fections. They do not treat viral infections (e.g., the common cold). When SOLOSEC is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by SOLOSEC or other antibacterial drugs in the future.
Manufactured for and Distributed by:
Lupin Pharmaceuticals, Inc.
Baltimore, MD 21202
© 2017 Symbiomix Therapeutics, LLC (A Lupin Company). All Rights Reserved
Solosec™ is a trademark of Symbiomix Therapeutics, LLC (A Lupin Company)
7179660
PATIENT PACKAGE INSERT
PATIENT INFORMATION
SOLOSEC (SO-lo-sec)
(secnidazole) oral granules
What is SOLOSEC?
SOLOSEC is a prescription medicine used to treat bacterial vaginal infections in adult women.
It is not known if SOLOSEC is safe and effective in children under 18 years of age.
Do not take SOLOSEC if you:
are allergic to secnidazole or other nitroimidazole medicines. See the end of this leaflet for a complete list of ingredients in SOLOSEC.
Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if SOLOSEC will harm your unborn baby. Tell your healthcare provider if you learn that you were pregnant when you took SOLOSEC.
are breastfeeding or plan to breastfeed. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC. SOLOSEC may pass into breast milk. Talk with your healthcare provider about the best way to feed your baby while taking SOLOSEC.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take SOLOSEC?
See "Instructions for Use" at the end of this leaflet for instructions on how to take SOLOSEC.
Take SOLOSEC exactly as your healthcare provider tells you to. Do not take SOLOSEC more often than it is prescribed. Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve.
What are the possible side effects of SOLOSEC?
SOLOSEC can cause side effects including vaginal yeast infections. Symptoms of a vaginal yeast infection include white or yellowish discharge (discharge may be lumpy or look like cottage cheese) and vaginal itching.
The most common side effects of SOLOSEC include headache, nausea, vomiting, diarrhea, abdominal pain, and vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia).
These are not all of the side effects of SOLOSEC. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of SOLOSEC.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOLOSEC for a condition for which it was not prescribed. Do not give SOLOSEC to other people, even if they have the same sym
