- Do not take UCERIS if you are allergic to budesonide or any of the ingredients in UCERIS.
- Before you take UCERIS, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
- Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other causing side effects.
- Do not eat grapefruit or drink grapefruit juice while taking UCERIS because these can increase the level of UCERIS in your blood.
- Long-time use of UCERIS can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
- When UCERIS is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS, including tiredness, weakness, nausea and vomiting, and low blood pressure.
- UCERIS weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
- If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to UCERIS may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking UCERIS.
- The most common side effects with UCERIS are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.
About SantarusSantarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products. UCERIS® (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products is available at www.santarus.com or by contacting Santarus at 1-888-778-0887. Santarus’ product development pipeline includes the investigational drug RUCONEST ® (recombinant human C1 esterase inhibitor). A Biologics License Application for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema is under review by the U.S. Food and Drug Administration with a response expected in April 2014. Santarus is also developing rifamycin SV MMX ®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at www.santarus.com. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Santarus ® , FENOGLIDE ® , UCERIS ® and ZEGERID ® are registered trademarks of Santarus, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET ® is a trademark of VeroScience LLC. MMX ® is a trademark of Cosmo Technologies Limited. RUCONEST ® is a trademark of Pharming Group N.V.