Goofice Adverse Reactions

Any of the adverse reactions listed as follows may occur. Therefore, patients receiving GOOFICE treatment should be carefully monitored, and if any abnormalities are noted, appropriate measures should be taken including discontinuation of GOOFICE treatment. (See Table 7.)

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Adverse events related to the study drug reported in clinical studies: Phase III Double-blind, Placebo-controlled Comparative Study (see Pharmacology: Pharmacodynamics under Actions): In adult Japanese patients with chronic constipation (except for constipation associated with organic diseases, drug-induced and disease-induced constipations), placebo (n=63) or GOOFICE 10 mg (n=69) was orally administered once daily before breakfast for 2 weeks. The frequency of adverse events related to the study drug was 30% (21/69 patients). Major adverse events related to the study drug included abdominal pain 19% (13/69 patients) and diarrhoea 13% (9/69 patients). These adverse events related to the study drug were non-serious and patients recovered from them while using, after interruption or discontinuation of the study drug. (See Table 8.)

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Long-term Treatment Study (see Pharmacology: Pharmacodynamics under Actions): In adult Japanese patients with chronic constipation (except for constipation associated with organic diseases, drug-induced and disease-induced constipations) (n=340), GOOFICE was orally administered once daily before breakfast for 52 weeks. The initial dose was 10 mg, and after 7 days from starting administration, the daily dose could be adjusted to 5 mg, 10 mg or 15 mg depending on symptoms. The frequency of adverse events related to the study drug was 48% (163/340 patients). Major adverse events related to the study drug included abdominal pain 24% (82/340 patients) and diarrhoea 15% (50/340 patients). These adverse events related to the study drug were non-serious and patients recovered from them while using, after interruption or discontinuation of the study drug. (See Table 9.)

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