LUPIN CALIFORNIA NOTICE AT COLLECTION: SOLOSEC

Effective Date: 03/12/2024

Lupin Pharmaceuticals, Inc. ("Company," "Lupin," "we", "us," or "our") respects your privacy. This California Notice at Collection ("Notice") provides you with timely notice before or at the time when we collect Personal Information from you. In this Notice, we explain the categories and sources of Personal Information we collect from you and how we use, share, and protect that Personal Information. This Notice applies to Personal Information you provide whether your visit our Solosec product websites at www.solosec.com and www.solosechcp.com (together, "Website"), or interact with us over the phone, or email.

Please visit our Privacy Statement for more information on our privacy practices and specific provisions for California and Connecticut residents.

If you are a California resident and would like to submit a request to opt out of the selling or sharing of your Personal Information, please see the Your Privacy Choices webpage.

WE MAY MODIFY THIS NOTICE AT ANY TIME. ALL CHANGES WILL BE EFFECTIVE IMMEDIATELY UPON POSTING TO THE WEBSITE.

IF YOU PROVIDE PERSONAL INFORMATION WITH REGARD TO OUR PHARMACOVIGILANCE PROGRAM, PLEASE SEE OUR PHARMACOVIGILANCE PRIVACY STATEMENT WHICH DESCRIBES HOW WE COLLECT, USE AND SHARE THE PERSONAL INFORMATION YOU PROVIDE IN CONNECTION WITH THAT PROGRAM.

IF YOU ARE A WASHINGTON OR NEVADA RESIDENT, PLEASE SEE OUR CONSUMER HEALTH PRIVACY STATEMENT WHICH DESCRIBES HOW WE COLLECT, USE, AND SHARE THE PERSONAL INFORMATION YOU PROVIDE IN CONNECTION WITH YOUR HEALTH STATUS.

1. WHAT IS PERSONAL INFORMATION?

"Personal Information" is information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with you or your household. Personal Information does not include publicly available information or aggregated information that does not include personal identifiers.

2. CATEGORIES OF PERSONAL INFORMATION

We may collect the following categories of your Personal Information. We have collected the following categories of Personal Information from consumers within the twelve (12) months preceding the effective date of this Privacy Statement:

3. WHAT ARE THE PURPOSES FOR WHICH WE COLLECT PERSONAL INFORMATION?

We collect Personal Information for the following business or commercial purposes:

 

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What is SOLOSEC?

SOLOSEC® (secnidazole) 2g oral granules is a prescription medicine used to treat bacterial vaginosis in females 12 years of age and older. SOLOSEC is used to treat Trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. People taking SOLOSEC for Trichomoniasis should avoid having sex until they and their sex partners are treated with the same dose and at the same time, to prevent reinfection. It is not known if SOLOSEC is safe and effective in children under 12 years of age.

How should I take SOLOSEC?

SOLOSEC is a single-dose therapy for oral use. Use SOLOSEC by sprinkling an entire packet of SOLOSEC onto applesauce, yogurt, or pudding. The entire dose should be taken at once, and finished within 30 minutes. Avoid chewing or crunching the granules. SOLOSEC should not be taken by dissolving the granules in any liquid. Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC.

Important Safety Information

  • You should not use SOLOSEC if you've had an allergic reaction to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives or have Cockayne syndrome.
  • Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you
    • Are pregnant or plan to become pregnant.
    • Are breastfeeding or plan to breastfeed. Breastfeeding is not recommended. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC.
  • Vaginal yeast infections may occur with SOLOSEC and require an antifungal treatment.
  • The most common side effects of SOLOSEC include headache, nausea, vomiting, diarrhea, abdominal pain, vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia).
  • Take SOLOSEC exactly as your healthcare provider tells you to. Do not take SOLOSEC more often than it is prescribed.

Call your doctor for medical advice on side effects. You are encouraged to report suspected side effects of prescription drugs to FDA at www.fda.gov/MedWatch also at 1-800-FDA-1088 or contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732).

Please see full prescribing information for SOLOSEC, available here.

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