California Declaration Of Compliance

Statement regarding compliance with California Health & Safety Code § 119402 California Health and Safety Code §§ 119400-119402 (“California Compliance Law”) requires pharmaceutical companies adopt a Comprehensive Compliance Program in accordance with the PhRMA Code on Interactions with Healthcare Professionals (the “PhRMA Code”) and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Compliance Guidance”) and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California Compliance Law. IBSA shall make conforming changes to its Comprehensive Compliance Program within six (6) months of any update or revision of the PhRMA Code.

IBSA Pharma Inc. (“IBSA”) agrees to comply with all applicable laws and regulations and industry standards, including the PhRMA Code and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the OIG Compliance Guidance. As a result, IBSA has established a Comprehensive Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code for its pharmaceutical businesses.

For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, IBSA established a specific annual aggregate dollar limit of $500.00 per covered healthcare professional for gifts, promotional materials, or items or activities that the IBSA may give or otherwise provide to an individual healthcare professional in California.  Such items or activities primarily include: medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; modest meals associated with a substantive discussion of an IBSA product or a disease state; and other items or activities permitted under the PhRMA Code and OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. t. This limit may be revised by IBSA from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that IBSA may provide generally to a healthcare professional. The average could be a lower amount. IBSA has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes. In accordance with the California Compliance Law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:

  • Drug samples provided to physicians and healthcare professionals intended for free distribution to patients;
  • Financial support for continuing medical education forums;
  • Financial support for health educational scholarships; and
  • Payments for legitimate professional services provided by health care or medical professionals, including but not limited to consulting fees, that are based on the fair market value of the services provided.;

Declaration of Compliance

As stated in its Compliance Program description, IBSA is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, IBSA has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. IBSA has tailored its Compliance Program to meet the specific needs of IBSA and continuously assesses the effectiveness of the Compliance Program. IBSA has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and is working to establish additional corporate tracking and monitoring processes. Thus, subject to the limitations described above, IBSA declares that, as of the date of this declaration, IBSA is, in all material respects, in compliance with the Compliance Program and the California Health & Safety Code, Sections 119400-119402. Our declaration is based upon information available during the twelve-month period from January 1, 2018 through December 31, 2018. The next declaration will be based upon information captured beginning January 1, 2019.

As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the IBSA has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the IBSA takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.

Conclusion

As appropriate and consistent with applicable law, IBSA will amend and make conforming changes to its Comprehensive Compliance Program. IBSA is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling IBSA.

For a written copy of the Compliance Program description or this declaration, call 1-800-587-3513

Use

TIROSINT® (levothyroxine sodium) capsules, is a prescription medicine that contains a hormone called levothyroxine which is normally produced in your body by the thyroid gland. It is meant to replace the hormone to treat a condition called hypothyroidism. TIROSINT is not for use in people with temporary hypothyroidism caused by thyroiditis, or inflammation of the thyroid gland.

Tirosint Important Product Information

IMPORTANT SAFETY INFORMATION for TIROSINT (levothyroxine sodium) CAPSULES

NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

What is the most important information you should know about TIROSINT?
TIROSINT® (levothyroxine sodium) is a prescription medicine that contains a hormone called levothyroxine which is normally produced in your body by the thyroid gland. It is used to treat adults and children 6 years of age and older:

  • To replace or give extra levothyroxine in people whose thyroid gland does not naturally produce enough (a condition called hypothyroidism).
  • Who need surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.

Do not use TIROSINT to treat weight problems or for weight loss. Do not take more TIROSINT than your doctor prescribes. Over dosage or taking too much TIROSINT may cause life-threatening side effects or death.

TIROSINT should not be used by children less than 6 years of age or who cannot swallow an intact capsule. TIROSINT is also not for use in people with temporary hypothyroidism caused by thyroiditis, or inflammation of the thyroid gland.

Do not take TIROSINT if your adrenal glands are not working well and you have not been treated with glucocorticoid replacement for this problem. Before you take TIROSINT, tell your healthcare provider about all your medical conditions, including if you: Currently have or have previously had heart problems; currently have or have previously had thyroid nodules; have kidney or pituitary gland problems; have any food or drug allergies; have a low red blood cell count; have diabetes; have weak or weakening bones (osteoporosis); currently have or have previously had a history of blood clotting problems. Also tell your healthcare provider if you are: Pregnant or planning to become pregnant, or are breastfeeding. TIROSINT may harm your unborn baby. Your doctor may need to change your TIROSINT dose while you are pregnant. TIROSINT passes into breast milk. Talk to your doctor about the best way to feed your baby if you take TIROSINT.

It is important that you tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. TIROSINT may affect the way other medicines work, and other medicines may affect how TIROSINT works. Ask your doctor or pharmacist for a list of medicines that may interact with TIROSINT. Certain foods such as soybean flour, cottonseed meal, walnuts, dietary fiber, and grapefruits or grapefruit juice may affect the way that your body absorbs TIROSINT. Tell your healthcare provider if you regularly eat these foods, as they may require your dose of TIROSINT to be adjusted.

Important information about taking TIROSINT: You should take TIROSINT exactly as your doctor tells you to take it. Your doctor will tell you how much TIROSINT to take each day. You should not stop taking TIROSINT or change your dose unless your doctor tells you to. Take TIROSINT once each day, on an empty stomach, approximately 30 minutes to 1 hour before breakfast. Certain medicines can interfere with how TIROSINT is absorbed by your body. Take TIROSINT: At least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate); and at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins. Ask your doctor if you are not sure whether any medicines you are taking may contain these ingredients. Your doctor should do certain blood tests while you are taking TIROSINT and may change your daily dose of TIROSINT as needed.

What are the possible side effects of TIROSINT? The most common side effects of TIROSINT include irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleep problems (insomnia), tremors, muscle weakness, change in appetite, weight loss, vomiting, diarrhea, sweating a lot, heat intolerance, fever, changes in menstrual period, and hives or skin rash. TIROSINT may cause serious side effects, including heart problems. Your risk for these problems may be greater if you are elderly, have heart problems, or if you take too much TIROSINT. Tell your doctor right away if you develop heart problems, as your doctor may choose to reduce your dose or stop treatment with TIROSINT. TIROSINT may also cause worsening of blood sugar control in diabetic patients and weak or brittle bones. Tell your doctor if you are diabetic or if you already have weak or brittle bones (osteoporosis) before taking TIROSINT. Partial hair loss may occur during the first months of treatment with TIROSINT. This is usually temporary and lasts a short period of time.

USE ONLY AS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL. These are not all the possible side effects of TIROSINT. Talk to your healthcare provider or pharmacist for more information or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch. For more dosing information, please see the accompanying full Prescribing Information and Patient Information.

IBSA Pharma Inc.
(USA) 49962