20 g

*smith&nephew

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

20 g

*smith&nephew

FLAMAZIN

E™Cream

1.0% w

/wSilver Sulfadiazine

100% EAN-13truncated

5000223420727

20 g

*smith&nephew

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

20 g

*smith&nephew

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

STERILE UNTIL OPENEDPOM

Product Licence Holder:Smith & Nephew Pharmaceuticals Limited.,Hessle Road, Hull HU3 2BN.™Trade Mark of Smith & NephewPL13374/0006 MA: 029/00101

161

27SA

PXX

XX

XX

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66150257

For external (topical) use only. Use as directed by yourdoctor. 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 7 days after opening.Use only if carton seal is unbroken.

OTHER INGREDIENTS: Polysorbates, glycerolmonostearate, cetyl alcohol, liquid paraffin, propyleneglycol (see leaflet for further information), purified water.

#66150257

#66150257

#66150257

GTIN: 12345678901234BATCH: 1234567MAN: MM-YYYY EXP: MM-YYYYSN: 123456789012

with waterproof tape.- Your medicine should be re-applied every 2-3

days.If you use more FLAMAZINE Cream than you shouldWhen used as directed an overdose is not likely. Do not use your medicine for a period longer than that prescribed by your doctor.

If you forget to use FLAMAZINE CreamIn 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.4. Possible side effectsLike all medicines, FLAMAZINE Cream can causeside effects, although not everyone gets them. The following side effects may happen with thismedicine:

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

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 mayharm them, even if their symptoms are thesame 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 leaflet1. What FLAMAZINE Cream is and what it is

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.

1. What FLAMAZINE Cream 1.0% is and what itis 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 CreamDo not use FLAMAZINE Cream if:• you are allergic to silver sulfadiazine or any of

the ingredients such as cetyl alcohol andpropylene glycol (see section 6 Further information).

• 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 CreamConsult 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-phosphatedehydrogenase?

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

• if you are using a biological product to removedead tissue from the leg ulcer or woundbefore using your medicine.

Using other medicinesThe effects of using other medication may be altered where large areas of burns are treated.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 alcoholThere are no known effects of food, drink or alcohol on the use of FLAMAZINE Cream.

Pregnancy and breast-feedingDo 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 machinesThere are no known effects.

3.How to use FLAMAZINE CreamIt is unlikely that you will apply this medicine toyourself. A nurse or a doctor will normally applythe cream in which case the following directionsapply:

• 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 plasticbag or glove, which is then closed at thewrist.

- 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 hasbuilt 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 thewound with an absorbent pad.

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

- Dressings should normally be changed at leastevery 1-2 days. Before re-applying yourmedicine, the ulcer or sore should be cleanedand the dead tissue removed.

• Finger-tip Injuries:- Before applying the 3-5mm layer of your

medicine, ensure that the injured finger hasstopped bleeding.

- Cover the finger-tip with the finger of a plasticor non sterile surgical glove and fix in place

• Irritation.• Rashes around the wound area (including

eczema and contact dermatitis).• Decreased white blood cells (leukopenia). Thiscan lead to an increased risk of infection. Thisusually returns to normal within a few days;however a doctor will need to closely monitoryou 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 ofsilver over prolonged periods).

Very rare (less than 1 per 10,000);• Kidney failure. Inform your doctor if you havedifficulty in passing urine, passing a greater or smaller amount of urine than usual, or if you notice any blood or cloudiness in your urine. Thismay be a sign that your kidneys are not working properly.

Reporting of side effectsIf 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 thetube or on the jar label. Do not use yourmedicine after this date.

• Do not use if you notice any visible signs ofdeterioration such as the cream being darkbrown or black. Return it to your pharmacistand obtain fresh supplies.

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

• If you are using tubes, then you may use thecream 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 informationWhat FLAMAZINE Cream contains• The active substance is silver sulfadiazine.

Each 100g of cream contains 1g of silversulfadiazine.

• FLAMAZINE Cream: the other ingredients arepolysorbates, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol andpurified water.

What FLAMAZINE Cream looks like and the contents of the packFLAMAZINE 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 ManufacturerSmith & Nephew Pharmaceuticals Ltd,101 Hessle Road, Hull HU3 2BN, England, UK.Marketing Authorisation (PL 13374/0006).

Date of Revision: November 2018™Trade Mark of Smith & Nephew

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STERILE UNTIL OPENEDPOM Product Licence Holder: Smith & Nephew Pharmaceuticals Ltd.,

101 Hessle Rd, Hull HU3 2BN, UK. ™Trade Mark of 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, liquidparaffin, propylene glycol (see leaflet for further information), purified water.PL13374/0006 MA: 029/00101

Use only if seal is unbroken

Use only if seal is unbroken

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.PL13374/0006 MA: 029/00101

Pharma Position

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*smith&nephew

50 g

50 g

50 gFLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

*smith&nephew

50 g

*smith&nephew

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine

*smith&nephew

STERILE UNTIL OPENEDPOM

FLAMAZIN

E™C

ream 1.0%

w/w

Silver Sulfadiazine

Product Licence Holder:Smith & Nephew PharmaceuticalsLimited., Hessle Road, Hull HU3 2BN.™Trade Mark of Smith & NephewPL13374/0006 MA: 029/00101

50 g

100% EAN-13truncated

5000223418007

66150153

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 7 days after opening.Use only if carton seal is unbroken.OTHER INGREDIENTS:Polysorbates, glycerol monostearate, cetyl alcohol,liquid paraffin, propylene glycol (see leaflet for furtherinformation), purified water.

