A. Menarini
Concise Prescribing Info
Mesalazine (5-aminosalicylic acid)
Tab: Crohn's disease (acute attack). Tab/Granules: Ulcerative colitis & proctitis (acute attack or relapse).
Dosage/Direction for Use
Tab 1 tab in the morning, midday & in the evening 1 hr before meals. Granules Adult & elderly Acute episodes of ulcerative colitis 1-2 sachets once daily. Maintenance of ulcerative colitis remission 0.5 g tid (in the morning, midday & evening) corresponding to a total dose of 1.5 g daily.
Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Hypersensitivity. Severe liver & kidney function disturbances.
Special Precautions
Pregnancy & lactation. Elderly (except granules). Tab: Not to be used in impaired hepatic function. Asthma. W/draw immediately if acute signs of intolerability eg, cramps, abdominal pain, fever, severe headache & skin rash occur. Tab/Granules: Determine blood tests & urinary status prior to & during treatment; perform follow-up tests 14 days after start of treatment, then a further 2-3 tests at intervals of 4 wk. Granules: Patients w/ pulmonary disease (particularly asthma). Discontinue in case of acute intolerance reactions eg, abdominal cramps/pain, fever, severe headache & rash; phenylketonuria. Liver & kidney problems. Childn.
Adverse Reactions
Tab/Granules: Abdominal pain, diarrhea, flatulence, nausea, vomiting; headache, dizziness. Tab: Peripheral neuropathy; renal impairment including acute & chronic interstitial nephritis & renal insufficiency; exanthema, drug fever, bronchospasm, pericarditis & myocarditis, pancreatitis, allergic & fibrotic lung reactions (including dyspnoea, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), butterfly rash (lupus erythematosus syndrome), pancolitis; myalgia, arthralgia; aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia; raised transaminase & parameters of cholestasis, hepatitis, cholestatic hepatitis; alopecia; reversible oligospermia. Enema: Allergic exanthema, drug fever; bronchospasm; lupus erythematosus-like syndrome. Granules: Pericarditis. Supp: Allergic skin rash, fever, breathing difficulty.
Drug Interactions
Tab/Granules: Possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Decreased anticoagulant effect of warfarin. Enhances hypoglycemic effects of sulfonylureas. Coumarins, methotrexate, probenecid, sulfinpyrazone, furosemide, rifampicin. Granules: Possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose.
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Salofalk gastro-resistant PR granules 1.5 g
2.79 g x 35 × 1's (P187/sachet)
Salofalk EC tab 500 mg
100's (P77.5/enteric-coated tab)
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