Product Details

Product Information of Sulfasalazine Tablets – 500mg Enteric Coated Tablets

What you need to know before you take Sulfasalazine EC-tabs

Your doctor will perform complete blood counts and liver function tests before starting Salazopyrin and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urine analysis and an assessment of kidney function should also be done periodically during treatment with Salazopyrin. Thereafter, monitoring will be performed as your doctor requires. Do not take Sulfasalazine EC-tabs if you • are allergic (hypersensitive) to any of the ingredients of Sulfasalazine EC-tabs (listed in section 6). • are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic). • have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease. Sulfasalazine EC-tabs are not to be used in children under 2 years of age. Warnings and precautions Tell your doctor if you are taking or have recently taken Sulfasalazine EC-tabs, or any other sulfasalazine containing products, because they may affect results of blood and urine tests. If you answer YES to any of these questions tell your doctor or pharmacist before taking this medicine: • Have you ever had any problems with your liver or kidneys? • Have you been told by your doctor that you have an inherited condition in which the body doesn’t have enough of an enzyme known as glucose-6-dehydrogenase which helps red blood cells function normally? • Have you ever had asthma? • If you are a child and have arthritis? Potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Sulfasalazine EC-tabs, 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 conjunctivitis (red and swollen eyes). These potentially 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 exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Sulfasalazine EC-tabs you must not be re-started on Sulfasalazine EC-tabs at any time. If you develop a rash or these skin symptoms, stop taking Sulfasalazine EC-tabs, seek immediate advice from a doctor and tell your doctor that you are taking this medicine. Severe, life-threatening allergic reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients taking various drugs including Sulfasalazine EC-tabs. It is important to note that early signs of severe allergy, such as fever or swollen lymph nodes, may be present even though rash is not evident. If such signs or symptoms are present, you should seek immediate advice from a doctor. Sulfasalazine EC-tabs should be discontinued if an alternative cause for the signs or symptoms cannot be established. Page 3 of 8 Tests on your blood, kidneys, liver and urine Your doctor will be taking blood tests to check your blood and your kidneys before you start treatment and regularly during treatment. They will also measure substances produced by your liver known as enzymes (liver function tests) before you start treatment and at regular intervals. They may also test your urine for protein and blood. Other medicines and Sulfasalazine EC-tabs Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine EC-tabs: • any medicine for high blood sugar/diabetes, • methenamine, an antibiotic for treating urinary tract infections, • digoxin, used to treat heart failure, • folate, sometimes taken during the first few weeks of pregnancy to reduce the risk of neural tube defects, e.g. Spina Bifida, • azathioprine and mercaptopurine – drugs used to help to suppress your body’s immune response in organ transplantation and certain chronic inflammations such as rheumatoid arthritis. • methotrexate, used to treat rheumatoid arthritis Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you MUST ask your doctor for advice before taking this medicine. The doctor will advise you on whether you may take or continue to take this medicine. You should avoid breast-feeding while taking this medicine. There have been reports of diarrhoea or blood in the stools of babies of breast-feeding mothers taking Sulfasalazine EC-tabs. Driving and using machines Sulfasalazine EC-tabs is unlikely to affect your ability to drive or use machinery. Sulfasalazine EC-tabs contains propylene glycol This medicine contains 5 mg propylene glycol in each tablet