Flamazine Cream 1% w/w

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SULFADIAZINE SILVER

Available from:

Smith & Nephew Pharmaceuticals Limited

ATC code:

D06BA01

INN (International Name):

SULFADIAZINE SILVER

Pharmaceutical form:

CREAM

Composition:

SULFADIAZINE SILVER 1 percent weight/weight

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2006-03-21

Patient Information leaflet

*smith&nephew
• 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:
•
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 
medici

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

FLAMAZINE Cream 1.0%w/w 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Silver sulfadiazine 1% w/w 

3. PHARMACEUTICAL 
FORM 

Cream 

Semi-solid oil in water emulsion. 

4. CLINICAL 
PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

FLAMAZINE cream is indicated for the prophylaxis and treatment of 
infection in burn wounds. FLAMAZINE cream may also be used as an
aid to 
the short-term treatment of infection in leg ulcers and
pressure sores, and as 
an aid to the prophylaxis of infection in skin graft donor sites and
extensive 
abrasions. FLAMAZINE cream is also indicated
for the conservative 
management of finger-tip injuries where pulp, nail loss and/or
partial loss of 
the distal phalanx has occurred. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

To be applied topically. 

BURNS:  The burn wound should be cleaned and FLAMAZINE
cream applied 
over all the affected areas to a depth of 3-5mm. 

This application is best achieved with a sterile gloved hand
and/or sterile 
spatula.  Where necessary, the cream should be re-applied
to any area from 
which it has been removed by patient activity. 

In burns, FLAMAZINE cream should be re-applied at least every 24
hours, or 
more frequently if the volume of exudate is large. 

HAND BURNS: FLAMAZINE cream can be applied to the burn and the
whole 
hand enclosed in a clear plastic bag or glove which is then closed
at the wrist. 

The patient should be encouraged to move the hand and fingers.  The
dressing 
should be changed when an excessive amount of exudate
has accumulated in 
the bag. 

LEG ULCERS/PRESSURE SORES: The cavity of the ulcer should
be filled with 
FLAMAZINE cream to a depth of at least 3-5mm.  As FLAMAZINE
cream 
can cause maceration of normal skin on prolonged contact, care
should be 
taken to