FLAMAZINE Cream 1.0 % w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Silver sulphadiazine

Available from:

Smith & Nephew GmbH

ATC code:

D06BA; D06BA01

INN (International Name):

Silver sulphadiazine

Dosage:

1.0 percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

Sulfonamides; silver sulfadiazine

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAMAZINE CREAM 1.0% W/W
silver sulfadiazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.>
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What FLAMAZINE Cream is and what it is used for
2.
What you need to know before you use FLAMAZINE Cream
3.
How to use FLAMAZINE Cream
4.
Possible side effects
5.
How to store FLAMAZINE Cream
6.
Contents of the pack and other information
1.
WHAT FLAMAZINE CREAM IS AND WHAT IT IS USED FOR
FLAMAZINE Cream contains silver sulfadiazine as the active ingredient.
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.
•
treat finger-tip injuries where nail loss or partial loss of the ends
of the finger occurred.
2.
WHAT YOU NEED TO KNOW 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)
-
if you are allergic to sulphonamide medicines
-
if 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.
WARNINGS AND PRECAUTIONS
Consult your doctor, pharmacist or nurse before using your medicine if
any of the following apply to
you:
-
if you suffer from kidney, liver or breathing problems
-
if you suffer from a deficiency of the enzyme known as
glucose-6-phosp

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2023
CRN00D97P
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FLAMAZINE Cream 1.0 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains silver sulfadiazine 1 % w/w.
Excipients: Contains 4% w/w cetyl alcohol and 7% w/w propylene glycol.
For a full list excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White to off-white, oil in water, sterile homogeneous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FLAMAZINE Cream is indicated for the prophylaxis and treatment of
infection in burn wounds, leg ulcers and pressure sores
due to micro-organisms sensitive to this anti-infective.
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 have occurred.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Burns and Leg Ulcers/Pressure Sores: A layer approximately 3 to 5mm
thick should be applied to the affected area using a
sterile glove or spatula. The area should then be covered by an
absorbent gauze dressing and support bandage where
necessary. The dressing should be changed and FLAMAZINE Cream applied
at least every 24 hours in burn treatment, or at
least three times weekly otherwise, and debridement carried out as
necessary.
As FLAMAZINE Cream can cause maceration of normal skin on prolonged
contact; care should be taken to avoid spread onto
non-ulcerated areas.
Finger-Tip Injuries: Haemostasis of the injury should be achieved
prior to the application of a 3-5mm layer of FLAMAZINE
Cream. A conventional finger dressing may be used. Alternatively the
finger of a plastic or unsterile surgical glove can be used
and fixed in place with waterproof adhesive tape. Dressings should be
changed every 2-3 days.
_Paediatric population_
FLAMAZINE Cream is contraindicated in infants aged three months and
younger (see section 4.3).
Method of administration
To be applied topically.
4.3 CONTRAINDICATIONS
As sulphonamides are known to cause ke