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(UK Solvay P A. 6 6150154

17.03.2014

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ADAMS DESIGN Record Q007mi

35.3 x 195 overall finished size ■ Orange PMS151

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FLAMAZINE™

Cream 1.0% w/w Silver Sulfadiazine 10mg/g

FpoM i sterile UNiL OPENED I

su^iPSin

90% EAN-13 500022341802'

Basis Label 195 mm

your medicine for a period longer than that prescribed by your

f you forget to use fLAMAZINE Cream n the even o a missed treatment, contact your doctor as soon as possible.

mportant: Always keep the corners of one tube or pot for the treatment of one person only.

4. Possible side effects

Like all medicines, fiamazine Cream can cause side effects

although not everyone gets them. The following side effects may

happen with this medicine:

Common (ess than 1 per 10 but more than 1 per 100);

•    Irritation.

•    Rashes around the wound area (including eczema and contact dermatitis).

•    Decreased white blood cels leukopenia). This can ead to an increased risk of iMectioh This usually returns to normal within a few days; however a doctor wil need to cosely monitor you to ensure that the coun returns to normal

Rare (less than 1 per 1,000 but more than 1 per 10,000);

•    Discolouration of the skin (due to absorpton of silver over prolonged periods).

Very rare (ess than 1 per 10,000);

•    Kidney failure. norm your doctor if you have diff culty in passing urine, passing a greater or smaler amount of urine than usual, or if you notice any blood or coudiness in your urine. This may be a sgn that your kidneys are not working properly.

Reporting of side effects

If you get any side effects, tak to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this eeaflet. You can also report side effects directly via the Yelow Card Scheme at: www.mhragov.uk/yelowcard

5. How to store fLAMAZINE Cream

•    Keep out of the reach and sght of children.

•    Sore your medicine below 25°C. Protect from the light.

•    The expiry date is printed on the base of the tube or on the

jar Bbe. Do not use your medicine after this date.

•    Do not use if you notice any visible signs of deterioraton such as the cream being dark brown or black. Return it to your

•    If you are using pots, discard any¹ remaining cream 24 hows

• If you are using tubers, then you may use the cream for up to 7 days after opening.

Medicines should not be disposed of via wastewater or household waste Ask your pharmacist how to dispose of

medicines no longer required. These measures wil hep protect the environment.

What fLAMAZINE Cream contains

•    The active substance is silver sulfadiazine. Each 100g of cream

•    FLAMAZINE Cream: the other ingredents are polysorbates, glycerol mono-stearate, cetyl acohoL liquid paraffin, propyene glycol and purified water.

What FLAMAZINE Cream looks like and the contents of the Date ct Hjvson: March 2014 pack    "Trade Mark of Smith & Nephew

FLAMAZINE Cream is a white to off-white, sterile cream. t is avaiabe in tubers containing 20g and 50g and pots containing 250g and 500g.

Marketing Authorisation Holder and Manufacturer Smith & Nephew Pharmaceuticals Ltd,

101 Hesse Road, Hull HU3 2BN, England, UK.

Marketing Authorsation (PL 13374/0006).    48318

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Rage 8 147mm

Page 9 147mm

Page 10 148mm

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

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

In this leaflet

1.    What FLAMAZINE Cream is and what it is us

2.    Before you use FLAMAZINE Cream.

3.    How to use FLAMAZINE Cream.

4. Possible side effects.

5.    How to store your FLAMAZINE Cream.

•    If you have any further questions, please 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 6.Further information.

•    If any othe side effects get serious, or if you notice any side effects 1. What fLAMAZINE Cream 1.0% is and what it is used for not listed n this eeaflet, peease tell your doctor or pharmacist.

FLAMAZINE Cream contains silver sufadiazine as the active

phadiazine). It ks by killing bacteria or stopping their growth.

MAZINE Cream is a sterile antibacterial cream used to: eat bacterial infections in eg ucers or pressure sores for

2. Before you use fLAMAZINE Cream Do not use fLAMAZINE Cream if:

of the finger has occurred

or sites and large ial oss of the end

•    you are alergic to silver sulfadiazine or any of the ingredents such as cetyl alcohol and Further tnformahoh).

•    you are pregnant or breast-feeding

re babies or on newborn

Consult your doctor, pharmacist or nurse before using your

•    f you know you are a^gcto sulphonamde treatment.

•    f you suffer from kidney or iver problems.

•    if you suffer from a deficiency of the enzyme known as

•    if you are taking tablets prescribed by your doctor to control epilepsy or diabetes.

