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FLAMAZINE CREAM 1%

Active substance(s): SULFADIAZINE SILVER

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Smith & Nephew Record

35.3 x 195 overall finished size

Date:

17.03.2014

This Revision:

01

Black
Orange PMS151

*smith&nephew

#66150154

FLAMAZINE™

Glue
Area

250 g

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

STERILE UNTIL OPENED

90% EAN-13
5000223418021

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

VARNISH FREE
AREA

Prev BSC/Asset: 20934

Product Licence Holder:
Smith & Nephew Pharmaceuticals
Ltd., 101 Hessle Rd, Hull HU3 2BN,
UK. ™Trade Mark of Smith & Nephew

Q007mi

Colours:
(Match to
Pantone
colors)

This BSC/Asset: 48318

35.5mm

ADAMS DESIGN Record
Job No:
Dims:

Glue
Area

EXP.

66150154

LOT

Flamazine 250g Fix-a-Form
(UK) Solvay R.A.

Code:

D.O.M.

Item:

48318

Base Label 195mm

your medicine for a period longer than that prescribed by your
doctor.
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).
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.

Page 7 146mm

35.5mm

Non
Print
Area

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.
Page 2 160mm

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
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

Page 8 147mm

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.
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.

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.

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.

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

Page 3 148mm

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

FLAMAZINE™

48318

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

250 g

from the leg ulcer or wound before using your medicine.

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

Page 4 147mm

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

90% EAN-13
5000223418021

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

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.

Lateus Print Area

48318

Page 10 148mm

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.

*smith&nephew

#66150154
Glue
Area

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

Page 9 147mm

2. Before you use FLAMAZINE Cream

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

PEEL HERE
BUT
DO NOT
REMOVE

35.5mm

Page 1 (Front Page)

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.

Page 5 147mm

- 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

Page 6 146mm

ADAMS DESIGN Record

01

Orange PMS151

Scale / size of this print out

%

*smith&nephew

#66150155

FLAMAZINE™

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

500 g
48319

STERILE UNTIL OPENED

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

Base Label

EXP.

17.03.2014

Black

VARNISH FREE
AREA

Prev BSC/Asset: 20932
This Revision:

75 x 173 overall base label +6pp

Colours:
(Match to
Pantone
colors)

This BSC/Asset: 48319
Date:

Dims:

D.O.M.

66150155

Q007mi

LOT

Code:

Job No:

100% EAN-13

Flamazine 500g Fix-a-Form
(UK) Solvay R.A.

5000223418038

Smith & Nephew Record
Item:

100% EAN-13

FLAMAZINE™

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

5000223418038

*smith&nephew

STERILE UNTIL OPENED

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

Area SAMPLE

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.

• 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.

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:

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

• 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.
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.

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

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.

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

Page 5

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).

• 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.

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.

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

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.

Page 2

Page 3

4. Possible side effects

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.

2. Before you use FLAMAZINE Cream

ONLY

Cover of Leaflet Page 1

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

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.

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

Page 6

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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