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Tillotts.x-sited.ch

Abbreviated prescribing information
AsacolTM formulations, pack sizes, indications and dosages may vary from country to country. Additional information is
available at Tillotts Pharma AG, Switzerland.
Presentations: Gastro-resistant tablets containing 400mg or 800mg mesalazine. Suppositories containing 500mg mesalazine.
Enemas containing mesalazine 2g in 50mL and 4g in 100mL.
Indications: Induction and maintenance of remission of mild to moderate ulcerative colitis, maintenance of remission of Crohn’s
ileo-colitis (Tablets). Induction and maintenance of remission of proctitis and proctosigmoiditis (Suppositories). Induction and
maintenance of remission of proctitis, procto-sigmoiditis and left-sided colitis (Enemas).
Pharmacokinetics: AsacolTM gastro-resistant tablets release mesalazine at a pH above 7 from the terminal ileum throughout
the colon. AsacolTM tablets are designed to minimise systemic absorption of mesalazine in the digestive tract. The majority of
the administered dose remains in the lumen of the colon and the colonic mucosal tissue. Mesalazine is metabolised both by the
intestinal mucosa and the liver to the inactive metabolite N-acetyl mesalazine. The elimination of mesalazine is essentially
faecal and urinary in the form of mesalazine and its N-acetyl metabolite.
Dosage and administration: Tablets: 2.4g – 4.8g mesalazine daily in divided doses for induction of remission of ulcerative
colitis in adults. 1.2g – 2.4g mesalazine daily in divided doses for maintenance of remission of ulcerative colitis in adults. 2.4g
mesalazine daily in divided doses for maintenance of remission of Crohn’s
ileo-colitis in adults. The tablets must be swallowed whole and not chewed or broken. Suppositories: 500mg mesalazine 3 times
daily after defecation for induction of remission of proctitis and proctosigmoiditis in adults. 500mg mesalazine twice daily after
defecation for maintenance of remission of proctitis and proctosigmoiditis in adults. Enemas: One 2g or 4g mesalazine enema
administered at night after defecation daily for induction of remission of proctitis, proctosigmoiditis and left-sided colitis in adults.
One 2g or 4g mesalazine enema administered at night after defecation two times a week for maintenance of remission of
proctitis, proctosigmoiditis and left-sided colitis in adults. Contra-indications: Patients with known allergy to salicylates,
hypersensitivity to mesalazine, severe liver or renal impairment.
Precautions: Prior to initiation of therapy all patients should have their renal function evaluated and hematological
investigations should be performed, including a complete blood count. During AsacolTM therapy renal function and
hematological values should be monitored periodically based on physician’s judgement. AsacolTM is not recommended for use
in patients with renal impairment. Caution should be exercised in patients with: raised blood urea, proteinuria, liver impairment,
previous myo- or pericarditis of allergic background regardless of its origin, existing gastric or duodenal ulcers and in the elderly.
In case of previous mesalazine-induced cardiac hypersensitivity AsacolTM must not be reintroduced. Treatment must be
stopped immediately and patients must seek immediate medical attention in case of acute
symptoms of intolerance such as cramps, abdominal pain, fever, severe headache or rash or if blood dyscrasia is suspected. In
patients with a history of sensitivity to sulphasalazine, therapy should be initiated only under close medical supervision. Safety
and effectiveness of AsacolTM tablets in children have not been established.

Pregnancy and lactation:
Data on a limited number (627) of pregnant women exposed to mesalazine do not indicate an
increased risk of congenital malformations. Some studies have shown an increased incidence of premature births and reduced
birth weight in babies born to mothers treated with mesalazine during pregnancy. Low concentrations of mesalazine and its N-
acetyl metabolite have been detected in human breast milk. The clinical significance of this has not been determined. Caution
should be exercised when mesalazine is administered to pregnant women and nursing mothers.
Interactions: Mesalazine can increase the immunosuppressive effects of azathioprine and 6-mercaptopurine. Life-threatening
infection can occur. Patients should be
closely observed for signs of infection and immunosuppression. Leukocyte cell count should be monitored weekly, especially at
initiation of such combination therapy. There have been isolated reports of altered INR when taken with warfarin. AsacolTM 400
mg/800mg tablets contain lactose (76mg/152mg). Patients with galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
Adverse reactions: Very common: headache. Common: nausea, dyspepsia, abdominal pain dizziness, rash, vomiting,
arthralgia, diarrhea, and drug fever. Post-marketing experience: Myo- and pericarditis, pancreatitis, hepatitis, myalgia, arthralgia,
renal reactions, lupus erythematosus-like reactions, allergic lung and skin reactions, blood dyscrasia, eosinophilia, paresthesia,
and alopecia. Exacerbations of ulcerative colitis symptoms have been reported. Several of these reactions are sometimes
attributable to the underlying disease. Licence holder and supplier: Tillotts Pharma AG, Switzerland. Last update: August 2009.

Source: http://tillotts.x-sited.ch/docs/product-marketing/abbreviated-prescribing-information.pdf?sfvrsn=0

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