•    if you are using a biological product to remove dead tissue

from the eg ucer or wound before using your medcine. ^Using ^{other medicines}

The effects of using other medcation may be atered where laige areas of burns are treated. Tell your doctor or pharmacist if you are taking or have recenty taken any other medicines, including medcines obtained wthout a prescription.

of FLAMAZINE Cream.

Pregnancy and breast-feeding Do not use If you are pregnant, thinking of becoming pregnant, or breast feeding. Ask your doctor or pharmacist before taking or using any medicines.

Driving and using machines There are no known effects.

3. How to use fLAMAZINE Cream

It is unlikely that you wil apply this medicine to yourself

A nurse or a doctor wil normaly apply the cream in which

case the following directions apply:

-    The bun shoud first be ceaned.    ;

-    Apply a 3-5 mm layer of your medicine to the burned area ; using a sterie glove or spatula.

-    Cover the area with a non-stick dressing.

-    Your medicine shoud be re-applied to the burn at east every day. • Hand Burns:

-    Once your medicine has been applied as above, the hand may be encosed n a plastic bag or eove, which is then cosed at the wrist.

-    The hand and fingers shoud be moved as much as possibe.

-    Your medicine shoud be re-applied to the burn when an excessive amount of fluid has built up in the bag and at east

every day.

Leg Ulcers & Pressure Sores:

Fil the cavity of the ucer or sore with medicine to a depth of 3-5mm and cover the wound with an absorbent pad.

The doctor or nurse may tell you to apply a pressure bandage over the pad.

DreesingA should normally be changed at east evrry 1-2 days.

riedcine, the ucer or sore should

medicine, ensure

be re-applied every 2-3 days.

If you use more fLAMAZINE Cream than you should When used as directed an rverdn=e is not likely Do not i

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FLAMAZINE™

Cream 1.0% w/w Silver Sulfadiazine 10mg/g

fPOM I STERILE UNTIL OPENED I

For external (topical) use only. Use as directed by your doctor. Keep out of reach and sight of children. Store below 25°C. Protect from light. The contents are intended for one person. Discard any unused cream 24 hours after opening. OTHER INGREDIENTS: Polysorbates, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol (see leaflet for further information), purified water.

Product Licence Holder: Smith & Nephew Pharmaceuticals Ltd., 101 Hessle Road, Hull HU32BN, UK. ™Trade Mark of Smith & Nephew PL13374/0006 MA: 029/00101

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Base Label

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FLAMAZINE™

Cream 1.0% w/w Silver Sulfadiazine 10mg/g

• •

[POM I sterile until OPENED I

*smith&nephew

• •• •

For external (topical) use only. Use as directed by your doctor. Keep out of reach and sight of children Store below 25°C. Protect from light. The contents are intended for one person. Discard any unused cream 24 hours after opening. OTHER INGREDIENTS: Polysorbates, glycerol monostearate, cetyl alcohol liquid paraffin, propylene glycol (see leaflet for further information), purified water.

Product Licence Holder: Smith & Nephew Pharmaceuticals Ltd., 101 Hessle Road,    Lateus

Hull HU3 2BN, UK. ™Trade Mark of Smith & Nephew. PL13374/0006 MA: 029/00101_____Print

Cover of Leaflet Page 1

•    you are pregnant or breast-feeding

Do not use your medicine on premature babies or on newborn babies within the first few months of life.

Take special care with FLAMAZINE Cream

Consult your doctor, pharmacist or nurse before using your medicine if any of the following apply to you:

•    if you know you are allergic to sulphonamide treatment.

•    if you suffer from kidney or liver problems.

•    if you suffer from a deficiency of the enzyme known as glucose-6-phosphate dehydrogenase?

•    if you are taking tablets prescribed by your doctor to control epilepsy or diabetes.

•    if you are using a biological product to remove dead tissue from the leg ulcer or wound before using your medicine.

Using other medicines

The effects of using other medication may be altered where large areas of burns are treated.

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Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using FLAMAZINE Cream with food, drink and alcohol

There are no known effects of food, drink or alcohol on the use of FLAMAZINE Cream.

Pregnancy and breast-feeding

Do not use If you are pregnant, thinking of becoming pregnant, or breast feeding. Ask your doctor or pharmacist before taking or using any medicines.

Driving and using machines

There are no known effects.

3. How to use FLAMAZINE Cream

It is unlikely that you will apply this medicine to yourself. A nurse or a doctor will normally apply the cream in which case the following directions apply:

Page 3

4. Possible side effects

i

Like all medicines, FLAMAZINE Cream can cause side effects, although not everyone gets them. The following side effects may happen with this medicine:

Common (less than 1 per 10 but more than 1 per 100);

•    Irritation.