#66150153

#66150153

#66150153

#66150153

GTIN

: 12

3456

7890

1234

BATC

H: 1

2345

67MA

N: M

M-YY

YY

EXP:

MM-

YYYY

SN:

1234

5678

9012

16571

500g

*smith&nephew

STERILE UNTIL OPENEDPOMFor 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 unusedcream 24 hours after opening. OTHER INGREDIENTS: Polysorbates, glycerol monostearate, cetyl alcohol,liquid paraffin, propylene glycol (see leaflet for further information), purified water.

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine 10mg/g

Product Licence Holder: Smith & Nephew Pharmaceuticals Ltd., 101 Hessle Road, Hull HU3 2BN, UK.™Trade Mark of Smith & Nephew PL13374/0006 MA: 029/00101

#66150155

Use only if seal is unbroken.

Use only if seal is unbroken.

Important: Always keep the contents of one tubeor pot for the treatment of one person only.4. Possible side effectsLike all medicines, FLAMAZINE Cream can causeside effects, although not everyone gets them.The following side effects may happen with thismedicine: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. Thisusually returns to normal within a few days;however a doctor will need to closely monitoryou 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 greateror smaller amount of urine than usual, or if younotice any blood or cloudiness in your urine.This may be a sign that your kidneys are notworking properly.

Reporting of side effectsIf you get any side effects, talk to your doctor,pharmacist or nurse. This includes any possibleside effects not listed in this leaflet. You can alsoreport side effects directly via the Yellow CardScheme at: www.mhra.gov.uk/yellowcard

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, evenif their symptoms are the same as yours.

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

In this leaflet1. What FLAMAZINE Cream is and what it is

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.

1. What FLAMAZINE Cream 1.0% is andwhat it is used for

FLAMAZINE Cream contains silver sulfadiazine asthe active ingredient. (This is the new name forsilver sulphadiazine). It works by killing bacteriaor stopping their growth.

FLAMAZINE Cream is a sterile antibacterialcream 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 andpropylene glycol (see section 6 Furtherinformation).

• you are pregnant or breast-feeding

Do not use your medicine on premature babiesor on newborn babies within the first few monthsof life.

Take special care with FLAMAZINE CreamConsult your doctor, pharmacist or nurse before

using your medicine if any of the following applyto 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-phosphatedehydrogenase?

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

• if you are using a biological product to removedead tissue from the leg ulcer or woundbefore using your medicine.

Using other medicinesThe effects of using other medication may bealtered where large areas of burns are treated.Tell your doctor or pharmacist if you are taking or

have recently taken any other medicines,including medicines obtained without aprescription.

Using FLAMAZINE Cream with food, drink andalcoholThere are no known effects of food, drink oralcohol on the use of FLAMAZINE Cream.

Pregnancy and breast-feedingDo not use If you are pregnant, thinking ofbecoming pregnant, or breast feeding. Ask yourdoctor or pharmacist before taking or using anymedicines.

Driving and using machinesThere are no known effects.

3. How to use FLAMAZINE Cream

It is unlikely that you will apply this medicine toyourself. A nurse or a doctor will normally applythe cream in which case the following directionsapply:

•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 plasticbag or glove, which is then closed at the wrist.

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

- our medicine should be re-applied to theburn when an excessive amount of fluid hasbuilt 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 thewound with an absorbent pad.

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

- Dressings should normally be changed atleast every 1-2 days. Before re-applying yourmedicine, the ulcer or sore should be cleanedand the dead tissue removed.

• Finger-tip Injuries:- Before applying the 3-5mm layer of your

medicine, ensure that the injured finger hasstopped bleeding.

- Cover the finger-tip with the finger of a plasticor non sterile surgical glove and fix in placewith waterproof tape.

- Your medicine should be re-applied every2-3 days.

If you use more FLAMAZINE Cream than youshouldWhen used as directed an overdose is not likely.Do not use your medicine for a period longerthan that prescribed by your doctor.If you forget to use FLAMAZINE CreamIn the event of a missed treatment, contact yourdoctor as soon as possible.

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 useyour medicine after this date.

• Do not use if you notice any visible signsof deterioration such as the cream beingdark brown or black. Return it to yourpharmacist and obtain fresh supplies.

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

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

Medicines should not be disposed of viawastewater or household waste. Ask your

pharmacist how to dispose of medicines nolonger required. These measures will helpprotect the environment.

6. Further information

What FLAMAZINE Cream contains• The active substance is silver sulfadiazine.

Each 100g of cream contains 1g of silversulfadiazine.

• FLAMAZINE Cream: the other ingredientsare polysorbates, glycerol monostearate,cetyl alcohol, liquid paraffin, propyleneglycol and purified water.

What FLAMAZINE Cream looks like and thecontents of the packFLAMAZINE Cream is a white to off-white,sterile cream. It is available in tubescontaining 20g and 50g and pots containing250g and 500g.

Marketing Authorisation Holder andManufacturerSmith & Nephew Pharmaceuticals Ltd,101 Hessle Road,Hull HU3 2BN, UK.Marketing Authorisation (PL 13374/0006).

Date of Revision: November 2018™Trade Mark of Smith & Nephew

16571 16571

500g

*smith&nephew

STERILE UNTIL OPENEDPOMFor 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 unusedcream 24 hours after opening. OTHER INGREDIENTS: Polysorbates, glycerol monostearate, cetyl alcohol,liquid paraffin, propylene glycol (see leaflet for further information), purified water.

FLAMAZINE™Cream 1.0% w/wSilver Sulfadiazine 10mg/g 10

0% E

AN

-13

5000

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1803

8

Product Licence Holder: Smith & Nephew Pharmaceuticals Ltd., 101 Hessle Road, Hull HU3 2BN, UK.™Trade Mark of Smith & Nephew PL13374/0006 MA: 029/00101

#66150155

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