Sulfadiazine 500mg Tablets BP

• 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.

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

• 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.

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.

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.

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

• 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)

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 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.

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.

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.

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.

Sulfadiazine Tablets do not affect the ability to drive or operate machinery.

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.

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.

Sulfadiazine Tablets should not be given to newborn babies.

Your dosage will be reduced if you have kidney problems.

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

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.

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.

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.

• blood problems causing bluish skin and lips
• 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.

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.

United Kingdom

Malta

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

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.

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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Product name Reference number

Sulfadiazine 500mg Tablets 29831/0191

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