[norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets]
What is the most important information I should know about WYMZYA Fe?
Do not use WYMZYA Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is WYMZYA Fe?
WYMZYA Fe is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does WYMZYA Fe work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of one clinical study of a 28-day regimen of norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets, about 1 to 2 out of 100 women may get pregnant during the first year they use WYMZYA Fe.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
If any of these conditions happen while you are taking WYMZYA Fe , stop taking WYMZYA Fe right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking WYMZYA Fe.
What should I tell my healthcare provider before taking WYMZYA Fe?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
WYMZYA Fe may affect the way other medicines work, and other medicines may affect how well WYMZYA Fe works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible serious side effects of WYMZYA Fe?
Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
Call your healthcare provider or go to a hospital emergency room right away if you have:
Other serious side effects include:
What are the most common side effects of WYMZYA Fe?
The most common side effects of WYMZYA Fe include:
These are not all the possible side effects of WYMZYA Fe . For more information, ask your healthcare provider or pharmacist.
General information about the safe and effective use of WYMZYA Fe.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use WYMZYA Fe for a condition for which it was not prescribed. Do not give WYMZYA Fe to other people.
This Patient Information summarizes the most important information about WYMZYA Fe. You can ask your pharmacist or healthcare provider for information about WYMZYA Fe that is written for health professionals.
For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
Does hormonal birth control cause cancer?
It is not known if hormonal birth control pills causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
What should I know about my period when taking WYMZYA Fe?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking WYMZYA Fe, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
White pills: norethindrone and ethinyl estradiol
White pills: lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, sucralose, vanillin and vitamin E.
Brown pills: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and sucrose.
[norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets]
If you start taking WYMZYA Fe and you have not used a hormonal birth control method before:
If you start taking WYMZYA Fe and you are switching from another birth control pill:
If you start taking WYMZYA Fe and previously used a vaginal ring or transdermal patch:
If you start taking WYMZYA Fe and you are switching from a progestin-only method such as an implant or injection:
If you start taking WYMZYA Fe and you are switching from an intrauterine device or system (IUD or IUS):
Remove the white pill by pressing the pill through the foil in the bottom of the pill pack. Continue taking the white pills for 21 days.
When you have taken all of the brown pills in your pill pack, get a new pill pack and start taking the white pills.
Begin your next pill pack on the same day of the week as your first cycle pill pack.
If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:
If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
WYMZYA™ Fe is a trademark of Lupin Pharmaceuticals, Inc.