Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sulfadiazine 500mg Tablets BP
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sulfadiazine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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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Sulfadiazine 500mg – 56 Tabs Wockhardt UK FP1829 Daman (Bhimpore) (w)210 x (h)290mm 2501 221617 9 pt. Sulfadiazine 500mg_Leaflet_104546-4.ai Adobe Illustrator CS5 Helvetica Neue Regular / Bold 7th & 13th August, 2015 R 1st PDF sent on – 14TH AUG. 2015 R 2nd PDF sent on – 20TH AUG. 2015
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends • New Wockhardt logo
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.
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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How to store it
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 104546/4 221617
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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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Frequently asked questions about Sulfadiazine 500mg Tablets BP
How do I take Sulfadiazine 500mg Tablets BP?
Sulfadiazine 500mg Tablets BP comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Sulfadiazine 500mg Tablets BP?
The active substance in Sulfadiazine 500mg Tablets BP is sulfadiazine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sulfadiazine 500mg Tablets BP, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Sulfadiazine 500mg Tablets BP without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sulfadiazine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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. 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. Use with caution in patients with predisposition to folate deficiency. Sulfonamides inhibit the absorption and metabolism of folic acid and may cause folic acid deficiency potentially resulting in serious blood disorders (e.g., macrocytosis and pancytopenia), this can be normalised by administration of folic acid or folinic acid (leucovorin). Reactions are more likely in acquired immune deficiency syndrome, lupus erythematosus, glucose-6-phosphate dehydrogenase deficiency or history of allergy or asthma Reactions are more likely in acquired immune deficiency syndrome, lupus erythematosus, glucose-6-phosphate dehydrogenase deficiency or history of allergy or asthma. Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of Sulfadiazine. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, sulfadiazine treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of Sulfadiazine, Sulfadiazine must not be re-started in this patient at any time.Full blood counts should be carried out during prolonged therapy with sulfadiazine in order to detect blood dyscrasias (see Section 4.8). Discontinue sulfadiazine treatment immediately if blood disorders develop. Urinalyses with microscopic examination may be required prior to and periodically during treatment to detect crystalluria and/or urinary calculi formation in patients on long-term or high dose therapy and in patients with impaired renal function. To reduce the risk of crystalluria, fluid intake should be high (5-6 pints in 24 hours), to maintain a high urine output (minimum of 1200mL daily). If necessary, the urine may be rendered alkaline to prevent crystallisation of acetyl Sulfadiazine.
4.5. Interaction with other medicinal products and other forms of interaction
Anaesthetics, general: sulphonamides may potentiate the effect of thiopentone anaesthetics.Anti-infectives: Like other sulphonamides, Sulfadiazine demonstrated synergy with the difolate reductase release inhibitors, pyrimethamine and trimethoprim. Risk of pancytopenia and megloblastic anaemia with concurrent pyrimethamine. Increased risk of crystalluria with methenamine.Anticoagulants: sulphonamides may potentiate the effects of coumarins, such as warfarin. Antidiabetics: antidiabetic effect of sulphonylureas, e.g. chlorpropramide and tolbutamide, may be enhanced.Antiepileptics: sulphonamides may potentiate the effect of phenytoin.Antipsychotics: avoid concurrent clozapine (increased risk of agranulocytosis); see Section 4.3.Aspirin: the toxcicty of sulphonamides may be increased by aspirin.Ciclosporin: plasma ciclosprin concentrations may be reduced; increased risk of nephrotoxicity).Diuretics: caution should be exercised with diuretics such as thiazide due to the importance of maintaining urinary output; increased risk of crystalluria (see Section 4.4).Local anaesthetics: antibacterial activity of sulphonamides may be antagonised by benzocaine or tetracaine. The action of sulphonamides may be antagonised by p-aminobenzoic acid (PABA) and compounds derived from it, particularly potassium aminobenzoate and the procaine group of local anaesthetics. There is an increased risk of methaemoglobinaemia when sulphonamides administered with prilocaineMethotrexate: sulphonamides may potentiate the effect of methotrexateOestrogen-containing oral contraceptives: sulphonamides may reduce the contraceptive effect of oestrogen-containing oral contraceptives- additional contraceptive precautions should be taken during treatment and for seven days after stopping. Potassium aminobenzoate: may antagonise action of sulfadiazine.Probenecid: sulphonamides are displaced by probenecid. This interaction is theoretical and unlikely to be clinically significant.Vaccines: antibacterials should be avoided for 3 days before and after oral typhoid vaccinationInterference with diagnostic tests: sulphonamides may produce false-positive Benedict's test for urinary glucose; may interfere with test for urinary urobilinogen.
