Skip to Content

SILVER SULFADIAZINE 1% W/W CREAM

Active substance(s): SULFADIAZINE SILVER

View full screen / Print PDF » Download PDF ⇩
Transcript
Flamazine® 1%w/w Cream

Take special care with Flamazine Cream

(silver sulfadiazine)

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

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.

The name of your medicine is Flamazine 1%w/w Cream,
but it will be referred to as Flamazine Cream throughout
the remainder of this leaflet.

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.




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.

5. How to store your Flamazine Cream.
6. Further information.

Pregnancy and breast-feeding

1. What Flamazine Cream is and what it is
used for

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.

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

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:

• 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
atleast every day.

Do not use Flamazine Cream if:

• Hand Burns:



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.

-

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.

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
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Flamazine Cream


Keep out of the sight and reach of children.



Store your medicine below 25°C. Protect from the
light.
Do not use your cream after the expiry date which is
stated on the base of the tube label after ‘Exp’. The
expiry date refers to the last day of that month.
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 tubes, then you may use the cream
for up to 7 days after opening.

If you forget to use Flamazine Cream

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.

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

6. Further information

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

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.

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.

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 50g.
Manufactured by: SOLVAY PHARMA S.A., C/ Ramon
Cajal, Barcelona, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

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.

Flamazine 1%w/w Cream

POM

PL No: 18799/1987
Leaflet date: 08.06.2015
®

Flamazine is a registered trademark of Smith &
Nephew

Silver sulfadiazine 1%w/w Cream

Take special care with Silver sulfadiazine
Cream

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

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



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.







The name of your medicine is Silver sulfadiazine 1%w/w
Cream, but it will be referred to as Silver sulfadiazine
Cream throughout the remainder of this leaflet.

In this leaflet
1. What Silver sulfadiazine Cream is and what it is used
for.
2. Before you use Silver sulfadiazine Cream.
3. How to use Silver sulfadiazine Cream.
4. Possible side effects.
5. How to store your Silver sulfadiazine Cream.





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

6. Further information.

Pregnancy and breast-feeding

1. What Silver sulfadiazine Cream is and
what it is used for
Silver sulfadiazine 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.

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.

Silver sulfadiazine Cream is a sterile
antibacterial cream used to:

3. How to use Silver sulfadiazine Cream



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.

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:




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

• 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.

-

2. Before you use Silver sulfadiazine Cream

-

Do not use Silver sulfadiazine 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’).

• 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.

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.

Your medicine should be re-applied to the burn
atleast 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.

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
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Silver sulfadiazine Cream


Keep out of the sight and reach of children.



Store your medicine below 25°C. Protect from the
light.
Do not use your cream after the expiry date which is
stated on the base of the tube label after ‘Exp’. The
expiry date refers to the last day of that month.
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.



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

If you forget to use Silver sulfadiazine Cream

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.

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

6. Further information

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

What Silver sulfadiazine Cream contains


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



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

4. Possible side effects
Like all medicines, Silver sulfadiazine 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.

What Silver sulfadiazine Cream looks like and
the contents of the pack
Silver sulfadiazine Cream is a white to off-white, sterile
cream.
It is available in tubes containing 50g.
Manufactured by: SOLVAY PHARMA S.A., C/ Ramon
Cajal, Barcelona, Spain.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Silver sulfadiazine 1%w/w Cream
PL No: 18799/1987
Leaflet date: 08.06.2015

POM

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.

Hide