Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
Hypersensitivity to the active substance, to its metabolites, including mesalazine, or to any of the excipients listed in section 6.1.
History of hypersensitivity to salicylates.
Severe hepatic impairment, moderate-severe renal impairment.
Pregnant and breast feeding women.
Colazide should be used with caution in patients with asthma, bleeding disorders, active ulcer disease, mild renal impairment or those with established hepatic disease.
Renal function should be monitored before starting an oral aminosalicylate, at 3 months of treatment, and then annually during treatment (more frequently in renal impairment). Blood disorders can occur with aminosalicylates (see recommendation below).
During treatment with Colazide blood counts, BUN/creatinine and urine analysis should be performed. Patients receiving aminosalicylates should be advised to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during treatment. A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia.
Formal interaction studies have not been performed with Colazide. Available data suggest that the systemically available amounts of balsalazide and its metabolites may be increased if Colazide is administered in the fasting as compared with the fed state. Therefore, Colazide should preferably be administered with food.
The acetylated metabolites of balsalazide are actively secreted in the renal tubule to a high degree. Therefore, plasma levels of co-prescribed drugs also eliminated by this route may be raised and this should be noted in the case of those with a narrow therapeutic range, such as methotrexate.
Pharmacodynamic interactions have not been studied. However, while balsalazide, mesalazine, and N-acetylmesalazine are salicylates chemically, their properties and kinetics make classical salicylate interactions such as those found with acetylsalicylic acid very unlikely.
The uptake of digoxin has been impaired in some individuals by concomitant treatment with sulphasalazine. Even if it is not known whether this would occur also during treatment with balsalazide, it is recommended that plasma levels of digoxin should be monitored in digitalised patients starting Colazide.
Mesalazine inhibits thiopurine methyltransferase. In patients receiving azathioprine or 6-mercaptopurine, caution is recommended for concurrent use of mesalazine as this can increase the potential for blood dyscrasias.
Human experience with balsalazide is limited, therefore Colazide should not be given to pregnant women.
Colazide should not be given to breast feeding women as the active metabolite mesalazine has produced adverse effects in nursing infants.
Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide.
Colazide has no or negligible influence on the ability to drive and use machines.
The adverse effects are expected to be those of mesalazine.
Reactions reported during treatment with oral mesalazine are listed in the table below.
| Organ group | Adverse Event |
|---|---|
| Blood and lymphatic system disorders | Blood dyscrasias Aplastic anaemia Leucopenia Neutropenia Agranulocytosis Thrombocytopenia |
| Nervous system disorders | Headache Neuropathy |
| Cardiac disorders | Myocarditis Pericarditis |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm Allergic alveolitis Eosinophilic pneumonia |
| Gastrointestinal disorders | Abdominal pain Diarrhoea Nausea, vomiting Aggravation of ulcerative colitis Acute pancreatitis |
| Hepatobiliary disorders | Hepatitis Cholelithiasis |
| Skin and subcutaneous tissue disorders | Alopecia Angioedema Rash |
| Musculoskeletal and connective tissue disorders | Systemic lupus erythematosus-like syndrome Arthralgia Myalgia |
| Renal and urinary disorders | Interstitial nephritis Acute renal failure Renal insufficiency Renal impairment |
| Immune system disorders | Hypersensitivity |
See Section 4.4 Special warnings and precautions for use.
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, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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