SOLOSEC - CONSUMER HEALTH DATA PRIVACY STATEMENT

Effective Date: 03/18/2024

You care about the protection of your Consumer Health Data - and so do we. At Lupin Pharmaceutical, Inc. (USA) ("Lupin"), we work to maintain the privacy and data security of all Consumer Health Data we collect or receive from you, including when you use our websites at www.solosec.com and https://www.solosechcp.com/ (together, the "Website").

This Consumer Health Data Privacy Statement ("Statement") applies to the Consumer Health Data of residents of the State of Washington and the State of Nevada that Lupin collects, uses or shares, including when you visit the Website or otherwise interact with us. Please read this Statement carefully. Should you have any questions about this Statement or how we handle Consumer Health Data, please contact us at complianceandethicsoffice@lupin.com.

We may modify this Statement at any time. All changes will be effective immediately upon posting to the Website. Material changes will be conspicuously posted on the Website or otherwise communicated to you.

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

THIS CONSUMER HEALTH DATA PRIVACY STATEMENT APPLIES SOLELY TO WASHINGTON AND NEVADA CONSUMERS. PLEASE SEE OUR WEBSITE PRIVACY STATEMENT FOR GENERAL INFORMATION ABOUT HOW WE COLLECT USE AND SHARE PERSONAL INFORMATION.

1. What is Consumer Health Data?

Consumer Health Data is personal information linked or reasonably linkable to a consumer and that identifies the consumer's past, present, or future physical or mental health status ("Consumer Health Data") as defined under Washington's My Health My Data Act.

2. What Consumer Health Data Do We Collect?

The types of Consumer Health Data we collect include:

  • Contact information including your name, phone number, email address, and home address
  • Health conditions, treatment, diseases, or diagnosis
  • Diagnoses or diagnostic testing, treatment, or medication
  • Bodily functions, vital signs, symptoms, or measurements
  • Use or purchase of prescribed medication
  • Diagnoses, treatment, or medication
  • Data that identifies a consumer seeking healthcare services including the purchase of medication
  • Information regarding possible adverse events associated with the use of our pharmaceutical products
  • Genetic Data

3. Why We Collect Consumer Health Data?

Where you have provided us with your express consent or to the extent necessary to provide you a product or service you have requested, we will collect your Consumer Health Data for the following purposes:

  • For Customer Service reasons:
    • To respond to your requests including requests for information about our products
    • To provide you the ability to download a savings card for Solosec
  • To operate our business and to communicate with you:
    • To determine the suitability of certain products or programs
    • To improve our products
    • To perform market research on our products and product developments, in which case the data will be pseudonymized to prevent your identification
    • To administer our contracts with service providers
    • For the security of our Website
  • To meet our legal and regulatory obligations:
    • Management of adverse events, including investigating the adverse event and contacting you or a person reporting on your behalf for further information on the adverse event that you have reported or was reported on your behalf as required under 21 CFR 314.80 entitled “Post Marketing Reporting on Adverse Drug Experiences”
    • Monitor and report on product safety and quality
    • Administration and legal maintenance of product registries (where required under applicable laws)
    • Provision of reports to authorities with respect to the safety of our products
    • Responding to court orders, subpoenas or other legal processes with which we are required to comply
    • Complying with legal, regulatory, and other requirements under applicable U.S. federal and state laws

4. What are the Sources of the Consumer Health Data We Collect?

We may collect Consumer Health Data described in Section 2 of this Statement (a) from you when you contact us for a customer service request; (b) when we receive a report of an adverse event from you or an individual reporting on your behalf and (c) from sources as otherwise described in our Pharmacovigilance Privacy Statement.

5. How Do We Share Consumer Health Data?

Categories of Consumer Health Data We Share

We may share any of the types of Consumer Health Data described in Section 2 of this Statement with Lupin Affiliates and third parties.

Categories of Third Parties and Affiliates with Whom We Share Consumer Health Data

We may share Consumer Health Data with the following categories of third-party recipients:

  • Affiliates. We enable other Lupin related entities access to Consumer Health Data on a limited basis. For example, we share common data information systems to comply with good pharmacovigilance practices and our obligations under international, federal and state laws.