•    Rashes around the wound area (including eczema and contact dermatitis).

•    Decreased white blood cells (leukopenia). This can lead to an increased risk of infection. This usually returns to normal within a few days; however a doctor will need to closely monitor you to ensure that the count returns to normal.

Rare (less than 1 per 1,000 but more than 1 per 10,000);

•    Discolouration of the skin (due to absorption of silver over prolonged periods).

Very rare (less than 1 per 10,000);

•    Kidney failure. Inform your doctor if you have

difficulty in passing urine, passing a greater or smaller amount of urine than usual, or if you notice any blood or cloudiness in your urine. This may be a sign that your kidneys are not working properly.

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

5. How to store FLAMAZINE Cream

•    Keep out of the reach and sight of children.

•    Store your medicine below 25°C. Protect from the light.

•    The expiry date is printed on the base of the tube or on the jar label. Do not use your medicine after this date.

•    Do not use if you notice any visible signs of deterioration such as the cream being

__dark brown or black. Return it to your

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

In this leaflet

1.    What FLAMAZINE Cream is and what it is

l used for.

2.    Before you use FLAMAZINE Cream.

3.    How to use FLAMAZINE Cream.

4.    Possible side effects.

5.    How to store your FLAMAZINE Cream.

6.    Further information.

i

1.    What FLAMAZINE Cream 1.0% is and what it is used for

FLAMAZINE Cream contains silver sulfadiazine as the active ingredient. (This is the new name for silver sulphadiazine). It works by killing bacteria or stopping their growth.

FLAMAZINE Cream is a sterile antibacterial cream used to:

•    prevent or treat bacterial infections in burns.

•    treat bacterial infections in leg ulcers or pressure sores for short periods of time.

•    prevent bacterial infections in skin graft donor sites and large abrasions.

•    treat finger-tip injuries where nail loss or partial loss of the end of the finger has occurred.

2.    Before you use FLAMAZINE Cream

Do not use FLAMAZINE Cream if:

•    you are allergic to silver sulfadiazine or any of the ingredients such as cetyl alcohol and propylene glycol (see section 6 Further information).

Page 2

•    Burns:

-    The burn should first be cleaned.

-    Apply a 3-5 mm layer of your medicine to the burned area using a sterile glove or spatula.

-    Cover the area with a non-stick dressing.

-    Your medicine should be re-applied to the burn at least every day.

•    Hand Burns:

-    Once your medicine has been applied as above, the hand may be enclosed in a plastic bag or glove, which is then closed at the wrist.

-    The hand and fingers should be moved as much as possible.

-    Your medicine should be re-applied to the burn when an excessive amount of fluid has built up in the bag and at least every day.

•    Leg Ulcers & Pressure Sores:

-    Fill the cavity of the ulcer or sore with medicine to a depth of 3-5mm and cover the wound with an absorbent pad.

-    The doctor or nurse may tell you to apply a pressure bandage over the pad.

Dressings should normally be changed at _

least every 1-2 days. Before re-applying your medicine, the ulcer or sore should be cleaned and the dead tissue removed.

• Finger-tip Injuries:

-    Before applying the 3-5mm layer of your medicine, ensure that the injured finger has stopped bleeding.

-    Cover the finger-tip with the finger of a plastic or non sterile surgical glove and fix in place with waterproof tape.

-    Your medicine should be re-applied every 2-3 days.

If you use more FLAMAZINE Cream than you should

When used as directed an overdose is not likely. Do not use your medicine for a period longer than that prescribed by your doctor.    i

If you forget to use FLAMAZINE Cream

In the event of a missed treatment, contact your doctor as soon as possible.

Important: Always keep the contents of one tube or pot for the treatment of one person only.

Page 4

pharmacist and obtain fresh supplies.

•    If you are using pots, discard any remaining cream 24 hours after opening.

•    If you are using tubes, then you may use the cream for up to 7 days after opening.

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 FLAMAZINE Cream contains

•    The active substance is silver sulfadiazine. Each 100g of cream contains 1g of silver sulfadiazine.

•    FLAMAZINE Cream: the other ingredients are polysorbates, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol and purified water.

I_________________

What FLAMAZINE Cream looks like and the contents of the pack

FLAMAZINE Cream is a white to off-white, sterile cream. It is available in tubes containing 20g and 50g and pots containing 250g and 500g.

Marketing Authorisation Holder and Manufacturer

Smith & Nephew Pharmaceuticals Ltd,

101 Hessle Road,

Hull HU3 2BN, UK.

Marketing Authorisation (PL 13374/0006).

Date of Revision: March 2014 ™Trade Mark of Smith & Nephew

48319