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SILVER SULFADIAZINE 1% W/W CREAM

Active substance(s): SULFADIAZINE SILVER

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

FLAMAZINE® 1% w/w CREAM
(silver sulfadiazine)
Patient Information Leaflet

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

This medicine is known by the above name but will be referred to as Flamazine Cream in this leaflet.
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 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.

PROOF HISTORY:
v.1 - waymade - 19/04/12

Leaflet Flat Size = 148 x 317

27mm

1. What Flamazine Cream 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.

WARNING!

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).
• you are pregnant or breast-feeding.

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.

UK PIL DATED SEPT 2007

6464/2481A
CODE:

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:
• 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.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

DATE:

Using Flamazine Cream with food, drink and alcohol
There are no known effects of food, drink or alcohol on the use of Flamazine Cream.

WARNING!

DATE:

Using other medicines
The 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.

19/04/12

DT

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.

DATE OF PROOF:

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Flamazine 1% w/w cream

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.
4. Possible side effects
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).

WARNING!

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.






DATE:

CUSTOMER
APPROVED:

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.






5. How to store Flamazine Cream
Do not use after the expiry date printed on the carton or tube.
Flamazine 1% w/w Cream should not be stored above 25°C. Protect from light.
Keep all medicines out of the reach and sight of children.
If the cream becomes discoloured or shows signs of any deterioration, you should consult your
pharmacist who will advise you what to do.
Please take it back to the pharmacist for safe disposal.
If you are using tubes, discard any unused cream 7 days after opening.
The contents of one container are for the treatment of one person.
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.

Flamazine 1% w/w cream also contains the following:
polysorbate 60, polysorbate 80, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol and
purified water.

DATE:

Q.A.
APPROVED:

6. Further information
Your medicine is called Flamazine 1% w/w cream. Each gram of white to off-white aqueous cream contains
10mg of the active ingredient silver sulfadiazine.

Leaflet revision and issue date (Ref.) 10.4.2012
Flamazine® is a registered trademark of Smith & Nephew

UK PIL DATED SEPT 2007

19/04/12
DATE OF PROOF:

PL No: 6464/2481

This product is manufactured by Solvay Pharma B.V., 1381 CP Weesp, The Netherlands and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

6464/2481A

DT
ARTWORKER:

POM

CODE:

05-0440

CUSTOMER: Waymade
PRODUCT: Flamazine 1% w/w cream

PRE-PRESS NO.:

Flamazine 1% w/w cream is available as a plastic tube containing 50 grams of cream.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 19/04/12

Leaflet Flat Size = 148 x 317

27mm

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.

WARNING!



THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

SILVER SULFADIAZINE 1% w/w CREAM
Patient Information Leaflet

1. What Silver Sulfadiazine 1% w/w cream is and what it is used for
Silver Sulfadiazine 1% w/w 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.
Silver Sulfadiazine 1% w/w 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.

Take special care with Silver Sulfadiazine 1% w/w 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.

DATE:

CUSTOMER
APPROVED:

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

Using other medicines
The 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.

DATE:
19/04/12

UK PIL DATED SEPTEMBER 2007

787-2481A
CODE:

DT
ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Silver Sulfadiazine 1% w/w cream

DATE OF PROOF:

Q.A.
APPROVED:

Driving and using machines
There are no known effects.

PRE-PRESS NO.:

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.

05-0440

Using Silver Sulfadiazine 1% w/w cream with food, drink and alcohol
There are no known effects of food, drink or alcohol on the use of Silver Sulfadiazine 1% w/w cream.

3. How to use Silver Sulfadiazine 1% w/w 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:
• 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.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

2. Before you use Silver Sulfadiazine 1% w/w cream
Do not use Silver Sulfadiazine 1% w/w 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).
• you are pregnant or breast-feeding.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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 Silver Sulfadiazine 1% w/w cream is and what it is used for.
2. Before you use Silver Sulfadiazine 1% w/w cream.
3. How to use Silver Sulfadiazine 1% w/w cream.
4. Possible side effects.
5. How to store your Silver Sulfadiazine 1% w/w cream.
6. Further information.

PROOF HISTORY:
v.1 - waymade - 19/04/12

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you forget to use Silver Sulfadiazine 1% w/w 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.
4. Possible side effects
Like all medicines, Silver Sulfadiazine 1% w/w 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).

WARNING!

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.






DATE:

CUSTOMER
APPROVED:

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.






5. How to store Silver Sulfadiazine 1% w/w cream
Do not use after the expiry date printed on the carton or tube.
Silver Sulfadiazine 1% w/w cream should not be stored above 25°C. Protect from light.
Keep all medicines out of the reach and sight of children.
If the cream becomes discoloured or shows signs of any deterioration, you should consult your
pharmacist who will advise you what to do.
Please take it back to the pharmacist for safe disposal.
If you are using tubes, discard any unused cream 7 days after opening.
The contents of one container are for the treatment of one person.
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.

Silver Sulfadiazine 1% w/w cream also contains the following:
polysorbate 60, polysorbate 80, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol and
purified water.

POM

PL No: 6464/2481

This product is manufactured by Solvay Pharma B.V., 1381 CP Weesp, The Netherlands and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

UK PIL DATED SEPTEMBER 2007

Leaflet revision and issue date (Ref.) 10.4.2012

787-2481A

19/04/12
DATE OF PROOF:

Silver Sulfadiazine 1% w/w cream is available as a plastic tube containing 50 grams of cream.

CODE:

DT
ARTWORKER:

DATE:

05-0440

CUSTOMER: Waymade
PRODUCT: Silver Sulfadiazine 1% w/w cream

PRE-PRESS NO.:

Q.A.
APPROVED:

Your medicine is called Silver Sulfadiazine 1% w/w cream. Each gram of white to off-white aqueous cream
contains 10mg of the active ingredient silver sulfadiazine.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

If you use more Silver Sulfadiazine 1% w/w 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.

PROOF HISTORY:
v.1 - waymade - 19/04/12

Leaflet Flat Size = 148 x 317

27mm

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.

WARNING!



Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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