROBASE contains

r The ingredients are white soft paraffin and liquid paraffin.

What DIPROBASE looks like and contents of the pack

Diprobase ointment is a smooth white ointment. It is available in an aluminium tube containing 50g and a plastic jar containing 500g.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

MAH (UK): Bayer pic, Consumer Care Division, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, U.K.

MAH (Ireland): Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18, Ireland

The manufacturer is: Famar A.V.E. Avion Plant, 49th km National Road Athens-Lamia, Avlona Attiki, 19011, Greece.

This leaflet was last revised in February 2016.

Bayer

31036506

31035377"