Each pale yellow HEATHER tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone USP daily, and the inactive ingredients include corn starch, lactose monohydrate, magnesium stearate, povidone, talc, D&C Yellow No. 10 aluminium lake and FD&C Yellow No. 6 aluminium lake.
The chemical name for norethindrone USP is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:
Norethindrone USP
HEATHER does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.
The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is no effect on total cholesterol, HDL, LDL, or VLDL.
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your doctor or clinic.
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.
WARNING:
WARNING:
Before taking a POP, inform your health care provider of any other medication, including over-the-counter medicine that you may be taking.
If you are taking medicines for seizures (epilepsy) or tuberculosis (TB), tell your doctor or clinic. These medicines can make POPs less effective:
Medicines for seizures:
Medicine for TB:
Before you begin any new medicines be sure your doctor or clinic knows you are taking birth control pills that contain a progestin.
1. Pick the day label strip that starts with the first day of your period.
2. Place this day label strip on the tablet blister card over the area that has the days of the week (starting with Sunday) imprinted in the plastic.
Note
If you become pregnant, or think you might be, stop taking POPs and contact your physician. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don’t need when you are pregnant.
You should get a pregnancy test:
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.
If you have any questions or concerns, check with your doctor or clinic. You can also ask for the more detailed “professional package labeling” written for doctors and other health care providers.
Store your POPs at controlled room temperature 20 - 25C (68 - 77F).
Be certain to read new revisions of this leaflet. You may check the date of the most recent revision by phoning the manufacturer toll-free at 1 (888)721-7115.
Manufactured by:
Glenmark Generics Ltd.
Manufactured for:
Glenmark Generics Inc., USAMahwah, NJ 07430
Questions? 1 (888)721-7115
March 2010
