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AMITIZA(R) (lubiprostone) 8 mcg Now Available to Treat Irritable Bowel Syndrome with Constipation in Adult Women
Date:5/27/2008

fies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their physician.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their physician if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their physician.

In clinical trials of AMITIZA (24 mcg) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).

In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).

Please see complete Prescribing Information at http://www.amitiza.com.

AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.

AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the hu
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SOURCE Takeda Pharmaceuticals North America, Inc.; SucampoPharmaceuticals
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