Asacol 500mg Suppositories

ASACOL SUPPOSITORIES is used for the treatment and maintenance of remission in ulcerative colitis. The suppositories are used for the treatment of mild to moderate proctitis and proctosigmoiditis.

Adult dose: In proctitis and proctosigmoiditis one suppository to be inserted rectally up to three times daily, after defaecation. The dosage is dependent upon the severity of the disease and it may be possible to reduce the dosage as the condition improves.

Hypersensitivity to mesalazine or to any other ingredient. History of allergy to salicylates. Severe liver impairment. Patients with impaired renal function (GFR less than 30 ml per minute). Safety in pregnancy and lactation has not been established. Safety and efficacy have not been established in children. Bleeding tendencies. History of mesalazine-induced cardiac hypersensitivity. Salicylate sensitive asthma.

Renal impairment ASACOL SUPPOSITORIES should not be used in patients with renal impairment. Caution should be exercised in patients with raised blood urea or proteinuria. The possibility of ASACOL SUPPOSITORIES-induced nephrotoxicity, which may be reversible on withdrawal, should be suspected in patients developing impairment of renal function during treatment. It is recommended that all patients have an evaluation of their renal function prior to initiation of ASACOL SUPPOSITORIES therapy and periodically while on ASACOL SUPPOSITORIES therapy. Such a test is generally recommended within 14 days of initiation of therapy with 2 to 3 repeat evaluations each after another 4 weeks for the following 12 weeks. If the results are normal, tests are recommended to be carried out every three months. In case additional signs of illness appear, these tests should be performed immediately. Treatment with ASACOL SUPPOSITORIES should be stopped immediately if there is evidence of renal impairment and patients should seek immediate medical advice.

Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100 % mesalazine content. It is recommended to ensure adequate fluid intake during treatment. Concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs) or azathioprine may increase the risk of renal reactions (see section 4.5). Liver impairment There have been reports of increased liver enzyme levels in patients taking preparations containing mesalazine. Caution is recommended if ASACOL SUPPOSITORIES is administered to patients with liver impairment. Blood tests (liver function parameters such as ALT or AST) should be performed prior to and during treatment, at the discretion of the treating medical practitioner. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately. Blood dyscrasia Very rarely serious blood dyscrasia has been reported. To avoid blood dyscrasia resulting from developing bone marrow depression patients should be monitored with care. Haematological investigations including a complete blood count should be performed prior to initiation and whilst on therapy. Such tests are generally recommended within 14 days of initiation of therapy with 2 to 3 repeat tests each after another 4 weeks. If the results are normal, tests are recommended quarterly. In case additional signs of illness appear, further control tests are necessary. This procedure is to be followed especially, if a patient develops signs and symptoms suggestive of blood dyscrasia during treatment, such as unexplained bleeding, haematoma, purpura, anaemia, persistent fever or sore throat. Treatment with ASACOL SUPPOSITORIES should be stopped immediately if there is a suspicion or evidence of blood dyscrasia and patients should seek immediate medical advice (see section 4.8). Co-administration of immunosuppressive medicines such as azathioprine or 6-MP can precipitate leucopoenia (see section 4.5). Lung function impairment In case of lung function impairment, especially asthma, patients need to be monitored very closely. Cardiac hypersensitivity reactions Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely with ASACOL SUPPOSITORIES. In case of previous mesalazine-induced cardiac hypersensitivity ASACOL SUPPOSITORIES must not be reintroduced. Caution should be used in patients with previous myo- or pericarditis of allergic background regardless of its origin. Hypersensitivity to sulphasalazine In patients with a history of hypersensitivity to sulphasalazine, therapy should be initiated only under close medical supervision. Treatment must be stopped immediately if acute symptoms of intolerance occur such as cramps, abdominal pain, fever, severe headache or rash. Geriatric patients Use in the elderly should be handled with caution and ASACOL SUPPOSITORIES should only be prescribed to patients having a normal or non-severely impaired liver and renal function (see section 4.3). Paediatric population There is little experience and only limited documentation for an effect in children.

