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SULFADIAZINE 500MG TABLETS BP

Active substance(s): SULFADIAZINE

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Sulfadiazine Tablets should not be given to babies under one
month of age.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sulfadiazine 500mg Tablets
Sulfadiazine

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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
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.

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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 cells)
• are taking clozapine, a drug used to treat schizophrenia
If any of the above statements apply to you, you should not take
Sulfadiazine Tablets.

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Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported with
the use of Sulfadiazine, appearing initially as reddish target-like
spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivits (red and swollen eyes).
These potentailly life-threatening skin rashes are often
accompanied by flu-like symptoms. The rash may progress to
widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within
the first weeks of treatment.

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Your doctor may carry out blood tests or take urine samples if
you are taking Sulfadiazine for a long time or if you are elderly.
Sulfadiazine treatment should be discontinued if a blood disorder
develops. Tell the doctor or laboratory staff that you are taking
sulfadiazine if you have to provide a urine sample.
If any of the above statements apply to you, you should speak to
your doctor before taking Sulfadiazine Tablets.
Taking other medicines
Taking another medicine while you are taking Sulfadiazine
Tablets can affect how it or the other medicine works.

Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines or herbal products, including
those you may have bought yourself without a prescription.

Sulfadiazine Tablets are used in the treatment of a wide range of
infections including food poisoning and meningitis.

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Speak to your doctor before taking Sulfadiazine Tablets if
you:
• are elderly
• have liver or kidney problems
• are predisposed to a lack of folic acid
• suffer from asthma or allergies
• have AIDS
• have a problem with your immune system called lupus
erythematosus
• have a type of hereditary anaemia called
glucose-6-phosphate dehydrogenase deficiency
• have jaundice (yellowing of the skin and/or whites of the eyes)

If you have developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of sulfadiazine, you must not
be re-started on sulfadiazine at any time.
If you develop a rash or these skin symptoms, seek immediate
advice from a doctor and tell him that you are taking this
medicine.

Please check with your doctor if you are taking any of the
following (or any other medication):
• other antibiotics such as pyrimethamine, methamine or
trimethoprim
• drugs used to thin the blood e.g. warfarin
• diuretics, also called water tablets, which get rid of excess
water in the body
• anti-diabetic drugs such as chlorpropamide or tolbutamide
• drugs taken for epilepsy, such as phenytoin
• some drugs used to treat gout, such as probenecid
• some anti-inflammatory drugs, such as aspirin
• methotrexate, a drug used for cancer
• some general and local anaesthetics such as procaine,
prilocaine, benzocaine or tetracaine
• drugs used to treat schizophrenia, such as clozapine
• oral contraceptives – these may not work properly, so you
should take additional contraceptive precautions during and
for seven days after finishing a course of sulfadiazine
• Potassium aminobenzoate, used to treat a skin condition
known as scleroderma
• sunscreens containing para amino benzoic acid (PABA)
• ciclosporin.
If you have had or are going to have an oral typhoid vaccination,
Sulfadiazine should be avoided for 3 days before and after
vaccination.
If you have any doubts about whether you should take this
medicine then discuss the matter with your doctor before taking
it.
Taking Sulfadiazine Tablets with food and drink
You should drink plenty of fluids (five to six pints per day) whilst
taking Sulfadiazine Tablets, particularly in warm weather. Your
doctor may give you something to make your urine more
alkaline.

Pregnancy and breast-feeding
You should talk to your doctor before taking Sulfadiazine Tablets
if you are pregnant or wish to become pregnant. Your doctor may
allow you to take Sulfadiazine Tablets during the early stages of
pregnancy. However, since sulfadiazine may affect your unborn
child you should not take Sulfadiazine Tablets during late
pregnancy.
Small amounts of sulphonamides pass into breast milk. You
should talk to your doctor if you wish to breast-feed whilst taking
Sulfadiazine Tablets since there is a risk of brain damage to your
newborn child.
Driving and operating machines
Sulfadiazine Tablets do not affect the ability to drive or operate
machinery.

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Stopping Sulfadiazine Tablets
You should continue to take Sulfadiazine Tablets for as long as
your doctor tells you to. Do not stop taking the medicine without
talking to your doctor first.

