SALAZOPYRIN EN-TABLET 500 mg

4.1 Therapeutic indications

Tablets and enteric coated tablets

Ulcerative colitis

In the treatment of mild to moderate ulcerative colitis and as adjunctive therapy in severe ulcerative colitis. For maintenance of remission in ulcerative colitis.

Crohn’s disease

In the treatment of active Crohn’s disease, especially in patients with colonic involvement.

Enteric coated tablets

Ulcerative colitis and Crohn’s disease.

Rheumatoid Arthritis.

Suppositories

Ulcerative proctitis

4.3 Contraindications

• Known hypersensitivity to sulfasalazine, its metabolites, or any other component of the product as well as sulfonamides, or salicylates.
• Porphyria.

4.2 Posology and method of administration

Tablets and enteric coated tablets

The dosage should be adjusted according to the patient’s response to treatment and tolerance to the drug. The tablets should be taken at regular intervals during the day, preferably in connection with meals. Patients not previously treated with Salazopyrin/Salazopyrin EN-tabs are recommended to increase the dose gradually during the first few weeks. The use of enteric coated tablets will reduce the incidence of gastrointestinal side effects. The enteric coated tablets must be swallowed intact, preferably after meals, and should not be crushed or broken.

Inflammatory bowel diseases

Acute attacks:

Adults

Severe attacks: 2–4 tablets 3–4 times a day may be given in conjunction with steroids as part of an intensive management regime.

Moderate and mild attacks: 2 tablets 3–4 times a day.

Children

40–60 mg/kg body weight and day, divided into 3–6 doses.

Prophylaxis against relapses:

Adults

In ulcerative colitis in a state of remission a maintenance dose is recommended for keeping the patient free from symptoms, as a rule 2 tablets 2(–3) times a day.

Treatment with this dosage should continue indefinitely, unless adverse effects are observed. In case of deterioration, the dosage is raised to 2(–4) tablets 3–4 times a day.

Children

20–30 mg/kg body weight and day, divided into 3–6 doses.

Enteric coated tablets

Rheumatoid Arthritis

Experience has shown that the clinical effect appears within 1–2 months’ treatment.

Concurrent treatment with analgesics and/or non-steroidal anti-inflammatory agents is recommended at least until the disease-modifying effect of Salazopyrin EN-tabs is apparent. Salazopyrin EN-tabs has been shown effective and well tolerated in long-term treatment.

Adults

Two enteric coated tablets twice a day, i.e., 2 g a day. The enteric coated tablets should not be crushed or broken. When starting therapy, it is advisable to increase the daily dose according to the following schedule:

If no response has been seen after 2 months’ treatment, the dose may be increased to 3 g per day.

Children

At present no recommendation regarding treatment with Salazopyrin EN-tabs in juvenile chronic arthritis can be given.

Suppositories

Individual. 1–2 suppositories in the morning after defaecation and in the evening. After 4–5 weeks, the dosage can be reduced by half. The local treatment can be combined with oral therapy with Salazopyrin/Salazopyrin EN tabs.