There have been isolated reports of supposedly altered INR when taken with warfarin. ASACOL SUPPOSITORIES can increase the immunosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. As a result, life-threatening infection can occur. Patients should be closely observed for signs of infection and myelosuppression. At initiation of such combination therapy a blood count, especially the leukocyte, thrombocyte and lymphocyte cell counts should be monitored repeatedly (see section 4.4). If white blood cells are stable after 1 month, testing every 4 weeks for the following 12 weeks followed by 3 monthly monitoring intervals appears to be justified. The concurrent use of known nephrotoxic medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs) or azathioprine, may increase the risk of renal reactions (see section 4.4). ASACOL SUPPOSITORIES (5-aminosalicylic acid) should not be given with preparations which lower stool pH e.g. lactulose, and thereby preventing release of the active ingredient.

Pregnancy Safety in pregnancy has not been established. Breastfeeding Low concentrations of mesalazine and its N-acetyl metabolite have been detected in human breast milk. Safety in lactation has not been established. Fertility No effects on fertility have been observed.

ASACOL SUPPOSITORIES have no or negligible influence on the ability to drive and use machines.

a) Summary of the safety profile Side effects are presented by system organ class. The only common side effect is abdominal pain (1,2 %). Organ specific allergic reactions affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported. In patients with a history of hypersensitivity to sulphasalazine, treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache or rash (see section 4.4).

b) Tabulated summary of adverse reactions Rare (u2265 1/10 000 to < 1/1 000) Very rare (< 1/10 000) Frequency not known Blood and lymphatic system disorders Altered blood counts (agranulocytosis, pancytopenia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia), bone marrow depression. Eosinophilia, blood disorder. Immune system disorders Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome with pericarditis and pleuropericarditis as prominent symptoms as well as rash., pancolitis. Nervous system disorders Headache, dizziness. Peripheral neuropathy. Cardiac disorders Myocarditis, pericarditis. Respiratory, thoracic and mediastinal disorders Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis eosinophilic pneumonia, lung infiltration, pneumonitis). Pleurisy, pneumonia, interstitial pneumonia, lung disorder, chest pain. Gastrointestinal disorders Abdominal pain, diarrhoea, flatulence, nausea, vomiting, medicine ineffective. Acute pancreatitis. Chronic pancreatitis, exacerbation of the symptoms of colitis. Hepato-biliary disorders Changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis. Skin and subcutaneous tissue disorders Photosensitivity* * See section c). Alopecia. Musculoskeletal, connective tissue and bone disorders Myalgia, arthralgia. Renal and urinary disorders Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency. Nephrotic syndrome, renal failure which may be reversible on withdrawal, nephrolithiasis** ** see section 4.4 for further information. Reproductive system and breast disorders Oligospermia (reversible). General disorders and administration site conditions Intolerance to mesalazine with C-reactive protein increased and/or exacerbation of symptoms of underlying disease, local reaction.

c) Description of selected adverse reactions An unknown number of the above undesirable effects are probably associated to the underlying IBD rather than ASACOL SUPPOSITORIES /mesalazine medication. This holds true especially for gastrointestinal undesirable effects. To avoid blood dyscrasia resulting from developing bone marrow depression patients should be monitored with care, see section 4.4. Under co-administration of immunosuppressive medicines such as azathioprine, or 6-MP or thioguanine life-threatening infection can occur, see section 4.5. Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.

d) Paediatric population There is only limited safety experience with the use of ASACOL SUPPOSITORIES in the paediatric population. It is expected that the target organs of possible adverse reactions in the paediatric population are the same as for adults (heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue).

In case of accidental oral ingestion symptoms of overdosage include that of salicylism, e.g.: dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, mental confusion, hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma; cardiovascular collapse and respiratory failure. There is no specific treatment for overdosage of ASACOL SUPPOSITORIES, but early lavage is recommended, if accidentally taken by mouth. Treatment is symptomatic and supportive.