LYZA™


Lyza /LI•za/
(Norethindrone Tablets USP, 0.35 mg)

Lyza compares to Ortho Micronor®, Nor-QD®, Nora-BE®, Errin®, Heather®, Jolivette®, Camilia®, and norethindrone.

This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Afaxys Products may be purchased at Family Planning Centers, Colleges and Universities, Reproductive Health Centers, Community Health Centers, City, County, and State Facilities, and Federal and Government Agencies in the United States. If you are unable to return to one of these clinics for your refill, you may also be able to get Afaxys products through one of our participating mail order pharmacies.

WHAT IS LYZA?
Lyza is a birth control pill that is a progestin-only contraceptive containing one hormone, a progestin. Progestin-only pills are often called “POPs” or “the minipill.” POPs have less progestin than the combined birth control pill (or “the pill”) which contains both an estrogen and a progestin.

HOW EFFECTIVE ARE POPs?
About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 “typical” POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use.
Reference: Hatcher RA, et al, Contraceptive Technology, 17th Revised Edition, 1998

Lyza Tablets have not been studied for and are not indicated for use in emergency contraception.

YOU SHOULD NOT TAKE POPs if there is any chance you may be pregnant, if you have breast cancer, if you have bleeding between your periods that has not been diagnosed, if you are taking certain drugs for epilepsy (seizures) or for TB, or medicine for pulmonary hypertension or certain herbal products, if you are hypersensitive, or allergic, to any component of this product, if you have liver tumors, either benign or cancerous, or if you have acute liver disease.

RISKS OF TAKING POPs
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.

RISKS include ectopic pregnancy, ovarian cysts, cancer of the reproductive organs and breasts, liver tumors and possible changes in insulin requirements in diabetic women.

SEXUALLY TRANSMITTED DISEASES (STDs)
WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.

SIDE EFFECTS include irregular bleeding (the most common side effect of POPs), headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.
If you are concerned about any of these side effects, check with your healthcare professional.

IMPORTANT POINTS TO REMEMBER ABOUT TAKING POPs

  • POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.

  • Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.

  • You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.

  • If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.

  • If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don’t wish to become pregnant, be certain to use another birth control method.

  • If you are not sure about how to take POPs, ask your healthcare professional.

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DETAILED PATIENT LABELING