Sulfadiazine 500mg Tablets BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SULFADIAZINE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

J01EC02

INN (International Name):

SULFADIAZINE 500 mg

Pharmaceutical form:

TABLET

Composition:

SULFADIAZINE 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SULFADIAZINE 500MG TABLETS
SULFADIAZINE
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 further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should
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 Sulfadiazine 500mg Tablets. In the rest
of this leaflet it is called
Sulfadiazine Tablets.
IN THIS LEAFLET:
1. What Sulfadiazine Tablets are and what they are used for
2. Before you take Sulfadiazine Tablets
3. How to take Sulfadiazine Tablets
4. Possible side effects
5. How to store Sulfadiazine Tablets
6. Further information
1. WHAT SULFADIAZINE TABLETS ARE AND WHAT
1. WHAT SULFADIAZINE
TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Sulfadiazine Tablets is sulfadiazine, which
belongs to a group of medicines
called sulphonamides. These are antibiotics that work by preventing
the growth and multiplication of
bacteria that cause infections.
Sulfadiazine Tablets are used in the treatment of a wide range of
infections including food poisoning
and meningitis.
2. BEFORE YOU TAKE SULFADIAZINE
TABLETS
2. BEFORE YOU TAKE SULFADIAZINE TABLETS
DO NOT TAKE SULFADIAZINE TABLETS IF YOU:
• are allergic to sulfadiazine or sulphonamides or any of the other
ingredients contained in
Sulfadiazine Tablets (see list under heading ‘What Sulfadiazine
Tablets contain’ in section 6)
• have a kind of meningitis caused by meningococcus bacteria unless
your doctor decides it is
appropriate
• suffer from severe liver or kidney problems
• have jaundice (yellowing of the skin and/or whites of the eyes) or
blood problems
• have porphyria (a rare condition affecting the production of haem,
the red colouring in blood

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sulfadiazine 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfadiazine 500mg
3
PHARMACEUTICAL FORM
Tablet
Sulfadiazine tablets are plain white, biconvex tablets, with CP on one
face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sulfadiazine is a short-acting sulphonamide with bacteriostatic
activity against
a broad spectrum of organisms.
_Gram-positive _- particularly group _A Streptococci _and some strains
of
_Streptococcus pneumoniae, Bacillus ant hracis, Nocardia _(especially
_N.asteroides) _and, to a lesser extent, _Staphylococci _and
_Clostridium _
_perfringens. _
_ _
_Gram-negative _- _Haemophilus influenzae _and _H.ducreyi _are often
sensitive,
sensitivity varies among the _enterobacteriae-Escherichia _coli,
_Klebsiella, _
_proteus, Salmonella _and _Serratia _and _Vibrio cholerae _are
sometimes sensitive.
Other organisms reported to be sensitive include, _Actinomyces spP.,
Brucella, _
_Calymmatobacterium granulomatis, Legionella, Yersinia pestis,
Chlamydia, _
_Pseudomonas pseudomallei. _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults and elderly _
The initial dose is usually 2-4 grams followed by a maintenance dose
of up to
4 grams daily in divided doses for a maximum of seven days.
Dosage reduction may be necessary in renal impairment.
_ _
_ _
Page 2 of 7
_Children _
Initially 75mg/kg, followed by a maintenance dose of 150mg/kg daily in
divided doses. Maximum of 6 grams daily.
Sulphonamides should not be used for initial treatment of
meningococcal
meningitis although oral Sulfadiazine may be substituted for
parenteral
penicillin once susceptibility to sulphonamides has been established.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any sulphonamide.
Severe renal or hepatic failure.
Acute porphyria.
Jaundice or blood disorders.
Neonates _ _
Concomitant use with clozapine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution in elderly, renal or hepatic impairment_ _and jaundice. Us