SULAZINE EC

EC tablets should be used where there is gastro-intestinal intolerance of plain tablets. They should not be crushed or broken. The dose is adjusted according to the severity of the disease and the patient’s tolerance to the drug, as detailed below.

1.

Ulcerative colitis:

Adults and Elderly: • Severe attacks: 2-4 tablets four times a day which may be given in conjunction with steroids as part of an intensive management regime. Rapid passage of the tablets may reduce the effect of the drug. Night-time interval between doses should not exceed 8 hours.

When remission occurs maintenance therapy should be commenced. • Moderate attacks: 2-4 tablets four times a day may be given in conjunction with steroids • Mild attacks: 2 tablets four times a day with or without steroids • Maintenance therapy: With induction of remission gradually reduce the dose to 4 tablets per day.

The dosage should be continued indefinitely to avoid relapse, since discontinuation even several years after an acute attack is associated with a four-fold increase in risk of relapse.

Children over 2 years:

Adjust the dose in proportion to bodyweight • Acute attack or relapse: 40-60 mg/kg per day • Maintenance therapy: 20-30 mg/kg per day Sulfasalazine suspension may provide a more flexible dosage form. 2. Crohn’s disease In active Crohn’s disease, sulfasalazine should be administered as in attacks of ulcerative colitis (see above) 3.

Rheumatoid arthritis:

Patients with rheumatoid arthritis, and those treated over a long period with NSAIDs, may have sensitive stomachs and for this reason enteric-coated sulfasalazine tablets are recommended for this disease. NSAIDs may be taken concurrently with sulfasalazine.

5 g daily (one tablet) for one week, thereafter increasing the dose by one tablet each week until one tablet four times a day, or two three times a day are reached, according to tolerance and response, to a maximum of 3 g/day (six tablets).

Should a patient experience nausea, the dose should be reduced to a previously tolerated dose for one week and then increased. Onset of effect is slow and a marked effect may not be seen for six weeks. A reduction in ESR and C-reactive protein should accompany an improvement in joint mobility.

Children:

Not recommended Route of administration: Oral

Overall, about 75% of ADRs occur within 3 months of starting therapy, and over 90% by 6 months. Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose. Sulfasalazine is split by intestinal bacteria to sulfapyridine and 5-amino salicylate so ADRs to either sulfonamide or salicylate are possible.

Patients with slow acetylator status are more likely to experience adverse effects due to sulfapyridine. The most commonly encountered ADRs are nausea, headache, rash, loss of appetite and raised temperature.

The following adverse reactions have been reported with the frequencies:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Not known frequency cannot be estimated from the available data Infections and infestations: Not known: Pseudomembranous colitis Blood and the lymphatic system disorders: Common: Leukopenia Uncommon: Thrombocytopenia* Not known: Agranulocytosis, aplastic anaemia, haemolytic anaemia, Heinz body anaemia, hypoprothrombinaemia, lymphadenopathy, macrocytosis, megaloblastic anaemia, methaemoglobinaemina, neutropenia, pancytopenia The risk of sulfasalazine-associated blood disorders is substantially higher in patients treated for rheumatoid arthritis than it is for patients treated for inflammatory bowel disease.

4 for further information 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.

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Haematological and hepatic side effects may occur. Complete blood counts, including differential white cell, red cell and platelet counts and liver function tests should be performed before starting sulfasalazine, 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. Assessment of renal function (including urinalysis) should be performed in all patients initially and at least at monthly intervals for a minimum of the first three months of treatment.

Thereafter, monitoring should be performed as clinically indicated. Patients should be counselled to report immediately any development of sore throat, fever, malaise, pallor, purpura, jaundice, or non-specific illness, this may indicate myelosuppression, haemolysis or hepatoxicity; a Patient Information Leaflet should also be supplied to warn patients of this requirement, and of the risks of serious blood dyscrasias.

Treatment should be stopped immediately while awaiting the results of blood tests. Sulfasalazine should not be given to patients with impaired hepatic or renal function or with blood dyscrasias, unless the potential benefit outweighs the risk.

Patients with severe allergy or bronchial asthma should be treated with caution. Use in children with the concomitant condition systemic onset juvenile rheumatoid arthritis may result in a serum sickness like reaction; therefore sulfasalazine is not recommended in these patients.

Patients with glucose-6-phosphate dehydrogenase deficiency should be closely observed for signs of haemolytic anaemia (Heinz body anaemia). , macrocytosis and pancytopenia), this can be normalised by administration of folic acid or folinic acid (leucovorin).

Because sulfasalazine causes crystalluria and kidney stone formation, adequate fluid intake should be ensured during treatment. The drug may colour the urine orange yellow. Extended wear soft lenses have been reported as being permanently stained during Sulfasalazine treatment.

Daily wear soft contact and glass permeable lenses should respond to standard cleaning. Oligospermia and infertility may occur in men treated with sulfasalazine. Discontinuation of the drug appears to reverse these effects within 2 to 3 months.

Sulfasalazine is contraindicated in; • patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients, as well as salicylate and sulfonamide hypersensitivity; • children under the age of 2 years; • patients with porphyria