    Lupin related entities with access to your Consumer Health Data include Lupin Ltd, Lupin Inc., Lupin Research, Inc., Novel Laboratories, Inc., Hormosan Pharma GmbH, Lupin Europe GmbH, Lupin Healthcare (UK) Ltd. and Lupin Atlantis Holdings SA. You may contact any of these entities by sending an email to complianceandethicsoffice@lupin.com. By contacting us, you understand that you may share and we may collect your health information as part of your communication with us.
  • Processors. We may disclose Consumer Health Data to third parties that process your Consumer Health Data on our behalf. For example, you may provide your Consumer Health Data to the processor that operates our call center; the processor that provides our email services; the processor that services our pharmacovigilance report database; or our processor that supports the security of our Website.
  • Government agencies. As described in this Statement and our Pharmacovigilance Privacy Statement, we may be required to disclose Consumer Health Data to law enforcement or other government agencies when we believe doing so is necessary to comply with applicable law or respond to valid legal process.
  • Parties to a Business Transaction. We may disclose Consumer Health Data in connection with a sale of all or a portion of our business, a merger, financing, acquisition, bankruptcy, dissolution, or a transfer, divestiture, or sale of all or a portion of our business or assets.

6. My Health My Data Rights

Under the State of Washington My Health My Data Act, Washington residents and natural persons whose Consumer Health Data is collected in the State of Washington may have the following rights, subject to verification, exceptions, and limitations:

Right to Confirm/Access/Know

Up to twice annually, you have the right to (a) confirm whether we are collecting, sharing, or selling your Consumer Health Data, and (b) access such Consumer Health Data, including a list of all third parties and affiliates with whom we have shared or sold Consumer Health Data and an active email address or other online mechanisms that you may use to contact these third parties.

Right to Delete

You have the right to request deletion of your Consumer Health Data held by us and our affiliates, processors, contractors, and other third parties.

Right to Withdraw

Your Consent/Opt-Out You may withdraw any consent you have provided for the Selling or Sharing of your Consumer Health Data at any time.

Right to Non-Discrimination

You have the right to not to receive discriminatory treatment as a result of your exercise of your rights conferred by the Washington My Health My Data Act.

How to Exercise Your Rights

You may submit your rights request to us by contacting us at any of the following:

If you have any questions or wish to appeal any refusal to take action in response to a rights request, contact us at complianceandethicsoffice@lupin.com. We will respond to any request to appeal within the period required by law.

By contacting us, you understand that you may share and we may collect your health information as part of your communication with us.

APPEAL PROCESS

Right to Seek and Appeal.

If you disagree with our refusal to take action on your request to exercise your Washington Consumer Health Data privacy rights, you have the right to ask us to reconsider. You may submit your request to us by:

By contacting us, you understand that you may share and we may collect your health information as part of your communication with us.

Appeal Timeframe.

Once we receive your request, we will acknowledge and start processing your request. Within 45 days of receiving your request, we will inform you in writing of any action taken or not taken in response to an appeal of your request, including a written explanation of the reasons for our decision.

If we deny your appeal, you can raise a concern or lodge a complaint by contacting the Washington State Attorney General at www.atg.wa.gov/file-complaint.

7. Nevada Supplement to Consumer Health Data Privacy Statement

This Supplement applies to Nevada consumers. It contains additional information as required under Nevada law with regard to how we process consumer health data of Nevada residents.

Purposes & Manner of Processing.

We collect, use, process and share Consumer Health Data for the purposes and in the manners described in Sections 2 and 3 of our Consumer Health Data Privacy Statement.

Review & Revision of Consumer Health Data.

You may submit a request to review and revise your Consumer Health Data, using any of the methods set forth in our Consumer Health Data Privacy Statement. We will respond to your requests in accordance with applicable law, but in any event within 45 days after receiving your request. We have the right to extend the time for our response an additional 45 days if permitted under applicable law.

Third Party Collection of Consumer Health Data.

We do not use cookies, web beacons, pixels, or other online trackers on our website.

Changes to this Supplement.

We will notify you before making any changes to our privacy practices with respect to your Consumer Health Data by posting an updated notice on this Consumer Health Data Privacy Statement and updating the effective date.

 

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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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