4.6. Pregnancy and lactation
Pregnancy
There is epidemiological evidence of the safety of Sulfadiazine in human pregnancy, but the clinician should assess the risk benefit factors before recommending Sulfadiazine to pregnant women. There is evidence of embryotoxicity and teratogenicity in animals at high dosage, especially during the first trimester. It is generally considered that sulphonamides are not given late in pregnancy because of the risk of haemolytic anaemia in the newborn. Fear of increased risk of kernicterus in neonates appears to be unfounded. Although kernicterus has been reported in neonates following direct administration of sulphonamides, kernicterus in the neonate following in utero exposure has not been reported. Lactation
Sulphonamides are excreted in the breast milk in small amounts and should be used with caution in nursing mothers of healthy newborn, ill, stressed or premature infants, or infants with jaundice or hyperbilirubinaemia (risk of kernicterus) and mothers of infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency (risk of haemolytic anaemia). A decision to continue/discontinue breast-feeding or to continue/discontinue therapy with sulfadiazine should be made following careful risk benefit evaluation.
4.7. Effects on ability to drive and use machines
Not known.
4.8. Undesirable effects
These are common to all sulphonamides and more likely in slow acetylators.Blood and lymphatic system disorders: Occasional blood disorders include, agranulocytosis, aplastic anaemia, thrombocytopenia, leucopenia, neutropenia, hypoprothrombinaemia, eosinophilia; methaemoglobinaemia with cyanosis; rarely, acute haemolytic anaemia (with glucose-6-phosphate dehydrogenase deficiency). Immune system disorders: hypersensitivity. Hypersensitivity reactions may take the form of fever, rashes, photosensitivity, exfoliative dermatitis, toxic epidermal, necrolysis, urticaria, pruritus, erythema nodosum, erythema multiforme, erythroderma, fixed drug eruption, Stevens-Johnson syndrome, contact dermatitis, systemic lupus erythematosus, serum sickness like syndrome, liver necrosis, hepatitis, hepatomegaly, jaundice, myocarditis, pancreatitis, pulmonary eosinophilia, fibrosing alveolitis, vasculitis, including polyarteritis nodosa, nephrotoxic reactions (interstitial nephritis, tubular necrosis) may result in renal failure. Anaphylaxis is very rare.Metabolism and nutrition disorders: hypoglycaemia, hypothyroidism.Psychiatric disorders: depression, psychosis, hallucinationsNervous system disorders: neurological reactions (including aseptic meningitis, ataxia, benign intracranial hypertension, convulsions, dizziness, vertigo, drowsiness, fatigue, headache, insomnia, peripheral or optic neuropathies).Ear and labyrinth disorders: tinnitusRespiratory, thoracic and mediastinal disorders: cough, dyspnoeaGastrointestinal disorders: Most commonly, nausea, anorexia, vomiting, diarrhoea, stomatitis. Pseudomembranous colitis may occur with alterations in bacterial flora of the gastrointestinal tract. Salivary gland enlargement.Hepatobiliary disorders: hepatitis, jaundice and kernicterus in premature neonates.Skin and subcutaneous tissue disorders: purpura, severe cutaneous adverse reactions (SCARS): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4)Renal and urinary disorders: Crystalluria may occur, with lumbar pain, haematuria, oliguria and anuria. Reduce risk by high fluid intake. Treat by alkalinisation of urine. Increased blood urea and serum creatinine concentrations. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms:
Nausea, diarrhoea. Treatment.
Continuous forced fluids may be necessary and the urine should be rendered alkaline. Otherwise treatment is symptomatic.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- CICATROL 10 mg/g over the counterSULFADIAZINUM · skin / topical
- REGEN-AG 10 mg/g over the counterSULFADIAZINUM · skin / topical
- DERMAZIN 10 mg/g over the counterSULFADIAZINUM · skin / topical
- FLAMMAZINE prescriptionSULFADIAZINUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Sulfadiazine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Ditrivet 120 partial — not the same combinationSulfadiazinum + Trimethoprimum · taken by mouth
- Konsulfatrim granulat partial — not the same combinationSulfadiazinum + Trimethoprimum · taken by mouth
- Ditrivet 480 partial — not the same combinationSulfadiazinum + Trimethoprimum · taken by mouth
- Equibactin vet. partial — not the same combinationSulfadiazinum + Trimethoprimum · taken by mouth
- Hydrotrim partial — not the same combinationSulfadiazinum natricum + Trimethoprimum · taken by mouth
- Triquest partial — not the same combinationSulfadiazinum + Trimethoprimum · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Sulfadiazine 500mg Tablets BP. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.