rapy over the additional 4 weeks. Patients on placebo who were allocated to LINZESS had an increase in CSBM and SBM frequency similar to the levels observed in patients taking LINZESS during the treatment period.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
• 145 mcg Capsules: White to off-white opaque hard gelatin capsules with grey imprint "FL 145"
Bottle of 30: NDC 0456-1201-30
• 290 mcg Capsules: White to off-white opaque hard gelatin capsules with grey imprint "FL 290"
Bottle of 30: NDC 0456-1202-30
Storage
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Patients should be instructed as follows:
• Do not give LINZESS to children who are under 6 years of age. You should not give LINZESS to children 6 to 17 years of age. It may harm them [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].
•Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles closed tightly in a dry place [see How Supplied/Storage and Handling (16)].
•Take LINZESS once daily on an empty stomach as prescribed. Swallow the capsule whole and do not break apart or chew [see Dosage and Administration (2.1 and 2.2)].
•Stop LINZESS and contact your physician if you experience severe diarrhea [see Warnings and Precautions (5.2)].
•Seek immediate medical attention if you develop unusual or severe abdominal pain, and /or severe diarrhea, especially if in combination with hematochezia or melena [see Adverse Reactions (6.1)].
Revised: August 2012
LINZESS is a trademark of Ironwood Pharmaceuticals, Inc.
Distributed by:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, Missouri, 63045
Marketed by:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc. Ironwood Pharmaceuticals, Inc.
St. Louis, Missouri, 63045 Cambridge, MA, 02142
© Copyright 2012 Forest Laboratories, Inc.
MEDICATION GUIDE
LINZESSTM (lin-ZESS)
(linaclotide)
capsules
Read this Medication Guide before you start taking LINZESS and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about LINZESS?
• Do not give LINZESS to children who are under 6 years of age. It may harm them.
• You should not give LINZESS to children 6 to 17 years of age. It may harm them.
See the section “What are the possible side effects of LINZESS?” for more i