4. Possible side effects
Like many medicines Sulfadiazine Tablets may cause side effects
in some patients, although not everybody gets them.
Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported rarely
(see section 2).

If you experience any of the following symptoms, contact your
doctor immediately as these may be signs of an allergic
reaction:
• difficulty breathing, swelling of your face or throat, or collapse
• rash, itching
• redness and blistering of the skin
• peeling of the skin
• sensitivity to light
• fever
• painful joints
• swelling of your lymph nodes
• feeling generally unwell
• problems with your kidneys
• problems with your liver which may become larger than usual
• jaundice (yellowing of your skin or whites of your eyes)
• inflammation of your heart muscle, blood vessels, pancreas or
lungs
• blood disorders causing sore throat, mouth ulcers, infections
or a tendency to bruise or bleed easily.
Also contact your doctor immediately if you get:
• severe diarrhoea
• lower back pain, and/or blood in your urine or if you seem to
be passing less urine than usual. If any of these occur you
should drink plenty of fluids.
Common side effects include:
• feeling sick
• being sick
• loss of appetite
• diarrhoea.

Other side effects include:
• blood problems causing bluish skin and lips

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5. How to store Sulfadiazine Tablets
Keep out of the reach and sight of children.
Do not take this medicine if the expiry date on the label has
passed. The expiry date refers to the last day of that month.
Sulfadiazine Tablets should not be taken if they show signs of
deterioration such as discolouration.

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If you miss a dose of Sulfadiazine Tablets
If you forget to take a dose, take another as soon as you
remember. If it is almost time for your next dose, then do not
take the missed dose at all. Do not take a double dose to make
up for a forgotten tablet.

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

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If you take more Sulfadiazine Tablets than you should
If you accidentally take too many tablets contact your doctor,
pharmacist or nearest hospital casualty department. Take this leaflet
and any remaining tablets with you to show the doctor or
pharmacist. Signs of an overdose include feeling sick and diarrhoea.

Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal

Do not store above 25°C.
Store in the original container or package in order to protect from
light and moisture.
Do not transfer the tablets to another container.
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 to protect the environment.

6. Further information

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Blood Tests
If you have to take Sulfadiazine Tablets for a long time, you
should have regular blood tests.

United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

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If you have kidney problems
Your dosage will be reduced if you have kidney problems.

What Sulfadiazine Tablets contain
The active ingredient in Sulfadiazine Tablets is sulfadiazine.
Other ingredients are maize starch, pre-gelatinised maize starch,
pre-gelatinised starch, talc, magnesium stearate, microcrystalline
cellulose and sodium starch glycollate.
What Sulfadiazine Tablets look like and contents of the pack
Sulfadiazine Tablets are plain, white tablets, curved on both
faces and marked with CP on one face.
Sulfadiazine Tablets are available as 56 tablets in a plastic
container packed in a carton.

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Sulfadiazine Tablets should not be given to newborn babies.

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
national reporting systems listed below.

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Children
The usual starting dose in children is 75mg per kg bodyweight
followed by a maintenance dose of 150mg per kg bodyweight
daily in divided doses, up to a maximum of six grams daily.

Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.

Other formats:
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge:
0800 198 5000 (UK Only)

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Adults
The usual adult dose of Sulfadiazine Tablets is two to four grams
(four to eight tablets) at the start of treatment, followed by four
grams (eight tablets) daily in divided doses for up to seven days.

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Unless instructed differently, take your tablets with a glass of water.

Please be ready to give the following information:
Product name

Reference number

Sulfadiazine 500mg Tablets

29831/0191

This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in 08/2015
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Your doctor will decide the dose which is best for you. Always
follow your doctor's instructions completely and also follow any
special instructions or warnings which appear on the label which
the pharmacist has put on the package. If you do not
understand, or are in any doubt, ask your doctor or pharmacist.

• low blood glucose
• underactive thyroid
• nervous system disorders such as symptoms of meningitis,
problems with co-ordination, high pressure in your brain,
headache, fatigue, dizziness, drowsiness, difficulty sleeping,
fits or problems with your eyes
• depression
• cough or difficulty breathing
• swelling of the glands that produce
saliva
• ringing in the ears
• fits, hallucinations.

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3. How to take Sulfadiazine Tablets

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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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